Attain Stability™ Quad Clinical Study
Phase: NA
Conditions: Heart Failure
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Official Title: Attain Stability Quad™ Clinical Study 
 
NCT03099655 
 
CIP Version 
Document Date 
1 
26 Nov 2016 
2 
13 Jan 2017 
3 
20 Mar 2017 
 
 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Attain StabilityTM Quad Clinical Study 
Study Product Name Attain StabilityTM Quad MRI SureScan Left 
Ventricular Lead (Model 4798) 
Sponsor/Local Sponsor Sponsor: 
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 U.S.A.  
1-800-328-2518 
Local Sponsors: 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
+1-905-460-3800 
 
Europe, Middle East, Africa (EMEA)Medtronic, 
Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
 
Hong Kong 
Medtronic Hong Kong Medical Ltd. 1104-11, 11/F, 
Tower 1,  
The Gateway,  
Harbour City, Kowloon,  
Hong Kong SAR, China 
+852-2919-1300 
 
Malaysia 
Medtronic International Ltd (Malaysia) 
B-23-1 Level 23, The Ascent, Paradigm  
No 1 Jalan SS7/26A Kelena Jaya 46301 
PetalingJaya 
Selangor 
Malaysia 
+603 7883 8000 
Document Version Version 1.0; 29/NOV/2016 

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Lead Principal Investigators Dr. George H. Crossley III, MD (Co-Chair) 
Associate Professor of Medicine; Electrophysiologist 
Fellowship Program Director 
Vanderbilt University Medical Center 
1211 Medical Center Drive 
Nashville, TN 37232 
(615) 322-5000 
 
Dr. Kevin Jackson, MD (Co-Chair) 
Assistant  Professor of Medicine; Electrophysiologist 
Director, Duke Cardiac Resynchronization Therapy 
Center 
Medical Director, Electrophysiology Services 
Duke University Medical Center Rm 7451-D 
Durham, North Carolina 27710 
(919) 681-5441 
 
  
 
 
 
 
 

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1. Sponsor Contact 
Medtronic, Inc. is sponsoring the Attain Stability Quad Clinical Study.  Regional contact information is 
provided below.  This information may be subject to change during the course of the Attain Stability 
Quad Clinical Study.  Periodic updates to study contact information will be sent to sites as needed.  
Table 1: Study Sponsor Contact Information 
Study Contacts 
Worldwide Clinical Study Leader  
 
Melissa Thalin, Principal Clinical Research 
Specialist 
 
melissa.a.thalin@medtronic.com 
United States 
 
Ann Vacca, Prin. Customer Specialist  
 
ann.vacca@medtronic.com 
Canada 
 
Mary McCann, Sr. Clinical Research Specialist 
 
mary.mccann@medtronic.com  
Europe, the Middle East and Africa (EMEA) 
 
Rinie Peters, Associate Clinical Research 
Specialist 
  
rinie.peters@medtronic.com 
Hong Kong 
 
Grace Wong, Clinical Research Supervisor 
 
grace.wong@medtronic.com 
Malaysia 
 
Sheikh Abdul Aziz, Sr. Clinical Research 
Specialist 
 
sheikh.hafiz@medtronic.com 
Study Monitors and Contacts 
Worldwide Monitoring Leader 
 
Taryn Randall, Clinical Monitoring Manager 
Direct Phone: (+1-763) 250-0785  
Direct Fax: (+1-651) 367-0759 
taryn.randall@medtronic.com  
Monitoring Leader EMEA, Hong Kong, Malaysia 
 
Anja Hesse, CRHF Portfolio Specialist CRHF 
Direct Phone: +49215981490 
Direct Fax: +4921027069069 
anja.hesse@medtronic.com 
Sponsor’s Medical Expert 
David Steinhaus, M.D., VP & GM Heart Failure and Medical Director CRHF 
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure 
8200 Coral Sea Street N.E., MVC42 
Mounds View, MN 55112 
United States 
Phone: (+1-763) 526-1250 
Fax: (+1-651) 367-0671 
david.m.steinhaus@medtronic.com 
 

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2. CROs/Core Laboratories 
This information may be subject to change during the course of the Attain Stability Quad Clinical Study.  
Periodic updates to study contact information will be sent to sites as needed. 
Table 2: CRO and Core Laboratory Information 
Contact Information 
Role 
Cognizant Technology Solutions 
500 Frank W. Burr Blvd. 
Teaneck, NJ 07666 
United States 
Direct Phone: (201) 801-0233 
Direct Fax: (201) 801-0243 
Review of electronic case report forms and 
management of discrepancies 
 
 

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3. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
o 
Initial Release 
Melissa Thalin, Principal Clinical 
Research Specialist 
 
Rinie Peters, Associate Clinical 
Research Specialist 
 
Ann Vacca, Principal Customer 
Specialist 
 
Shelby Li, Senior Principal 
Statistician 
 
Joao Monteiro, Senior Statistician 

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4. Investigator Statement 
Investigators will be provided with a separate investigator agreement to document their obligation and 
commitment with respect to study conduct.  
 
 

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5. Index 
 
1. 
Sponsor Contact .......................................................................................................... 3 
2. 
CROs/Core Laboratories ............................................................................................ 4 
3. 
Version History ........................................................................................................... 5 
4. 
Investigator Statement................................................................................................. 6 
5. 
Index ........................................................................................................................... 7 
6. 
List of Tables ............................................................................................................ 10 
7. 
List of Figures ........................................................................................................... 11 
8. 
Glossary ..................................................................................................................... 11 
9. 
Synopsis .................................................................................................................... 15 
10. 
Introduction .............................................................................................................. 27 
10.1. 
Background ................................................................................................................. 27 
10.2. 
Purpose ........................................................................................................................ 28 
11. 
Objectives and Endpoints ......................................................................................... 28 
11.1. 
Objectives ................................................................................................................... 28 
11.1.1. 
Primary Objective(s) ....................................................................................................... 28 
11.1.2. 
Secondary Objective(s) .................................................................................................. 29 
11.2. 
Endpoints .................................................................................................................... 29 
12. 
Study Design ............................................................................................................. 30 
12.1. 
Duration ....................................................................................................................... 31 
12.2. 
Rationale ..................................................................................................................... 31 
12.3. 
Study Oversight ......................................................................................................... 32 
13. 
Product Description .................................................................................................. 33 
13.1. 
General......................................................................................................................... 33 
13.2. 
Manufacturer .............................................................................................................. 40 
13.3. 
Packaging .................................................................................................................... 41 
13.4. 
Intended Population ................................................................................................. 41 
13.5. 
Equipment ................................................................................................................... 41 
13.6. 
Product Use ................................................................................................................. 42 
13.7. 
Product Receipt, Tracking, and Accountability ................................................... 42 
13.8. 
Product Storage ......................................................................................................... 42 
13.9. 
Product Return ........................................................................................................... 42 
14. 
Selection of Subjects .................................................................................................. 43 
14.1. 
Study Population ....................................................................................................... 43 
14.2. 
Subject Enrollment .................................................................................................... 43 
14.3. 
Inclusion Criteria ....................................................................................................... 44 
14.4. 
Exclusion Criteria ....................................................................................................... 44 
14.5. 
Minimization of Bias.................................................................................................. 44 

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15. 
Study Procedures ....................................................................................................... 45 
15.1. 
Study Personnel Requirements .............................................................................. 45 
15.2. 
Site Activation ............................................................................................................ 46 
15.3. 
Equipment Requirements ........................................................................................ 47 
15.4. 
Schedule of Events .................................................................................................... 47 
15.5. 
Subject Consent ......................................................................................................... 49 
15.6. 
Enrollment ................................................................................................................... 51 
15.7. 
Baseline ....................................................................................................................... 51 
15.8. 
Implant/PHD .............................................................................................................. 51 
15.8.1. 
Final System Configuration ............................................................................................ 52 
15.8.2. 
Implant Procedure ........................................................................................................... 52 
15.8.2.1. 
Venogram ..................................................................................................................... 52 
15.8.2.2. 
Implanting the LV lead ............................................................................................... 52 
15.8.2.3. 
CRT System Testing and Programming During Implant ........................................ 54 
15.8.2.4. 
Final Lead Placement Data Collection ....................................................................... 54 
15.8.2.5. 
Pre-Hospital Discharge CRT System Testing and Programming........................... 55 
15.9. 
3 Months Post-Implant (remote or in office visit) ............................................. 55 
15.10. 
6 Months Post-Implant (in office visit) ............................................................. 56 
15.11. 
12 Months Post-Implant (in office visit) ........................................................... 57 
15.12. 
Recurring 6 Month Follow-ups ............................................................................ 57 
15.13. 
Device Interrogation/Save-to-Media ................................................................ 58 
15.14. 
System Modifications ............................................................................................ 58 
15.15. 
Study Exit ................................................................................................................. 60 
15.15.1. 
Study Completed ......................................................................................................... 61 
15.15.2. 
Lost to Follow-up ......................................................................................................... 61 
15.15.3. 
Study Exit Upon Sponsor Request ............................................................................ 61 
15.16. 
Subject Withdrawal or Discontinuation ............................................................ 61 
15.16.1. 
Subject Chooses to Exit (i.e. revokes consent) ....................................................... 61 
15.16.2. 
Investigator Withdraws Subject ................................................................................ 61 
15.17. 
Assessment of Efficacy .......................................................................................... 63 
15.18. 
Assessment of Safety ............................................................................................ 63 
15.19. 
Recording Data ....................................................................................................... 63 
15.20. 
Deviation Handling ................................................................................................ 63 
16. 
Risks and Benefits ..................................................................................................... 64 
16.1. 
Potential Risks ........................................................................................................... 64 
16.2. 
Risk Minimization ...................................................................................................... 66 
16.3. 
Potential Benefits ...................................................................................................... 67 
16.4. 
Risk-Benefit Rationale.............................................................................................. 67 
17. 
Adverse Event Assessments....................................................................................... 67 
17.1. 
Adverse Event and Device Deficiency Assessment ............................................ 67 
17.1.1. 
Adverse Events ................................................................................................................ 67 
17.1.2. 
Device Deficiencies.......................................................................................................... 68 
17.1.3. 
Event Updates and Resolution ...................................................................................... 68 
17.2. 
Definitions/Classifications ...................................................................................... 69 
17.3. 
Reporting of Adverse Events ................................................................................... 74 
17.3.1. 
Adverse Events and Device Deficiency Classification ................................................. 74 

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17.3.2. 
Adverse Events and Device Deficiency Reporting Requirements ............................. 75 
17.4. 
Subject Death ............................................................................................................. 77 
17.4.1. 
Death Data Collection ..................................................................................................... 77 
17.4.2. 
Death Classification and Reporting ............................................................................... 78 
17.5. 
Product Complaint Reporting ................................................................................. 79 
18. 
Data Review Committees .......................................................................................... 80 
18.1. 
Clinical Events Committee ....................................................................................... 80 
18.2. 
Data Monitoring Committee .................................................................................... 80 
19. 
Statistical Design and Methods ................................................................................. 81 
19.1. 
Primary Objectives .................................................................................................... 81 
19.1.1. 
Primary Safety Objective ................................................................................................ 81 
19.1.2. 
Primary Efficacy Objective #1 ....................................................................................... 83 
19.1.3. 
Primary Efficacy Objective # 2 ...................................................................................... 85 
19.2. 
Secondary Objectives ............................................................................................... 86 
19.2.1. 
Secondary Objective # 1 ................................................................................................ 86 
19.2.2. 
Secondary Objective # 2 ................................................................................................ 86 
19.2.3. 
Secondary Objective # 3 ................................................................................................ 90 
19.3. 
Additional Analysis .................................................................................................... 91 
19.3.1. 
Poolability Analysis .......................................................................................................... 91 
19.3.2. 
Sensitivity Analysis .......................................................................................................... 91 
19.3.3. 
Additional Data Collection .............................................................................................. 91 
19.3.3. 
Overall Study Sample Size Requirements .................................................................... 91 
20. 
Ethics ........................................................................................................................ 92 
20.1. 
Statement(s) of Compliance ................................................................................... 92 
21. 
Study Administration ................................................................................................. 93 
21.1. 
Monitoring ................................................................................................................... 93 
21.2. 
Data Management ..................................................................................................... 94 
21.3. 
Direct Access to Source Data/Documents ........................................................... 95 
21.4. 
Confidentiality ............................................................................................................ 95 
21.5. 
CIP Amendments ....................................................................................................... 95 
21.6. 
Warranty/Insurance Information ......................................................................... 95 
21.6.1. 
Warranty ........................................................................................................................... 95 
21.6.2. 
Insurance (EMEA) ........................................................................................................... 95 
21.6.3. 
Insurance (Canada) ........................................................................................................ 96 
21.6.4. 
Insurance (Malaysia) ...................................................................................................... 96 
21.6.5. 
Insurance (Hong Kong) .................................................................................................. 96 
21.7. 
Record Retention ....................................................................................................... 96 
21.7.1. 
Investigator Records ....................................................................................................... 96 
21.7.2. 
Investigator Reports ....................................................................................................... 97 
21.7.3. 
Sponsor Records .............................................................................................................. 98 
21.7.4. 
Sponsor Reports .............................................................................................................. 98 
21.8. 
Publication and Use of Information .................................................................... 100 
21.8.1. 
Publication Committee .................................................................................................. 101 
21.8.2. 
Management of Primary, Secondary, and Ancillary Publications ........................... 101 
21.8.3. 
Criteria for Determining Authorship............................................................................ 101 

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21.8.4. 
Transparency ................................................................................................................. 102 
21.9. 
Suspension or Early Termination ......................................................................... 102 
21.9.1. 
Planned Study Closure .................................................................................................. 102 
21.9.2. 
Early Termination or Suspension ................................................................................ 102 
21.9.3. 
Procedures for Termination or Suspension ............................................................... 103 
22. 
Appendices .............................................................................................................. 105 
23. 
References ............................................................................................................... 121 
 
6. List of Tables 
Table 1: Study Sponsor Contact Information ................................................................................................ 3 
Table 2: CRO and Core Laboratory Information ........................................................................................... 4 
Table 3: Glossary of Terms .................................................................................................................... 11 
Table 4: Steering Committee Members ...................................................................................................... 32 
Table 5: Comparison of Medtronic Quadripolar LV Leads............................................................................. 35 
Table 6: Comparison of Medtronic Attain Stability Bipolar and Quadripolar LV Leads ......................................... 37 
Table 7: Study Component Information .................................................................................................... 39 
Table 8: Data Collection and Study Procedure Requirements at Subject Visits .................................................... 48 
Table 9: Visit Windows ......................................................................................................................... 49 
Table 10: Additional adverse events related to the lead and programmed parameters ............................................ 65 
Table 11: Implant Techniques that may damage the lead ............................................................................... 66 
Table 12: Adverse Event and Device Deficiency Definitions .......................................................................... 69 
Table 13: Adverse Event Classification Responsibilities ................................................................................. 74 
Table 14: Reporting Requirements ........................................................................................................... 75 
Table 15: Subject Death Classification Responsibilities .................................................................................. 79 
Table 16: Safety Performance of Market Released Quadripolar Lead ................................................................ 82 
Table 17: Prior weight from Attain Stability (Model 20066) and prior weight from Attain Performa as a function of the 
posterior Bayesian p-value (𝒑𝒑) ................................................................................................................. 88 
Table 18: Required Sample Size by Study Objective...................................................................................... 91 
Table 19: Investigator Reports Applicable for All Geographies per Medtronic Requirements ................................. 97 
Table 20: Sponsor Reports for Canada ...................................................................................................... 98 
Table 21: Sponsor Reports for EMEA, Malaysia, Hong Kong ........................................................................ 99 
Table 22: Sponsor Reports for the United States ......................................................................................... 99 
Table 23: Listing of Potential Adverse Events Associated with System Implant ................................................ 106 
Table 24: System or procedure-related adverse events from previous clinical studies .......................................... 107 
Table 25: Complications reported in Ahsan et al. ....................................................................................... 118 

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Table 26: Complications reported in Dickstein et al. ................................................................................... 118 
Table 27: Complications reported by Kirkfeldt et al. ................................................................................... 119 
 
7. List of Figures 
Figure 1: Study Visits ............................................................................................................................ 31 
Figure 2: Attain Stability Quad MRI SureScan LV Lead (Model 4798) Specifications Drawing ................................ 34 
Figure 3: Comparison of Attain Performa Leads and the Attain Stability Lead Model 4798 .................................... 37 
Figure 4: Attain Stability Bipolar (Model 20066/4796) & Attain Stability Quad MRI SureScan (Model 4798) Active 
Fixation Leads .................................................................................................................................... 39 
Figure 5: Primary Safety Objective Sample Size Consideration by Difference Performance Assumption ................... 83 
Figure 6: Simulated PCT Distribution ....................................................................................................... 84 
Figure 7: Loss Function 𝒂𝒂𝒂𝒂= 𝟏𝟏−𝒆𝒆−𝒑𝒑∗𝟓𝟓𝟓𝟓41T .......................................................................................... 88 
Figure 8: Credible Intervals for Scenarios of Agreement Between Historical and Current Data ............................... 89 
 
8. Glossary 
Table 3: Glossary of Terms 
Term 
Definition 
2090 
Medtronic CareLink Programmer with the 
application software installed.   
2290 
Medtronic Analyzer 
Medtronic Attain Stability Quad MRI SureScan 
(Model 4798) LV Lead 
The quadripolar LV lead being studied 
(investigational in the United States/Canada, 
commercially available in EMEA, Hong Kong, and 
Malaysia).   
Active Fixation Helix 
A non-electrically active side helix, positioned 
between the LV 3 and LV 4 electrodes that will 
allow fixation of the Attain Stability Quad MRI 
SureScan (Model 4798) LV Lead in the cardiac vein.  
ADE 
Adverse Device Effect 
AE 
Adverse Event 
Ag 
Silver 
CABG 
Coronary Artery Bypass Graft 

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Term 
Definition 
CAD 
Coronary Artery Disease 
CDF 
Cumulative Distribution Function 
CEC 
Clinical Events Committee 
CIP 
Clinical Investigation Protocol 
CRF 
Case Report Form 
CRT 
Cardiac Resynchronization Therapy: Established 
pacing therapy for patients with heart failure 
CRT-D 
Cardiac Resynchronization Therapy - Defibrillator 
CRT-P 
Cardiac Resynchronization Therapy - Pacemaker 
CS 
Coronary Sinus 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DEKRA 
Deutscher Kraftfahrzeug-Überwachungs-Verein 
(German Motor Vehicle Inspections Association) 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
EMEA 
Europe, the Middle East, and Africa 
eCRF 
Electronic Case Report Form 
MEC/IRB/HREB/Ethics Board 
Ethics Committee 
FAL 
Foreseeable Adverse Event List 
FDA 
Food and Drug Administration 
Fr 
French 
GCP 
Good Clinical Practice 

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Term 
Definition 
HF 
Heart Failure 
HTN 
Hypertension 
IC 
Informed Consent 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigation Device Exemption 
Ir 
Iridium 
IRB 
Institutional Review Board 
LAR 
Legally Authorized Representative 
LBBB 
Left Bundle Branch Block 
LV 
Left Ventricular 
LVEF 
Left Ventricular Ejection Fraction 
MCRD 
Monolithic Controlled Release Device which is 
located on the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) electrodes which elutes 
steroid to reduce inflammatory response within the 
cardiac vein. 
Mechanical Stop 
A component on the Attain Stability Quad MRI 
SureScan (Model 4798) LV Lead located at the 
base of the helix to prevent wedging of endothelial 
tissue in the helix and to prevent tissue ingrowth. 
MedDRA 
Medical Dictionary for Regulatory Activities 
OC 
Oracle Clinical (database management system) 
OTW 
Over-the-wire 
PCT 
Pacing Capture Threshold 
PHD 
Pre-Hospital Discharge means the point at which a 
subject has been released from the hospital post 
implant procedure. 

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Term 
Definition 
PMA 
Premarket Approval 
PNS 
Phrenic Nerve Stimulation 
POR 
Power On Reset 
Pt 
Platinum 
PTCA 
Percutaneous Transluminal Coronary Angioplasty 
QOL 
Quality of Life 
RA 
Right Atrial 
RRT 
Recommended Replacement Time 
RV 
Right Ventricular 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SC 
Steering Committee 
SDN 
Software Distribution Network 
TÜV 
Technischer Überwachungsverein (German safety 
validation organization) 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
USADE 
Unanticipated Serious Adverse Device Effect 
VF 
Ventricular Fibrillation 
VT 
Ventricular Tachycardia 
 
 

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9. Synopsis 
Title 
Attain StabilityTM Quad Clinical Study 
Product Name 
Attain StabilityTM Quad MRI SureScan Left Ventricular Lead 
(Model 4798) 
Sponsor  
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 U.S.A. 
1-800-328-2518 
Local Sponsor 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
+1-905-460-3800 
 
EMEA 
Medtronic, Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
 
Hong Kong 
Medtronic Hong Kong Medical Ltd. 
1104-11, 11/F, Tower 1,  
The Gateway,  
Harbour City, Kowloon,  
Hong Kong SAR, China 
+852-2919-1300 
 
Malaysia 
Medtronic International Ltd (Malaysia) 
B-23-1 Level 23, The Ascent, Paradigm, No 1 Jalan 
SS7/26A Kelena Jaya 46301 Petaling Jaya 
Selangor 
Malaysia 
+603 7883 8000 
Indication under investigation  
All subjects included in the study will be implanted with a 
Medtronic market released de novo CRT-P or CRT-D 
device, compatible market released Medtroinc RA and 
Medtronic RV leads and an Attain Stability QuadSureScan 
LV lead (Model 4798). For subjects enrolled who are 
receiving an upgrade to a CRT system, existing non-
Medtronic RV and/or existing non-Medtronic RA leads that 
are not recalled, market withdrawn, and/or have a medical 
alert may be used.   

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Given the vast similarities between the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) and the Attain 
Performa family of leads, the proposed indications for use 
are the same.  The indications are as follows: 
The Attain Stability Quad MRI SureScan 4798 steroid-
eluting, quadripolar electrode, IS4 transvenous lead is 
indicated for chronic pacing in the left ventricle via the 
cardiac vein, when used with a compatible Medtronic 
Cardiac Resynchronization Therapy (CRT) System.  
Extended bipolar pacing is available using this lead in 
combination with a compatible market approved CRT-P or 
CRT-D system and RV lead. 
Investigation Purpose 
The Attain Stability Quad Clinical Study is a prospective, 
non-randomized, multi-site, Investigational Device 
Exemption (IDE) interventional clinical study.  The 
purpose of this clinical study is to evaluate the safety and 
efficacy of the Attain Stability Quad MRI SureScan LV lead 
(Model 4798).  This study will not be considered 
investigational in geographies with CE Mark of the Attain 
Stability Quadripolar LV lead (4798).  However, data 
collected from all study subjects will be represented in the 
final report and the PMA Supplement (PMA-S) to the 
Model 4196 Original PMA. 
Product Status 
The Attain Stability Quad Clinical Study will be conducted 
using a research system composed of an approved CRT-D 
or CRT-P System.  The Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) is an active fixation quadripolar LV 
lead based on the Attain Performa lead family models 
(4298, 4398, and 4598).  The lead incorporates an active 
fixation helix similar to the Attain Stability bipolar LV lead 
(Model 20066/4796) which is designed to allow an 
implanter more options in lead location.   
The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) will be considered investigational in geographies 
where the product is not available commercially and will 
be labeled for clinical use only.  These geographies include 
but are not limited to the US and Canada.  Investigational  
Attain Stability Quad Leads will be distributed to a site 
only when Medtronic has received all required 
documentation (including but not limited to Ethic 
Committee approval, a signed Clinical Trial Agreement and 
documentation of training) and has notified the site of site 
readiness.  Distribution of the investigational product to 
study sites will be managed by Medtronic and can only be 

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ordered by Medtronic personnel.  Site with these clinically 
labeled Attain Stability Quad MRI SureScan LV Leads 
(Model 4798) will track disposition upon receipt or return 
of the lead but also upon implant or explant of the lead. 
Disposition logs will be available within the electronic data 
management system and shall be maintained at each site 
in all geographies to track investigational product 
information.  
For geographies where the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is not considered 
investigational, commercially approved devices will be 
used.  Sites that use commercially available Attain Stability 
Quad MRI SureScan LV Leads (Model 4798) will track 
device disposition upon implant or explant on the lead 
CRFs. 
The Medtronic approved CRT-P or CRT-D devices will be 
programmed and interrogated using a Medtronic CareLink 
(2090) programmer.  Medtronic may incorporate 
additional programmers as they receive regulatory 
approval. 
The CareLink Monitor Model 2490C is an external monitor 
that is indicated for use in the transfer of patient and 
device data from implanted Medtronic devices.  The 
CareLink Monitor Model 2490C interrogates implanted 
devices and temporarily stores these data, collaborates 
with the appropriate Medtronic server to confirm the 
establishment of an Internet connection with server, 
performs any required file translation functions necessary 
for data transfer, executes data file transfer, and 
collaborates with the appropriate Medtronic server to 
confirm data file transfer through the Internet connection 
with the server.  The CareLink Monitor 2490C is not a 
programmer and cannot be used to program implanted 
device parameters.  CareLink monitors are not a substitute 
for appropriate medical attention in the event of an 
emergency and should only be used as directed by a 
physician. 
Approved Medtronic CRT-P and CRT-D devices used in this 
study qualify for use with the Medtronic CareLink Monitor 
and Medtronic CareLink Network.  
Medtronic may incorporate additional home monitors as 
they receive regulatory approval. 
Medtronic’s commercially available Model 2290 Analyzer 
must be available at each center during the implant 

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procedure to determine acceptable electrical parameters.  
Medtronic may incorporate additional analyzers as they 
receive regulatory approval. 
Primary Objective(s) 
Primary Safety Objective: Lead complication-free 
rate at 6 months 
The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) will be considered safe if the probability of subjects 
free of Model 4798 lead-related complications at 6 months 
post-implant is greater than 87% (i.e., the lower bound of 
a one-sided 97.5% confidence interval must be greater 
than 87%). 
The study primary safety endpoint is Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) related complications 
through 6 months post implant.  All reported system and 
procedure-related AEs will be reviewed by an event review 
committee for LV lead relatedness and severity 
(complication vs observation, refer to 17.1.2 for 
defintions).  
Primary Efficacy Objectives: Lead pacing capture 
thresholds at 6 months 
To demonstrate the effectiveness of the Attain Stability 
Quad MRI SureScan LV lead (Model 4798) the study will 
evaluate the likelihood that there are at least two 
programmable vectors  for each patient post implant.  The 
effectiveness of this lead will be evaluated based on two 
primary efficacy objectives.  More specifically, both 
primary efficacy objectives must be met simultaneously.   
Primary Efficacy Objective #1 
The Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) will meet the objective if the 
proportion of subjects with at least one LV lead 
pacing vector having a pacing capture threshold 
less than or equal to 2.5 V at 0.5ms pulse width at 
6 months post-implant is greater than 80% (i.e., 
the lower bound of a one-sided 97.5% confidence 
interval must be greater than 80%). 
The endpoint for the primary efficacy objective is 
whether or not there is at least one Model 4798 
LV lead pacing vector with pacing capture voltage 
thresholds less than or equal to 2.5V.  This 
endpoint will be measured at the 6-month post 
implant follow-up visit. 

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Primary Efficacy Objective #2 
The Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) will meet the objective if the 
proportion of subjects with at least one additional 
LV lead pacing vector having a pacing capture 
threshold less than or equal to 4.0 V at 0.5ms 
pulse width at 6 months post-implant is greater 
than 80% (i.e., the lower bound of a one-sided 
97.5% confidence interval must be greater than 
80%).  
The co-primary efficacy endpoint is whether or not 
a second Model 4798 lead configuration has a 
pacing capture threshold less than or equal to 4V, 
excluding the pacing vector that is already 
counted to the primary efficacy endpoint #1. This 
endpoint will be measured at 6-month post 
implant follow-up visit. 
Secondary  
Objective(s) 
The secondary objectives are descriptive in nature and are 
intended to provide additional information about the Attain 
Stability Quad Model 4798 LV lead. There will be no 
established performance requirements for these secondary 
objectives. 
o 
Implant procedure related information: success 
rate, implant related times 
o 
Endpoints will include implant success rate 
and procedure durations.  
o 
6-month reliability: post implant lead failure 
modes (i.e. complication rate) 
o 
Endpoint is Model 4798 lead related 
complications. 
o 
Electrical measurements (PCT and Impedance) at 
follow-ups 
o 
Endpoints are the electrical measurements 
are pacing capture thresholds and 
impedance values for the four extended 
bipolar configurations, i.e. LV1 to RVCoil, 
LV2 to RV Coil, LV3 to RV Coil and LV4 to 
RV Coil (refer to 15.8.2.3 for the testing 
procedure requirements) 
 
Study Design 
The Attain Stability Quad Clinical Study is a prospective, 
non-randomized, multi-site, global, Investigational Device 
Exemption (IDE) interventional clinical study.  The 

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purpose of this clinical study is to evaluate the safety and 
efficacy of the Attain Stability Quad MRI SureScan LV lead 
(Model 4798) in patients indicated for a de novo LV lead 
implant.  This will be assessed through primary safety and 
primary efficacy endpoints. 
All subjects included in the study will be implanted with a 
Medtronic market released CRT-P or CRT-D device and an 
Attain Stability Quad MRI SureScan LV Lead (Model 4798).  
For de novo CRT systems, compatible market released 
Medtronic RA and Medtronic RV leads will be required.  
For subjects enrolled who are receiving an upgrade to a 
CRT system, existing non-Medtronic RV and/or existing 
non-Medtronic RA leads that are not recalled, market 
withdrawn, and/or have a medical alert may be used.   
Up to 471 subjects will be enrolled into the study and up 
to 471 Attain Stability Quad MRI SureScan LV Leads 
(Model 4798) implanted, to ensure a minimum effective 
sample size of 400 Model 4798 leads implanted with 6 
months post implant follow up visits (assuming 15% 
attrition).  For the secondary endpoint of individual lead 
failure modes, Bayesian methods utilizing data from up to 
37 historical patients will be used.  All other objectives will 
be analyzed using only patients enrolled in this study.  
After a successful implant, threshold testing will occur to 
show one LV vector with pacing capture threshold (PCT) ≤ 
2.5 V @ 0.5ms and with sufficient safety margin was 
programmed.  Subjects will then be followed at implant, 
three months, six months and every six months thereafter 
until FDA approval is obtained or until study closure, 
whichever comes first. 
The study duration is expected to be approximately 19 
months.  This represents 13 months for subject enrollment 
and 6 months for subject follow-up for the last subject 
enrolled.  Subjects are anticipated to be in the study for 
on average 12 months.  The first enrollment is projected 
to occur in May 2017.   
Sample Size 
Up to 471 subjects will be enrolled into the study, to 
ensure a minimum effective sample size of 400 Model 
4798 leads implanted with 6 months post implant follow 
up visits (assuming 15% attrition) at up to 50 sites 
worldwide. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
• 
Patient meets CRT implant criteria as determined 
by local regulatory and/or hospital policy  

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• 
Patient (or legally authorized representative) has 
signed and dated the study-specific 
Consent Form 
• 
Patient is 18 years of age or older, or is of legal 
age to give informed consent per local and 
national law 
• 
Patient is expected to remain available for follow-
up visits 
Exclusion Criteria: 
• 
Patient has had a previous unsuccessful LV lead 
implant attempt 
• 
Patient has an existing epicardial LV lead 
• 
Patient is currently implanted with a recalled (i.e. 
market-withdrawn, recalled or safety alert) RA 
and/or RV lead  
• 
Patient has known coronary venous vasculature 
that is inadequate for lead placement 
• 
Patient has unstable angina pectoris or has had an 
acute myocardial infarction (MI) within the past 30 
days 
• 
Patient has had a coronary artery bypass graft 
(CABG) or percutaneous transluminal coronary 
angioplasty (PTCA) within the past 90 days 
• 
Patient has contraindications for standard 
transvenous cardiac pacing (e.g., mechanical right 
heart valve) 
• 
Patient has had a heart transplant (patients 
waiting for heart transplants are allowed in the 
study) 
• 
Patient has known renal insufficiency that would 
prevent them from receiving an occlusive 
venogram during the implant procedure 
• 
Patient is contraindicated for <1mg 
dexamethasone acetate 
• 
Patient is enrolled in any concurrent drug and/or 
device study that may confound the results of this 
study 
• 
Patient has a terminal illness and is not expected 
to survive more than six months 
• 
Patient meets exclusion criteria required by local 
law (e.g. age, pregnancy, breast feeding, etc.) 
• 
Patient is unable to tolerate an urgent 
thoracotomy 
Study Procedures and Assessments 
Clinical data will be collected at the study milestones: at 
enrollment, baseline, implant/PHD, 3M, 6M, thereafter 
every occurring 6M and study exit visits: 

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Enrollment/Baseline:  
o 
Subject Informed Consent  
o 
Inclusion/Exclusion criteria verified 
o 
Subject demographics  
o 
Cardiovascular medications 
o 
Cardiovascular medical history 
o 
NYHA classification 
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
Implant:  
o 
Occlusive venogram with pre-determined 
target vessel location identified 
o 
System and procedure information 
o 
Analyzer PCT data collection post lead 
fixation and prior to connecting the leads 
to the CRT-P/D device: 
1) Following guidewire/stylet has been pulled 
back prozimal to the helix and electrodes 
2) Post slitting the cannulation catheter 
PHD CRT System Testing and Programming using the 
implanted CRT-P or CRT-D device and the device 
programmer: 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors  
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors LV1 to RVcoil, LV2 to RVcoil, LV3 
to RVcoil, LV4 to RVcoil or the final 
programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors  
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil, LV2 to RVcoil, 
LV3 to RVcoil, LV4 to RVcoil or the final 
programmed vector  

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o 
Retain printouts for any manually tested 
vector at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
3 Month (remote or in office visit):  
Lead Impedance 
o 
Perform a manual LV Lead Impedance 
Test for the final programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width on the 
final programmed vector 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width on the final programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Rationale for selecting specific LV lead 
pacing vectorfor final programming 
o 
Final device interrogation/save-to-media 

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o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
6 Month:  
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors 
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors  LV1 to RVcoil, LV2 to RVcoil, LV3 
to RVcoil, LV4 to RVcoil or the final 
programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors  
o 
NOTE: A one time manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil, LV2 to RVcoil, 
LV3 to RVcoil, LV4 to RVcoil or the final 
programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on vectors LV1 to RVcoil, LV2 to RVcoil, 
LV3 to RVcoil, LV4 to RVcoil 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 

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o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
12 Month:  
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors 
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors LV1 to RVcoil, LV2 to RVcoil, LV3 
to RVcoil, LV4 to RVcoil or the final 
programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors 
o 
NOTE: A one time manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil, LV2 to RVcoil, 
LV3 to RVcoil, LV4 to RVcoil or the final 
programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 

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Recurring 6 Month follow-ups (remote or inoffice 
visit):  
Lead Impedance 
o 
Perform a manual LV Lead Impedance 
Test for the final programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width on the 
final programmed vector 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width on the final programmed vector  
o 
Retain printouts for any manually tested 
vector at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Rationale for selecting specific LV lead 
pacing vectorfor final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
Study Exit:  
o 
Report the reason for exit 
o 
Final Interrogation file (or Carelink 
transmissions)- for exits occuring priorto 
the 6 month visit) 
o 
Study Deviations 
o 
AEs and Device Deficiencies 
Safety Assessments 
Adverse Event and Device Deficiency handling in the 
Attain Stability Quad Clinical Study is ISO 14155:2011 
compliant for all participating geographies with the 
exception (to Section 17 of the ISO standard) that only 

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those AEs which are related to the subject’s system, 
procedure, accessory, or are cardiovascular-related, and 
all Serious AEs, will be collected. This ensures any AEs 
which could potentially be relevant will be collected. 
Reporting of these events to Medtronic will occur on an 
Adverse Event (AE) Form, including date of AE, treatment, 
resolution, assessment of both the seriousness of the AE 
and the relatedness to the investigational device or 
procedure.  Each AE must be recorded on a separate AE 
eCRF.  Documented pre-existing conditions are not 
considered AEs unless the nature or severity of the 
condition has worsened. 
 Statistics 
The primary objective will be analyzed using the time-to-
first event Kaplan-Meier survival analysis method.  A 
minimum number of subjects who have completed their 6 
months post-implant visits will be required.  Time 0 will be 
the day a subject undergoes the implant procedure of a 
Attain Stability Quad MRI SureScan LV Lead (Model 4798), 
which will be independent of success status of this implant 
procedure.  Event date is the onset date of a subject’s first 
complication that is related to the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) according to CEC 
adjudication.  Subjects who undergo an Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) implant 
attempt and do not experience any LV lead related 
complications, will be censored at the time of their last 
known exposure to the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) for the survival analysis.  For any 
lost-to-follow up subject, the last contact date will be used 
as the censor date.  The 1-sided 97.5% confidence limit 
lower bound for the survival probability at 6 months (183 
days) will be calculated using the log-log survival function 
approach (Kalbfleisch and Prentice 2002). 
 
10. Introduction  
10.1. Background 
Several clinical trials (including MIRCLE1, MIRACLE-ICD2, CONTAK-CD3, MUSTIC4, PATH-CHF5, 
COMPANION6, MADIT CRT7, and CARE-HF8) have demonstrated the benefit of cardiac resynchronization 
therapy (CRT) among patients with moderate to severe heart failure (HF) with a prolonged QRS duration 
and depressed Left Ventricular (LV) function.   
Approximately 5.7 million people in the United States (US) are living with HF9.  Heart Failure may be a 
chronic condition which causes the heart to not pump oxygenated blood efficiently through the body due 

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to stiffening of the heart muscle.  Heart Failure may affect one or both sides of the heart.  It is most 
often caused by coronary artery disease (CAD) or uncontrolled hypertension (HTN).  Patients who suffer 
from HF experience a variety of different symptoms including most often fatigue, cough, and shortness of 
breath, swollen feet (edema) and weight gain. 
Heart Failure is treated with medications and sometimes cardiac devices (i.e. pacemaker or defibrillator 
with CRT).  Medications work to relieve symptoms and reverse the effects of HF.  Cardiac 
Resynchronization Therapy devices treat HF by synchronizing the left and right ventricles of the heart 
which improves the heart’s ability to pump oxygenated blood to the body.10 11 12 13 14 15 16 17 18 19 20 21 
Cardiac Resynchronization Therapy devices are made up of 4 main components; the can or battery, a 
Right Atrial (RA) lead, a Right Ventricular (RV) lead, and a Left Ventricular (LV) lead. 
The LV lead specifically is important at maintaining ventricular synchrony.  In 2014, Medtronic released 
the Attain® PerformaTM family of LV leads (models 4298, 4398 and 4598).  The three different shapes of 
these leads (double canted, straight, and S-shaped) were designed to enable the lead to be passively 
fixed within different anatomies of coronary vessels.  In addition, the 4 strategically placed electrodes on 
the lead were designed to offer 16 different electrical vector programming configurations.  
Medtronic also released the Attain Stability bipolar LV lead (Model 20066/4796) (CE Mark approved in 
September 30, 2013) in Europe.  This lead has a side helix which enables it to be actively fixated to the 
vessel wall.  The active fixation is an advantageous component in vessels that are wide or have short 
take-offs.  The next generation of LV lead is known as the Attain StabilityTM Quad MRI SureScan LV lead 
(Model 4798).  This is a quadripolar lead similar to its Attain Performa predecessor leads and has a side 
helix for active fixation like the Attain Stability bipolar lead.   
10.2. Purpose 
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, Investigational 
Device Exemption (IDE), interventional clinical study.  The purpose of this clinical study is to evaluate the 
safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798).  This study will 
not be considered investigational in geographies with CE Mark of the Attain Stability™ Quad MRI 
SureScan LV lead (Model 4798).  However, data collected from all study subjects will be represented in 
the final clinical report and the PMA Supplement (PMA-S) to the Attain Ability Model 4196 Original PMA 
(P080006, approved April 7, 2009). 
Subjects successfully implanted with the Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be 
followed at implant, three months, six months and every six months thereafter until FDA approval is 
obtained or until study closure, whichever comes first. 
11. Objectives and Endpoints 
11.1. Objectives 
11.1.1. 
Primary Objective(s) 
Primary Safety Objective: Lead complication-free rate at 6 months 

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The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered safe if the probability of 
subjects free of Model 4798 lead-related complications at 6 months post-implant is greater than 87% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 87%). 
Primary Efficacy Objectives: Lead pacing capture thresholds at 6 months 
To demonstrate the effectiveness of the Attain Stability Quad MRI SureScan LV Lead (Model 4798), the 
study will evaluate the likelihood that there are at least two programmable vectors  for each patient post 
implant. The effectiveness of this lead will be evaluated based on two primary efficacy objectives.  More 
specifically, both primary efficacy objectives must be met simultaneously.   
Primary Efficacy Objective #1 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet this objective if the 
proportion of subjects with at least one LV lead pacing vector having a pacing capture threshold 
less than or equal to 2.5 V at 0.5 ms pulse width at 6 months post-implant is greater than 80% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 80%). 
Primary Efficacy Objective #2 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet this objective if the 
proportion of subjects with at least one additional (or second) LV lead pacing vector having a 
pacing capture threshold less than or equal to 4.0 V at 0.5 ms pulse width at 6 months post-
implant is greater than 80% (i.e., the lower bound of a one-sided 97.5% confidence interval 
must be greater than 80%).  
11.1.2. 
Secondary Objective(s)  
The secondary objectives are descriptive in nature and are intended to provide additional information 
about the Attain Stability Quad MRI SureScan LV Lead (Model 4798).  There will be no established 
performance requirements for these secondary objectives. 
o 
To summarize implant procedure related information: success rate, implant related times 
o 
To estimate 6-month reliability: post implant lead failure modes (i.e. complication rate)  
o 
To estimate electrical measurement values (Pacing Capture Thresholds (PCTs) and Lead 
Impedance) at 6 months post-implant 
11.2. Endpoints 
11.2.1 Primary Endpoints 
Primary Safety Endpoint 
The study primary safety endpoint is Attain Stability Quad MRI SureScan LV Lead (Model 4798) related 
complications through 6 months post implant.  All reported system and procedure-related AEs will be 
reviewed by an event review committee for LV lead relatedness and severity (complication vs 
observation, refer to 17.1.2 for defintions).  
Primary Efficacy Endpoint #1 
The Model 4798 LV lead has sixteen (16) programmable pacing configurations. The endpoint for the 
primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with 
pacing capture voltage thresholds less than or equal to 2.5V.  This endpoint will be measured at the 6-
month post implant follow-up visit. 

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Primary Efficacy Endpoint #2 
The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing 
capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the 
primary efficacy endpoint #1. This endpoint will be measured at 6-month post implant follow-up visit. 
11.2.2 Secondary Endpoints 
To summarize implant procedure related information 
Implant procedure related endpoints will include implant success rate and procedure durations.  
To estimate 6-month reliability 
The Model 4798 LV lead 6-month reliability endpoint is Model 4798 lead related complications.  
To estimate electrical measurement values (Pacing Capture Thresholds (PCTs) and Lead 
Impedance) at 6 months post-implant 
The electrical measurements are pacing capture thresholds and impedance values for the four extended 
bipolar configurations, i.e. LV1 to RVCoil, LV2 to RV Coil, LV3 to RV Coil and LV4 to RV Coil (refer to 
15.8.2.3 for the testing procedure requirements). 
12. Study Design  
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, Investigational 
Device Exemption (IDE), interventional clinical study.  The purpose of this clinical study is to evaluate the 
safety and efficacy of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) in patients indicated 
for a de novo LV lead implant.  This will be assessed through a primary safety and primary efficacy 
endpoints. 
All subjects included in the study will be implanted with a Medtronic market released CRT-P or CRT-D 
device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).  For de novo CRT systems, 
compatible market released Medtronic RA and Medtronic RV leads will be required.  For subjects enrolled 
who are receiving an upgrade to a CRT system, existing non-Medtronic RV and/or existing non-Medtronic 
RA leads that are not recalled, market withdrawn, and/or have a medical alert may be used.   
Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads 
implanted with 6 months post implant follow up visits (assuming 15% attrition).  For the secondary 
endpoint of individual lead failure modes, Bayesian methods utilizing data from up to 37 historical 
patients will be used.  All other objectives will be analyzed using only patients enrolled in this study.  
After a successful implant, threshold testing will occur to show one LV vector with pacing capture 
threshold (PCT) ≤ 2.5 V @ 0.5ms and with sufficient safety margin was programmed.  Subjects will then 
be followed at implant, three months, six months and every six months thereafter until FDA approval is 
obtained or until study closure, whichever comes first. 
The study will look to collect the following information: demographics, medical history, standard physical, 
NYHA class, implanted device information, pacing capture thresholds, device interrogations or save-to-
media, medications, adverse events , system modifications, device deficiencies, and exit information.  See 
Figure 1 and Section 15 for further detail on study procedures and data collection as well as time-points 
for data collection.  

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Figure 1: Study Visits 
Enrollment/Baseline Visit
De novo LV Lead (Attain Stability 
Quad MRI SureScan LV lead) 
Implant
(Implant/PHD visit)
Follow-up @ 3 months
(in office or remote visit)
Follow-up @ 6 months
(in office visit)
Follow-up 12 months
(in office visit)
Exit if unsuccessful Attain Stability 
Quad MRI SureScan LV lead 
implant
Follow-up every 6 months 
thereafter
(in office or remote visit)
 
The study is expected to be conducted at up to 50 sites worldwide.  Participating geographies are 
expected to include, but are not limited to: the United States, Canada, EMEA, Malaysia, and Hong Kong.  
To ensure a widespread distribution of data and to minimize site bias in the study results, the maximum 
number of subjects allowed at a single site is 50 subjects.  
12.1. Duration 
The study duration is expected to be approximately 19 months.  This represents 13 months for subject 
enrollment and 6 months for subject follow-up for the last subject enrolled.  Subjects are anticipated to 
be in the study for on average 12 months.  The first enrollment is projected to occur in May 2017.  
Subjects will complete visits at enrollment/baseline, implant, 3 months, 6 months, and then every 6 
months thereafter.  Subjects will not be replaced with newly enrolled subjects upon early exit.  As 
described in Section 19, the sample size accounts for attrition.  
12.2. Rationale 
Upon market release, this Attain Stability Quad MRI SureScan LV Lead (Model 4798) will provide 
physicians an alternative option to actively fixate the lead utilizing a side helix feature to achieve stability.  
The Attain Stability Quad Clinical Study is designed to demonstrate that the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is safe and effective.  See Section 19 for further background information 
and evaluation of clinical data.  See Section 10 for further background on the study design. 

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12.3. Study Oversight 
The study will utilize a Steering Committee (SC).  The SC is responsible for the scientific content of the 
study and for providing input for the execution of the study.  Members of the SC may be study site 
investigators.  The purpose of the SC is to provide unbiased opinions and expertise to the Attain Stability 
Quad Clinical Study design and process.  The SC will support the execution of the Attain Stability Quad 
Clinical Study and provide guidance, feedback and direction to the clinical study.  The SC is comprised of 
the members as indicated in Table 4 below.   
Table 4: Steering Committee Members 
Committee Member  
Contact information 
George H. Crossley III, MD  
Steering Committee Co-Chair 
Electrophysiology 
Fellowship Program Director 
Vanderbilt University Medical Center 
1211 Medical Center Drive 
Nashville, TN 37232 
United States 
(615) 322-5000 
george.crossley@vanderbilt.edu 
Kevin P. Jackson, MD  
Steering Committee Co-Chair 
Electrophysiologist 
Duke Cardiology of Raleigh 
Medical Office Building 6 
3320 Wake Forest Road 
2nd Floor, Suite 200 
Raleigh, NC 27609 
United States 
(919) 862-5100 
k.j@duke.edu 
Dr. Maria Grazia Bongiorni 
Electrophysiologist 
University Hospital of Pisa 
Lungarno Antonio Pacinotti 
43, 56126  
Pisa PI Italia 
+39 050 221 2111 
m.g.bongiorni@med.unipi.it 
Prof. Svein Faerestrand 
Electrophysiologist 
University of Bergen 
Jonas Liesvei 65  
Bergen, Norway 5021 
+47 55 97 67 04 
svein.faerestrand@helse-bergen.no 
Dr. Axel Kloppe 
Electrophysiologist 
Berufsgenossenschaftliches Universitätsklinikum  
Bergmannsheil GmbH,  
Bürkle-de-la-Camp-Platz 1,  
44789 Bochum, Germany  
+49 234 3026050 
axel.kloppe@bergmannsheil.de 

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Melissa Kong, MD 
Electrophysiologist 
Silicon Valley Cardiology 
1300 Stockbridge Ave   
Redwood City, CA 94061 
United States 
(650) 363-5262 
mhkong1@gmail.com 
Raymond Yee, MD 
Electrophysiologist 
London Health Sciences Centre  
339 Windemere Road  
London, ON N6A 5A5 
Canada 
(519) 663-3671 
ryee@uwo.ca 
Francois Philippon, MD 
Electrophysiologist 
Institut Universitaire de Cardiologie et de Pneumologie de Quebec  
2725 Chemin Ste-Foy 
Quebec G1V 4G5 
Canada 
(418) 656-8711 
francois.philippon@fmed.ulaval.ca 
 
The study will also utilize a Clinical Events Committee (CEC) who will be responsible for adjudicating 
adverse events and deaths, including procedure and/or system-related complications.  Further details for 
the CEC are provided in Section 18.1. 
13. Product Description 
13.1. General 
The Medtronic Attain Stability Quad MRI SureScan (Model 4798) is a steroid-eluting, quadripolar 
electrode, transvenous, over-the-wire (OTW), IS4-LLLL compatible, active fixation, cardiac vein pacing LV 
lead.  This lead is similar to the Attain Performa family of quadripolar leads (Models 4298, 4398, and 
4598) but also has a side helix for active fixation which is similar to the Attain Stability bipolar lead 
(Model 20066/4796) (available outside of the United States).  Figure 2 is a drawing of the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) illustrating the specifications and location of the four 
electrodes in comparison to the side helix. 

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Figure 2: Attain Stability Quad MRI SureScan LV Lead (Model 4798) Specifications Drawing 
 
 
Table 5 provides compares of the Attain Performa family of leads design features to the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798). 
 

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Table 5: Comparison of Medtronic Quadripolar LV Leads 
 
Attain Performa 
Attain Stability 
Quad 
Design Feature 
Model 4298 
Model 4398 
Model 4598 
Model 4798 
Shape 
Double Canted 
Straight 
S-Shaped 
Single Canted 
Implant Method 
Guide wire, 
stylet, or hybrid 
guide wire via 
Medtronic 
Delivery System 
Same as 4298 
Same as 4298 
Guide wire, 
stylet, or hybrid 
guide wire via 
Medtronic 
Delivery System 
and active 
fixation 
Delivery System 
Inner Diameter 
≥ 5.7 Fr ID 
Same as 4298 
Same as 4298 
Same as 4298 
Lead Body 
Diameter 
5.3 Fr 
proximal/3.9 Fr 
distal 
Same as 4298 
Same as 4298 
4.4 Fr 
proximal/3.9 Fr 
distal 
Lead Body 
Conductor 
Single Quadfilar 
Coil 
(Multiconductor) 
Same as 4298 
Same as 4298 
Same as 4298 
Conductor 
Material 
Ag core-low 
Titanium 
MP35Ncoil 
Same as 4298 
Same as 4298 
Same as 4298 
Insulation 
(Outer/Inner) 
Polyurethane 
55D SI-PI 
Same as 4298 
Same as 4298 
Same as 4298 
Polarity 
Selectable Quad-
electrode 
Same as 4298 
Same as 4298 
Same as 4298 
Electrode 
Material 
PT/Ir* alloy with 
TiN coating 
Same as 4298 
Same as 4298 
Same as 4298 
Fixation Helix 
Material 
N/A 
N/A 
N/A 
Pt/Ir** alloy 
Electrode 
Spacing 
21mm/ 1.3mm/ 
21mm 
Same as 4298 
Same as 4298 
Same as 4298 
Surface Area per 
5.8 
Same as 4298 
Same as 4298 
Same as 4298 

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Electrode (mm2) 
Steroid and Dose 
/  MCRD 
Dexamethasone 
acetate 
Each (4) Ring 
72µg 
Same as 4298 
Same as 4298 
Same as 4298 
Total Target 
Dose 
288 µg/lead 
Same as 4298 
Same as 4298 
Same as 4298 
*90/10 Platinum Iridium 
**80/20 Platinum Iridium 
Similar to the Attain Performa family of leads, the Attain Stability Quad MRI SureScan LV Lead (Model 
4798) contains 4 electrodes with surface area of 5.8 mm2 per electrode and is designed to function as 
cathodes or anodes, depending on how the device LV pacing vector is programmed:  
• 
electrode LV1, the distal electrode, positioned near the distal tip of the lead  
• 
electrode LV2, positioned 21 mm proximal to electrode LV1 
• 
electrode LV3, positioned 1.3 mm proximal to electrode LV2 
• 
electrode LV4, the proximal electrode, positioned 21 mm proximal to electrode LV3 
The electrode spacing on the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is identical to the 
approved Attain Performa family of leads.  This includes a non-uniform electrode spacing consisting of a 
reduced electrode spacing configuration (LV2-LV3) that alters the size of the electric field that is 
generated when stimulating the heart tissue.  This close electrode spacing is designed to reduce the 
likelihood of stimulating the phrenic nerve while still allowing for optimal lead placement and acceptable 
pacing capture thresholds.  
Similar to Attain Performa, each electrode contains a Monolithic Controlled Release Device (MCRD) for 
elution of steroid to reduce inflammatory response within the cardiac vein.  The MCRDs contain a 
combined-total target dosage of 288 μg of dexamethasone acetate steroid.  The target dose of the 
steroid is 72 μg at each MCRD.  Upon exposure to body fluids, the steroid elutes from the MCRDs.  The 
steroid suppresses the inflammatory response that is believed to cause threshold rise typically associated 
with implanted pacing electrodes.  
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) has the same lead body conductor (Single 
Quadfilar Coil (Multiconductor), conductor material (Ag core-low Titanium MP35N coil), insulation 
(outer/inner) (Polyurethane 55D SI-PI), and requires a similar delivery system inner diameter as the 
Attain Performa family of leads (≥ 5.7 Fr ID). 
Unlike the Attain Performa family of leads, the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
has a slightly smaller lead body diameter.  The lead body diameter of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is 4.4 Fr proximal (compared to 5.3 Fr on the Attain Performa family of 
leads) and 3.9 French distal (same as Attain Performa family of leads).  This slightly smaller lead body 
tubing diameter is designed to enhance torquability and steerability to facilitate adherence of the side helix 
in the target location. 
Figure 3 is a visual comparison between the Attain Perform leads and the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) illustrating the similar electrode location but different lead body diameter. 
 

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Figure 3: Comparison of Attain Performa Leads and the Attain Stability Lead Model 4798 
 
A detailed comparison of the Attain Stability bipolar lead (Model 4796) and Attain Stability Quad lead 
(Model 4798) is presented in Table 6. 
Table 6: Comparison of Medtronic Attain Stability Bipolar and Quadripolar LV Leads 
 
Attain Stability 
Attain Stability Quad 
Design Feature 
Model 4796/20066 
Model 4798 
Shape 
Single Canted 
Same as 4796/20066 
Implant Method 
Guide wire, Stylet, or 
hybrid guide wire via 
Medtronic Delivery 
System and active 
fixation 
Same as 4796/20066 
Delivery System 
Inner Diameter 
> 5.7 Fr ID 
Same as 4796/20066 
Lead body 
diameter 
3.9 Fr proximal / 3.4 Fr 
distal 
4.4 Fr proximal /3.9 Fr 
distal 
Lead Body 
Conductor 
Single 2 Filar Coil 
(Multiconductor) 
Single Quadfilar Coil 
(Multiconductor) 
Conductor Material 
Ag core-low Titanium 
MP35N coil 
Same as 4796/20066 

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Attain Stability 
Attain Stability Quad 
Design Feature 
Model 4796/20066 
Model 4798 
Shape 
Single Canted 
Same as 4796/20066 
Insulation 
(Outer/Inner) 
Polyurethane 55D 
SI-PI 
Same as 4796/20066 
Polarity 
bipolar 
Selectable Quad-
electrode 
Electrode Material 
Pt/Ir* alloy with TiN 
coating 
Same as 4796/20066 
Fixation Helix 
Material 
Pt/Ir** alloy 
 
Same as 4796/20066 
Electrode Spacing 
21 mm 
21mm / 1.3mm / 21mm 
Surface Area per 
electrode  (mm2) 
5.8 
Same as 4796/20066 
Steroid and Dose /  
MCRD 
Dexamethasone acetate 
Tip 160µg , Ring 72µg 
Dexamethasone acetate 
Each (4) Ring 72µg 
Total Target Dose 
232µg/lead 
288 µg/lead 
Molded Tip Seal 
Silicone (with steroid), 
pierced hole 
Silicone (without 
steroid), cross-cut hole 
Fixation Method 
Helix 
Same as 4796/20066 
Connector 
IS-1 B1 
IS4-LLLL 
Length (cm) 
88 cm only 
78 and 88 cm 
*90/10 Platinum Iridium 
**80/20 Platinum Iridium 
The non-electrically active side fixation helix component is similar to the Attain Stability Bipolar LV lead 
(Model 20066/4796) and is designed to enable active fixation in the cardiac vein.  The Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) side helix is positioned between the LV3 and LV4 electrode; 
specifically 10 mm proximal from the LV3 electrode (see Figure 2).   
A mechanical stop component is located at the base of the helix to prevent wedging of the endothelial 
tissue in the helix and to prevent tissue ingrowth.  The helix component is platinum (Pt) iridium (Ir) alloy 
(Pt/Ir 80/20).  This same Pt/Ir material is also used in the market released right ventricular active 
fixation lead Models 5076, 3830, and 4076.  Both the helix and mechanical stop components are identical 
to those used on the CE Mark approved Medtronic Attain Stability model 20066/4796 active fixation lead 
and are shown in Figure 4.  

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The Model 4798 lead has one distal curve/cant.  This distal curve geometry (angle) is identical to the 
Attain Performa model 4298, as well as Attain Ability models 4196 and 4296 most distal cant.  The 
single distal cant is also identical to the CE Mark approved model 20066/4796 active fixation lead 
(Figure 4). The purpose of the distal cant is to provide physicians the ability to “steer” the distal tip of 
the lead when navigating difficult vein anatomy or acute vasculature angulation by rotating the lead 
(counterclockwise) and aligning the distal tip towards the desired direction.  The distal cant for the 
Model 4798 lead is not intended, or necessary, to provide any fixation of the implanted lead as any 
retention force from the cant would be negligible compared to the stability provided by the properly 
implanted and verified fixated helix.  
Figure 4: Attain Stability Bipolar (Model 20066/4796) & Attain Stability Quad MRI SureScan 
(Model 4798) Active Fixation Leads 
 
The Attain Stability Quad Clinical Study will be conducted to evaluate the safety and efficacy of the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) in combination with CRT system components 
mentioned in Table 7. 
Table 7: Study Component Information 
Component  
US/Canada 
EMEA/Hong Kong/Malaysia 
Attain Stability Quad MRI 
SureScan LV Lead (Model 
Investigational 
Market-released 

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4798) 
Medtronic CRT-P or 
Medtronic CRT-D (with 
VectorExpress capabilities) 
Market-released 
Market-released 
Medtronic RV lead (non-
Medtronic and non-
recalled/non-market 
withdrawaled/non-safety 
alerted lead acceptable for 
upgrades) 
Market-released 
Market-released 
Medtronic RA lead (optional) 
(non-Medtronic and non-
recalled/non-market 
withdrawn/non-safety 
alerted lead acceptable for 
upgraded systems) 
Market-released 
Market-released 
 
Given the similarities between the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the 
Attain Performa family of leads, the proposed indications for use are the same.  The indications are as 
follows: 
Proposed Indication Statement for Use for the Attain Stability Quad Lead: 
The Attain Stability Quad MRI SureScan 4798 steroid-eluting, quadripolar electrode, IS4 transvenous lead 
is indicated for chronic pacing in the left ventricle via the cardiac vein, when used with a compatible 
Medtronic Cardiac Resynchronization Therapy (CRT) System.  Extended bipolar pacing is available using 
this lead in combination with a compatible market approved CRT-D system and RV lead. 
Market-Released Right Atrial Lead 
Commercially available Medtronic RA lead models with an IS-1 connector are required when an RA lead is 
implanted with de novo CRT systems.  An RA lead is not required to be implanted in circumstances 
determined appropriate per physician’s medical assessment.  Medtronic commercially available RA leads 
with an IS-1 connector are recommended but compatible non-Medtronic leads are permissible in enrolled 
patients receving a CRT system upgrades.   
Medtronic Market-Released Right Ventricular Lead 
Commercially available Medtronic RV defibrillation leads with a DF4 connector are required for de novo 
CRT systems.  Medtronic RV defibrillation leads with DF1 connectors may be incorporated in the study as 
DF1-compatible CRT-P and CRT-D devices are made available for the study.  A non-Medtronic RV lead is 
permissible in enrolled patients receving a CRT system upgrades. 
13.2. Manufacturer 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is manufactured by Medtronic, Inc.  

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13.3. Packaging 
Packaging and labeling for all market approved system components can be found with each package 
insert.  Manuals can be found on http://manuals.medtronic.com.  For CE Marked devices the labeling is in 
the appropriate local language. 
For investigational products in the US and Canada, the language of labeling and clinical manuals will be in 
English and/or local language where it is required.  Investigational products will be clearly labeled e.g. 
“exclusively for clinical investigation.”   
In Canada, each investigational device will be labelled with the statements “Investigational Device”; “To 
be Used by Qualified Investigators Only”; “Instrument de recherche” and “Réservé uniquement à l’usage 
de chercheurs compétents”. 
13.4. Intended Population 
In the Attain Stability Quad Clinical Study, the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
is to be used in subjects where a de novo LV lead is indicated.  The Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) is intended to be used in conjunction with a market released Medtronic CRT-P or 
CRT-D device, a Medtronic (for de novo CRT implants) RV lead, and a Medtronic (for de novo CRT 
implants) RA lead (optional).    
A complete SureScan system is required for use in the MRI environment.  Before performing an MRI 
scan, refer to the SureScan MRI technical manual for MRI-specific warnings and precautions. 
13.5. Equipment 
All commercially available equipment will be used according to their approved intended use. 
Medtronic CareLink (2090) Programmer 
The Medtronic approved CRT-P or CRT-D devices will programmed and interrogated using a Medtronic 
CareLink (2090) programmer.  Medtronic may incorporate additional programmers as they receive 
regulatory approval. 
Medtronic CareLink Home Monitor 2490C and Network 
The CareLink Monitor Model 2490C is an external monitor that is indicated for use in the transfer of 
patient and device data from implanted Medtronic devices.  The CareLink Monitor Model 2490C 
interrogates implanted devices and temporarily stores these data, collaborates with the appropriate 
Medtronic server to confirm the establishment of an Internet connection with server, performs any 
required file translation functions necessary for data transfer, executes data file transfer, and collaborates 
with the appropriate Medtronic server to confirm data file transfer through the Internet connection with 
the server.  The CareLink Monitor 2490C is not a programmer and cannot be used to program implanted 
device parameters.  CareLink monitors are not a substitute for appropriate medical attention in the event 
of an emergency and should only be used as directed by a physician.  Approved Medtronic CRT-P and 
CRT-D devices used in this study qualify for use with the Medtronic CareLink Monitor and Medtronic 
CareLink Network.  Medtronic may incorporate additional home monitors as they receive regulatory 
approval. 
Pacing System Analyzer 

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Medtronic’s commercially available Model 2290 Analyzer must be available at each center during the 
implant procedure to determine acceptable electrical parameters.  Medtronic may incorporate additional 
analyzers as they receive regulatory approval. 
13.6. Product Use 
See Section 13 Product Description. 
13.7. Product Receipt, Tracking, and Accountability 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered investigational in 
geographies where the product is not available commercially and will be labeled for clinical use only.  
These geographies include but are not limited to the US and Canada.  Investigational Attain Stability 
Quad Leads will be distributed to a site only when Medtronic has received all required documentation 
(including but not limited to Ethic Committee approval, a signed Clinical Trial Agreement and 
documentation of training) and has notified the site of site readiness.   
Distribution of the investigational product to study sites will be managed by Medtronic and investigational 
products can only be ordered by Medtronic personnel.  Site with these clinically labeled Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) will track disposition upon receipt or return of the lead but 
also upon implant or explant of the lead.  Disposition logs will be available within the electronic data 
management system and shall be maintained at each site in all geographies to track investigational 
product information.  The logs should be updated when an investigational product is received, opened, 
implanted explanted, disposed of or returned to Medtronic.  The logs will track the following 
investigational lead data (but are not limited to) model and serial numbers of devices delivered to the 
site, subject IDs of the subjects, implanted, received dates of devices, implant/used dates, explant dates, 
returned-to-sponsor dates and reasons, initials of all persons who received, used or disposed each 
device, and method of disposal.  Medtronic will perform periodic reconciliation of investigational product 
to ensure traceability. 
For geographies where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is not considered 
investigational, commercially approved devices will be used.  Sites that use commercially available Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) will track device disposition upon implant or explant 
of the lead on the CRFs. 
13.8. Product Storage 
All investigational products must be stored in a secure location at the site.  It is the responsibility of the 
investigator to correctly handle, store and track the investigational products.  Further details may be 
found in the Clinical Manual or User Manual (dependent on each geography’s commercial release of the 
product). 
13.9. Product Return 
All explanted, open but unused, and defective products (devices or leads, etc.) should be returned to 
Medtronic for analysis whenever possible and when permissible by local laws and regulations.  If the 
products are explanted but not returned, a justification is required to be reported on the appropriate case 
report form(s) or disposition log(s) (note that this is not considered a study deviation).  In geographies 
where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is considered investigational, the 

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Disposition Log must be updated in the event of an explant.  To receive a Returned Product Mailer Kit, 
please contact your local Medtronic field personnel or representative.  All unused investigational products 
must be returned to Medtronic upon study closure at the site. 
14. Selection of Subjects 
14.1. Study Population 
Patients of both genders that are 18 years of age and older (or of legal age to give informed consent per 
local and national law) that are indicated for a de novo LV lead implantation and who meet all inclusion 
and no exclusion criteria are eligible for an Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implant attempt.  There will be no control group for this study. 
14.2. Subject Enrollment 
Patients who meet all of the inclusion and none of the exclusion criteria (see sections 14.3 and 14.4) are 
eligible to be enrolled in this study.  Upon signing and dating the Informed Consent Form (ICF), the 
patient is considered a subject enrolled in the study. 

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14.3. Inclusion Criteria 
• 
Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy  
• 
Patient (or legally authorized representative) has signed and dated the study-specific Informed 
Consent Form 
• 
Patient is 18 years of age or older, or is of legal age to give informed consent per local and 
national law 
• 
Patient is expected to remain available for follow-up visits 
14.4. Exclusion Criteria 
• 
Patient has had a previous unsuccessful LV lead implant attempt 
• 
Patient has an existing epicardial LV lead 
• 
Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA 
and/or RV lead  
• 
Patient has known coronary venous vasculature that is inadequate for lead placement 
• 
Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the 
past 30 days 
• 
Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary 
angioplasty (PTCA) within the past 90 days 
• 
Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right 
heart valve) 
• 
Patient has had a heart transplant (patients waiting for heart transplants are allowed in the 
study) 
• 
Patient has known renal insufficiency that would prevent them from receiving an occlusive 
venogram during the implant procedure 
• 
Patient is contraindicated for <1mg dexamethasone acetate 
• 
Patient is enrolled in any concurrent drug and/or device study that may confound the results of 
this study 
• 
Patient has a terminal illness and is not expected to survive more than six months 
• 
Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.) 
• 
Patient is unable to tolerate an urgent thoracotomy 
14.5. Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias.  
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
• 
Subjects will be evaluated at baseline to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria  
• 
Subject demographics and medical history will be collected at baseline and differences that may 
affect primary endpoints will be identified 
• 
To ensure widespread distribution of data between sites, the maximum number of subjects 
allowed per site is 50 
• 
All implanters in the study will be experienced in the implant of CRT-P and/or CRT-D systems 
• 
Data collection requirements and study procedures will be standardized across all sites and 
geographies 

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• 
All study site personnel and Medtronic personnel will be trained on their respective aspects of the 
study using standardized training materials, and required to follow the CIP 
• 
Per the specifications in the Monitoring Plan, monitoring visits will be conducted for adherence to 
the CIP and to verify the CRF data against source data 
• 
Pre-defined statistical methods specified in the CIP and the Statistical Analysis Plan (SAP) will be 
followed 
• 
The SC members will not have influence on the treatment decisions by study site investigators 
during the trial 
• 
An independent and blinded CEC will regularly review and adjudicate reported adverse events 
and deaths (per Section 18.1) 
• 
Registration of the trial on ClinicalTrials.gov and the publication plan will ensure that study results 
will be reported 
• 
All study investigators are required to meet 21 CFR Part 54, Financial Disclosure by Clinical 
Investigators, to identify potential bias due to financial interest in the outcome of the study  
In summary, potential sources of bias that may be encountered in this Attain Stability Quad Clinical Study 
have been considered and minimized by careful study design. 
15. Study Procedures  
Prior to performing study related procedures, all sites must have Ethics Committee (EC) and associated 
regulatory authority approval if applicable (e.g., Competent Authority approval) as well as documentation 
from Medtronic of site readiness. 
Medtronic representatives may perform the following activities at the study sites during the study, if 
appropriately trained and under supervision of the Principal Investigator: 
• 
Study training relevant and pertinent to the involvement of personnel conducting study activities 
and investigator responsibilities 
• 
Technical support at all visits (e.g. programming of the CRT-P or CRT-D device according to 
study requirements, performing device interrogations/save-to-media, etc.), but no CRF data entry 
shall be performed by Medtronic personnel  
• 
Monitoring activities 
15.1. Study Personnel Requirements 
Site personnel training and delegation will be completed prior to participation in the Attain Stability Quad 
Clinical Study.  The site personnel training consists of required training topics (CIP, Informed Consent 
Form, CRFs, regulations). Members of the study site team will receive training on the applicable clinical 
study requirements relevant to their role before contributing to the clinical study. 
All Principal Investigators shall: 

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• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
• 
Be qualified practitioners and experienced in the diagnosis, management, and treatment of HF 
subjects with CRT devices 
• 
Be experienced in the field of application and trained in the use of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) 
• 
Disclose potential conflicts of interest, including financial that interfere with the conduct of the 
clinical investigation or interpretation of results 
• 
Be knowledgeable with the method of obtaining an informed consent 
In addition, the Principal Investigator shall be able to demonstrate that the proposed investigational site: 
• 
Has an experienced CRT implanter who is experienced and trained in the handling/implanting of 
CRT-P and/or CRT-D devices 
• 
Has the required number of eligible subjects needed within the agreed recruitment period 
• 
Has one or more qualified investigators, a qualified investigation site team and adequate facilities 
for the foreseen duration of the clinical investigation  
15.2. Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train site personnel on the CIP, 
the implant procedure, relevant standards and regulations, informed consent process, and on data 
collection and reporting tools.  If new members join the study site team, they will receive training on the 
applicable clinical study requirements relevant to their role before contributing to the clinical study.  For 
new members, local Ethics Committee notification requirements must be met, as well as Medtronic 
requirements noted on the training and delegation form.  
A Clinical Trial Agreement (CTA) shall be entered into effect by Medtronic, the participating investigation 
site and/or the principal clinical investigator at each investigational site as per local legal requirements, 
and returned, fully executed, to Medtronic prior to the commencement of any study activities.  Financial 
aspects of conducting and reporting a study will be specified in the agreement.  By signing and dating the 
agreement the investigator indicates approval of the CIP. 
Prior to performing study related activities, all sites must have Ethics Committee approval, as applicable 
for that geography. 
All local and regional regulatory requirements will be fulfilled prior to site activation and enrollment of 
subjects into the study.  Each study site must have written documentation from Medtronic of site and 
investigator readiness before beginning any study-related activities.  Requirements for activation vary by 
geography, and may include, but are not limited to the following:  
• 
Written documentation of Ethics Committee approval of the current version of the CIP and 
ICF, subject materials (e.g. Global Assessment and KCCQ), and voting list (as required by 
local law)   
• 
Regulatory authority approval or notification (as required per local law)  
• 
Fully executed CTA on file with the sponsor  
• 
Financial Disclosure (for Principal Investigators and Co-Investigators)   
• 
Current Curriculum Vitae (CV) (signed and dated as required by local law) of investigators 
and key members (as required by local law) of the investigation site team on file with the 
sponsor  
• 
Documentation of delegated tasks 

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• 
Documentation of study site personnel training  
Additional requirements imposed by the Ethics Committee and regulatory authority shall be followed, if 
applicable.  
Medtronic will provide each study site with documentation of study site readiness; this letter must be sent 
prior to subject enrollment. 
15.3. Equipment Requirements 
The following equipment must be available at each site to support study activities: 
• 
Medtronic 2090 programmer (or latest market released Medtronic programmer) 
• 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) (either clinically labeled product or 
commercial released product located at the site or carried to the implant by the Medtronic 
representative) 
• 
Computer with high speed internet access using a web browser compatible with the electronic 
data management system for electronic database entry  
The equipment necessary for the assessment for the study is the Medtronic 2090 programmer. The 
maintenance and calibration of the programmers used for this study will be assessed outside of this 
clinical study.  Sites are responsible for maintaining and calibrating non-programmer equipment used in 
the course of this study in accordance with established site practice.  Records should be kept and able to 
be provided upon request by the Sponsor or regulatory agency.  For sites located in EMEA, programmer 
calibration and maintenance will be performed by the Medtronic office in Heerlen, The Netherlands.  In 
Germany, the calibration of the programmers are under the responsibility of the hospitals and this 
calibration will be done mainly by DEKRA or TÜV. 
15.4. Schedule of Events 
Clinical data will be collected at the study milestones detailed in Table 8.  Data will be collected via 
electronic case report forms (eCRFs), programmer print-outs, and interrogation files.  Post-implant follow-
ups apply only to those subjects in whom an Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
was successfully implanted or an implant was attempted.  Subject visits will occur at enrollment, baseline, 
implant/pre-hospital discharge (PHD), 3 months post-implant, 6 months post-implant, and every 6 
months thereafter until PMA approval of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implanted or study termination, whichever comes first.  Medtronic personnel may assist study personnel 
during implant and study visits.

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Table 8: Data Collection and Study Procedure Requirements at Subject Visits 
 
STUDY PROCEDURE 
Enrollment
/Baseline 
Implant
/PHD 
3 months 
post-
implant 
(remote or 
inoffice 
visit) 
6 months 
post-
implant 
 (inoffice 
visit) 
12 
months 
post-
implant 
 (inoffice 
visit) 
  Recurring 6 
month 
follow-ups 
(remote or 
inoffice visit)  
Exit  
Subject Informed Consent 
 
 
 
 
 
 
 
Inclusion / Exclusion criteria 
verified 
 
 
 
 
 
 
 
Subject demographics  
 
 
 
 
 
 
 
Cardiovascular medications 
 
 
 
 
 
 
 
Cardiovascular medical history 
 
 
 
 
 
 
 
NYHA classification 
 
 
 
 
 
  
 
Patient Global Assessment 
 
 
 
 
 
 
 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
 
 
 
 
 
 
 
Occlusive venogram with pre-
determined pacing location 
identified 
 
 
 
 
 
 
 
System and procedure 
information 
 
 
 
 
 
 
 
Lead Impedance (all 16 
vectors) 
 
 
 (final 
programmed  
vector only) 
 
 
  (final 
programmed  
vector only) 
 
Pacing Capture Thresholds 
(all 16 vectors) 
 
 
 (final 
programmed  
vector only) 
 
 
  (final 
programmed  
vector only) 
 
Phrenic Nerve Stimulation 
(final programmed vector) 
 
 
 (inoffice 
visit only) 
 
 
 
 
 
Phrenic Nerve Stimulation 
(vectors LV1 to RVcoil, LV2 to 
RVcoil, LV3 to RVcoil, LV4 to 
RVcoil) 
 
 
 
 
 
 
 
Rationale for selecting specific 
LV lead pacing vector for final 
programming 
 
 
 
 
 
 
 
Final device 
interrogation/save-to-media 
 
 
 (CareLink 
transmission 
is acceptable 
for remote 
visits) 
 
 
 
 (required 
only if 
subject exits 
prior to 6 
months post-
implant visit; 
CareLink 
transmission 
is acceptable) 
AE Assessment 
 
 
 
 
 
 
 
Exit Subject 
 
 
 
 
 
 
 
Adverse Events (incl. AE with 
outcome of death)  
As they occur 
Device Deficiencies 
System Modifications 
Study Deviations 
CareLink Transmissions 
(optional) 

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Table 9 below specifies permitted time windows for the required subject visits.  Subject visit target dates 
and windows for each follow-up will be made available to the study site.  Should a subject miss a visit or 
the visit falls outside the pre-specified window, a study deviation must be reported and the original 
follow-up schedule maintained for subsequent visits.  Data analyses will include follow-up visits, 
regardless of whether the visit occurs within the window.  Therefore, a late visit is preferred over a 
missed visit but must be accompanied by a deviation.  
Table 9: Visit Windows 
Visit 
Window 
Implant 
0-30 days since Baseline 
Assessment 
  
(days since implant) 
Pre-hospital discharge 
0-7 
3-month 
76 - 106 
6-month 
183 - 213 
12-month 
350 - 380 
18-month 
518 - 578 
24-month 
701 - 761 
 
15.5. Subject Consent 
Informed consent (IC) is defined as a legally effective documented confirmation of a subject’s voluntary 
agreement to participate in a particular clinical study after information has been given to the subject on 
all aspects of the clinical study that are relevant to the subject’s decision to participate (ISO 14155:2011).  
This process includes obtaining IC and an Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language (data protection authorization; i.e. HIPAA in 
the US) as required by law.  Informed Consent Forms are required to be approved by the study site’s 
Institutional Review Board (IRB) or Ethics Committee (EC) and Medtronic, and signed and dated by the 
subject and the Principal Investigator.  A subject may only consent after information has been given to 
the subject on all aspects of the clinical study that are relevant to the subject’s decision to participate.  
Prior to enrolling subjects, each site must have documented IRB/EC approval of the IC Form (ICF) and 
the data protection authorization as required by law.  Any changes to a previously approved ICF 
throughout the course of the study must be reviewed and approved by Medtronic and the IRB/EC 
reviewing the application before being used to consent or re-consent a study subject.  The document(s) 
must be controlled (i.e. versioned and dated) to ensure it is clear which version(s) was approved by 
Medtronic and the IRB/EC.  All important new information should be provided in written form to new and 
existing subjects throughout the study.  If relevant, all affected subjects must be asked to confirm their 
continuing IC in writing.   

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Prior to initiation of any study-specific procedures, IC must be obtained from the subject (or legally 
authorized representative).  Likewise, privacy or health information protection regulation may require 
subjects to sign additional forms to authorize sites to submit subject information to the study sponsor.  
The IC process must be conducted by the principal investigator or an authorized designee, and the ICF 
and data protection authorization, as required by law, must be given to the subject in a language he/she 
is able to read and understand.  
The process of obtaining informed consent shall: 
• 
Ensure that the principal investigator or an authorized designee conducts the IC process. 
• 
Include all aspects of the Attain Stability Quad Clinical Study that are relevant to the subject's 
decision to participate throughout the clinical study. 
• 
Avoid any coercion or undue improper influence on, or inducement of the subject to participate. 
• 
Not waive or appear to waive the subject’s legal rights. 
• 
Ensure the ICF and data protection authorization, as required by law, are given to the subject in 
a non-technical language the subject is able to read and understand. 
• 
Provide ample time and opportunity for the subject to read and understand the ICF to inquire 
about details of the study, and to consider participation.  All questions about the study should be 
answered to the satisfaction of the subject. 
• 
Include a personally dated signature of the subject acknowledging that their participation in the 
study is voluntary. 
• 
Include a personally dated signature by the principal investigator or authorized designee 
responsible for conducting the IC process, as required by local law. 
• 
Include any other locally required signatories, such as witnesses, as indicated by country-specific 
legislations. 
• 
Provide the subject with a copy of the ICF, the data protection authorization, as required by law, 
and any other written information, signed and dated if required by local law. 
• 
Ensure subjects are notified of any significant new findings about the study that become 
available during the course of the study which are pertinent to the safety and well-being of the 
subject, as this could impact a subject’s willingness to participate in the study. 
If IC is obtained the same day the subject begins participating in study-related procedures, it must be 
documented that consent was obtained prior to participation in any study-related procedures.  It is best 
practice for the IC process to be documented in the subject’s case history, regardless of circumstance. 
In the event the subject cannot read and/or write, witnessed (impartial third party) IC will be allowed, 
provided detailed documentation of the process is recorded in the subject’s case history and the witness 
signs and dates the ICF.  Informed consent shall be obtained through a supervised oral process.  An 
independent witness must be present throughout the process.  The ICF and any other information must 
be read aloud and explained to the prospective subject, if allowed by local law.  The witness signs and 
personally dates the ICF, attesting that the information was accurately explained and that informed 
consent was freely given.  The subject should “make his mark” (sign or otherwise physically mark the 
document so as to indicate consent) on the ICF as well.  The ICF should document the method used for 
communication with the prospective subject and the specific means by which the prospective subject 
communicated agreement to participate in the study.  
The original of the signed ICF must be filed in the hospital/clinical chart and/or with the subject’s study 
documents.  A second signed original or a copy should be given to the subject for their records (if 
applicable). 

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The ICF and data protection authorization, as required by law, must be available for monitoring, auditing 
and regulatory inspections.  
Geography specific ICF Templates will be provided under separate cover.  
15.6. Enrollment 
The point of enrollment is defined as the time at which a patient has signed and dated the ICF.  The date 
the subject signed (or legally authorized representative) the ICF and data protection authorization, as 
required by law, must be documented in the subject’s medical records.  At that point, the patient is 
considered a subject in the study, a study subject ID number will be assigned, and the subject must be 
followed for the duration of the study unless the subject exits the study prior to study closure.  Each 
investigational center will be responsible for maintaining subject identification records (e.g. subject 
identification log) according to ISO 14155.  
Enrollment will occur on the same day as the baseline visit.  Once IC is obtained, report AEs/deaths, 
study deviations and subject exits as they occur.  To accurately track subject enrollment, Medtronic 
should be notified of the enrollment as soon as possible after a patient has signed the ICF. 
15.7. Baseline 
The baseline visit can be a stand-alone visit or can occur on the same day as, but not later than, the 
implant visit.  The following procedures will be completed/data will be collected at the baseline visit: 
o 
Subject Informed Consent  
o 
Inclusion/Exclusion criteria verified 
o 
Subject demographics  
o 
Cardiovascular medications 
o 
Cardiovascular medical history 
o 
NYHA classification 
o 
Patient Global Assessment 
Kansas City Cardiomyopathy Questionnaire (KCCQ) Cardiovascular medications include ACE inhibitors, 
ARBs, antiarrhythmic, anti-coagulants, antithrombotics, and antiplatelet, antihypertensive, antilipidemics 
(statins), beta blockers, calcium channel blockers, diuretics, digitalis, inotropes, nitrates, digoxin, and 
vasodilators. 
If implant does not occur within 30 days of enrollment, verification of all inclusion and all exclusion 
criteria must be repeated before an implant attempt. 
15.8. Implant/PHD 
Information collected at Implant/PHD will include data from the day of the implant procedure until 
released from the hospital.  The implant CRF will be used to collect data at implant.  Implantation of the 
CRT device and right heart leads should be performed according to the Instruction for Use (IFU) in 
geographies where the devices are commercially available. 
Any Medtronic commercially released right atrial (RA) and any Medtronic commercially released right 
ventricular (RV) lead may be implanted.  Existing non-Medtronic RV and/or RA leads that are not recalled, 
market withdrawn, and/or have a medical alert may be used in enrolled who are receiving an upgrade to 

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a CRT system.  The right-heart leads should be implanted according to the labeling provided with the 
applicable lead. 
The implanted system device must include a Medtronic commercially released CRT device which can be 
programmed to utilize all electrodes, allowing upgrades from implantable pulse generators (IPGs) and 
implantable cardioverter defibrillators (ICDs).  Device and lead requirements are as follows: 
• 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
• 
For de novo CRT implants, any Medtronic commercially released transvenous (active or passive 
fixation) RA pacing lead (unless medical justification to exclude this lead) and any Medtronic 
commercially released transvenous (active or passive fixation) RV lead 
• 
For upgrades to a CRT system, existing non-Medtronic RV and/or non-Medtronic RA leads that 
are not recalled, market withdrawn, and/or have a medical alert may be used in enrolled who are 
receiving an upgrade to a CRT system  
• 
Medtronic commercially released CRT devices that measure discrete LV electrical values from all 
four electrodes (i.e. Vector Express) 
15.8.1. 
Final System Configuration 
For information on the requirements for the implanted system refer to Section 13.  The system is 
successfully implanted when the Medtronic CRT device is successfully connected to the RA, RV and the 
LV lead (except if a medical condition such as chronic atrial fibrillation excludes the need for an RA lead).  
The configuration of the successfully implanted system components will be collected.  This will include 
the serial number of each implanted component (CRT-D or CRT-P device, and leads), and the location of 
lead placement. 
15.8.2. 
Implant Procedure 
Implantation of the CRT device and cardiac leads must be performed by a trained clinical study 
investigator and according to the manufacturer’s instructions for use.  It is recommended to use 
Medtronic catheters that are compatible with the Attain Stability Quad MRI SureScan LV Lead (Model 
4798) (e.g., > 7 Fr) during the implant for gaining access to the coronary sinus (CS).   
For complete information regarding the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and 
the implant procedure, reference the Clinical Manual in the US and Canada or the Instructions for 
Intended Use (Technical Manual in EMEA, Hong Kong, and Malaysia).  These documents are located 
under a separate cover. 
15.8.2.1. Venogram 
An occlusive venogram is required for venous visualization of the subject’s coronary vasculature and will 
be used to pre-determine a target implant vessel prior to placing the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798).  Once the pre-determined target vessel site is determined, a venous image will be 
collected.  A copy of the venous image will be submitted to Medtronic and kept on file at the center.  
15.8.2.2. Implanting the LV lead 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be implanted according to the implant 
instructions found within the lead packaging.  The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) can be positioned with the aid of a guide wire (0.36 mm to 0.46 mm or 0.014 inches to 0.018 
inches in diameter), stylet, an inner catheter, or an inner catheter plus hybrid guide wire.  If a stylet is 

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used for lead positioning, only use the stylets packaged with the lead or in a stylet kit (downsized knob).   
Always use a stylet that is 3 cm shorter than the lead length listed on the IS4 connector label.  Other 
stylets may extend beyond the lead tip causing injury or perforation of the cardiac vein or heart.  If using 
a Medtronic integrated valve system (e.g. SureValve), rotate the helix counterclockwise to allow safe 
passage of the helix when inserting the lead into the delivery system to prevent the side helix from 
inadvertently attaching to the valve.  Rust stylets are not recommended with this lead due to the risk of 
conductor coil/insulation perforation. 
Follow the Attain Stability Quad MRI SureScan LV Lead (Model 4798) package insert carefully for fixating 
the side helix to the vein.  Consider using a J-shaped stylet if fixation is unsuccessful.  An overview of the 
key implanting tips includes: 
• 
Rotate the lead counterclockwise when inserting the lead through the SureValve to prevent the 
helix from attaching to the valve 
• 
Refrain from wedging the lead into the vessel so that the lead can easily rotate during fixation 
allowing torque to transfer from the proximal end to the distal end of the lead 
• 
To fixate the side helix in the desired location, rotate the lead clockwise with the guidewire 
inserted in the lead which will provide extra stiffness to the lead 
• 
Ensure the guidewire is removed to allow for lead pliability to visualize and confirm lead fixation 
during the Push Test and the Pull Test  
• 
To reposition the lead, insert the guidewire and rotate the lead counterclockwise without applying 
tension to the lead to unfixate 
Information on surgical data, such as tool use, and implant times, etc. will be collected during the implant 
procedure. 
In an event that one Attain Stability Quad MRI SureScan LV Lead (Model 4798) is determined to be not 
suitable for a patient after the initial lead insertion; the implanting physician must assess the onset of any 
potential AEs.  A second Attain Stability Quad MRI SureScan LV Lead (Model 4798) may only be 
introduced upon confirmation that no system-related AEs resulted from the first Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) implant attempt.  Any LV lead related AE observed during the initial LV 
lead attempt prohibits an attempt of a second Attain Stability Quad MRI SureScan LV Lead (Model 4798). 
If the subject does not have a successful Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implant at the conclusion of the initial implant procedure, the subject should be followed until procedure 
or system related AEs are resolved or are unresolved with no further actions planned, whichever occurs 
later. 
If an attempt to implant the Attain Stability Quad MRI SureScan LV Lead (Model 4798) does not occur, or 
if the Model 4798 LV lead cannot be implanted, the reasons why the lead was not attempted or 
attempted but not implanted must be documented on the Implant and Study Exit CRF.  See additional 
definitions below. 
No Attain Stability Quad MRI SureScan LV Lead (Model 4798) Attempted (lead not inserted 
into the body) 
An Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt is defined as any time a Model 
4798 lead is introduced into the body.  Subjects that do not have an Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) implant attempted will be exited from the study following their implant procedure 
unless another Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt is scheduled.  Adverse 
events, device deficiencies and deviations must be documented before the subject is exited. 

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Attain Stability Quad MRI SureScan LV Lead (Model 4798) Attempted but Not Implanted 
An Attain Stability Quad MRI SureScan LV Lead (Model 4798) that is inserted into the body that is not 
successfully placed will be considered an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 
4798) attempt.  Note: An unsuccessful implant itself is not considered an AE.  Adverse Events occurring 
during an unsuccessful implant (e.g. dissection, perforation) will be recorded and classified.  Subjects 
with an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt will be followed 
until procedure or system related AEs have been resolved or are deemed unresolvable with no further 
action planned. 
15.8.2.3. CRT System Testing and Programming During Implant 
Prior to connecting the leads to the CRT can, initial electrical measurements will be taken using the 
Analyzer (Model 2290 or market released equivalent) to confirm adequate pacing thresholds (PCTs) prior 
to closing the pocket per the center’s standard testing method.  These PCTs will be collected on the same 
vector, at two timepoints once the lead is fixated and prior to connecting the leads to the can using the 
Analyzer.  The timepoints are as follows; 
1.) Prior to slitting the cannulation catheter - Collect the first PCT using the Analyzer after the 
lead is fixated and the guidewire/stylet has been pulled back proximal to the helix and electrodes.  
2.) Post slitting the cannulation catheter – Collect the second PCT using the Anlyzer after the lead 
is fixated and following slitting of the cannulation catheter.   
These PCT measurements will be collected on the CRF.  This data will only be collected if an Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) is successfully placed. 
Pacing voltage thresholds are measured to determine whether the underlying myocardium will respond 
effectively to pacing and to evaluate lead stability in the cardiac vein.  It is required to perform LV pacing 
threshold measurements during implant using the pacing threshold test at a 0.5ms pulse width.  It is 
recommended to begin at 2.5 Volts and decrease amplitude after at least 3 pulses until capture is lost.  If 
there is no capture at 2.5 V; stop the test and repeat at a higher voltage using the 0.5ms pulse width.  
The lowest amplitude where capture consistently occurs is the pacing threshold value.  Collect data using 
the Analyzer (Model 2290 or market released equivalent). 
It is recommended that physicians locate a final LV pacing site that can be captured using less than or 
equal to 2.5 V at 0.5ms, R-wave sensing of at least 4.0 mV, and does not cause diaphragmatic 
stimulation at 10V at 0.5ms.  For additional details regarding the left ventricular leads and implant tools, 
refer to the respective technical manuals provided with each product.  
Individual patient venous anatomies as well as pathologies present in the left ventricular myocardium are 
factors that will influence LV lead placement.  Therefore, the best cardiac vein lead electrode location to 
stimulate the LV may vary for each patient.  
15.8.2.4. Final Lead Placement Data Collection 
Following fixation and once the final position of the lead is determined, collect a venous image of the final 
placement of the lead.  A copy of the venous image will be submitted to Medtronic and kept on file at the 
center.  

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15.8.2.5. Pre-Hospital Discharge CRT System Testing and Programming  
The following electrical testing will be performed using the implanted CRT-P or CRT-D device and the 
device programmer once the leads are connected to the CRT-P or CRT-D and pre-hospital discharge: 
Lead Impedance 
• 
Collect LV Lead Impedances using Vector Express on all vectors  
• 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors LV1 to 
RVcoil, LV2 to RVcoil, LV3 to RVcoil, LV4 to RVcoil or the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Pacing Capture Thresholds (PCT) 
• 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors 
• 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out of the 
box pulse width is set at 0.4ms) 
• 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on vectors  
LV1 to RVcoil, LV2 to RVcoil, LV3 to RVcoil, LV4 to RVcoil or the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Phrenic Nerve Stimulation (PNS) 
• 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
• 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
• 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
Other data collected prior to hospital discharge following the implant includes; 
• 
Rationale for selecting specific LV lead pacing vector for final programming 
• 
Final device interrogation/save-to-media 
• 
AE Assessment 
• 
Study deviations 
• 
Device deficiencies  
15.9. 3 Months Post-Implant (remote or in office visit) 
The 3 month scheduled follow-ups may be done remotely or inoffice.  For remote visits, CareLink 
transmissions may substitute device interrogations.  The following procedures will be completed and data 
will be collected at the 3 month Follow-up visit; 
Lead Impedance 
• 
Perform a manual LV Lead Impedance Test  the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Pacing Capture Thresholds (PCT) 
• 
Perform PCTs at 0.5ms pulse width on the final programmed vector 
• 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out of the 
box pulse width is set at 0.4ms) 
• 
Perform a manual PCT test at 0.5ms pulse width on the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 

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• 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
• 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
• 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
• 
NYHA classification  
• 
Patient Global Assessment 
• 
Rationale for selecting specific LV lead pacing vector for final programming 
• 
Final device interrogation/save-to-media 
• 
AE Assessment 
• 
Study deviations 
• 
Device deficiencies 
15.10. 
6 Months Post-Implant (in office visit) 
The following procedures will be completed and data will be collected during the 6 month in office Follow-
up visit. 
Lead Impedance 
• 
Collect LV Lead Impedances using Vector Express on all vectors  
• 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors LV1 to 
RVcoil, LV2 to RVcoil, LV3 to RVcoil, LV4 to RVcoil or the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Pacing Capture Thresholds (PCT) 
• 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
• 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out of the 
box pulse width is set at 0.4ms) 
• 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on vectors 
LV1 to RVcoil, LV2 to RVcoil, LV3 to RVcoil, LV4 to RVcoil or the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Phrenic Nerve Stimulation (PNS) 
• 
Test for presence of PNS at 8.0V at 0.5ms on vectors LV1 to RVcoil, LV2 to RVcoil, LV3 to RVcoil, 
LV4 to RVcoil 
• 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
• 
NOTE: If at any tested vector PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 
0.5ms 
• 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 

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• 
NYHA classification  
• 
Patient Global Assessment 
• 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
• 
Rationale for selecting specific LV lead pacing vector for final programming 
• 
Final device interrogation/save-to-media 
• 
AE Assessment 
• 
Study deviations 
• 
Device deficiencies 
15.11. 
12 Months Post-Implant (in office visit) 
The following procedures will be completed and data will be collected during the 12 month in office 
Follow-up visit. 
Lead Impedance 
• 
Collect LV Lead Impedances using Vector Express on all vectors  
• 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors LV1 to 
RVcoil, LV2 to RVcoil, LV3 to RVcoil, LV4 to RVcoil or the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Pacing Capture Thresholds (PCT) 
• 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
• 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out of the 
box pulse width is set at 0.4ms) 
• 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on vectors 
LV1 to RVcoil, LV2 to RVcoil, LV3 to RVcoil, LV4 to RVcoil or the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Phrenic Nerve Stimulation (PNS) 
• 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
• 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
• 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
• 
NYHA classification  
• 
Patient Global Assessment 
• 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
• 
Rationale for selecting specific LV lead pacing vector for final programming 
• 
Final device interrogation/save-to-media 
• 
AE Assessment 
• 
Study deviations 
• 
Device deficiencies 
15.12. 
Recurring 6 Month Follow-ups  
After the 12 Month Follow-Up visit, subjects will be seen every 6 months. These scheduled follow-ups are 
considered “Recurring 6 month follow-up visits”.  These scheduled follow-ups may be done remotely or 
inoffice.  For remote visits, CareLink transmissions may substitute device interrogations.  The following 
procedures will be completed during these visits: 

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Lead Impedance 
• 
Perform a manual LV Lead Impedance Test for the final programmed vector  
• 
Retain printouts for any manually tested vector at the site 
Pacing Capture Thresholds (PCT) 
• 
Perform PCTs at 0.5ms pulse width on the final programmed vector  
• 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out of the 
box pulse width is set at 0.4ms) 
• 
Perform a manual PCT test at 0.5ms pulse width on the final programmed vector   
• 
Retain printouts for any manually tested vector at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 
• 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
• 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
• 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
• 
NYHA classification  
• 
Rationale for selecting specific LV lead pacing vector for final programming 
• 
Final device interrogation/save-to-media 
• 
AE Assessment 
• 
Study deviations 
• 
Device deficiencies 
15.13. 
Device Interrogation/Save-to-Media 
For the implant and follow-up visits, a final “Interrogate All” device interrogation file (.pdd) must be 
obtained and saved in a digital format (Save-to-Media).  Store one copy of the save-to-media at the site 
and send a copy to Medtronic.  Do not clear device data.  
A device interrogation (final “Interrogate All”) and Save-to-Media should also be completed at the time of 
study exit (prior to 6 month visit), a system modification (initial and final “Interrogate All”), and in the 
case of a death (where possible).   
15.14. 
System Modifications 
A system modification will be reported in the event the device and/or leads require invasive modification 
(e.g. generator or lead explant, generator or lead replacement, lead repositioning, etc.).  In the event of 
a system modification, regardless of outcome of the modification, subjects should remain in the study 
when possible and the follow-up visit schedule for the subject will remain unchanged.  For a system 
modification the following information/activities are required to be collected: 

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• 
Modification or replace/explant date 
• 
Reason for modification  
• 
Information on device or lead modified   
• 
Information on any replacement device(s) 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
It is recommended that all explanted Medtronic products (device, leads, etc.) are returned to Medtronic 
for analysis per local process and when permissible by local laws and regulations. 
In the event that subject has a re-attempt after a previous unsuccessful system modification, the 
subsequent attempt(s) must be reported via CRF as separate system modifications.    
Attain Stability Quad MRI SureScan LV Lead (Model 4798) repositioned or replaced with 
another Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is repositioned or replaced, the following 
LV lead electrical tests and data collection must be completed:  
Lead Impedance 
• 
Collect LV Lead Impedances using Vector Express on all vectors  
• 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors  LV1 to 
RVcoil, LV2 to RVcoil, LV3 to RVcoil, LV4 to RVcoil or the final programmed vector  
• 
NOTE: Retain printouts for any manually tested vector at the site 
Pacing Capture Thresholds (PCT) 
• 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
• 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out of the 
box pulse width is set at 0.4ms) 
• 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on vectors  
LV1 to RVcoil, LV2 to RVcoil, LV3 to RVcoil, LV4 to RVcoil or the final programmed vector  
• 
NOTE: Retain printouts for any manually tested vector at the site 
Phrenic Nerve Stimulation (PNS) 
• 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
• 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
• 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
• 
Record the reason why the final configuration was selected for final programming 
• 
Record any programming changes to the LV lead apart from the LV lead pacing vector since the 
last visit and provide rationale for the change(s) 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) capped or explanted without 
replacement with another Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is capped or explanted without 
replacement while the subject is in the study, subjects will continue to be followed per their original 
follow-up schedule for safety monitoring until study closure.  LV lead electrical testing and interrogation 
files will not be required at follow-ups for subjects without the full protocol required system implanted. 

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Explant of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the Medtronic 
CRT-P or CRT-D device without replacement with another Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) and Medtronic CRT-P or CRT-D device 
Subjects who have their Attain Stability Quad MRI SureScan LV Lead (Model 4798) and Medtronic CRT-P 
or CRT-D device explanted without replacement during a system modification procedure should be exited 
from the study as soon as all system related and/or system modification procedure related AEs are 
resolved.  If no system or procedure related AEs are present at the conclusion of such a system 
modification procedure, the subject should be exited immediately. 
Medtronic CRT-P or CRT-D device explanted without replacement, Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) remains implanted 
If the Medtronic CRT-P or CRT-D device is explanted and a replacement device will be implanted, all 
attempts should be made to replace with another Medtronic CRT-P or CRT-D device.  In the event that an 
explanted Medtronic CRT-P or CRT-D device cannot be replaced with a new Medtronic CRT-P or CRT-D 
device, subjects who still have an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted 
will continued to be followed for safety monitoring in person per their original follow-up schedule until 
study closure.  Events related to the Attain Stability Quad MRI SureScan LV Lead (Model 4798) should be 
reported.  Left ventricular lead electrical testing will not be required at follow-ups for subjects without the 
full protocol required system implanted.  In an event that a second Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) was implanted as a result of an Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) related complication, the subject will be followed for safety, however the second implanted 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) will not be included for the analyses of study 
objectives except reportable system related adverse events. 
15.15. 
Study Exit  
Study Exit is defined as the moment when a subject officially stops participating in the study.  Date and 
reason for subject exit must be reported to Medtronic at the earliest opportunity. 
Subjects will be exited from the study for any of the following situations: 
• Study completed 
• Subject lost to follow-up 
• Subject did not meet eligibility criteria and was not yet implanted with an Attain Stability Quad 
MRI SureScan LV Lead (Model 4798)    
• Subject did not have a successful implant and no attempt at re-implant is made 
• Subject did not provide consent or data protection authorization, as required by law 
• Subject chooses to exit (i.e. revokes consent) 
• Investigator withdraws subject  
Prior to exiting a subject from the study, it is recommended to follow the subject until all ongoing system- 
and procedure-related AEs are resolved, unresolved with no further actions planned, or 30 days post the 
6 month visit, whichever occurs first.  Following exit, subjects will continue to receive standard medical 
care.  There will be no further required study-related follow-up visits for these subjects.  All data through 
the time of the subject’s exit will be available for data analyses. 
If possible, the following procedures should be performed / data collected at the exit visit: 

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• 
Report the reason for exit 
• 
Final interrogation file (or CareLink transmission) for exits occurring prior to the 6 month visit 
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
After subjects are exited from the study they should receive standard medical care and should be 
managed and followed per physician discretion.  
15.15.1. Study Completed 
All subjects will be followed until FDA Pre-Market Approval (PMA) of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798).  Medtronic will notify sites when the study is complete.  Upon exiting 
subjects, if the current follow-up visit and exit visit are combined, then both the follow-up CRF and a 
Study Exit CRF need to be completed but only one device interrogation/save-to-media needs to be 
completed and collected.  If AEs are unresolved at time of exit, it should be noted on the AE CRF that the 
AE is unresolved at time of study exit.   
15.15.2. Lost to Follow-up 
In the case that the subject is determined to be lost to follow-up, details of a minimum of two attempts 
and the method of attempt (e.g., one letter and one phone record or two letters) to contact the subject 
must be recorded.  In addition, follow the regulations set forth by the governing IRB or EC. 
15.15.3. Study Exit Upon Sponsor Request 
A subject must be exited from the study if the sponsor suspends study enrollment and a subject has 
signed the ICF but no implant attempt of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
has occurred (see Section 15.8.2.2). 
15.16. 
Subject Withdrawal or Discontinuation  
15.16.1. Subject Chooses to Exit (i.e. revokes consent) 
A subject can withdraw from the study at any time.  If the subject wishes to exit from the study (i.e. the 
subject revokes consent), the site is required to document the reason for exit on the Exit CRF.  In 
addition, study sites shall follow the regulations set forth by the governing Ethics Committee.  For 
countries following ISO 14155, permission may be requested to follow up with the patient outside of the 
study due to withdrawal based on problems related to the investigational feature safety or performance.  
If possible, the following data should be collected prior to subject withdrawal: 
• 
Report the reason for subject withdrawal 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
15.16.2. Investigator Withdraws Subject 
No subjects should be withdrawn by investigators unless compelling medical justification is present.  It is 
recommended investigators discuss any withdrawals with the study sponsor prior to exiting subjects.  If 

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an Investigator withdrawal is necessary, the following data should be collected prior to subject 
withdrawal if possible: 
• 
Report the reason for subject withdrawal 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
 The following are reasons for investigator-initiated subject withdrawal; 
Medical Necessity 
A subject may be exited from the study if an investigator feels it is necessary to withdraw the subject 
from the study due to a medical condition or other reason.  In such cases, the subject will be notified and 
provided an explanation regarding the reasons for the study exit. 
Explant of Medtronic CRT-P or CRT-D Device and Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) 
Subjects in which the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the Medtronic CRT-P 
or CRT-D device are explanted without replacement (i.e., subject no longer has a Medtronic CRT-P or 
CRT-D device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted) shall be 
exited from the study (refer to Section 15.8.2.2).  Subjects exposed to an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) through a lead attempt must be followed through at least one month or 
until all implant related AEs (system-, and/or procedure-related) have resolved or are unresolved with no 
further actions planned.  Subjects who have either an Attain Stability Quad MRI SureScan LV Lead (Model 
4798) (active or not active) or a Medtronic CRT-P or CRT-D device implanted will continued to be 
followed for safety until study completion. 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) Not Implanted 
Subjects that are not anticipated to have an implant attempt (e.g. do not meet inclusion/exclusion 
criteria) must be exited from the study.  Subjects that have a CRT system implant attempt, but who do 
not have an Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempted (See Section 15.8.2.2 
for definition) will be exited from the study following their procedure unless an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) attempt is scheduled.  If this attempt is more than 30 days from the 
baseline assessment, verification of the baseline data must be completed prior to a subsequent implant 
attempt. 
Subjects with an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant attempt 
will be followed at pre hospital discharge and one month unless there are ongoing implant related AEs 
(system- and/or procedure related), in which case they will be followed beyond one month until the 
implant related (i.e., system-, and/or procedure related) AEs have been resolved or are considered 
unresolved with no further actions planned.  The subjects may be followed via a clinic visit or by phone 
contact.  In geographies where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is market-
released, subjects will be exited from the study after the assessment of implant procedure or CRT system 
related AEs if the initial attempt of one Attain Stability Quad MRI SureScan LV Lead (Model 4798) model 
was unsuccessful.  The subject may undergo implant attempts with any market released LV lead that 
provides the best benefit to the patient, but data collection on these subsequent attempts will not be 
required as these subjects will be considered exited from the study. 

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15.17. 
Assessment of Efficacy 
The primary efficacy objective is based on the pacing capture threshold data collected as discussed in 
Section 19.1.  
15.18. 
Assessment of Safety  
The primary safety objective is based on the Adverse Event data collected.  Further information on the 
collection of Adverse Events is discussed in Section 17.1.1.  
15.19. 
Recording Data 
The study will collect data using Oracle Clinical, an electronic data management system for clinical 
studies.  Sites will enter data onto CRFs within the Oracle Clinical database.  
Data reported on the CRFs shall be derived from source documents, which may include worksheets, 
patient medical records, programmer printouts and device interrogation/save-to-media files.  These 
source documents must be created and maintained by the investigational site team.  Further detail on 
data management is provided in Section 21.2. 
15.20. 
Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the Clinical 
Investigation Plan or the Clinical Trial Agreement.  
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, or 
makes a conscious decision to deviate.  In all geographies, prior approval is not required when a 
deviation is necessary to protect the safety, rights or well-being of a subject in an emergency or in 
unforeseen situations beyond the investigator’s control (e.g. subject failure to attend scheduled follow-up 
visits, inadvertent loss of data due to computer malfunction, inability to perform required procedures due 
to subject illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward.   
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis).  However, 
prior approval from Medtronic is required for such situations.  
All study deviations must be reported to Medtronic regardless of whether they are medically justifiable, 
pre-approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
The deviation must be recorded in Oracle Clinical with an explanation for the deviations.  In the 
occurrence of a corrupted device interrogation/save-to-media file, Medtronic will request a deviation to 
document that a readable device interrogation/save-to-media file is unavailable.  
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the IRB/EC as well as 
Medtronic as soon as possible but no later than five (5) working days, or according to local requirements.  
Reporting of all other study deviations should comply with IRB/EC policies and/or local laws and 
deviations must be reported to Medtronic as soon as possible upon the site becoming aware of the 
deviation.    

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Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, and 
terminate the study).  Repetitive or serious investigator compliance issues may result in initiation of a 
corrective action plan with the investigator and site, and in some cases, necessitate suspending 
enrollment until the problem is resolved or ultimately terminating the investigator's participation in the 
study.  Medtronic may provide site-specific reports to investigators summarizing information on deviations 
that occurred at the investigational site on a periodic basis. 
16. Risks and Benefits 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of the product, 
from the research and development phase through the study phase and market release.  The risk 
analysis process for the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is being performed in 
accordance with ISO 14971, and will ensure that the level of risk has been reduced as low as possible 
and is acceptable prior to starting the Attain Stability Quad Clinical Study.   
Potential Risks 
Standard risks associated with the medical device used in this study, an analysis of Adverse Device 
Effects and a history of modification or recall of device under investigation or equivalent devices are listed 
in the Instruction for Use Manual or Clinical Manual. 
The potential adverse events (listed in alphabetical order) related to the use of transvenous leads inlcude, 
but are not limited to, the following conditions: 

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• 
Air embolism 
• 
Avulsion or other damage to the endocardium, valve, or vein (particularly in fragile hearts) 
• 
Cardiac dissection or perforation 
• 
Cardiac tamponade 
• 
Coronary sinus dissection  
• 
Death 
• 
Endocarditis or pericarditis 
• 
Erosion through the skin 
• 
Extracardiac muscle or nerve stimulation 
• 
Fibrillation or other arrhythmias 
• 
Heart Block 
• 
Heart wall or vein wall rupture 
• 
Hematoma/seroma 
• 
Infection 
• 
Lead conductor fracture or insulation failure 
• 
Lead dislodgement 
• 
Myocardial irritability 
• 
Myopotential sensing 
• 
Pericardial effusion or rub 
• 
Pneumothorax 
• 
Rejection phenomena (local tissue reaction, fibrotic tissue formation) 
• 
Threshold elevation or exit block 
• 
Thrombosis 
• 
Thrombotic embolism 
Additional potential adverse events related to the lead and the programmed paramenters include, but are 
not limited to, the following: 
Table 10: Additional adverse events related to the lead and programmed parameters 
Potential adverse event 
Indicator of potential 
adverse event 
Corrective actions to 
consider 
Lead dislodgementi 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Reprogram the LV pacing 
polarity. Reposition the lead. 
Lead dislodgementi 
Intermittent or continuous 
oversensing 
Reprogram the LV pacing 
polarity. Reposition the lead. 
Lead conductor fracture 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Replace the lead. Reprogram the 
LV pacing polarity. 
Lead conductor insulation failure 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Replace the lead. Reprogram the 
LV pacing polarity. 
Threshold elevation or exit block 
Loss of capturei 
Adjust the implantable device 
output. Reprogram the LV pacing 
polarity. Replace or reposition 
the lead. 
I Transient loss of capture or LV EGM signal integrity (including sensing) may occur following surgery until 
lead stabilization takes place. If stabilization does not occur, lead dislodgement may be suspected. 

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Implant techniques that may damage the lead include, but are not limited to, the following techniques: 
Table 11: Implant Techniques that may damage the lead 
Implant techniques that may 
damage the lead 
Possible effects on the lead 
Corrective action to consider 
Forcing the lead through the 
introducer/delivery system 
Electrode, conductor coil, or 
insulation damage 
Replace the lead. 
Use of too medial of an approach 
with venous introducer resulting 
in clavicle and first rib binding 
Conductor coil fracture, insulation 
damage 
Replace the lead. 
Using too stiff a stylet 
Conductor coil/insulation 
perforation 
Replace the lead. 
Puncturing the periosteum or 
tendon when using subclavian 
introducer approach resulting in 
binding 
Conductor coil fracture, insulation 
damage 
Replace the lead. 
Advancing the lead through the 
non-coronary central access 
veins without the stylet or guide 
wire fully inserted 
Tip distortion or insulation 
perforation 
Replace the lead. 
Inserting the proximal end of the 
guide wire through the lead tip 
seal without using the guide wire 
insertion tool 
Lead tip seal damage or 
conductor coil/insulation damage 
Replace the lead. 
 
Subjects who are pregnant may be at increased risk (e.g., radiation exposure, and other unforeseen risk 
to the fetus), and are excluded from participation in the study.  If a subject becomes pregnant during the 
study, she must notify the physician immediately.  The subject will remain in the study for intention to 
treat analysis, but the investigator will avoid any procedures that may be determined harmful. 
There may be other discomforts and risks related to the CRT-P or CRT-D device, the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798), and/or this study that are not foreseen at this time.  Interactions 
with concomitant medical treatment are not expected. 
The adverse event collection requirements in this study will ensure that risks associated with the study 
device and the Attain Stability Quad MRI SureScan LV Lead (Model 4798) are adequately monitored.  
16.2. Risk Minimization 
Medtronic has minimized the risks to the subject by the following: 
• 
Performing required laboratory and pre-clinical testing prior to the Attain Stability Quad Clinical 
Study; this information is available under  separate cover in the RPI with the FDA IDE submission 
and the CER with the CE-Mark 
• 
Implementing quality control measures into development and production processes 
• 
Providing guidelines for subject selection and evaluation, and subject inclusion and exclusion 
criteria 
• 
Providing adequate instructions via the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
User Manual, training, and labeling 

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• 
Selecting implanters that have demonstrated previous experience with implanting CRT-P or CRT-
D devices and specifically LV leads 
• 
Selecting investigators that have demonstrated previous experience with the programming, 
interrogating, and monitoring of CRT-P or CRT-D devices 
• 
After enrollment in the Attain Stability Quad Clinical Study, at each protocol required follow-up, 
the investigator must interrogate the study device to verify appropriate study device function and 
to evaluate the subject’s health and assess for any AEs 
16.3. Potential Benefits 
The potential benefits of having the Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted 
are similar to other LV leads currently available to the public.  The Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) is expected to increase lead stability and reduce the need for patients to undergo an 
additional procedure to replace a dislodged/displaced lead.  Due to the active fixation helix, it may be 
possible to place the lead in veins of various sizes.  There is a possibility that the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) may offer no additional benefit over similar LV leads.  The 
information gained from this study could result in the improved management of other CRT patients. 
16.4. Risk-Benefit Rationale 
The risk-benefit analysis has shown that there are no major additional risks associated with the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798), other than those associated with the implant, while 
benefits to the patient are possible.  Any residual risk associated with this study is considered low and 
acceptable. 
17. Adverse Event Assessments 
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are crucial 
for the protection of subjects.  Reporting and analysis of safety data are mandated by regulatory 
authorities worldwide.  Medtronic has established procedures in conformity with worldwide regulatory 
requirements to ensure appropriate reporting of safety information.  This study is conducted in 
accordance with these procedures and regulations. 
Data collected in this study may be used in support of global regulatory approvals.  Since the safety 
reporting requirements and classification systems vary for each regulatory agency, requirements from all 
geographies are taken into account for the collection and reporting of safety information.  Adverse Events 
and Device Deficiencies will be reported in all geographies. 
17.1. Adverse Event and Device Deficiency Assessment 
17.1.1. 
Adverse Events 
Adverse Event definitions are provided in Table 12.   The following AEs will be collected throughout the 
study duration, starting at the time the informed consent form is signed:  

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• 
All procedure related AEs  
• 
All system related AEs 
• 
All accessory related AEs 
• 
All cardiovascular related AEs  
• 
All Serious Adverse Events (SAEs), regardless of relatedness  
Reporting of these events to Medtronic will occur on an AE Form, including date of AE, treatment, 
resolution, assessment of both the seriousness of the AE and the relatedness to the investigational device 
or procedure.  Each AE must be recorded on a separate AE eCRF.  Documented pre-existing conditions 
are not considered AEs unless the nature or severity of the condition has worsened.  In addition, AEs 
impacting users or other persons, Non-subject Adverse Events, (reportable per ISO 14155) will be 
collected.  
In all geographies, Unavoidable AEs, listed in Table 12, need not be reported unless the AE worsens or is 
present outside the stated timeframe post-implant.  
For AEs that require immediate reporting (see Table 14), initial reporting may be done by contacting the 
study sponsor per the sponsor contact information.  The original completed AE CRF must be submitted to 
Medtronic as soon as possible.   
Any medication, whether cardiovascular or not, associated with the treatment of an AE must be reported.  
Medication changes that are not related to adverse events will not be collected.  
Subject deaths are also required to be reported.  Refer to Section 17.4 for Subject Death collection and 
reporting requirements.  
17.1.2. 
Device Deficiencies 
Device deficiency (DD) information will be collected throughout the study and reported to Medtronic. 
Note that DDs that result in an Adverse Device Effect (ADE) to the subject should be captured as an AE 
only.  Device Deficiencies that did not lead to an AE but could have led to a Serious Adverse Device Effect 
(SADE) (i.e., if suitable action had not been taken, if intervention had not been made, or if the 
circumstances had been less fortunate) require immediate reporting (see Table 14).  For DDs that require 
immediate reporting, initial reporting may be done by contacting the study sponsor per the sponsor 
contact information. 
17.1.3. 
Event Updates and Resolution 
For any changes in status of a previously reported AE (i.e. change in actions taken, change in outcome, 
change in relatedness), information needs to be updated on, or added to the original AE form.  All AEs 
must be followed until the AE has been resolved, is unresolved with no further actions planned, the 
subject dies or exits the study, or until study closure, whichever occurs first.  
In the event that a subject is exited from the study prior to their 6 month visit, all efforts should be made 
to continue following the subject until all unresolved system or procedure related adverse events, as 
classified by the investigator, are resolved or unresolved with no further actions planned.  
At the time of study exit, all collected AEs with an outcome of ”Unresolved” must be reviewed and an 
update to the original AE must be reported.  At a minimum, if there are no changes to the description, 
relatedness, test and procedures or actions taken, the outcome must be updated to reflect “Unresolved 
at time of study exit”. 

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17.2. Definitions/Classifications 
Where the definition indicates “device”, it refers to any device used in the study.  This might be the 
device under investigation, or any market released component of the system, and includes but is not 
restricted to: the CRT-P or CRT-D  device, the RA, RV or LV leads, the programmer, and implant tools.   
Table 12: Adverse Event and Device Deficiency Definitions 
General 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory findings) 
in subjects, users or other persons, whether or not related to the 
investigational medical device 
 
NOTE 1: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to 
events related to investigational medical devices. 
(ISO 14155:2011, 3.2) 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical 
device 
 
NOTE 1: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from an error 
use or from intentional misuse of the investigational medical 
device. (ISO 14155:2011, 3.1) 
Device Deficiency (DD) 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance.  
 
NOTE: Device deficiencies include malfunctions, use errors and 
inadequate labeling (ISO 14155:2011, 3.15) 
Relatedness 
Procedure Related 
An Adverse Event that is directly related to the implantation or 
surgical modification of the system.  
 
NOTE: In general, this excludes events that are inherent to any 
surgical procedure (e.g. anesthesia complications) as well as 
indirect subsequent consequences of the procedure (e.g. reaction 
to pain medication). 

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System Related 
 
 
(includes all implantable components 
and features, associated introduction 
tools, operational and installed software 
and programmers as defined in the 
Clinical Investigation Plan) 
An adverse event that results from the presence or performance 
of any component of the system. 
 
Device-related: An adverse event that results from the presence 
or performance (intended or otherwise) of the device.  
RA lead-related: An adverse event that results from the presence 
or performance (intended or otherwise) of the RA lead.  
RV lead-related: An adverse event that results from the presence 
or performance (intended or otherwise) of the RV lead.  
LV lead-related: An adverse event that results from the presence 
or performance (intended or otherwise) of the LV lead.  
a) 
LV Lead Fixation-related: An adverse event that results 
from the presence or performance of the side-helix. 
 
Accessory Related 
Programmer Related:  An adverse event that results from the 
presence or performance (intended or otherwise) of the 
programmer 
 
Implant tool-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the implant 
tool.  
Cardiovascular Related 
An Adverse Event relating to the heart and the blood vessels or 
the circulation (e.g. Atrial Fibrillation, Myocardial Infarction, 
stroke, perivascular disease) 
Heart Failure Related 
An adverse event related to worsening heart failure signs and 
symptoms such as hypervolemic and hypovolemic status requiring 
the administration, alteration, adjustment or augmentation of HF 
therapy (diuretics, inotropes and/or vasodilators etc.) or the 
utilization of ultrafiltration devices. 
MRI Related 
An adverse event which is caused by the interaction between the 
pacing system and the MRI system that occurs during the MRI 
procedure and up through the one-month post-MRI/waiting period 
follow-up visit. 

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Not Related 
Relationship to the device or procedures can be excluded when: 
 
The event is not a known side effect of the product 
category the device belongs to or of similar devices and 
procedures; 
 
The event has no temporal relationship with the use of 
the device or the procedures; 
 
The serious event does not follow a known response 
pattern to the medical device (if the response pattern is 
previously known) and is biologically implausible; 
 
The discontinuation of medical device application or the 
reduction of the level of activation/exposure – when 
clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure) do not 
impact the serious event; 
 
The event involves a body-site or an organ not expected 
to be affected by the device or procedure; 
 
The serious event can be attributed to another cause 
(e.g., an underlying or concurrent illness/clinical 
condition, an effect of another device, drug, treatment, 
or other risk factors); 
 
The event does not depend on a false result given by the 
device used for diagnosis (when applicable); 
 
Harms to the subject are not clearly due to use error; 
 
In order to establish the non-relatedness, not all the 
criteria listed above might be met at the same time, 
depending on the type of device/procedures and the 
event. 
Unlikely 
The relationship with the use of the device seems not relevant 
and/or the event can be reasonably explained by another cause, 
but additional information may be obtained. 
Possible 
The relationship with the use of the investigational device is weak 
but cannot be ruled out completely. Alternative causes are also 
possible (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment). Cases 
were relatedness cannot be assessed or no information has been 
obtained should also be classified as possible. 
Probable 
The relationship with the use of the investigational device seems 
relevant and/or the event cannot reasonably explained by another 
cause, but additional information may be obtained.  

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Causal Relationship 
The event is associated with the device or study procedures 
beyond reasonable doubt when: 
 
The event is a known side effect of the product category 
the device belongs to or of similar devices and 
procedures; 
 
The event has a temporal relationship with device 
use/application or procedures; 
 
The event involves a body-site or organ that the device 
or procedures are applied to or the device or procedures 
have an effect on; 
 
The serious event follows a known response pattern to 
the medical device (if the response pattern is previously 
known); 
 
The discontinuation of medical device application (or 
reduction of the level of activation/exposure) and 
reintroduction of its use (or increase of the level of 
activation/exposure) impact on the serious event (when 
clinically feasible); 
 
Other possible causes (e.g., an underlying or concurrent 
illness/clinical condition or/and an effect of another 
device, drug, or treatment) have been adequately ruled 
out; 
 
Harm to the subject is due to error in use; 
 
The event depends on a false result given by the device 
used for diagnosis (when applicable); 
 
In order to establish the relatedness, not all the criteria 
listed above might be met at the same time, depending 
on the type of device/procedures and the serious event. 
Seriousness 
Serious Adverse Event (SAE) 
 
Adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the subject, that 
either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body 
function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment to 
a body structure or a body function, 
c) led to fetal distress, fetal death or a congenital abnormality 
or birth defect 
 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the CIP, without serious deterioration in 
health, is not considered a serious adverse event. 
(ISO 14155:2011, 3.37) 
 
Serious Adverse Device Effect (SADE)  
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
(ISO 14155:2011, 3.36) 
 

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Unanticipated Adverse Device Effect 
(UADE) 
 
Any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, a 
device, if that effect, problem, or death, was not previously 
identified in a nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan 
or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or 
welfare of subjects. (21 CFR 812.3(s)) 
Unanticipated Serious Adverse Device 
Effect (USADE) 
 
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the current version 
of the risk analysis report 
 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an 
effect which by its nature, incidence, severity or outcome has 
been identified in the risk analysis report. 
(ISO 14155:2011, 3.42) 
 
Complication 
An adverse event that includes the following is considered a 
complication:  
• 
Results in death,  
• 
Involves any termination of significant device 
function, or  
• 
Requires an invasive intervention  
 
Non-invasive (21 CFR 812.3 (k)): when applied to a diagnostic 
device or procedure, means one that does not by design or 
intention:  Penetrate or pierce the skin or mucous membranes of 
the body, the ocular cavity, or the urethra, or enter the ear 
beyond the external auditory canal, the nose beyond the nares, 
the mouth beyond the pharynx, the anal canal beyond the 
rectum, or the vagina beyond the cervical os 
 
Note (FDA): Blood sampling that involves simple venipuncture is 
considered noninvasive, and the use of surplus samples of body 
fluids or tissues that are left over from samples taken for non-
investigational purposes is also considered noninvasive. 
 
*** Only system or procedure related AEs will be classified as 
complication or observation 
Observation 
Any Adverse Event that is not a complication. 
 
*** Only system or procedure related AEs will be classified as 
complication or observation 
Other 

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Unavoidable Adverse Event 
An Adverse Event inherent to a surgical procedure that is 
expected to occur in all subjects for a projected duration 
according to the Investigator’s opinion, including, but not limited 
to:  
 
Event Description 
Timeframe 
(hours) from 
the Surgical 
Procedure 
Anesthesia related nausea / vomiting  
24 
Low-grade fever (<100°F or 37.8°C) 
48 
Pocket site / Incisional pain 
72 
Mild to moderate bruising / ecchymosis 
168 
Sleep problems (insomnia) 
72 
Back pain related to laying on table 
72 
Shoulder pain/discomfort/stiffness related to 
shoulder immobilization during procedure 
72 
17.3. Reporting of Adverse Events 
17.3.1. 
Adverse Events and Device Deficiency Classification 
All reported AEs and DDs will be reviewed by a Medtronic representative.  Adverse Events will be 
classified according to the definitions provided. 
Upon receipt of AEs at Medtronic, a Medtronic representative will review the AE/DD for completeness and 
accuracy and when necessary will request clarification and/or additional information from the 
Investigator.  Medtronic will utilize the Medical Dictionary for Regulatory Activities (MedDRA), to assign a 
MedDRA term for each AE based on the information provided by the investigator.  
Regulatory reporting of AEs and DDs that could have led to an SADE will be completed according to local 
regulatory requirements.  Refer to Table 14 for a list of required investigator and Medtronic reporting 
requirements and timeframes.  It is the responsibility of the investigator to abide by any additional AE 
reporting requirements stipulated by the IRB/EC responsible for oversight of the study. 
APPENDIX 1 contains the Foreseeable Adverse Event List (FAL), which is a list of adverse events related 
to the system or procedure that have been observed in previous studies and may be experienced by 
subjects.  This list may help to assess if an AE is unanticipated in nature.   
For emergency contact regarding a UADE, SAE and/or SADE, contact a Attain Stability Quad Clinical Study 
representative immediately (refer to the study contact list provided in the site’s study documents 
binder/investigator site file or refer to the Sponsor Contact Information section provided in the CIP). 
Adverse Events and Deaths will be classified according to the standard definitions as outlined below:  
Table 13: Adverse Event Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 

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Relatedness 
Investigator 
Device, RA Lead, RV Lead, LV Lead, Implant Tool(s), 
Programmer, Procedure, Cardiovascular, Heart Failure, 
MRI 
Sponsor 
Device, RA Lead, RV Lead, LV Lead, Implant Tool(s), 
Programmer, Procedure 
Seriousness 
Investigator 
SAE  
Sponsor 
SAE, UADE/USADE, Device Deficiency with SADE potential 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided by 
Investigator 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-Cardiac, 
Unknown 
An independent Clinical Events Committee (CEC) will review and adjudicate, at a minimum, all events 
classified by the investigator or Medtronic as procedure or system related to determine relatedness and 
complication or observation classifications.    In addition, the CEC will also review and adjudicate all 
Adverse Events resulting in death. 
17.3.2. 
Adverse Events and Device Deficiency Reporting Requirements 
Regulatory reporting of AEs and device deficiencies will be recorded and reported according to local 
regulatory requirements.  It is the responsibility of the Investigator to abide by the adverse event 
reporting requirements stipulated by local law and the site’s IRB/EC.  
Table 14: Reporting Requirements 
Serious Adverse Events (SAEs) 
Investigator submit to: 
Medtronic 
Canada: Investigators are required to report SAEs to the sponsor immediately except for 
those SAEs that the protocol or other document (e.g. Investigator’s Brochure (IB)) identifies 
as not needing immediate reporting.   The immediate reports should be followed promptly by 
detailed, written reports.  
Medical Devices Regulations, sections 59-61.  A guidance for “immediately” is within 72 hours 
of the investigator becoming aware of the event;  Report to sponsor, without unjustified 
delay ISO 14155:2011, sec 9.8.b). 
EMEA: Immediately after the investigator first learns of the event or new information in 
relation with an already reported event.  
All geographies: Report to the sponsor, without unjustified delay, all serious adverse 
events. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies:  Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 

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Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Adverse Device Effects (ADEs),  
Investigator submit to: 
Medtronic 
EMEA: Immediately after the investigator first learns of the event or new information in 
relation with an already reported event. 
All geographies: Submit in a timely manner after the investigator first learns of the effect. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Serious Adverse Device Effects (SADEs), Unanticipated Adverse Device Effects (UADEs), 
Unanticipated Serious Adverse Device Effects (USADEs),  
Investigator submit to: 
Medtronic 
US: Submit as soon as possible, but no later than within 10 working days after the 
investigator first learns of the event.  (21 CFR 812.150(a)(1)) 
Canada: SADEs on the patient, the user or any other person must be reported to the 
Sponsor within 72 hours after it comes to the attention of the qualified investigator. 
It is recommended for the investigator to report safety events as soon as possible but no 
longer than 15 calendar days.”  
All geographies:  Immediately after the investigator learns of the event or of new 
information in relation to an already reported event. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement 
Ethics 
Committee 
All geographies: Submit to Ethics Committees per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies:  Submit to Ethics Committee per local reporting requirement. 
Investigators All geographies: Submit per local reporting requirement. 
All other reportable Adverse Events  
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the event. 

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Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Device Deficiencies with SADE potential 
Investigator submit to: 
Medtronic 
Canada: DDs that have resulted in any of the consequences characteristic of an SAE on the 
patient, the user or any other person or could do so were it to reoccur must be reported to 
the Sponsor within 72 hours after it comes to the attention of the qualified investigator 
EMEA: Immediately after the investigator first learns of the deficiency or of new information 
in relation with an already reported deficiency. 
All other geographies: Submit or report as required per local reporting requirements. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
All other Device Deficiencies 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the 
deficiency. 
Regulatory 
authorities 
Canada: any DD that: 
a. 
has resulted in any of the consequences characteristic of an SAE on the patient, 
the user or any other person; These must be reported by Medtronic to the 
Regulator within 10 days from the date Medtronic becomes aware. 
or 
b. 
could do so were it to reoccur.  These must be reported by Medtronic to the 
Regulator within 30 days from the date Medtronic becomes aware. 
 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
17.4. Subject Death 
17.4.1. 
Death Data Collection 
All subject deaths must be reported by the investigator to Medtronic on an AE form (AE with outcome of 
death) as soon as possible after the investigator first learns of the death.  In case of death, there should 
be one SAE with the outcome of death reported.  

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In the event of a subject’s death, it is recommended that the implanted system be explanted and 
returned to Medtronic for analysis whenever possible per local process.  Local laws and procedures must 
be followed where applicable. 
System Interrogation Data Recommendations: 
• 
After the subject has died but prior to explant, it is strongly recommended that the system be 
interrogated and a full summary interrogation (Interrogate All) performed when possible, and 
saved in a digital format (Save-to-Media).  Store one copy of the save-to-media at the site and 
send a copy to Medtronic.   
• 
Make the device interrogation/save-to-media file before any programming to prevent overwriting 
information in the device’s memory and/or distinguishing between events detected during versus 
before the explant procedure. 
• 
Recommend obtaining the exact date and time of death as lower temperatures after death can 
cause ERI and other “event flags” to be stored in the device memory. 
If the system is not interrogated, an explanation must be entered on the AE form.  For ICD systems, the 
ventricular tachycardia (VT) and ventricular fibrillation (VF) detection capabilities must be disabled to 
avoid inadvertent shocks.  If any system component is returned to Medtronic, internal return product 
reporting systems may be used to gather additional information about the returned device/component. 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic Attain Stability Quad Clinical Study team.  When a death occurs in a hospital, a copy of the 
death summary report and all relevant hospital records should be sent to the Medtronic Attain Stability 
Quad Clinical Study team, if available.  If an autopsy is conducted, the autopsy report should also be sent 
to the Medtronic Attain Stability Quad Clinical Study team if available and allowed by state/local law.  
When the death occurs at a remote site, it is the investigative site’s responsibility to attempt retrieval of 
information about the death.  Additionally, device disposition information should be updated.  In 
summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death  
• 
Relatedness to system and/or procedure 
• 
Device interrogation and Save-to-Media (if available) 
• 
Device disposition information 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and allowed by state/local law) 
17.4.2. 
Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. The Investigator 
shall classify each subject death per the following definitions: 
Cardiac Death: A death directly related to the electrical or mechanical dysfunction of the heart. 
Sudden Cardiac Death (SCD): Natural death due to cardiac causes, indicated by abrupt loss of 
consciousness within one hour of the onset of acute symptoms; preexisting heart disease may have been 
known to be present, but the time and mode of death are unexpected. If time of onset cannot be 

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determined, SCD will alternatively be defined as any unexpected cardiac death occurring out of the 
hospital or in the emergency room as dead on arrival. 
Non-sudden Cardiac Death: All cardiac deaths that are not classified as sudden deaths, including all 
cardiac deaths of hospitalized subjects on inotropic support. 
Non-cardiac Death: A death not classified as a cardiac death. 
Unknown Classification: Unknown death classification is intended for use only when there is insufficient or 
inadequate information to classify the death. 
Table 15: Subject Death Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-cardiac, 
Unknown 
The Clinical Events Committee will review all deaths and provide a final adjudication of the death 
classification.  
Regulatory reporting of Subject Deaths will be completed according to local regulatory requirements.  
17.5. Product Complaint Reporting 
Product complaint reporting and vigilance reporting are applicable and AEs related to any market-
released device during the study must be reported.  The reporting of product complaints is not part of 
the Attain Stability Quad Clinical Study and should be done in addition to the AE reporting requirements.  
Refer to local regulations for reporting requirements.  
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that has 
been placed on the market. 
• 
Abuse: Abnormal use (definition acc. #4.1 of Meddev 2.12-1 rev8) 
• 
Misuse: Use error (definition acc. #4.20 of Meddev 2.12-1 rev8) 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse of 
the product.  Reporting must be done immediately and via the regular channels for market-released 
products.  The reporting of product complaints by the clinical team must be done according to the local 
Standard Operating Procedures.  Medtronic will notify the regulatory authorities (e.g. Competent 
Authority) as applicable for the following incidents immediately upon learning of them: 
• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as 
any inadequacy in the labeling or instructions for use which led or might have led to the death or 
serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
• 
Any serious deterioration in the state of health, including: 
o 
Life-threatening illness or injury 
o 
Permanent impairment of a body function or permanent damage to a body structure 

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o 
A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 
18. Data Review Committees  
18.1. Clinical Events Committee 
The study will utilize a Clinical Events Committee (CEC). At regular intervals, an independent CEC will 
review events and adjudicate at a minimum all system, and procedure-related events.  Additionally, the 
CEC will provide an adjudication of the death classification for all reported deaths. 
The CEC will consist of a minimum of three (3) non-Medtronic-employed physicians that are not 
participating investigators for the study, including a CEC chairperson.  
Medtronic personnel may facilitate and participate in CEC meetings but will be non-voting members. 
For AEs and deaths reviewed by the CEC, Medtronic will provide the CEC with the Investigator’s 
description and classification and supportive documentation (when available).  The CEC is responsible for 
reviewing the Investigator’s assessment and supportive documentation (when available), reviewing 
applicable definitions, and determining final classifications for all adjudication parameters. For AEs, 
classification includes system/procedure relatedness and complication or observation.  Additionally, the 
CEC will provide an adjudication for all reported deaths, including system/procedure relatedness and 
cardiac relatedness. 
If the CEC disagrees with the investigator’s classification of the event, the difference will be provided to 
the investigator.  If the investigator agrees with the CEC’s adjudication, the CRF documenting the AE will 
be updated accordingly. 
If the investigator does not agree with the CEC’s adjudication classification, both determinations will be 
provided within the final report; however the CEC’s adjudication will be used for data analysis.  The 
disagreement will also be included in reporting to ethics committees and regulatory authorities, if 
required. 
18.2. Data Monitoring Committee 
A Data Monitoring Committee (DMC) will not be utilized for this study considering: 
 

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• 
An independent CEC will be formed to adjudicate at minimum all system and procedure related 
events and all deaths. 
• 
This study does not meet FDA’s recommended criteria (Guidance for Clinical Trial Sponsors: 
Establishment and Operation of Clinical Trial Data Monitoring Committees) for when a study 
should use a DMC, primarily because the study is not evaluating the effectiveness of a treatment 
intended to prolong life or reduce the risk of a major adverse health outcome. 
• 
As a result of risk analysis and mitigation efforts as outlined in Section 16, any residual risk 
associated with this study is considered low and acceptable. 
• 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is a modification of the currently 
market approved Attain Performa lead Models 4298, 4398, and 4598 is a modification of the 
currently market approved Model 4396 LV lead.  The Attain Stability Quad lead Model 4798 has a 
similar electrode spacing as the Attain Performa lead Models 4298, 4398, and 4598.  
• 
Study will be conducted under FDA oversight via an investigational device exemption (IDE). 
19. Statistical Design and Methods 
This section presents statistical considerations for the study design and provides a high-level description 
of planned analysis and reporting.  More details will be given in a separate Statistical Analysis Plan (SAP) 
that will be completed before data freeze for the primary objective analysis.  Any deviation to the pre-
specified statistical analyses will be noted in the study report.  The analysis of the study objectives will be 
completed when the sample size requirements (see Table 18) for all the study primary and secondary 
objectives are met.  An interim analysis will be conducted when 360 subjects are enrolled in the study.  
This interim analysis is specifically designed for one of the secondary objectives (details in Section 
19.2.2). 
19.1. Primary Objectives 
19.1.1. 
Primary Safety Objective 
Objective 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered safe if the probability of 
subjects free of Model 4798 lead-related complications at 6 months post-implant is greater than 87% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 87%). 
Hypothesis: 
H0: S(6-month) ≤ 87% 
H1: S(6-month) > 87% 
where S6-month is the probability that a subject remains free from Model 4798 lead related complications 
through 6 months since implant. 
Endpoint Justification 
The study primary safety endpoint is Attain Stability Quad MRI SureScan LV Lead (Model 4798) related 
complications.  All reported system and procedure-related AEs will be reviewed by an event review 
committee  for LV lead relatedness and severity (see Section 18.1).  
Lead related complication free survival probability to evaluate lead safety performance is widely accepted 
across cardiac device manufacturers and in the medical literature.  Current already market-released 
Quadripolar LV lead 6-month safety performance is summarized in Table 16.  The population 

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performance of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is expected to be similar to 
the Medtronic Attain Performa Model 4298 lead. 
Table 16: Safety Performance of Market Released Quadripolar Lead 
 
Medtronic  
Attain Performa 
St. Jude Medical 
Quartet22  
Boston Scientific 
ACUITY X423 
6-month LV 
Lead 
Complication 
Free 
Survival 
Probability 
Estimate 
Model 4298 (Canted): 96.0% 
Model 4398 (Straight): 98.8% 
Model 4598 (S-shape): 96.2% 
96% at 3 months 
Straight: 96.5%  
Spiral: 98.5%  
Statistical Analysis Methods  
The primary objective will be analyzed using the time-to-first event Kaplan-Meier survival analysis 
method.  A minimum number of subjects who have completed their 6-month post-implant visit will be 
required.  Time 0 will be the day a subject undergoes the implant procedure of a Attain Stability Quad 
MRI SureScan LV Lead (Model 4798), which will be independent of success status of this implant 
procedure. Event date is the onset date of a subject’s first complication that is related to the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) according to CEC adjudication.  Subjects who 
undergo an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant attempt and do not 
experience any LV lead related complications,  will be censored at the time of their last known exposure 
to the Attain Stability Quad MRI SureScan LV Lead (Model 4798) for the survival analysis.  For any lost-
to-follow up subject, the last contact date will be used as the censor date.  The 1-sided 97.5% 
confidence limit lower bound for the survival probability at 6 months (183 days) will be calculated using 
the log-log survival function approach (Kalbfleisch and Prentice 2002).  
Sample Size Consideration 
The primary safety objective performance criterion is set to be identical to Medtronic’s Attain Performa 
Clinical Study (IDE Number: G120213).  Therefore, the sample size calculation assumptions are derived 
based on the Model 4298 lead study results.  The Attain Performa Model 4298 lead reported a 6-month 
complication free survival probably of 96.0%, with 97.5% Confidence Lower Limit of 94.3% (PMA-s 
clinical report).  
The binomial calculation (Z-test) is used for initial sample size estimation.  In order to preserve the 
overall study power, a type II error less than 10% was used for the sample size calculation.  A sample 
size of 170 subjects completing their 6-month visit achieves greater than 90% power to detect a 
difference of 7% using the one-sided binomial test.  The target significance level is 0.025.  These results 
assume that the population proportion under the null hypothesis is 87% with an expected value of 94% 
(Figure 5). To account for 15% attrition, the enrollment size for this objective is 200. 

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Figure 5: Primary Safety Objective Sample Size Consideration by Difference Performance 
Assumption 
 
Determination of Patients / Data for Analysis 
All consented subjects who undergo an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant 
attempt will be included in the analysis cohort.  If a patient experiences multiple Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) implant procedures during the study, the analysis cohort will only 
consider the first procedure.  In the event multiple complications occur, the survival analysis endpoint is 
reached when the first Attain Stability Quad MRI SureScan LV Lead (Model 4798) related complication 
occurs. 
19.1.2. 
Primary Efficacy Objective #1 
Objective 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet the first primary efficacy 
objective if the proportion of subjects with at least one Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) pacing vector having a pacing capture threshold (PCT) less than or equal to 2.5 V at 0.5ms 
pulse width at 6 months post-implant is greater than 80% (i.e., the lower bound of the one-sided 97.5% 
confidence interval must be greater than 80%). 
Hypothesis 
H0: P16-month ≤ 80% 
HA: P16-month > 80%, 
where P16-month is the proportion of subjects with pacing voltage thresholds ≤ 2.5V at 0.5ms (with 
absence of PNS at this threshold) at 6 months follow-up visit post-implant for at least one LV lead pacing 
vector. 
Endpoint Justification 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is equipped with the identical four 
electrodes to the Attain Performa LV leads.  At the same time, the unique fixation mechanism may cause 
90.3% 
90.8% 
60.0%
65.0%
70.0%
75.0%
80.0%
85.0%
90.0%
95.0%
100.0%
170
180
190
200
210
220
Power 
Sample Size at 6 months 
0.93
0.94
0.95
0.96

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the distal end of the lead (tip) to be implanted away from the apical region of the heart, and therefore 
the PCT may be slightly higher than the values observed in other Quadripolar LV leads.  Therefore, we 
simulated the lead pacing threshold values based on the Attain Performa IDE study data, but excluding 
the PCT values collected at the most distal electrode.  The simulation estimated that 89% of the subjects 
will achieve this endpoint (Figure 6). 
Figure 6: Simulated PCT Distribution 
 
 
Statistical Analysis Methods 
All subjects with valid pacing thresholds measured at the 6 month follow-up visit will be included in this 
analysis.  The proportion of subjects having at least one LV lead pacing vector with voltage thresholds 
less than or equal to 2.5V will be calculated.  The lower bound of the 1-sided 97.5% Confidence Interval 
will be calculated using the Exact binomial method.  Any subject in which no valid pacing threshold value 
is measured  or who has an unable-to-capture result via all LV lead pacing vectors will be reviewed and 
adjudicated for a possible lead related AE but will not be included for this evaluation if the occurrence is 
deemed to be a system related event (e.g. lead dislodgement). However, this event may be counted 
against the safety primary endpoint based on the CEC’s final classification. 
Sample Size 
The primary efficacy endpoint will be analyzed using the Exact binomial method.  In order to preserve the 
overall study power, a type II error less than 10% was used for the sample size calculation.  A sample 
size of 145 subjects achieves 91% power to detect a difference of 0.1 using a one-sided binomial test at 
a target significance level of 0.025.  These results assume that the population proportion under the null 
hypothesis is 80%, with an expected proportion of 90%.  
Determination of Patients / Data for Analysis 
All subjects enrolled into this study satisfying the following conditions will be included in this analysis: 

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• 
Successfully implanted with a Medtronic Quad CRT-P or CRT-D  device and Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) 
• 
Completed 6-month follow-up visit  
• 
Initially implanted Attain Stability Quad MRI SureScan LV Lead (Model 4798) is active at the 6–
month follow-up visit 
• 
At least one available and valid pacing threshold at the 6-month follow-up visit 
19.1.3. 
Primary Efficacy Objective # 2 
Objective 
The Attain Stability Quad lead will meet the second primary efficacy objective if the proportion of subjects 
with at least one additional (or second) LV lead pacing vector having a pacing capture threshold less than 
or equal to 4.0 V at 0.5ms pulse width at 6 months post-implant is greater than 80% (i.e., the one-sided 
97.5% lower confidence bound must be greater than 80%).  
Hypothesis 
H0: P26-month ≤ 80% 
HA: P26-month > 80%, 
where P26-month is the proportion of subjects with at least one additional LV lead pacing vector with pacing 
voltage thresholds ≤ 4.0V at 0.5ms at 6 months post-implant follow-up visit. 
Endpoint Justification 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) has 16 LV programmable pacing vectors .  
Subjects may have the pacing configuration programmed or reprogrammed at each clinic visit.  A pacing 
threshold of 4.0 V will allow an adequate safety margin for programming LV pacing output.  The 
maximum pacing amplitude of the CRT-P or CRT-D devices capable of programming pacing output to any 
LV lead pacing vector is 8.0V.  In actual clinical practice, a less than 3V safety margin is used for the 
programmed LV lead pacing output in 99% of the patients.  
Statistical Analysis Methods  
The efficacy endpoint #2 will be analyzed using the Exact binomial method.  The proportion of subjects 
with at least 2 LV lead pacing vectors  having voltage thresholds less than or equal to 4.0V at 0.5ms will 
be calculated.  The lower bound of the 1-sided 97.5% Confidence Interval will be calculated using the 
Exact binomial method.  Any subject in which no valid pacing threshold values are measured  or with an  
Unable-to-capture result via all LV lead  pacing vectors  will be reviewed and adjudicated for possible lead 
related complications, and therefore may be counted against the study safety endpoint.  However, it will 
be counted as a failure if there is not any additional LV lead pacing vectors  (excluding the vector that is 
already include for the efficacy endpoint #1) are unable to capture with no lead related events reported. 
Sample Size 
The Attain Performa Model 4298 LV lead observed 97.7% subjects who were able to obtain a non-
programmed pacing vector with PCT less than or equal to 4 volts.  A sample size of 50 subjects 
completing the 6 month visit achieves 98% power to detect a difference of 0.18 using a one-sided 
binomial test at a target significance level of 0.025.  These results assume that the population proportion 
under the null hypothesis is 80%, with the expected proportion of 97%.  
Determination of Patients / Data for Analysis 
All subjects enrolled into this study satisfying the following conditions will be included in this analysis: 

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• 
Successfully implanted with a Medtronic Quad CRT-P or CRT-D  device and Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) 
• 
Completed 6-month follow-up visit  
• 
Initially implanted Attain Stability Quad MRI SureScan LV Lead (Model 4798) lead is active at the 
6–month follow-up visit 
• 
At least one available and valid pacing threshold at the 6-month follow-up visit. In the event a 
subject failed to provide more than one valid pacing threshold value, that subject will be 
considered as not having at least one additional LV lead pacing with PCT ≤ 4.0V at 0.5ms at 6 
months post-implant follow-up visit 
19.2. Secondary Objectives  
19.2.1. 
Secondary Objective # 1 
Objective - Implant procedure related information: success rate, implant related times 
The Attain Stability Quad LV lead implant success rate will be estimated as the number of subjects with 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) successfully implanted divided by the total 
number of subjects who had a Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant 
attempt.  A 2-sided 95% Confidence Interval will be calculated using the Exact Binomial method. 
The distribution of implant related times will be summarized through statistical summaries such as mean, 
standard deviation, minimum, median and maximum.  Only subjects with the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) successfully implanted will be included in this calculation.  The total 
implant time is defined as time from initial incision to final skin closure.  Fluoroscopy time is defined as 
the total time the fluoroscope is imaging.  Cannulation time is defined as the time from insertion of the 
first CS cannulation catheter to the first successful CS cannulation.  Successful lead placement time is 
defined as the time from lead insertion of the successfully placed lead to the time when the lead is placed 
in its first acceptable pacing location.   
19.2.2. 
Secondary Objective # 2 
Objective - 6-month reliability: post implant lead failure modes  
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is a composite of two existing market 
released Medtronic products.  The helix fixation is identical to the Attain Stability LV Lead Model 
20066/4796 (market released outside of the US).  The remainder of the lead is similar to the Attain 
Performa LV Lead Model 4298, released worldwide.   
Historical datasets will be used as informative priors for lead related complications.  More specifically, 
analysis of all complications related to fixation (helix performance) will use data from the Attain Stability 
(Model 20066/4796) research study, conducted outside of the US.  Analysis of all other lead related 
complications will use data from the Attain Performa clinical study, conducted globally.  Credible intervals 
will be constructed for each individual failure mode within the two groups. 
Historical Data (for secondary endpoints only) 

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o 
Fixation-related LV lead complications - Data from the 37 patients who completed 6-
month follow up with a successfully implanted 20066 lead in the Attain Stability study will 
be used as an informative prior.  
o 
All other LV lead-related complications - Data from the 401 patients who completed 6-
month follow up in the Attain Performa 4298 study will be used as an informative prior. 
These historical datasets will be downweighted such that their effective sample size will not exceed the 
9% of the total sample size (i.e at most 37 subjects at 6 months). 
Statistical Analysis Methods 
The weighted historical data will be incorporated using the power prior method24.  The weight of the 
historical data will be adjusted using a loss function25, which scales from 0 to 1 according to the similarity 
of the historical and observed data.  This loss function adjusts the amount of weight the prior receives.  
The comparison between historical and observed data will be performed twice, once for each group of 
complications (fixation-related and all other).  The objective of using a loss function with the power prior 
method is to reduce the influence of an informative prior in the parameter estimation, when the historical 
data does not agree with the current study data.  
If analysis of failure rate shows a high level of agreement between historical and current study data or 
there is better performance for Attain Stability Quad MRI SureScan LV Lead (Model 4798) compared to 
historical data, the historical data will be weighted at or near a maximum level (9% of total effective 
sample size).  If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) performs worse than 
historical data, the historical data will receive very little or zero weight.  Note that there will be two loss 
function weights, one for fixation-related complications and one for all other complications.  Credible 
interval calculations will be done separately for individual failure modes within the two groups of 
complications (fixation and all other).  
Denote by 𝜃𝜃𝑐𝑐 and 𝜃𝜃ℎ the probabilities of lead complication for the current and historical studies 
respectively.  The posterior distributions of 𝜃𝜃𝑐𝑐 and 𝜃𝜃ℎ respectively, both with minimally informative priors 
are: 
𝜃𝜃𝑐𝑐= 𝑏𝑏𝑏𝑏𝑏𝑏𝑎𝑎(𝑦𝑦𝑐𝑐+ 1, 𝑛𝑛𝑐𝑐−𝑦𝑦𝑐𝑐+ 1) 
𝜃𝜃ℎ= 𝑏𝑏𝑏𝑏𝑏𝑏𝑏𝑏(𝑦𝑦ℎ+ 1, 𝑛𝑛ℎ−𝑦𝑦ℎ+ 1) 
These posterior distributions are then stochastically compared using a posterior Bayesian p-value26 as: 
𝑝𝑝= 𝑃𝑃(𝜃𝜃𝑐𝑐≤𝜃𝜃ℎ) 
The desired characteristics for the loss function are: 
1. For 𝑝𝑝≥~0.5, there is a high level of agreement between current and historical data, therefore 
the loss function should allow a0 to be close to 1, allowing for full weight of historical data.  
2. Conversely, for 𝑝𝑝< ~0.5, there begins to be evidence of disagreement between current and 
historical data, and a0 should start to down-weight the prior, i.e. a0 approaches zero as 𝑝𝑝 
approaches zero. 
The Weibull cumulative distribution function (CDF) meets these criteria: 
𝑎𝑎0 = 1 −𝑒𝑒−(𝑝𝑝∗5)2 

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Note that for the case where the number of samples in the prior is different than the effective number, a 
scaling factor will be applied, where 𝑛𝑛ℎ is the desired effective number of prior samples and 𝑁𝑁ℎ is the 
actual number of prior samples: 
𝑎𝑎0 = 𝑛𝑛ℎ
𝑁𝑁ℎ
ൣ1 −𝑒𝑒−(𝑝𝑝∗5)2൧ 
Sample values are listed in Table 17 below and illustrated in Figure 7.  The comparison between current 
and historical data will be performed for all LV lead fixation related complications using Attain Stability 
(Model 20066) historical data and for all other LV lead related complications using Attain Performa 
historical data. 
Table 17: Prior weight from Attain Stability (Model 20066) and prior weight from Attain 
Performa as a function of the posterior Bayesian p-value (𝒑𝒑) 
 
Prior weight from Attain 
Stability (Model 20066) 
Prior weight from Attain 
Performa 
𝒑𝒑 
𝑎𝑎0 = 1 −𝑒𝑒−(𝑝𝑝∗5)2 
𝑎𝑎0 = 37
401 ൣ1 −𝑒𝑒−(𝑝𝑝∗5)2൧ 
0.01 
0.002 
0.000 
0.05 
0.061 
0.006 
0.1 
0.221 
0.020 
0.2 
0.632 
0.058 
0.5 
0.998 
0.092 
 
Figure 7: Loss Function 𝒂𝒂𝟎𝟎= 𝟏𝟏−𝒆𝒆−(𝒑𝒑∗𝟓𝟓)𝟐𝟐 
 
 
 

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Note that the loss function proposed here does not reduce the strength of the prior when the current 
study outperforms the historical data.  This implementation of the loss function is only concerned with 
negative impacts to patients, i.e. it penalizes an optimistic prior while not penalizing a pessimistic prior. 
Also, note that this function is selected for the shape of the CDF rather than due to conventional 
statistical properties of the Weibull distribution.  
Figure 8 illustrates the effect of the power prior coupled with the loss function.  The figure shows credible 
intervals in scenarios where the prior is optimistic (better performance than current study), in agreement 
(similar performance to the current study), and pessimistic (worse performance than the clinical study).  
Note that the prior data source in Figure 8 is the Attain Performa study, with 401 patients.  As will be 
discussed later, these data are scaled to represent a maximum of 37 patients (i.e. 9% weight).   
Figure 8: Credible Intervals for Scenarios of Agreement Between Historical and Current Data 
 
The prior data set in Figure 8 has 401 samples.  However, the maximum effective historical data sample 
size is 𝑛𝑛ℎ= 37, for a maximum weight of 9%.  Therefore, the prior will be scaled by a factor of (37/401).  
As an example, illustrated in the middle panel above, if the effective sample size is 34 out of 37, the prior 
has received 89% of the maximum weight, or 8.5%. 
The panels in Figure 8 can be interpreted as follows:  

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• 
Top panel: The current data shows lower performance than the prior.  The loss function 
produces a substantial penalty resulting in almost no weight to the prior (1%).  The posterior 
(final estimate) is essentially the same as the current study.   
• 
Middle panel: The current data is very similar to the prior.  The loss function penalty is small, 
resulting in a prior weight of 8.5% (recall that the maximum weight is 9.2%).  Because the 
agreement is good, the posterior(final estimate) is similar to both the prior and current study.   
• 
Bottom panel: The current data is very similar, with slightly better performance than the prior.  
The loss function produces a weight very close to the maximum of 9.2%.  The posterior (final 
estimate) is a balance between the prior and current study.  
Sample Size 
A Bayesian adaptive design is set up to enroll patients until a sufficient sample size is achieved to have 
high probability of meeting the required effective sample size of 𝑛𝑛𝑒𝑒= 400.  The number of enrolled 
patients in the study may vary from 363 to 400 subjects due to the adaptations to the trial.  This study 
follows methods from Berry, et.al.27  
The interim analysis will take place after 360 subjects have been enrolled into the study.   
The Adaptive Bayesian sample size algorithm will stop or continue enrollment accordingly to the 
following: 
1.) If the predictive probability of 𝑛𝑛𝑒𝑒≥400 is larger than 80% then enrollment will stop. 
2.) If the predictive probability of 𝑛𝑛𝑒𝑒≥400 is less than 80%, enroll sufficient additional patients to 
make the probability of 𝑛𝑛𝑒𝑒≥400 at least 80%.   
At the time of the interim analysis, some patients will not have completed the full evaluation period.  A 
longitudinal model will be employed to enable final observations to be imputed for those subjects with 
incomplete information.  
There are 3 types of subjects at a given interim analysis: 
1.) Subjects that have complete data 
2.) Subjects that have partial data (censored value at a particular time) 
3.) Subjects that have no information (subjects that have not been enrolled) 
Predictive probabilities for types 2 and 3 will have to be computed.  The predictive probability model that 
will be used is a piecewise exponential.  This will allow the final outcomes for the subjects who have not 
had an event and have not completed 6 month follow up to be simulated. 
Note this Bayesian approach to borrow information from historical datasets will only be used for the 
secondary objective #2. 
19.2.3. 
Secondary Objective # 3  
Objective – Electrical measurements (PCT and Impedance) at follow-ups 
Pacing Capture Threshold (PCT) and impedance data will be collected using VectorExpressTM.  Pacing 
vector changes will be monitored for all implanted patients at follow-up visits. 
Summary statistics for PCT and impedance at each time point (i.e. Implant, 6 months, etc.).  The 
distribution of the electrical measurements at the final programmed pacing vector will be presented as n, 
mean, standard deviation, minimum, median and maximum.  In the event of a replacement of a 
Medtronic Quad CRT-P or CRT-D  device and/or the implanted LV lead, only measurements from the 

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Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted at the initial implant procedure will 
be included in the analysis cohort for this objective. 
19.3. Additional Analysis  
19.3.1. 
Poolability Analysis 
Additional analysis will be conducted to summarize study primary objectives by patient characteristics, 
such as gender, age group,  race and study site geography.  The purpose of the poolability analysis is to 
identify if there is any clinical meaningful difference in a subgroup of patients.  These analyses will not be 
statistically powered, and there is no pre-specified statistical significance level for these analyses. 
19.3.2. 
Sensitivity Analysis 
All subjects enrolled into this study and successfully implanted with a Medtronic Quad CRT-P or CRT-D  
device and Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be included in the primary 
efficacy analysis datasets (efficacy objectives #1 and #2).  Sensitivity analysis such as the Tipping Point 
method or similar will be conducted to investigate the influence of subjects who were successfully 
implanted with the required system however missed a 6 month post implant follow-up test(s) (due to 
reasons such as missing in-office visit, subject exit, death and/or the initial implanted lead was 
deactivated).  For this purpose, all subjects with successful implant who do not meet analysis cohort 
requirements, will be considered as the worst case scenario (i.e. failure to meet the efficacy 
endpoints).The results will be submitted as part of the clinical reports.   
19.3.3. 
Additional Data Collection 
Heart failure clinical outcomes will be assessed. The measurements, including NYHA classification, death, 
heart failure related hospitalization, heart failure related study exits and subject self-reported global 
assessment for each subject will be obtained at 6 months post-implant.  Summary statistics will be 
provided.  
19.3.3. 
Overall Study Sample Size Requirements 
The sample size requirement  at 6-months for each of the study objectives is displayed in Table 18. The 
first row does not account for attrition, while the second row is inflated by 15% attrition. The sample size 
for Secondary Objective #2 assumes the conservative case that the interim look results in, no borrowing 
of historical data. Therefore, the overall sample size for the study is 471.  
Table 18: Required Sample Size by Study Objective  
 
Primary 
Safety 
Objective 
Primary 
Efficacy 
Objective 
#1 
Primary 
Efficacy 
Objective 
#2 
Secondary 
Objective 
#1  
Secondary 
Objective 
#2 (post-
implant 
failure 
modes) 
Secondary 
Objective 
#3 
Overall 
Number 
needed at 
6-months 
170 
145 
50 
NA 
400 
NA 
400 
Number of 
enrollments 
200 
171 
59 
NA 
471 
NA 
471  
 

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20. Ethics 
20.1. Statement(s) of Compliance  
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as good clinical practice (GCP).  Good Clinical Practice includes review and approval by an 
independent IRB/EC before initiating a study, continuing review of an ongoing study by an IRB/EC, and 
obtaining and documenting the freely given IC of a subject before initiating the study. 
The clinical investigation shall not begin until all required approvals and documents from the IRB/EC and 
a regulatory authority, if needed, have been received.  Any additional requirements imposed by the 
IRB/EC or regulatory authority shall be followed, if appropriate. 
The Attain Stability Quad Clinical Study was designed to reflect the GCP principles outlined in ISO 
14155:2011 and other international clinical requirements outlined below. These include the protection of 
the rights, safety and well-being of human subjects, controls to ensure the scientific conduct and 
credibility of the clinical investigation and the definition of responsibilities of the sponsor and 
investigators.  In accordance with ISO 14155:2011, the sponsor shall avoid improper influence on, or 
inducement of, the subject, monitor, any investigator(s) or other parties participating in, or contributing 
to, the clinical investigation.  All investigators shall avoid improper influence on or inducement of the 
subject, sponsor, monitor, other investigator(s) or other parties participating in or contributing to the 
clinical investigation.  Adverse Event and Device Deficiency handling in the Attain Stability Quad Clinical 
Study is ISO 14155:2011 compliant for all participating geographies with the exception  that only those 
AEs which are related to the subject’s system, procedure, accessory, or are cardiovascular-related, and all 
Serious AEs, will be collected. This ensures any AEs which could potentially be relevant will be collected. 
The scope and duration of the Attain Stability Quad Clinical Study would make collection of all AEs to be 
a significant burden for investigators and investigative sites. Therefore, only a subset of AEs will be 
collected in this study, including any that could be potentially relevant. 
The principles of the Declaration of Helsinki have been implemented through the IC process, IRB/EC 
approval, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment and 
publication policy.  
Ultimately, all sites in all geographies will follow and comply with: 
• 
Principles of Declaration of Helsinki 
• 
21 CFR Part 11 (Electronic Records, Electronic Signatures) (per local law) 
• 
21 CFR Part 54 (Financial Disclosure by Clinical Investigators) 
• 
The Clinical Trial Agreement 
• 
The procedures described within this CIP 
• 
Local Ethics Board Requirements 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to:  

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• 
In the United States, the study will be conducted under an FDA IDE in compliance with 21 CFR 
Parts: 
o 
50: Protection of Human Subjects 
o 
56: Institutional Review Boards 
o 
812: Investigational Device Exemptions 
• 
In Canada, SOR/98-282, Section 59-88 will be followed and Mandatory Problem Reporting 59(1), 
59(2), 60 (1)). 
• 
In EMEA the study will be conducted in compliance with the Active Implantable Medical Device 
Directive (AIMDD) and Declaration of Helsinki version 2013.  
• 
In Hong Kong and Malaysia, the study will be conducted in compliance with the Declaration of 
Helsinki version 2013.   
• 
In EMEA, an IB is not required for this study as it is a post market study 
The study will be publicly registered prior to first enrollment in accordance with the 2007 Food and Drug 
Administration Amendments Act FDAAA and Declaration of Helsinki on http://clinicaltrials.gov (PL 110-85, 
section 810(a)).  In addition, the study may be registered in local regulatory databases where required by 
local law.  
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law/regulations) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical ethics committee or institutional review board. 
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above 
mentioned groups prior to implementation of the revised CIP at the site.  
21. Study Administration 
21.1. Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this Attain Stability Quad Clinical 
Study.  Trained Medtronic personnel or delegates appointed by Medtronic may perform study monitoring 
at the study site in order to ensure that the study is conducted in accordance with the CIP, the CTA, and 
applicable regulatory and local requirements.  Medtronic, or delegates, must therefore be allowed access 
to the subjects’ case histories (clinic and hospital records, and other source data/documentation) upon 
request as per the Subject IC, Data Protection Authorization (where applicable) and CTA.  The principal 
investigator should also be available during monitoring visits.  
Monitoring for the study, including site initiation visits, interim monitoring visits, and closeout visits, will 
be done in accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess site study progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to IRB/EC approval and review of 
the study, maintenance of records and reports, and review of source documents against subject CRFs.  
Monitors review site regulatory and study compliance by identifying findings of non-compliance and 
communicating those findings along with recommendations for preventative/corrective actions to site 
personnel.  Monitors may work with study personnel to determine appropriate corrective action 

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recommendations and to identify trends within the study or at a particular site.  Regulatory documents 
may be reviewed at each study site.   
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, findings from previous monitoring visits 
and any suspected inconsistency in data that requires investigation. 
21.2. Data Management 
Data will be collected using Oracle Clinical, an electronic data management system for clinical studies.  
CRF data will be stored in a secure, password-protected database which will be backed up nightly.  Data 
will be reviewed using programmed and manual data checks.  Data queries will be made available to sites 
for resolution.  Study management reports may be generated to monitor data quality and study progress.  
At the end of the study, the data will be frozen and will be retained indefinitely by Medtronic. 
Only authorized persons can complete CRFs.  CRFs shall be signed by the Principle Investigator.  The 
Principle Investigator can delegate the CRF sign off task to Sub-Investigators only.  Delegation of 
authority will be specified on the appropriate documentation. 
All records and other information about subjects participating in this study will be treated as confidential.  
Data will be transferred and processed by Medtronic or a third party designated by Medtronic in a key 
coded form, unless it’s impossible to make it anonymous, for instance, where the subject’s name cannot 
be removed from the data carrier.     
Procedures in the CIP require source documentation.  Source documentation will be maintained at the 
site.  Source documents, which may include worksheets, patient medical records, programmer printouts 
and device interrogation files, must be created and maintained by the investigational site team.  For 
source documentation, the investigational site study team must sign and date any copies or printouts of 
original source documents with a statement that this is a complete and true reproduction of the original 
source document. 
The data reported on the CRFs shall be derived from source documents and be consistent with these 
source documents, and any discrepancies shall be explained in writing.  The CRF may be considered 
source for the following data collection elements recorded directly on the CRFs: 
• 
Enrollment Notification 
o 
Site assigned patient reference 
• 
Baseline 
o 
Administrative information 
• 
Adverse Event eCRF 
o 
Date study site became aware of event 
o 
Relatedness of adverse event 
• 
Device Deficiency eCRF 
o 
Date study site became aware of event 
• 
Subject Death 
o 
Date study site became aware of death 
o 
Relatedness of death 
• 
System Modification 
o 
Justification for explanted product not being returned to Medtronic 
• 
Deviations 

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o 
Reason for deviation 
• 
Investigational product Disposition Log 
o 
Date the Investigational Attain Stability Quad lead was implanted/explanted  
Even when the CRF may be considered as source, an alternate method of source documentation is 
always strongly encouraged. 
Save-to-media data collected at office visits will be sent to Medtronic.  Upon receipt, device data will be 
maintained within a Medtronic device database and retrieved for analysis and reporting. 
21.3. Direct Access to Source Data/Documents  
The sponsor or a regulatory authority may audit or inspect the study site to evaluate the conduct of the 
study.  The clinical investigator(s)/institution(s) shall allow study related monitoring, audits, IRB/EC 
review and regulatory inspection.  
21.4. Confidentiality 
All records and other information about subjects participating in this study will be treated as confidential.  
21.5. CIP Amendments 
Approval of subsequent revisions to the CIP is required at each study site from the following groups prior 
to implementation of the revised CIP at the site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical ethics committee or institutional review board. 
If a CIP amendment occurs, site personnel will need to be re-trained as necessary, and will need to 
submit any changes to their IRB/EC as required by the committee.  Protocol amendments will also be 
reported to and approved by the FDA, or regulatory authority. 
21.6. Warranty/Insurance Information 
21.6.1. 
Warranty 
Warranty information is provided in the product packaging for the commercially released CRT-P or CRT-D 
devices and leads, and additional copies are available upon request. 
21.6.2. 
Insurance (EMEA) 
Medtronic Bakken Research Center B.V. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical study liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the EC 
and/or Competent Authority (CA). 

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21.6.3. 
Insurance (Canada) 
Medtronic of Canada  is a wholly owned subsidiary of Medtronic, which as the parent company of such 
entity maintains appropriate general liability insurance coverage as required under applicable laws and 
regulations and will comply with applicable local law and custom concerning specific insurance coverage.  
If required, a General Liability insurance statement/certificate will be provided to the Ethics Committee. 
21.6.4. 
Insurance (Malaysia) 
Medtronic International Ltd. is a wholly owned subsidiary of Medtronic, which as the parent company of 
such entity maintains appropriate clinical trial liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the Ethics 
Committee. 
21.6.5. 
Insurance (Hong Kong) 
Medtronic Hong Kong Medical Ltd.   Ltd. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical trial liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the 
Ethics Committee. 
21.7. Record Retention 
21.7.1. 
Investigator Records 
The investigator is responsible for the preparation and retention of the records including, but not limited 
to, those cited below.  All of the below records, with the exception of case history records and case 
report forms, should be kept in the Investigator Site File (e.g., the study binder provided to the 
investigator) or Subject Study Binder.  Case Report Forms must be maintained and signed electronically 
by an investigator within the electronic data capture system during the study.  The following records are 
subject to inspection and must be retained for a period of two years (or longer as local law/regulation or 
hospital administration requires) after product approval.  Measures shall be taken to avoid loss or 
premature destruction. 
• 
All correspondence between the IRB/EC, sponsor, monitor, regulatory authority and/or the 
investigator that pertains to the investigation, including required reports.  
• 
Subject’s case history records, including:  
o 
Signed and dated informed consent form, in accordance with local requirements  
o 
Observations of adverse events/adverse device effects/device deficiencies 
o 
Medical history 
o 
Baseline, Implant and follow-up data (if applicable) 
o 
Documentation of the dates and rationale for any deviation from the protocol 
• 
Electronically signed and dated eCRFs and a blank set of CRFs where required by local law 
• 
All approved versions of the CIP, IC  
• 
Fully executed Clinical Trial Agreement 
• 
Ethics Committee approval documentation.  Written information that the investigator or other 
study staff, when member of the Ethics Committee, did not participate in the approval process. 

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Approval documentation must include the Ethics Board composition, where required per local 
law.   
• 
Regulatory authority notification, correspondence and approval, where required per local law. 
• 
List of investigation sites: This list is not yet final at the time of CIP development. The list will be 
provided under separate cover and will be maintained by the sponsor. 
• 
Financial disclosure (investigators) 
• 
Enrollment Log (for sites following ISO 14155) 
• 
For sites where the Attain Stability Quad lead is considered investigational, device disposition logs 
containing Model and serial numbers of devices implanted, subject IDs of the subjects implanted, 
implant/used dates, explant dates, returned-to-sponsor dates and reasons and method of 
disposal/destruction 
• 
Current curriculum vitae (signed and dated in EMEA only) of principal investigators and key 
members of investigation site team (as required by local law) 
• 
Documentation of delegated tasks 
• 
Study training records for investigation site team 
• 
Assurance certificates (EMEA, Hong Kong, and Malaysia) 
• 
Any other records that FDA and local regulatory agencies require to be maintained (e.g. Ethics 
Committee Roster, study equipment calibration information) 
• 
Final Study Report including the statistical analysis 
21.7.2. 
Investigator Reports 
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all CRFs, AEs and ADEs (reported per the country-specific collection requirements), DDs, deaths, 
crossovers and any deviations from the CIP.  If any action is taken by an IRB/EC with respect to this 
Attain Stability Quad Clinical Study, copies of all pertinent documentation must be forwarded to Medtronic 
in a timely manner.  Reports are subject to inspection and to the retention requirements as described 
above for investigator records.  
Investigator reporting requirements for safety data are listed in Section 17.3).  
Table 19: Investigator Reports Applicable for All Geographies per Medtronic Requirements 
Report  
Submit to 
Description/Constraints 
Withdrawal of Ethics 
Committee approval 
Sponsor and 
Relevant 
Authorities 
The investigator must report a withdrawal of approval by 
the reviewing Ethics Committee of the investigator’s part of 
the investigation within 5 working days. 
Study Deviations  
Sponsor and 
Ethics Committee 
Any deviation from the clinical investigation plan shall be 
recorded together with the explanation of the deviation. 
Notice of deviations from the CIP to protect the life or 
physical well-being of a subject in an emergency shall be 
given as soon as possible, but no later than 5 working days 
after the emergency occurred.  Except in such emergency, 
prior approval is required for changes in the plan or 
deviations.  
Failure to obtain 
informed consent 
Sponsor and 
Ethics Committee 
Informed consent shall be obtained in writing and 
documented before a subject is enrolled into the Attain 
Stability Quad Clinical Study 
Final Report 
Ethics Committee 
and  
Relevant 
Authorities 
This report must be submitted within 3 months of study 
completion or termination. 

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21.7.3. 
Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records that includes, but is not 
limited to: 
• 
All correspondence which pertains to the Attain Stability Quad Clinical Study 
• 
Executed Clinical Trial Agreement 
• 
Financial disclosures (investigators) 
• 
Current curriculum vitae (signed and dated in EMEA only) of principal investigators and key 
members of investigation site team (as required by local law) 
• 
Device Disposition Logs containing Model and serial numbers of devices implanted, subject IDs of 
the subjects implanted, implant/used dates, explant dates, returned-to-sponsor dates and 
reasons and method of disposal/destruction 
• 
Electronically signed and dated eCRFs 
• 
All approved informed consent templates, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all Ethics Committee approval letters and relevant Ethics Committee correspondence 
and Ethics Committee voting list/roster/letter of assurance 
• 
List of names, addresses, and professional position of the clinical investigators and coordinating 
clinical, if appointed.  
• 
Names and addresses of the institutions in which the Attain Stability Quad Clinical Study will be 
conducted: This list is not yet final at the time of CIP development. The list will be provided 
under separate cover and will be maintained by the sponsor. 
• 
Regulatory authorities correspondence, notification and approval as required by national 
legislation 
• 
Insurance certificates (EMEA, Hong Kong, and Malaysia)  
• 
Names/contact addresses of monitors 
• 
Monitoring reports (interim monitoring visit reports, follow-up letters and close-out visit reports) 
• 
Site qualification visit reports 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the Attain Stability Quad Clinical Study 
• 
The approved Clinical Investigation Plan and study related reports, and revisions 
• 
Documentation of delegated tasks 
• 
Study training records for site personnel and Medtronic personnel involved in the study 
• 
Sample of CRFs 
• 
Any other records that local regulatory agencies require to be maintained 
21.7.4. 
Sponsor Reports 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in the 
tables below (by geography).  In addition to the reports listed below, Medtronic shall, upon request of 
reviewing Ethics Committee, regulatory agency or FDA, provide accurate, complete and current 
information about any aspect of the Attain Stability Quad Clinical Study.  Safety data Medtronic reporting 
requirements are listed in Section 17.3). 
Table 20: Sponsor Reports for Canada 
Report  
Submit to 
Description/Constraints 

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Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities, and  
Head of the 
Institution 
Provide prompt notification of termination or suspension 
and reason(s).  
Recall and device 
disposition 
Investigators, 
Ethics Committee 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, 
or otherwise dispose of any devices.   
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  
Site specific study deviations will be submitted to 
investigators periodically.   
Table 21: Sponsor Reports for EMEA, Malaysia, Hong Kong 
Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities and 
Head of the 
Institution 
Provide prompt notification of termination or suspension 
and reason(s) per local law.  (ISO 14155:2011) 
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics Committee 
and relevant 
authorities 
Investigators and other Ethics Committees will be notified 
only if required by local laws or by the Ethics Committee. 
Withdrawal of CA 
approval 
Investigators, 
Ethics 
Committee, and 
relevant 
authorities 
Investigators, Ethics Committees and relevant authorities 
will be notified only if required by local laws or by the Ethics 
Committee. 
Progress Reports 
Ethics Committee 
and 
regulatory 
authorities 
This will be submitted to the Ethics Committee and 
regulatory authorities only if required by local law. 
Final report 
Investigators, 
Ethics 
Committee, and 
Regulatory 
authorities upon 
request 
• 
The investigator shall have the opportunity to review 
and comment on the final report.   
• 
If a clinical investigator does not agree with the final 
report, his/her comments shall be communicated to the 
other investigator(s).   
• 
The signature of the principal Investigator in each 
site should be obtained. 
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  (ISO 
14155:2011) 
Site specific study deviations will be submitted to 
investigators periodically.   
Table 22: Sponsor Reports for the United States 

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Report  
Submit to 
Description/Constraints 
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics 
Committee, 
FDA, and 
relevant 
authorities 
Notification within five working days.  (21 CFR 
812.150(b)(2))   
Withdrawal of FDA 
approval 
Investigators, 
Ethics 
Committee, and 
relevant 
authorities 
Notification within five working days.  (21 CFR 
812.150(b)(3)) 
Investigator List 
FDA 
Submit at 6-month intervals, a current list of the names and 
addresses of all investigators participating in the 
investigation.  (21 CFR 812.150(b)(4)) 
Progress Reports 
Ethics Committee 
and  
FDA 
Progress reports will be submitted at least annually.  (21 
CFR 812.150(b)(5), 812.36(f)   
Recall and device 
disposition 
Investigators, 
Head of 
Institution, 
Ethics 
Committee, 
relevant 
authorities, and  
FDA 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, 
or otherwise dispose of any devices.  (21 CFR 
812.150(b)(6)) 
Failure to obtain 
informed consent  
FDA 
Investigator’s report will be submitted to FDA within five 
working days of notification.  (21 CFR 812.150(b)(8)) 
Final report 
Investigators, 
Ethics 
Committee,  
Regulatory 
authorities upon 
request, and FDA 
Medtronic will notify FDA within 30 working days of the 
completion or termination of the investigation.   A final 
report will be submitted to the FDA, investigators, and 
IRBs/MECs within six months after completion or 
termination of this study.  (21 CFR 812.150(b)(7)) 
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  
Site specific study deviations will be submitted to 
investigators periodically.   
Other 
IRB, FDA 
Accurate, complete, and current information about any 
aspect of the investigation.  (21 CFR 812.150(b)(10)) 
 
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in secured file cabinets at Medtronic 
during the course of this study.  After closure of the study Medtronic will archive records and reports as 
required by applicable regulations. 
21.8. Publication and Use of Information 
Publications from the Attain Stability Quad Clinical Study will be handled according to Medtronic Policies 
and Standard Operating Procedures and as indicated in the CTA. 

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21.8.1. 
Publication Committee 
The Attain Stability Quad Clinical Study will utilize a Publication Committee which will include the Steering 
Committee members as well as Medtronic personnel.  This committee will manage study publications with 
the goal of publishing findings from the data.  The Publication Committee will develop the final 
Publication Plan as a separate document. 
The Publication Committee’s role is to:  
• 
Manage elements addressed in the publication plan as outlined in this section 
• 
Develop the final Publication Plan under separate cover 
• 
Execute the Publication Plan 
• 
Oversee the publication of primary, secondary and ancillary study results 
• 
Review and prioritize publication proposals 
• 
Provide input on publication content, and  
• 
Determine authorship 
In addition, the committee will apply and reinforce the authorship guidelines set forth in the Publication 
Plan.  Membership in the Publication Committee does not guarantee authorship.  The committee will 
meet as needed. 
21.8.2. 
Management of Primary, Secondary, and Ancillary Publications 
The Publication Committee reviews, prioritizes and manages all publications including primary, secondary 
and ancillary publications.  Primary and secondary publications are those that address analyses of any or 
all primary objectives or secondary/ancillary objectives, respectively, as specified in the Clinical 
Investigation Plan.  An ancillary publication is any publication that does not address the study objectives 
identified in the Clinical Investigation Plan.  They include publications proposed and developed by other 
Medtronic departments or entities, clinicians participating in this Attain Stability Quad Clinical Study and 
clinicians not participating in this Attain Stability Quad Clinical Study.  The committee will work with 
Medtronic to ensure that requests do not present conflicts with other proposals, are not duplicative and 
to determine which ancillary publication proposals, if any, will be supported. 
The committee may decide that no publications, including abstracts, will be published prior to the end of 
the study or with individual site data.  Requests for publications on study objectives utilizing subset data 
(e.g., regional) will be evaluated for scientific validity and the ability of Medtronic to provide resources.  
21.8.3. 
Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical Journal 
Editors (ICMJE), Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org).  Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data 
• 
Drafting the article or revising it critically for important intellectual content 
• 
Final approval of the version to be published 
Decisions regarding authorship and contributor-ship will be made by the publication committee.  The 
selected authors will be responsible for drafting the publication.  All selected authors must fulfill the 

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authorship conditions stated above to be listed as authors, and all contributors who fulfill the conditions 
must be listed as authors. 
All investigators not listed as co-authors will be acknowledged as the “Medtronic Attain Stability Quad 
Clinical Study Investigators” and will be individually listed according to the guidelines of the applicable 
scientific journal when possible.  Any other contributors will be acknowledged by name with their specific 
contribution indicated. 
21.8.4. 
Transparency 
Transparency of study results will be maintained by the following means: 
• 
A final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, IRB/ECs and Competent Authorities of participating countries when required by 
local law 
• 
Registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated  
• 
Submitting for publication the primary study results after the study ends  
• 
Disclosing conflicts of interest (e.g. financial) of the co-authors of publications according to the 
policies set forth by the corresponding journals and conferences  
• 
Making an individual sites study data accessible to the corresponding investigator after the 
completion of the study, if requested  
21.9. Suspension or Early Termination 
21.9.1. 
Planned Study Closure 
Study Closure is a process initiated by distribution of a study closure letter.  Study closure is defined as 
closure of a clinical study that occurs when Medtronic and/or regulatory requirements have been satisfied 
per the CIP and/or by a decision by Medtronic or regulatory authority, whichever occurs first.  The study 
closure process is complete upon distribution of the Final Report or after final payments, whichever 
occurs last.  Ongoing IRB/EC oversight is required until the overall study closure process is complete.  
Upon study closure, subjects should be managed and followed per physician discretion. 
21.9.2. 
Early Termination or Suspension 
Early Termination of the Study is the closure of a clinical study that occurs prior to meeting defined 
endpoints.  This is possible for the whole study or a single site.  Study Suspension is a temporary 
postponement of study activities related to enrollment and distribution of the product.  This is possible for 
the whole study or a single site.  In the event the whole study or a single site is terminated, subjects will 
be exited.  
Study-Wide Termination or Suspension 
Possible reasons for considering study suspension or termination of the study include but are not limited 
to: 
• 
Adverse events associated with the system or product under investigation which might endanger 
the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or regulatory body (where the study is operating under regulatory body 
authority)  

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• 
Technical issues during the manufacturing process 
Investigator/Site Termination or Suspension 
Possible reasons for clinical investigator or site termination or suspension include but are not limited to: 
• 
Failure to obtain initial IRB/EC approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups)  
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring findings in a timely manner, etc.)  
• 
Institutional Review Board/Ethics Committee suspension of the site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)  
• 
Investigator request (e.g. no longer able to support the study)  
21.9.3. 
Procedures for Termination or Suspension 
Medtronic-Initiated and Regulatory Authority-Initiated 
• 
Medtronic will promptly inform the clinical investigators of the (early) termination or suspension 
and the reasons and inform the regulatory authority(s) where required 
• 
In the case of study termination or suspension for reasons other than a temporary IRB/EC 
approval lapse, the investigator will promptly inform the IRB/EC  
• 
In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare 
Investigator-Initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension 
• 
The investigator will promptly inform the institution (where required per regulatory requirements)  
• 
The investigator will promptly inform the IRB/EC 
• 
The investigator will promptly inform the regulatory authorities (for regions following ISO only) 
• 
The investigator will promptly inform the subjects and/or the personal physician of the subjects 
to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare 
Institutional Review Board Ethics Committee-Initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days 
• 
Subject enrollment must stop until the suspension is lifted 
• 
Subjects already enrolled should continue to be followed in accordance with IRB/EC policy or its 
determination that an overriding safety concern or ethical issue is involved 
• 
The investigator will inform his/her institution (where required per local requirements)  

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• 
The investigator will promptly inform the subjects, and/or the personal physician of the subjects, 
with the rationale for the study termination or suspension 
• 
The investigator will promptly inform the regulatory authorities (for regions following ISO 14155 
only) 
 
 

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22. Appendices 
APPENDIX 1: Foreseeable Adverse Event List 
The information provided in this section pertains to foreseeable AEs that may be observed in study 
subjects and may collectively assist in identifying those events that are unexpected in nature.  The 
foreseeable adverse events information consists of three parts: (1) listing of potential adverse events 
associated with implantation of CRT system and transvenous leads, (2) rates of AEs reported from 
previous Medtronic studies evaluating CRT systems and transvenous leads, and (3) AEs rates reported in 
published literature for procedures similar to the CRT system implant procedure.  This information will be 
used in combination with device labeling, current event reporting information, and other published data 
to assess for an unexpected occurrence.  
The implantation of the study device, CRT-P or CRT-D, involves surgery, therefore, standard AEs 
associated with a surgical procedure may be experienced (e.g. anesthesia complications, injury, 
infections, bleeding, exacerbation of pre-existing conditions, healing complications, etc.).  The focus of 
this section is to specifically address in more detail, those events that are foreseeable due to the use, 
performance, and/or presence of the system under investigation.  
Additional potential risks associated with the implantation of the CRT system and the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798), as well as risk minimization are discussed within Section 16. 
Treatment required for procedure and/or system related adverse events that are experienced may 
include medication, device reprogramming, device modification (e.g. repositioning, surgical 
abandonment, surgical removal), or other surgical and medical remedies.  The AEs associated with the 
use of transvenous leads, pacing and defibrillation systems include, but are not limited to, the following: 

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Table 23: Listing of Potential Adverse Events Associated with System Implant 
• 
acceleration of tachyarrhythmias (caused by device) 
• 
air embolism 
• 
bleeding 
• 
body rejection phenomena, including local tissue reaction 
• 
cardiac dissection 
• 
cardiac perforation 
• 
cardiac tamponade 
• 
chronic nerve damage 
• 
constrictive pericarditis 
• 
death 
• 
device migration 
• 
endocarditis 
• 
erosion 
• 
excessive fibrotic tissue growth 
• 
extrusion 
• 
fibrillation or other arrhythmias 
• 
fluid accumulation 
• 
formation of hematomas/seromas or cysts 
• 
heart block 
• 
heart wall or vein wall rupture 
• 
hemothorax 
• 
infection 
• 
keloid formation 
• 
lead abrasion and discontinuity 
• 
lead migration/dislodgment 
• 
complications and mortality due to inability to deliver appropriate and intended therapy 
• 
muscle and/or nerve stimulation 
• 
myocardial damage 
• 
myocardial irritability 
• 
myopotential sensing 
• 
pericardial effusion 
• 
pericardial rub 
• 
pneumothorax 
• 
poor connection of the lead to the device, which may lead to oversensing, undersensing, or a 
loss of therapy 
• 
stroke 
• 
threshold elevation 
• 
thrombotic embolism 
• 
thrombosis 
• 
tissue necrosis 
• 
valve damage (particularly in fragile hearts) 
• 
venous occlusion 
• 
venous perforation 

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An additional potential AE associated with the use of transvenous left ventricular pacing leads is coronary 
sinus dissection. 
Additional potential AEs associated with the use of ICD systems include, but are not limited to, the 
following events: 
• 
inappropriate shocks 
• 
potential mortality due to inability to defibrillate 
• 
shunting current or insulating myocardium during defibrillation 
Patients susceptible to frequent shocks despite medical management could develop psychological 
intolerance to an ICD system that might include the following conditions: 
• 
dependency 
• 
depression 
• 
fear of premature battery depletion 
• 
fear of shocking while conscious 
• 
fear that shocking capability may be lost 
• 
imagined shocking (phantom shock) 
Adverse Events Reported in Previous Medtronic Studies 
The listing below provides an example of reported system and procedure related AEs in recent Medtronic 
studies.  This table includes a summary of combined system or procedure related AEs as reported in the 
Concerto-AT, Insync III US, 4194, 4195, 4196, 4396, Adaptive CRT, and Attain Performa studies along 
with their incidence.  The observed rate is based on the study populations that included a total of 3,246 
subjects.  In total, there were 1749 system or procedure related events.  This includes both serious and 
non-serious events.  The rate is calculated as number of subjects that experience the event, not 
accounting for duration of follow-up. 
Table 24: System or procedure-related adverse events from previous clinical studies 
MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Abdominal pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Acidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Acute respiratory failure 
4 
4 
0.12% 
(0.03%, 0.32%) 
Adverse drug reaction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Air embolism 
1 
1 
0.03% 
(0.00%, 0.17%) 
Alcohol withdrawal syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Alpha haemolytic streptococcal 
infection 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Anaemia 
7 
7 
0.22% 
(0.09%, 0.44%) 
Anaemia postoperative 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anaphylactic shock 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anticoagulation drug level below 
therapeutic 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anxiety 
3 
3 
0.09% 
(0.02%, 0.27%) 
Application site rash 
2 
2 
0.06% 
(0.01%, 0.22%) 
Arterial haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arteriovenous fistula 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arteriovenous fistula operation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arthralgia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arthritis bacterial 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ascites 
1 
1 
0.03% 
(0.00%, 0.17%) 
Atelectasis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Atrial fibrillation 
19 
19 
0.59% 
(0.35%, 0.91%) 
Atrial flutter 
4 
4 
0.12% 
(0.03%, 0.32%) 
Atrial tachycardia 
5 
4 
0.12% 
(0.03%, 0.32%) 
Atrioventricular block 
16 
16 
0.49% 
(0.28%, 0.80%) 
Back pain 
3 
3 
0.09% 
(0.02%, 0.27%) 
Bacteraemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac arrest 
8 
8 
0.25% 
(0.11%, 0.49%) 
Cardiac failure 
46 
43 
1.32% 
(0.96%, 1.78%) 
Cardiac failure chronic 
5 
5 
0.15% 
(0.05%, 0.36%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Cardiac pacemaker battery 
replacement 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac perforation 
8 
8 
0.25% 
(0.11%, 0.49%) 
Cardiac sarcoidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac tamponade 
3 
3 
0.09% 
(0.02%, 0.27%) 
Cardiac vein dissection 
38 
37 
1.14% 
(0.80%, 1.57%) 
Cardiac vein perforation 
5 
5 
0.15% 
(0.05%, 0.36%) 
Cardiogenic shock 
3 
3 
0.09% 
(0.02%, 0.27%) 
Cardiomyopathy 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiovascular disorder 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cellulitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Cerebral infarction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cerebrovascular accident 
3 
3 
0.09% 
(0.02%, 0.27%) 
Chest discomfort 
4 
4 
0.12% 
(0.03%, 0.32%) 
Chest pain 
8 
8 
0.25% 
(0.11%, 0.49%) 
Chronic obstructive pulmonary 
disease 
3 
3 
0.09% 
(0.02%, 0.27%) 
Circulatory collapse 
1 
1 
0.03% 
(0.00%, 0.17%) 
Colitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Complication of device insertion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Complication of device removal 
4 
4 
0.12% 
(0.03%, 0.32%) 
Constipation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Contusion 
2 
2 
0.06% 
(0.01%, 0.22%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Cough 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cystitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Decubitus ulcer 
1 
1 
0.03% 
(0.00%, 0.17%) 
Deep vein thrombosis 
14 
14 
0.43% 
(0.24%, 0.72%) 
Dehydration 
1 
1 
0.03% 
(0.00%, 0.17%) 
Delirium 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device alarm issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device battery issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device capturing issue 
30 
29 
0.89% 
(0.60%, 1.28%) 
Device computer issue 
19 
19 
0.59% 
(0.35%, 0.91%) 
Device connection issue 
19 
19 
0.59% 
(0.35%, 0.91%) 
Device damage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device dislocation 
125 
107 
3.30% 
(2.71%, 3.97%) 
Device electrical impedance issue 
12 
12 
0.37% 
(0.19%, 0.64%) 
Device extrusion 
2 
1 
0.03% 
(0.00%, 0.17%) 
Device failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device lead damage 
13 
13 
0.40% 
(0.21%, 0.68%) 
Device lead issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device misuse 
9 
9 
0.28% 
(0.13%, 0.53%) 
Device pacing issue 
69 
67 
2.06% 
(1.60%, 2.61%) 
Device psychogenic complication 
7 
7 
0.22% 
(0.09%, 0.44%) 
Device related infection 
3 
3 
0.09% 
(0.02%, 0.27%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Device signal detection issue 
2 
2 
0.06% 
(0.01%, 0.22%) 
Device stimulation issue 
443 
349 
10.75% 
(9.71%, 11.87%) 
Diabetes 
1 
1 
0.03% 
(0.00%, 0.17%) 
Diarrhea 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dizziness 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dressler's syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Drug hypersensitivity 
3 
3 
0.09% 
(0.02%, 0.27%) 
Dysarthria 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dyspnoea 
2 
2 
0.06% 
(0.01%, 0.22%) 
Dyspnoea exertional 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dyspnoea paroxysmal nocturnal 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ecchymosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Electromagnetic interference 
1 
1 
0.03% 
(0.00%, 0.17%) 
Endocarditis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Endocarditis staphylococcal 
1 
1 
0.03% 
(0.00%, 0.17%) 
Erythema multiforme 
1 
1 
0.03% 
(0.00%, 0.17%) 
Fatigue 
5 
5 
0.15% 
(0.05%, 0.36%) 
Fluid overload 
1 
1 
0.03% 
(0.00%, 0.17%) 
Gastroenteritis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Gastrointestinal haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Haematoma 
2 
2 
0.06% 
(0.01%, 0.22%) 
Haematuria 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Haemoptysis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Haemothorax 
4 
4 
0.12% 
(0.03%, 0.32%) 
Hot flush 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hydrothorax 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyperglycaemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyperkalaemia 
4 
4 
0.12% 
(0.03%, 0.32%) 
Hypersensitivity 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hypertension 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyponatraemia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Hypotension 
20 
20 
0.62% 
(0.38%, 0.95%) 
Hypovolaemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ileus 
1 
1 
0.03% 
(0.00%, 0.17%) 
Impaired healing 
2 
2 
0.06% 
(0.01%, 0.22%) 
Implant site bruising 
2 
2 
0.06% 
(0.01%, 0.22%) 
Implant site cellulitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site effusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site erosion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site erythema 
6 
6 
0.18% 
(0.07%, 0.40%) 
Implant site haematoma 
98 
96 
2.96% 
(2.40%, 3.60%) 
Implant site haemorrhage 
6 
6 
0.18% 
(0.07%, 0.40%) 
Implant site hypoaesthesia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site infection 
44 
44 
1.36% 
(0.99%, 1.82%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Implant site inflammation 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site irritation 
5 
5 
0.15% 
(0.05%, 0.36%) 
Implant site oedema 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site pain 
72 
64 
1.97% 
(1.52%, 2.51%) 
Implant site rash 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site swelling 
4 
4 
0.12% 
(0.03%, 0.32%) 
Implant site warmth 
1 
1 
0.03% 
(0.00%, 0.17%) 
Incision site complication 
1 
1 
0.03% 
(0.00%, 0.17%) 
Incision site haemorrhage 
5 
5 
0.15% 
(0.05%, 0.36%) 
Incision site pain 
4 
4 
0.12% 
(0.03%, 0.32%) 
Incisional drainage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Infection 
2 
2 
0.06% 
(0.01%, 0.22%) 
Infusion site extravasation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Intracardiac thrombus 
6 
6 
0.18% 
(0.07%, 0.40%) 
Lead dislodgement 
33 
30 
0.92% 
(0.62%, 1.32%) 
Leukocytosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Localized oedema 
1 
1 
0.03% 
(0.00%, 0.17%) 
Mediastinal effusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Medical device discomfort 
3 
3 
0.09% 
(0.02%, 0.27%) 
Medical device site reaction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Monoparesis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Muscle spasms 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Muscle twitching 
1 
1 
0.03% 
(0.00%, 0.17%) 
Musculoskeletal chest pain 
2 
2 
0.06% 
(0.01%, 0.22%) 
Musculoskeletal pain 
42 
40 
1.23% 
(0.88%, 1.67%) 
Musculoskeletal stiffness 
1 
1 
0.03% 
(0.00%, 0.17%) 
Myocardial infarction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nausea 
1 
1 
0.03% 
(0.00%, 0.17%) 
Neck pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nephrosclerosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Neuropathy peripheral 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nodal rhythm 
2 
2 
0.06% 
(0.01%, 0.22%) 
Non-cardiac chest pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Oedema peripheral 
12 
12 
0.37% 
(0.19%, 0.64%) 
Oliguria 
1 
1 
0.03% 
(0.00%, 0.17%) 
Operative haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Orthostatic hypotension 
2 
2 
0.06% 
(0.01%, 0.22%) 
Oversensing 
34 
33 
1.02% 
(0.70%, 1.42%) 
Oxygen saturation decreased 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pacemaker generated arrhythmia 
6 
6 
0.18% 
(0.07%, 0.40%) 
Pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pain in extremity 
1 
1 
0.03% 
(0.00%, 0.17%) 
Palpitations 
9 
9 
0.28% 
(0.13%, 0.53%) 
Paraesthesia 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Pericardial effusion 
16 
15 
0.46% 
(0.26%, 0.76%) 
Pericarditis 
4 
4 
0.12% 
(0.03%, 0.32%) 
Phantom shocks 
4 
3 
0.09% 
(0.02%, 0.27%) 
Phlebitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Pleural effusion 
21 
21 
0.65% 
(0.40%, 0.99%) 
Pneumonia 
9 
9 
0.28% 
(0.13%, 0.53%) 
Pneumothorax 
43 
43 
1.32% 
(0.96%, 1.78%) 
Pocket erosion 
4 
4 
0.12% 
(0.03%, 0.32%) 
Post procedural haemorrhage 
2 
2 
0.06% 
(0.01%, 0.22%) 
Presyncope 
3 
3 
0.09% 
(0.02%, 0.27%) 
Procedural haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Procedural headache 
2 
2 
0.06% 
(0.01%, 0.22%) 
Procedural pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pruritus 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pruritus generalized 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulmonary embolism 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulmonary oedema 
3 
3 
0.09% 
(0.02%, 0.27%) 
Pulmonary sepsis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulseless electrical activity 
2 
2 
0.06% 
(0.01%, 0.22%) 
Pyrexia 
5 
5 
0.15% 
(0.05%, 0.36%) 
Rash 
8 
8 
0.25% 
(0.11%, 0.49%) 
Rash generalized 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Renal failure 
8 
8 
0.25% 
(0.11%, 0.49%) 
Renal failure acute 
2 
2 
0.06% 
(0.01%, 0.22%) 
Renal impairment 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory acidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory distress 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sepsis 
3 
3 
0.09% 
(0.02%, 0.27%) 
Sepsis syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Septic shock 
4 
4 
0.12% 
(0.03%, 0.32%) 
Sinus arrest 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sinus bradycardia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sinus tachycardia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Staphylococcal infection 
2 
2 
0.06% 
(0.01%, 0.22%) 
Stitch abscess 
1 
1 
0.03% 
(0.00%, 0.17%) 
Subclavian vein thrombosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Subcutaneous emphysema 
1 
1 
0.03% 
(0.00%, 0.17%) 
Subcutaneous haematoma 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sudden cardiac death 
10 
10 
0.31% 
(0.15%, 0.57%) 
Superior vena cava stenosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Supraventricular extrasystoles 
1 
1 
0.03% 
(0.00%, 0.17%) 
Supraventricular tachycardia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Syncope 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Tachycardia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Thrombophlebitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Thrombosis 
8 
8 
0.25% 
(0.11%, 0.49%) 
Thrombotic stroke 
1 
1 
0.03% 
(0.00%, 0.17%) 
Toxicity to various agents 
1 
1 
0.03% 
(0.00%, 0.17%) 
Twiddler's syndrome 
5 
5 
0.15% 
(0.05%, 0.36%) 
Undersensing 
7 
7 
0.22% 
(0.09%, 0.44%) 
Urinary retention 
2 
2 
0.06% 
(0.01%, 0.22%) 
Vena cava thrombosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Venous occlusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular dyssynchrony 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular extrasystoles 
2 
2 
0.06% 
(0.01%, 0.22%) 
Ventricular fibrillation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular tachycardia 
11 
11 
0.34% 
(0.17%, 0.61%) 
Vomiting 
3 
3 
0.09% 
(0.02%, 0.27%) 
Weaning failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Weight decreased 
1 
1 
0.03% 
(0.00%, 0.17%) 
Wound dehiscence 
1 
1 
0.03% 
(0.00%, 0.17%) 
Adverse Events in Literature 
The potential AEs associated with the implantation of CRT-P or CRT-D  systems have been documented 
in various articles in medical scientific literature.  A summary of those events and their published 
incidence are included below. 
1. Ahsan SY, Saberwal B, Lambiase PD, Chaubey S, Segal OR, Gopalamurugan AB, McCready J, 
Rogers DP, Lowe MD, and Chow AWC.  An 8-year single-centre experience of cardiac 

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resynchronization therapy: procedural success, early and late complications, and left ventricular 
lead performance.  Europace 2013;15:711-717. 
Retrospective data were analyzed for all acute and chronic complications occurring over 490 consecutive 
CRT device procedures in 402 patients, from 2000 through 2008.  Associated complications were 
reported by timeframe. 
Table 25: Complications reported in Ahsan et al. 
 
 
2. Dickstein K, Bogale N, Priori S, Auricchio A, Cleland JG, Gitt A, Limbourg T, Linde C, van 
Veldhuisen DJ, Brugada J; Scientific Committee; National Coordinators.  The European Cardiac 
Resynchronization Therapy Survey.  European Heart Journal 2009; 30:2450–2460. 
The primary aim of this survey was to describe current European practice associated with CRT 
implantations.  A total of 140 centers from 13 European countries contributed data from consecutive 
patients successfully implanted with a CRT device with or without an ICD between November 2008 and 
June 2009.  The total number of patients enrolled was 2438. 
Table 26: Complications reported in Dickstein et al. 
Event 
Incidence (%) 
Peri-procedural complications 
10 
Bleeding 
1 
Pocket haematoma 
3 
Pneumothorax 
1 
Pericardial tamponade 
0.3 
Coronary sinus dissection 
1 
Phrenic nerve pacing 
2 
Lead dislocation 
3 

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Post–implantation device related complications 
4 
Lead displacement 
2 
Lead malfunction 
0 
Phrenic nerve stimulation 
2 
 
3. Kirkfeldt R.E., Johansen J.B., Nohr E.A., Jorgensen O.D., Nielsen J.C. Complications after cardiac 
implantable electronic device implantations: An analysis of a complete, nationwide cohort in 
Denmark.  European Heart Journal 2014 35:18 1186-1194. 
This was a population-based cohort study in all Danish patients who underwent a Cardiac Implantable 
Electronic Device (CIED) procedure from May 2010 to April 2011.  The study population consisted of 5918 
consecutive patients.  Total of 562 patients (9.5%) experienced at least one complication. 
Table 27: Complications reported by Kirkfeldt et al. shows cumulative incidence of complications at 6 
monthsa. 
Table 27: Complications reported by Kirkfeldt et al. 
Complication type 
All (n=5918) 
New Implant 
(n=4335) 
Generator 
replacement 
(n=1136) 
Upgrade/Lead 
revision (n=427) 
Any complication 
562 (9.5; 8.7–
10.2) 
432 (9.9; 9.0–
10.8) 
67 (5.9; 4.5–7.3) 
63 (14.8; 11.4–
18.1) 
Any major complicationb 
329 (5.6; 5.0–
6.1) 
253 (5.8; 5.1–
6.5) 
40 (3.5; 2.4–4.6) 
36 (8.4; 5.8–11.1) 
Any minor complicationc 
250 (4.2; 3.7–
4.7) 
189 (4.3; 3.7–
4.9) 
30 (2.6; 1.7–3.6) 
31 (7.3; 4.8–9.7) 
Major complications 
 
Lead related re-intervention 
143 (2.4; 2.0–
2.8) 
120 (2.8; 2.3–
3.2) 
10 (0.9; 0.3–1.4) 
13 (3.0; 1.4–4.7) 
Infection 
49 (0.8; 0.6–1.1) 
24 (0.6; 0.3–0.8) 
17 (1.5; 0.8–2.2) 
8 (1.9; 0.6–3.2) 
Local infection 
22 (0.4; 0.2–0.5) 
10 (0.2; 0.1–0.4) 
8 (0.7; 0.2–1.1) 
4 (1.0; 0.0–1.9) 
Systemic 
infection/endocarditis 
27 (0.5; 0.3–0.6) 
14 (0.3; 0.2–0.5) 
9 (0.8; 0.3–1.3) 
4 (0.9; 0.0–1.9) 
Pneumothorax requiring 
drainage 
51 (0.9; 0.6–1.1) 
45 (1.0; 0.7–1.3) 
0 
6 (1.4; 0.3–2.5) 
Cardiac perforation 
38 (0.6; 0.4–0.8) 
35 (0.8; 0.5–1.1) 
0 
3 (0.7; 0.0–1.5) 

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Cardiac perforation (No 
intervention) 
21 (0.4; 0.2–0.5) 
18 (0.4; 0.2–0.6) 
0 
3 (0.7; 0.0–1.5) 
Cardiac perforation 
(Intervention) 
17 (0.3; 0.2–0.4) 
17 (0.4; 0.2–0.6) 
0 
0 
Pocket revision because of pain 
25 (0.4; 0.3–0.6) 
10 (0.2; 0.1–0.4) 
9 (0.8; 0.3–1.3) 
6 (1.4; 0.3–2.5) 
Generator-lead interface 
problem with re-intervention 
7 (0.1; 0.0–0.2) 
3 (0.1; 0.0–0.1) 
4 (0.4; 0.0–0.7) 
0 
Haematoma requiring re-
intervention 
10 (0.2; 0.1–0.3) 
9 (0.2; 0.1–0.3) 
1 (0.1; 0.0–0.3) 
0 
Otherd 
16 (0.3; 0.1–0.4) 
16 (0.4; 0.2–0.5) 
0 
0 
Minor complications 
 
Haematomae 
138 (2.3; 1.9–
2.7) 
104 (2.4; 1.9–
2.8) 
20 (1.8; 1.0–2.5) 
14 (3.3; 1.6–5.0) 
Wound infection treated with 
antibiotics 
69 (1.2; 0.9–1.4) 
47 (1.1; 0.8–1.4) 
12 (1.0; 0.5–1.7) 
10 (2.3; 0.9–3.8) 
Pneumothorax conservatively 
treated 
39 (0.7; 0.5–0.9) 
32 (0.7; 0.5–1.0) 
0 
7 (1.6; 0.4–2.8) 
Lead dislodgement without re-
intervention 
10 (0.2; 0.1–0.3) 
9 (0.2; 0.1–0.3) 
0 
1 (0.2; 0.0–0.7) 
aReported as absolute frequencies and percentages with 95% CIs in parenthesis. 
bAll re-interventions were categorized as major complications due to their inherently higher risk of infections e.g. local CIED 
infections requiring re-intervention, systemic infections, pocket revisions etc. 
cMinor complications included haematomas resulting in a prolonged hospital stay, hospital re-admissions, or additional out-patient 
visits, wound infections treated with antibiotics, pneumothorax conservatively treated, and lead dislodgements without re-
intervention. 
dDeep venous thrombosis (n=8), Twiddler’s syndrome (n=3), wound revision (n=3), stroke (n=1), myocardial infarction (n=1) 
eResulting in prolonged hospital stay, hospital re-admission, or additional out-patient visit. 
 
 

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23. References 
                                               
 
1 Model 8040 InSync MIRACLE Study (IDE # G980219). 
 
2 Model 7272 InSync ICD Study (IDE # G990176). 
 
3 Thackray S, Coletta A, Jones P, Dunn A, Clark AL, Cleland, JGF.  Clinical trials update:  highlights of the 
scientific sessions of heart failure 2001, a meeting of the working group of heart failure of the European 
Society of Cardiology.  European Journal of Heart Failure 3 (2001): 491-494. 
 
4 Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood 
G, Santini M, Bailleul C, Daubert J.  Effects of multisite biventricular pacing in patients with heart failure 
and intraventricular conduction delay.  New England Journal of Medicine 344 (2001):873-880. 
 
5 Stellbrink C, Breithardt, O, Franke A, Sack S, Bakker P, Auticchio A, et al.  Impact of cardiac 
resynchronization therapy using hemodynamically optimized pacing on left ventricular remodeling in 
patients with congestive heart failure and ventricular conduction disturbances.  Journal of American 
College of Cardioliolgy 38 (2001): 1957-1965. 
 
6 Salukhe TV, Francis, DP, Sutton R.  Comparison of medical therapy, pacing and defibrillation in heart 
failure (COMPANION) trial terminated early; combines biventricular pacemaker defibrillators reduce all-
cause mortality and hospitalization.  International Journal of Cardiology 87 (2003): 119-120. 
 
7 MOSS AJ, Jackson Hall W, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NAM, Foster E, 
Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Silber D, ZarebaW, for the MADIT-CRT Trial 
Investigators.  Cardiac resynchronization therapy for the prevention of heart failure events.  New England 
Journal of Medicine (2009); 
 
8 Cleland JFG, Daubert J-C, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L, for the Cardiac 
Resynchronization-Heart Failure (CARE-HF) Study Investigators.  The effect of cardiac resynchronization 
on morbidity and mortality in heart failure.  New England Journal of Medicine 352 (2005): 1539-1549. 
 
9 Mozzafarian D, Benjamin EJ, Go AS, et al.  On behalf of the American Heart Association Statistics 
Committee and Stroke Statistics Subcommittee.  Heart disease and stroke statistics-2016 update: a report 
from the American Heart Association.  Circulation 133 ( 2016): e38-e360. 
 
10 Abraham, William T., et al.  “Cardiac resynchronization in chronic heart failure.” New England Journal 
of Medicine 346.24 (2002): 1845-1853. 
 
11 Higgins, Steven L., et al.  “Cardiac resynchronization therapy for the treatment of heart failure in 
patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias.” Journal of 
American College of Cardiology 42.8 (2003): 1454-1559. 
 
12 Tang, Anthony SL, et al.  “Cardiac-resynchronization therapy for mild-to-moderate heart failure.” New 
England Journal of Medicine 363.25 (2010): 2385-2395. 
 
 

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13 Moss, Arthur J., et al.  “Cardiac-resynchronization therapy for the prevention of heart-failure events.” 
New England Journal of Medicine 361.14 (2009): 1329-1338. 
 
14 Bristow, Michael R., et al.  “Cardiac-resynchronization therapy with or without an implantable 
defibrillator in advanced chronic heart failure.” New England Journal of Medicine 350.21 (2004): 2140-
2150. 
 
15 Sutton, Martin G. St John, et al.  “Effect of cardiac resynchronization therapy on left ventricular size 
and function in chronic heart failure.” Circulation 107.15 (2003): 1985-1990. 
 
16 Saxon, Leslie A., et al.  “Effects of long-term biventricular stimulation for resynchronization on 
echocardiographic measures of remodeling.” Circulation 105.11 (2002): 1304-1310. 
 
17 Auricchio, Angelo, et al.  “Long-term clinical effect of hemodynamically optimized cardiac 
resynchronization therapy in patients with heart failure and ventricular conduction delay.” Journal of 
American College of Cardiology 39.12 (2002): 2026-2033. 
 
18 Linde, Cecilia, et al.  “Randomized trial of cardiac resynchronization in mildly symptomatic heart failure 
patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure 
symptoms.” Journal of American College of Cardiology 52.23 (2008): 1834-1843. 
 
19 Cleland John GF, et al.  The effect of cardiac resynchronization on morbidity and mortality in heart 
failure.” New England Journal of Medicine 352.15 (2005): 1539-1549. 
 
20 Crossley, George H., et al.  “Performance of a novel left ventricular lead with short bipolar spacing for 
cardiac resynchronization therapy: primary results of the Attain Performa Quadripolar Left Ventricular 
Lead Study.” Heart Rhythm 12.4 (2015): 751-758. 
 
21 Yee, Raymond, et al. “Novel active fixation mechanism permits precise placement of a left ventricular 
lead: early results from a multicenter clinical study.” Heart Rhythm 11.7 (2014): 1150-1155. 
 
22 Tomassoni G, Baker J et.al.  Postoperative Performance of the Quartet Left Ventricular Heart Lead, J 
Cardiovasc Electrophysiology, Vol 24, pp. 449-456, April 2013 
 
23 Mittal S, Nair D, et.al,, Performance of Anatomically Designed Quadripolar Left Ventricular Leads: 
Results from the NAVIGATE X4 Clinical Trial, J Cardiovasc Electrophysiology, DOI: 10.1111/jce.13044 
 
24 J. G. Ibrahim and M.-H. Chen, "Power prior distributions for regression models," Statistical Science, vol. 
15, no. 1, pp. 46-60, 2000. 
 
25 T. Haddad, A. Himes, L. Thompson, T. Irony, R. Nair, "Incorporation of stochastic engineering models 
as prior information in Bayesian medical device trials", Draft manuscript 
 
26 A. Gelman, J. Carlin, H. Stern and D. Rubin, Bayesian Data Analysis, Boca Raton: Chapman & Hall / 
CRC, 2004. 
 
27 S.M. Berry, B.P. Carlin, J.J. Lee, P. Muller, Bayesian adaptive methods for clinical trials. CRC press, 
2010. 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Attain StabilityTM Quad Clinical Study 
Study Product Name Attain StabilityTM Quad MRI SureScan Left 
Ventricular Lead (Model 4798) 
Sponsor/Local Sponsor Sponsor: 
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 U.S.A.  
1-800-328-2518 
Local Sponsors: 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
+1-905-460-3800 
 
Europe, Middle East, Africa (EMEA)Medtronic, 
Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
 
Hong Kong 
Medtronic Hong Kong Medical Ltd. 1104-11, 11/F, 
Tower 1,  
The Gateway,  
Harbour City, Kowloon,  
Hong Kong SAR, China 
+852-2919-1300 
 
Malaysia 
Medtronic International Ltd (Malaysia) 
B-23-1 Level 23, The Ascent, Paradigm  
No 1 Jalan SS7/26A Kelena Jaya 46301 
PetalingJaya 
Selangor 
Malaysia 
+603 7883 8000 
Document Version Version 2.0; 13/JAN/2017 

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Lead Principal Investigators Dr. George H. Crossley III, MD (Co-Chair) 
Associate Professor of Medicine; Electrophysiologist 
Fellowship Program Director 
Vanderbilt University Medical Center 
1211 Medical Center Drive 
Nashville, TN 37232 
(615) 322-5000 
 
Dr. Kevin Jackson, MD (Co-Chair) 
Assistant  Professor of Medicine; Electrophysiologist 
Director, Duke Cardiac Resynchronization Therapy 
Center 
Medical Director, Electrophysiology Services 
Duke University Medical Center Rm 7451-D 
Durham, North Carolina 27710 
(919) 681-5441 
 
  
 
 
 
 
 

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1. Sponsor Contact 
Medtronic, Inc. is sponsoring the Attain Stability Quad Clinical Study.  Regional contact information is 
provided below.  This information may be subject to change during the course of the Attain Stability 
Quad Clinical Study.  Periodic updates to study contact information will be sent to sites as needed.  
Table 1: Study Sponsor Contact Information 
Study Contacts 
Worldwide Clinical Study Leader  
 
Melissa Thalin, Principal Clinical Research 
Specialist 
 
melissa.a.thalin@medtronic.com 
United States 
 
Ann Vacca, Prin. Customer Specialist  
 
ann.vacca@medtronic.com 
Canada 
 
Mary McCann, Sr. Clinical Research Specialist 
 
mary.mccann@medtronic.com  
Europe, the Middle East and Africa (EMEA) 
 
Rinie Peters, Associate Clinical Research 
Specialist 
  
rinie.peters@medtronic.com 
Hong Kong 
 
Grace Wong, Clinical Research Supervisor 
 
grace.wong@medtronic.com 
Malaysia 
 
Sheikh Abdul Aziz, Sr. Clinical Research 
Specialist 
 
sheikh.hafiz@medtronic.com 
Study Monitors and Contacts 
Worldwide Monitoring Leader 
 
Taryn Randall, Clinical Monitoring Manager 
Direct Phone: (+1-763) 250-0785  
Direct Fax: (+1-651) 367-0759 
taryn.randall@medtronic.com  
Monitoring Leader EMEA, Hong Kong, Malaysia 
 
Anja Hesse, CRHF Portfolio Specialist CRHF 
Direct Phone: +49215981490 
Direct Fax: +4921027069069 
anja.hesse@medtronic.com 
Sponsor’s Medical Expert 
David Steinhaus, M.D., VP & GM Heart Failure and Medical Director CRHF 
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure 
8200 Coral Sea Street N.E., MVC42 
Mounds View, MN 55112 
United States 
Phone: (+1-763) 526-1250 
Fax: (+1-651) 367-0671 
david.m.steinhaus@medtronic.com 
 

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2. CROs/Core Laboratories 
This information may be subject to change during the course of the Attain Stability Quad Clinical Study.  
Periodic updates to study contact information will be sent to sites as needed. 
Table 2: CRO and Core Laboratory Information 
Contact Information 
Role 
Cognizant Technology Solutions 
500 Frank W. Burr Blvd. 
Teaneck, NJ 07666 
United States 
Direct Phone: (201) 801-0233 
Direct Fax: (201) 801-0243 
Review of electronic case report forms and 
management of discrepancies 
 
 

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3. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
o 
Initial Release 
Melissa Thalin, Principal Clinical 
Research Specialist 
 
Rinie Peters, Associate Clinical 
Research Specialist 
 
Ann Vacca, Principal Customer 
Specialist 
 
Shelby Li, Senior Principal 
Statistician 
 
Joao Monteiro, Senior Statistician 
2.0 
o 
Added slitting information for Implant 
analyzer PCT at synopsis and table 8 
o 
Remote visits:  
 
Changed wording to clarify 
required actions 
 
Removed manual PCT test  
 
Deleted rationale for final 
vector progammed  
o 
Recurring 6 mth FU: 
 
Removed PNS test 
 
Removed Patient Global 
Assessment 
o 
System Modification 
 
Reduced electrical testing 
requirements 
o 
Patient Global Assessment 
 
Added to Glossary 
 
Removed from Baseline and 
3 month visits 
o 
Vectors 
 
Added additional 4 CRT-P 
vectors (LV to Can) 
throughout  
o 
Investigator Lead Handling 
Assessment 
 
Added to Implant visit 
o 
Adjusted # of participating centers 
o 
Updated exclusion criteria #2 
o 
Updates to grammer, version ,and 
footers 
Melissa Thalin, Principal Clinical 
Research Specialist 
 
Rinie Peters, Associate Clinical 
Research Specialist 

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4. Investigator Statement 
Investigators will be provided with a separate investigator agreement to document their obligation and 
commitment with respect to study conduct.  
 
 

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5. Index 
 
1. 
Sponsor Contact .......................................................................................................... 3 
2. 
CROs/Core Laboratories ............................................................................................ 4 
3. 
Version History ........................................................................................................... 5 
4. 
Investigator Statement................................................................................................. 6 
5. 
Index ........................................................................................................................... 7 
6. 
List of Tables ............................................................................................................ 10 
7. 
List of Figures ........................................................................................................... 11 
8. 
Glossary ..................................................................................................................... 11 
9. 
Synopsis .................................................................................................................... 15 
10. 
Introduction .............................................................................................................. 27 
10.1. 
Background ................................................................................................................. 27 
10.2. 
Purpose ........................................................................................................................ 28 
11. 
Objectives and Endpoints ......................................................................................... 28 
11.1. 
Objectives ................................................................................................................... 28 
11.1.1. 
Primary Objective(s) ....................................................................................................... 28 
11.1.2. 
Secondary Objective(s) .................................................................................................. 29 
11.2. 
Endpoints .................................................................................................................... 29 
12. 
Study Design ............................................................................................................. 30 
12.1. 
Duration ....................................................................................................................... 31 
12.2. 
Rationale ..................................................................................................................... 31 
12.3. 
Study Oversight ......................................................................................................... 32 
13. 
Product Description .................................................................................................. 33 
13.1. 
General......................................................................................................................... 33 
13.2. 
Manufacturer .............................................................................................................. 41 
13.3. 
Packaging .................................................................................................................... 41 
13.4. 
Intended Population ................................................................................................. 41 
13.5. 
Equipment ................................................................................................................... 41 
13.6. 
Product Use ................................................................................................................. 42 
13.7. 
Product Receipt, Tracking, and Accountability ................................................... 42 
13.8. 
Product Storage ......................................................................................................... 42 
13.9. 
Product Return ........................................................................................................... 43 
14. 
Selection of Subjects .................................................................................................. 43 
14.1. 
Study Population ....................................................................................................... 43 
14.2. 
Subject Enrollment .................................................................................................... 43 
14.3. 
Inclusion Criteria ....................................................................................................... 44 
14.4. 
Exclusion Criteria ....................................................................................................... 44 
14.5. 
Minimization of Bias.................................................................................................. 44 

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15. 
Study Procedures ....................................................................................................... 45 
15.1. 
Study Personnel Requirements .............................................................................. 45 
15.2. 
Site Activation ............................................................................................................ 46 
15.3. 
Equipment Requirements ........................................................................................ 47 
15.4. 
Schedule of Events .................................................................................................... 47 
15.5. 
Subject Consent ......................................................................................................... 49 
15.6. 
Enrollment ................................................................................................................... 51 
15.7. 
Baseline ....................................................................................................................... 51 
15.8. 
Implant/PHD .............................................................................................................. 51 
15.8.1. 
Final System Configuration ............................................................................................ 52 
15.8.2. 
Implant Procedure ........................................................................................................... 52 
15.8.2.1. 
Venogram ..................................................................................................................... 52 
15.8.2.2. 
Implanting the LV lead ............................................................................................... 52 
15.8.2.3. 
CRT System Testing and Programming During Implant ........................................ 54 
15.8.2.4. 
Final Lead Placement Data Collection ....................................................................... 54 
15.8.2.5. 
Pre-Hospital Discharge CRT System Testing and Programming........................... 55 
15.9. 
3 Months Post-Implant (remote or in office visit) ............................................. 55 
15.10. 
6 Months Post-Implant (in office visit) ............................................................. 56 
15.11. 
12 Months Post-Implant (in office visit) ........................................................... 57 
15.12. 
Recurring 6 Month Follow-ups (remote or inoffice visit) .............................. 58 
15.13. 
Device Interrogation/Save-to-Media ................................................................ 58 
15.14. 
System Modifications ............................................................................................ 58 
15.15. 
Study Exit ................................................................................................................. 60 
15.15.1. 
Study Completed ......................................................................................................... 61 
15.15.2. 
Lost to Follow-up ......................................................................................................... 61 
15.15.3. 
Study Exit Upon Sponsor Request ............................................................................ 61 
15.16. 
Subject Withdrawal or Discontinuation ............................................................ 61 
15.16.1. 
Subject Chooses to Exit (i.e. revokes consent) ....................................................... 61 
15.16.2. 
Investigator Withdraws Subject ................................................................................ 61 
15.17. 
Assessment of Efficacy .......................................................................................... 63 
15.18. 
Assessment of Safety ............................................................................................ 63 
15.19. 
Recording Data ....................................................................................................... 63 
15.20. 
Deviation Handling ................................................................................................ 63 
16. 
Risks and Benefits ..................................................................................................... 64 
16.1. 
Potential Risks ........................................................................................................... 64 
16.2. 
Risk Minimization ...................................................................................................... 66 
16.3. 
Potential Benefits ...................................................................................................... 67 
16.4. 
Risk-Benefit Rationale.............................................................................................. 67 
17. 
Adverse Event Assessments....................................................................................... 67 
17.1. 
Adverse Event and Device Deficiency Assessment ............................................ 67 
17.1.1. 
Adverse Events ................................................................................................................ 67 
17.1.2. 
Device Deficiencies.......................................................................................................... 68 
17.1.3. 
Event Updates and Resolution ...................................................................................... 68 
17.2. 
Definitions/Classifications ...................................................................................... 69 
17.3. 
Reporting of Adverse Events ................................................................................... 75 
17.3.1. 
Adverse Events and Device Deficiency Classification ................................................. 75 

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17.3.2. 
Adverse Events and Device Deficiency Reporting Requirements ............................. 76 
17.4. 
Subject Death ............................................................................................................. 79 
17.4.1. 
Death Data Collection ..................................................................................................... 79 
17.4.2. 
Death Classification and Reporting ............................................................................... 80 
17.5. 
Product Complaint Reporting ................................................................................. 80 
18. 
Data Review Committees .......................................................................................... 81 
18.1. 
Clinical Events Committee ....................................................................................... 81 
18.2. 
Data Monitoring Committee .................................................................................... 82 
19. 
Statistical Design and Methods ................................................................................. 82 
19.1. 
Primary Objectives .................................................................................................... 82 
19.1.1. 
Primary Safety Objective ................................................................................................ 82 
19.1.2. 
Primary Efficacy Objective #1 ....................................................................................... 84 
19.1.3. 
Primary Efficacy Objective # 2 ...................................................................................... 86 
19.2. 
Secondary Objectives ............................................................................................... 87 
19.2.1. 
Secondary Objective # 1 ................................................................................................ 87 
19.2.2. 
Secondary Objective # 2 ................................................................................................ 87 
19.2.3. 
Secondary Objective # 3 ................................................................................................ 91 
19.3. 
Additional Analysis .................................................................................................... 92 
19.3.1. 
Poolability Analysis .......................................................................................................... 92 
19.3.2. 
Sensitivity Analysis .......................................................................................................... 92 
19.3.3. 
Additional Data Collection .............................................................................................. 92 
19.3.3. 
Overall Study Sample Size Requirements .................................................................... 92 
20. 
Ethics ........................................................................................................................ 93 
20.1. 
Statement(s) of Compliance ................................................................................... 93 
21. 
Study Administration ................................................................................................. 94 
21.1. 
Monitoring ................................................................................................................... 94 
21.2. 
Data Management ..................................................................................................... 95 
21.3. 
Direct Access to Source Data/Documents ........................................................... 96 
21.4. 
Confidentiality ............................................................................................................ 96 
21.5. 
CIP Amendments ....................................................................................................... 96 
21.6. 
Warranty/Insurance Information ......................................................................... 96 
21.6.1. 
Warranty ........................................................................................................................... 96 
21.6.2. 
Insurance (EMEA) ........................................................................................................... 96 
21.6.3. 
Insurance (Canada) ........................................................................................................ 97 
21.6.4. 
Insurance (Malaysia) ...................................................................................................... 97 
21.6.5. 
Insurance (Hong Kong) .................................................................................................. 97 
21.7. 
Record Retention ....................................................................................................... 97 
21.7.1. 
Investigator Records ....................................................................................................... 97 
21.7.2. 
Investigator Reports ....................................................................................................... 98 
21.7.3. 
Sponsor Records .............................................................................................................. 99 
21.7.4. 
Sponsor Reports .............................................................................................................. 99 
21.8. 
Publication and Use of Information .................................................................... 101 
21.8.1. 
Publication Committee .................................................................................................. 102 
21.8.2. 
Management of Primary, Secondary, and Ancillary Publications ........................... 102 
21.8.3. 
Criteria for Determining Authorship............................................................................ 102 

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21.8.4. 
Transparency ................................................................................................................. 103 
21.9. 
Suspension or Early Termination ......................................................................... 103 
21.9.1. 
Planned Study Closure .................................................................................................. 103 
21.9.2. 
Early Termination or Suspension ................................................................................ 103 
21.9.3. 
Procedures for Termination or Suspension ............................................................... 104 
22. 
Appendices .............................................................................................................. 106 
23. 
References ............................................................................................................... 122 
 
6. List of Tables 
Table 1: Study Sponsor Contact Information ................................................................................................ 3 
Table 2: CRO and Core Laboratory Information ........................................................................................... 4 
Table 3: Glossary of Terms .................................................................................................................... 11 
Table 4: Steering Committee Members ...................................................................................................... 32 
Table 5: Comparison of Medtronic Quadripolar LV Leads............................................................................. 35 
Table 6: Comparison of Medtronic Attain Stability Bipolar and Quadripolar LV Leads ......................................... 37 
Table 7: Study Component Information .................................................................................................... 40 
Table 8: Data Collection and Study Procedure Requirements at Subject Visits .................................................... 48 
Table 9: Visit Windows ......................................................................................................................... 49 
Table 10: Additional adverse events related to the lead and programmed parameters ............................................ 65 
Table 11: Implant Techniques that may damage the lead ............................................................................... 66 
Table 12: Adverse Event and Device Deficiency Definitions .......................................................................... 69 
Table 13: Adverse Event Classification Responsibilities ................................................................................. 76 
Table 14: Reporting Requirements ........................................................................................................... 76 
Table 15: Subject Death Classification Responsibilities .................................................................................. 80 
Table 16: Safety Performance of Market Released Quadripolar Lead ................................................................ 83 
Table 17: Prior weight from Attain Stability (Model 20066) and prior weight from Attain Performa as a function of the 
posterior Bayesian p-value (𝒑𝒑) ................................................................................................................. 89 
Table 18: Required Sample Size by Study Objective...................................................................................... 92 
Table 19: Investigator Reports Applicable for All Geographies per Medtronic Requirements ................................. 98 
Table 20: Sponsor Reports for Canada .................................................................................................... 100 
Table 21: Sponsor Reports for EMEA, Malaysia, Hong Kong ...................................................................... 100 
Table 22: Sponsor Reports for the United States ....................................................................................... 101 
Table 23: Listing of Potential Adverse Events Associated with System Implant ................................................ 107 
Table 24: System or procedure-related adverse events from previous clinical studies .......................................... 108 
Table 25: Complications reported in Ahsan et al. ....................................................................................... 119 

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Table 26: Complications reported in Dickstein et al. ................................................................................... 119 
Table 27: Complications reported by Kirkfeldt et al. ................................................................................... 120 
 
7. List of Figures 
Figure 1: Study Visits ............................................................................................................................ 31 
Figure 2: Attain Stability Quad MRI SureScan LV Lead (Model 4798) Specifications Drawing ................................ 34 
Figure 3: Comparison of Attain Performa Leads and the Attain Stability Lead Model 4798 .................................... 37 
Figure 4: Attain Stability Bipolar (Model 20066/4796) & Attain Stability Quad MRI SureScan (Model 4798) Active 
Fixation Leads .................................................................................................................................... 39 
Figure 5: Primary Safety Objective Sample Size Consideration by Difference Performance Assumption ................... 84 
Figure 6: Simulated PCT Distribution ....................................................................................................... 85 
Figure 7: Loss Function 𝒂𝒂𝒂𝒂= 𝟏𝟏−𝒆𝒆−𝒑𝒑∗𝟓𝟓𝟓𝟓41T .......................................................................................... 89 
Figure 8: Credible Intervals for Scenarios of Agreement Between Historical and Current Data ............................... 90 
 
8. Glossary 
Table 3: Glossary of Terms 
Term 
Definition 
2090 
Medtronic CareLink Programmer with the 
application software installed.   
2290 
Medtronic Analyzer 
Medtronic Attain Stability Quad MRI SureScan 
(Model 4798) LV Lead 
The quadripolar LV lead being studied 
(investigational in the United States/Canada, 
commercially available in EMEA, Hong Kong, and 
Malaysia).   
Active Fixation Helix 
A non-electrically active side helix, positioned 
between the LV 3 and LV 4 electrodes that will 
allow fixation of the Attain Stability Quad MRI 
SureScan (Model 4798) LV Lead in the cardiac vein.  
ADE 
Adverse Device Effect 
AE 
Adverse Event 
Ag 
Silver 
CABG 
Coronary Artery Bypass Graft 

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Term 
Definition 
CAD 
Coronary Artery Disease 
CDF 
Cumulative Distribution Function 
CEC 
Clinical Events Committee 
CIP 
Clinical Investigation Protocol 
CRF 
Case Report Form 
CRT 
Cardiac Resynchronization Therapy: Established 
pacing therapy for patients with heart failure 
CRT-D 
Cardiac Resynchronization Therapy - Defibrillator 
CRT-P 
Cardiac Resynchronization Therapy - Pacemaker 
CS 
Coronary Sinus 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DEKRA 
Deutscher Kraftfahrzeug-Überwachungs-Verein 
(German Motor Vehicle Inspections Association) 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
EMEA 
Europe, the Middle East, and Africa 
eCRF 
Electronic Case Report Form 
MEC/IRB/HREB/Ethics Board 
Ethics Committee 
FAL 
Foreseeable Adverse Event List 
FDA 
Food and Drug Administration 
Fr 
French 
GCP 
Good Clinical Practice 

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Term 
Definition 
HF 
Heart Failure 
HTN 
Hypertension 
IC 
Informed Consent 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigation Device Exemption 
Ir 
Iridium 
IRB 
Institutional Review Board 
LAR 
Legally Authorized Representative 
LBBB 
Left Bundle Branch Block 
LV 
Left Ventricular 
LVEF 
Left Ventricular Ejection Fraction 
MCRD 
Monolithic Controlled Release Device which is 
located on the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) electrodes which elutes 
steroid to reduce inflammatory response within the 
cardiac vein. 
Mechanical Stop 
A component on the Attain Stability Quad MRI 
SureScan (Model 4798) LV Lead located at the 
base of the helix to prevent wedging of endothelial 
tissue in the helix and to prevent tissue ingrowth. 
MedDRA 
Medical Dictionary for Regulatory Activities 
OC 
Oracle Clinical (database management system) 
OTW 
Over-the-wire 
PCT 
Pacing Capture Threshold 
Patient Global Assessment 
Self-reported assessment to provide information on 
patient condition compared to previous heart 
failure status 

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Term 
Definition 
PHD 
Pre-Hospital Discharge means the point at which a 
subject has been released from the hospital post 
implant procedure. 
PMA 
Premarket Approval 
PNS 
Phrenic Nerve Stimulation 
POR 
Power On Reset 
Pt 
Platinum 
PTCA 
Percutaneous Transluminal Coronary Angioplasty 
QOL 
Quality of Life 
RA 
Right Atrial 
RRT 
Recommended Replacement Time 
RV 
Right Ventricular 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SC 
Steering Committee 
SDN 
Software Distribution Network 
TÜV 
Technischer Überwachungsverein (German safety 
validation organization) 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
USADE 
Unanticipated Serious Adverse Device Effect 
VF 
Ventricular Fibrillation 
VT 
Ventricular Tachycardia 
 
 

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9. Synopsis 
Title 
Attain StabilityTM Quad Clinical Study 
Product Name 
Attain StabilityTM Quad MRI SureScan Left Ventricular Lead 
(Model 4798) 
Sponsor  
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 U.S.A. 
1-800-328-2518 
Local Sponsor 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
+1-905-460-3800 
 
EMEA 
Medtronic, Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
 
Hong Kong 
Medtronic Hong Kong Medical Ltd. 
1104-11, 11/F, Tower 1,  
The Gateway,  
Harbour City, Kowloon,  
Hong Kong SAR, China 
+852-2919-1300 
 
Malaysia 
Medtronic International Ltd (Malaysia) 
B-23-1 Level 23, The Ascent, Paradigm, No 1 Jalan 
SS7/26A Kelena Jaya 46301 Petaling Jaya 
Selangor 
Malaysia 
+603 7883 8000 
Indication under investigation  
All subjects included in the study will be implanted with a 
Medtronic market released de novo CRT-P or CRT-D 
device, compatible market released Medtroinc RA and 
Medtronic RV leads and an Attain Stability QuadSureScan 
LV lead (Model 4798). For subjects enrolled who are 
receiving an upgrade to a CRT system, existing non-
Medtronic RV and/or existing non-Medtronic RA leads that 
are not recalled, market withdrawn, and/or have a medical 
alert may be used.   

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Given the vast similarities between the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) and the Attain 
Performa family of leads, the proposed indications for use 
are the same.  The indications are as follows: 
The Attain Stability Quad MRI SureScan 4798 steroid-
eluting, quadripolar electrode, IS4 transvenous lead is 
indicated for chronic pacing in the left ventricle via the 
cardiac vein, when used with a compatible Medtronic 
Cardiac Resynchronization Therapy (CRT) system.  
Extended bipolar pacing is available using this lead in 
combination with a compatible market approved  CRT-D 
system and RV defibrillation lead. 
Investigation Purpose 
The Attain Stability Quad Clinical Study is a prospective, 
non-randomized, multi-site, global, Investigational Device 
Exemption (IDE) interventional clinical study.  The 
purpose of this clinical study is to evaluate the safety and 
efficacy of the Attain Stability Quad MRI SureScan LV lead 
(Model 4798).  This study will not be considered 
investigational in geographies with CE Mark of the Attain 
Stability Quadripolar LV lead (4798).  However, data 
collected from all study subjects will be represented in the 
final report and the PMA Supplement (PMA-S) to the 
Model 4196 Original PMA. 
Product Status 
The Attain Stability Quad Clinical Study will be conducted 
using a research system composed of an approved CRT-D 
or CRT-P System.  The Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) is an active fixation quadripolar LV 
lead based on the Attain Performa lead family models 
(4298, 4398, and 4598).  The lead incorporates an active 
fixation helix similar to the Attain Stability bipolar LV lead 
(Model 20066/4796) which is designed to allow an 
implanter more options in lead location.   
The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) will be considered investigational in geographies 
where the product is not available commercially and will 
be labeled for clinical use only.  These geographies include 
but are not limited to the US and Canada.  Investigational  
Attain Stability Quad Leads will be distributed to a site 
only when Medtronic has received all required 
documentation (including but not limited to Ethic 
Committee approval, a signed Clinical Trial Agreement and 
documentation of training) and has notified the site of site 
readiness.  Distribution of the investigational product to 
study sites will be managed by Medtronic and can only be 

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ordered by Medtronic personnel.  Site with these clinically 
labeled Attain Stability Quad MRI SureScan LV Leads 
(Model 4798) will track disposition upon receipt or return 
of the lead but also upon implant or explant of the lead. 
Disposition logs will be available within the electronic data 
management system and shall be maintained at each site 
in all geographies to track investigational product 
information.  
For geographies where the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is not considered 
investigational, commercially approved devices will be 
used.  Sites that use commercially available Attain Stability 
Quad MRI SureScan LV Leads (Model 4798) will track 
device disposition upon implant or explant on the lead 
CRFs. 
The Medtronic approved CRT-P or CRT-D devices will be 
programmed and interrogated using a Medtronic CareLink 
(2090) programmer.  Medtronic may incorporate 
additional programmers as they receive regulatory 
approval. 
The CareLink Monitor Model 2490C is an external monitor 
that is indicated for use in the transfer of patient and 
device data from implanted Medtronic devices.  The 
CareLink Monitor Model 2490C interrogates implanted 
devices and temporarily stores these data, collaborates 
with the appropriate Medtronic server to confirm the 
establishment of an Internet connection with server, 
performs any required file translation functions necessary 
for data transfer, executes data file transfer, and 
collaborates with the appropriate Medtronic server to 
confirm data file transfer through the Internet connection 
with the server.  The CareLink Monitor 2490C is not a 
programmer and cannot be used to program implanted 
device parameters.  CareLink monitors are not a substitute 
for appropriate medical attention in the event of an 
emergency and should only be used as directed by a 
physician. 
Approved Medtronic CRT-P and CRT-D devices used in this 
study qualify for use with the Medtronic CareLink Monitor 
and Medtronic CareLink Network.  
Medtronic may incorporate additional home monitors as 
they receive regulatory approval. 
Medtronic’s commercially available Model 2290 Analyzer 
must be available at each center during the implant 

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procedure to determine acceptable electrical parameters.  
Medtronic may incorporate additional analyzers as they 
receive regulatory approval. 
Primary Objective(s) 
Primary Safety Objective: Lead complication-free 
rate at 6 months 
The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) will be considered safe if the probability of subjects 
free of Model 4798 lead-related complications at 6 months 
post-implant is greater than 87% (i.e., the lower bound of 
a one-sided 97.5% confidence interval must be greater 
than 87%). 
The study primary safety endpoint is Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) related complications 
through 6 months post implant.  All reported system and 
procedure-related AEs will be reviewed by an event review 
committee for LV lead relatedness and severity 
(complication vs observation, refer to 17.1.2 for 
defintions).  
Primary Efficacy Objectives: Lead pacing capture 
thresholds at 6 months 
To demonstrate the effectiveness of the Attain Stability 
Quad MRI SureScan LV lead (Model 4798) the study will 
evaluate the likelihood that there are at least two 
programmable vectors  for each patient post implant.  The 
effectiveness of this lead will be evaluated based on two 
primary efficacy objectives.  More specifically, both 
primary efficacy objectives must be met simultaneously.   
Primary Efficacy Objective #1 
The Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) will meet the objective if the 
proportion of subjects with at least one LV lead 
pacing vector having a pacing capture threshold 
less than or equal to 2.5 V at 0.5ms pulse width at 
6 months post-implant is greater than 80% (i.e., 
the lower bound of a one-sided 97.5% confidence 
interval must be greater than 80%). 
The endpoint for the primary efficacy objective is 
whether or not there is at least one Model 4798 
LV lead pacing vector with pacing capture voltage 
thresholds less than or equal to 2.5V.  This 
endpoint will be measured at the 6-month post 
implant follow-up visit. 

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Primary Efficacy Objective #2 
The Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) will meet the objective if the 
proportion of subjects with at least one additional 
LV lead pacing vector having a pacing capture 
threshold less than or equal to 4.0 V at 0.5ms 
pulse width at 6 months post-implant is greater 
than 80% (i.e., the lower bound of a one-sided 
97.5% confidence interval must be greater than 
80%).  
The co-primary efficacy endpoint is whether or not 
a second Model 4798 lead configuration has a 
pacing capture threshold less than or equal to 4V, 
excluding the pacing vector that is already 
counted to the primary efficacy endpoint #1. This 
endpoint will be measured at 6-month post 
implant follow-up visit. 
Secondary  
Objective(s) 
The secondary objectives are descriptive in nature and are 
intended to provide additional information about the Attain 
Stability Quad Model 4798 LV lead. There will be no 
established performance requirements for these secondary 
objectives. 
o 
Implant procedure related information: success 
rate, implant related times 
o 
Endpoints will include implant success rate 
and procedure durations.  
o 
6-month reliability: post implant lead failure 
modes (i.e. complication rate) 
o 
Endpoint is Model 4798 lead related 
complications. 
o 
Electrical measurements (PCT and Impedance) at 
follow-ups 
o 
Endpoints are the electrical measurements 
(pacing capture thresholds and impedance 
values) for the four extended bipolar 
(CRT-D) or unipolar (CRT-P) vectors, i.e. 
LV1 to RVCoil/Can, LV2 to RV Coil/Can, 
LV3 to RV Coil/Can and LV4 to RV 
Coil/Can (refer to 15.8.2.3 for the testing 
procedure requirements) 

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Study Design 
The Attain Stability Quad Clinical Study is a prospective, 
non-randomized, multi-site, global, Investigational Device 
Exemption (IDE) interventional clinical study.  The 
purpose of this clinical study is to evaluate the safety and 
efficacy of the Attain Stability Quad MRI SureScan LV lead 
(Model 4798) in patients indicated for a de novo LV lead 
implant.  This will be assessed through primary safety and 
primary efficacy endpoints. 
All subjects included in the study will be implanted with a 
Medtronic market released de novo CRT-P or CRT-D 
device and an Attain Stability Quad MRI SureScan LV Lead 
(Model 4798).  Compatible market released Medtronic RA 
and Medtronic RV leads will be required.  For subjects 
enrolled who are receiving an upgrade to a CRT system, 
existing non-Medtronic RV and/or existing non-Medtronic 
RA leads that are not recalled, market withdrawn, and/or 
have a medical alert may be used.   
Up to 471 subjects will be enrolled into the study and up 
to 471 Attain Stability Quad MRI SureScan LV Leads 
(Model 4798) implanted, to ensure a minimum effective 
sample size of 400 Model 4798 leads implanted with 6 
months post implant follow up visits (assuming 15% 
attrition).  For the secondary endpoint of individual lead 
failure modes, Bayesian methods utilizing data from up to 
37 historical patients will be used.  All other objectives will 
be analyzed using only patients enrolled in this study.   
After a successful implant, threshold testing will occur per 
protocol requirement.  Subjects will then be followed at 
implant, three months, six months and every six months 
thereafter until FDA approval is obtained or until study 
closure, whichever comes first. 
The study duration is expected to be approximately 19 
months.  This represents 13 months for subject enrollment 
and 6 months for subject follow-up for the last subject 
enrolled.  Subjects are anticipated to be in the study for 
on average 12 months.  The first enrollment is projected 
to occur in May 2017.   
Sample Size 
Up to 471 subjects will be enrolled into the study, to 
ensure a minimum effective sample size of 400 Model 
4798 leads implanted with 6 months post implant follow 
up visits (assuming 15% attrition) at up to 56 sites 
worldwide. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
• 
Patient meets CRT implant criteria as determined 

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by local regulatory and/or hospital policy  
• 
Patient (or legally authorized representative) has 
signed and dated the study-specific 
Consent Form 
• 
Patient is 18 years of age or older, or is of legal 
age to give informed consent per local and 
national law 
• 
Patient is expected to remain available for follow-
up visits 
Exclusion Criteria: 
• 
Patient has had a previous unsuccessful LV lead 
implant attempt 
• 
Patient has a previous CRT system or LV lead 
implanted (for example, transvenous or epicardial) 
• 
Patient is currently implanted with a recalled (i.e. 
market-withdrawn, recalled or safety alert) RA 
and/or RV lead  
• 
Patient has known coronary venous vasculature 
that is inadequate for lead placement 
• 
Patient has unstable angina pectoris or has had an 
acute myocardial infarction (MI) within the past 30 
days 
• 
Patient has had a coronary artery bypass graft 
(CABG) or percutaneous transluminal coronary 
angioplasty (PTCA) within the past 90 days 
• 
Patient has contraindications for standard 
transvenous cardiac pacing (e.g., mechanical right 
heart valve) 
• 
Patient has had a heart transplant (patients 
waiting for heart transplants are allowed in the 
study) 
• 
Patient has known renal insufficiency that would 
prevent them from receiving an occlusive 
venogram during the implant procedure 
• 
Patient is contraindicated for <1mg 
dexamethasone acetate 
• 
Patient is enrolled in any concurrent drug and/or 
device study that may confound the results of this 
study 
• 
Patient has a terminal illness and is not expected 
to survive more than six months 
• 
Patient meets exclusion criteria required by local 
law (e.g. age, pregnancy, breast feeding, etc.) 
• 
Patient is unable to tolerate an urgent 
thoracotomy 
Study Procedures and Assessments 
Clinical data will be collected at the study milestones: at 
enrollment, baseline, implant/PHD, 3M, 6M, thereafter 

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every occurring 6M and study exit visits: 
Enrollment/Baseline:  
o 
Subject Informed Consent  
o 
Inclusion/Exclusion criteria verified 
o 
Subject demographics  
o 
Cardiovascular medications 
o 
Cardiovascular medical history 
o 
NYHA classification 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
Implant:  
o 
Occlusive venogram with pre-determined 
target vessel location identified 
o 
Analyzer PCT data collection post lead 
fixation and prior to connecting the leads 
to the CRT-P/D device: 
1. Pre-slitting the cannulation 
catheter and following 
guidewire/stylet has been pulled 
back proximal to the helix and 
electrodes 
2. Post slitting the cannulation 
catheter 
o 
Investigator Lead Handling Assessment 
o 
System and procedure information 
PHD CRT System Testing and Programming using the 
implanted CRT-P or CRT-D device and the device 
programmer: 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors  
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors  
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 

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o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
3 Month (remote or in office visit):  
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the 
final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the 
final programmed vector 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media 
(or CareLink transmission) 
o 
AE Assessment 

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o 
Study deviations 
o 
Device deficiencies 
6 Month:  
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors 
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors  LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors  
o 
NOTE: A one time manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 

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o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
12 Month:  
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors 
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors 
o 
NOTE: A one time manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 

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Recurring 6 Month follow-ups (remote or inoffice 
visit):  
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the 
final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the 
final programmed vector 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Retain printouts at the site 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media 
(or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
Study Exit:  
o 
Report the reason for exit 
o 
Final Interrogation file (or Carelink 
transmissions) for exits occuring prior to 
the 6 month visit) 
o 
Study Deviations 
o 
AEs  
o 
Device Deficiencies 
Safety Assessments 
Adverse Event and Device Deficiency handling in the Attain 
Stability Quad Clinical Study is ISO 14155:2011 compliant for 
all participating geographies with the exception that only 
those AEs which are related to the subject’s system, 
procedure, accessory, or are cardiovascular-related, heart 
failure-related, MRI-related, and all Serious AEs, will be 
collected (refer to Section 17 for AE assessment).  This 
ensures any AEs which could potentially be relevant will be 
collected.  Reporting of these events to Medtronic will occur 
on an Adverse Event (AE) Form, including date of AE, 
treatment, resolution, assessment of both the seriousness of 
the AE and the relatedness to the investigational device or 
procedure.  Each AE must be recorded on a separate AE 
eCRF.  Documented pre-existing conditions are not 
considered AEs unless the nature or severity of the condition 
has worsened. 

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 Statistics 
The primary objective will be analyzed using the time-to-
first event Kaplan-Meier survival analysis method.  A 
minimum number of subjects who have completed their 6 
months post-implant visits will be required.  Time 0 will be 
the day a subject undergoes the implant procedure of a 
Attain Stability Quad MRI SureScan LV Lead (Model 4798), 
which will be independent of success status of this implant 
procedure.  Event date is the onset date of a subject’s first 
complication that is related to the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) according to CEC 
adjudication.  Subjects who undergo an Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) implant 
attempt and do not experience any LV lead related 
complications, will be censored at the time of their last 
known exposure to the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) for the survival analysis.  For any 
lost-to-follow up subject, the last contact date will be used 
as the censor date.  The 1-sided 97.5% confidence limit 
lower bound for the survival probability at 6 months (183 
days) will be calculated using the log-log survival function 
approach (Kalbfleisch and Prentice 2002). 
 
10. Introduction  
10.1. Background 
Several clinical trials (including MIRCLE1, MIRACLE-ICD2, CONTAK-CD3, MUSTIC4, PATH-CHF5, 
COMPANION6, MADIT CRT7, and CARE-HF8) have demonstrated the benefit of cardiac resynchronization 
therapy (CRT) among patients with moderate to severe heart failure (HF) with a prolonged QRS duration 
and depressed Left Ventricular (LV) function.   
Approximately 5.7 million people in the United States (US) are living with HF9.  Heart Failure may be a 
chronic condition which causes the heart to not pump oxygenated blood efficiently through the body due 
to stiffening of the heart muscle.  Heart Failure may affect one or both sides of the heart.  It is most 
often caused by coronary artery disease (CAD) or uncontrolled hypertension (HTN).  Patients who suffer 
from HF experience a variety of different symptoms including most often fatigue, cough, shortness of 
breath, swollen feet (edema) and weight gain. 
Heart Failure is treated with medications and sometimes cardiac devices (i.e. pacemaker or defibrillator 
with CRT).  Medications work to relieve symptoms and reverse the effects of HF.  Cardiac 
Resynchronization Therapy devices treat HF by synchronizing the left and right ventricles of the heart 
which improves the heart’s ability to pump oxygenated blood to the body.10 11 12 13 14 15 16 17 18 19 20 21 
Cardiac Resynchronization Therapy devices are primarily made up of 4 main components; the can or 
battery, a Right Atrial (RA) lead, a Right Ventricular (RV) lead, and a Left Ventricular (LV) lead. 

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The LV lead specifically is important at maintaining ventricular synchrony.  In 2014, Medtronic released 
the Attain® PerformaTM family of LV leads (models 4298, 4398 and 4598).  The three different shapes of 
these leads (double canted, straight, and S-shaped) were designed to enable the lead to be passively 
fixed within different anatomies of coronary vessels.  In addition, the 4 strategically placed electrodes on 
the lead were designed to offer 16 different electrical vector programming configurations.  
Medtronic also released the Attain Stability bipolar LV lead (Model 20066/4796) (CE Mark approved in 
September 30, 2013) in Europe.  This lead has a side helix which enables it to be actively fixated to the 
vessel wall.  The active fixation is an advantageous component in vessels that are wide or have short 
take-offs.  The next generation of LV lead is known as the Attain StabilityTM Quad MRI SureScan LV lead 
(Model 4798).  This is a quadripolar lead similar to its Attain Performa predecessor leads and has a side 
helix for active fixation like the Attain Stability bipolar lead.   
10.2. Purpose 
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, 
Investigational Device Exemption (IDE), interventional clinical study.  The purpose of this clinical study is 
to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798).  
This study will not be considered investigational in geographies with CE Mark of the Attain Stability™ 
Quad MRI SureScan LV lead (Model 4798).  However, data collected from all study subjects will be 
represented in the final clinical report and the PMA Supplement (PMA-S) to the Attain Ability Model 4196 
Original PMA (P080006, approved April 7, 2009).  Subjects successfully implanted with the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) will be followed at implant, three months, six months and 
every six months thereafter until FDA approval is obtained or until study closure, whichever comes first. 
11. Objectives and Endpoints 
11.1. Objectives 
11.1.1. 
Primary Objective(s) 
Primary Safety Objective: Lead complication-free rate at 6 months 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered safe if the probability of 
subjects free of Model 4798 lead-related complications at 6 months post-implant is greater than 87% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 87%). 
Primary Efficacy Objectives: Lead pacing capture thresholds at 6 months 
To demonstrate the effectiveness of the Attain Stability Quad MRI SureScan LV Lead (Model 4798), the 
study will evaluate the likelihood that there are at least two programmable vectors for each patient post 
implant.  The effectiveness of this lead will be evaluated based on two primary efficacy objectives.  More 
specifically, both primary efficacy objectives must be met simultaneously.   
Primary Efficacy Objective #1 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet this objective if the 
proportion of subjects with at least one LV lead pacing vector having a pacing capture threshold 
less than or equal to 2.5 V at 0.5 ms pulse width at 6 months post-implant is greater than 80% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 80%). 

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Primary Efficacy Objective #2 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet this objective if the 
proportion of subjects with at least one additional (or second) LV lead pacing vector having a 
pacing capture threshold less than or equal to 4.0 V at 0.5 ms pulse width at 6 months post-
implant is greater than 80% (i.e., the lower bound of a one-sided 97.5% confidence interval 
must be greater than 80%).  
11.1.2. 
Secondary Objective(s)  
The secondary objectives are descriptive in nature and are intended to provide additional information 
about the Attain Stability Quad MRI SureScan LV Lead (Model 4798).  There will be no established 
performance requirements for these secondary objectives. 
o 
To summarize implant procedure related information: success rate, implant related times 
o 
To estimate 6-month reliability: post implant lead failure modes (i.e. complication rate)  
o 
To estimate electrical measurement values (Pacing Capture Thresholds (PCTs) and Lead 
Impedance) at 6 months post-implant 
11.2. Endpoints 
11.2.1 Primary Endpoints 
Primary Safety Endpoint 
The study primary safety endpoint is Attain Stability Quad MRI SureScan LV Lead (Model 4798) related 
complications through 6 months post implant.  All reported system and procedure-related AEs will be 
reviewed by an event review committee for LV lead relatedness and severity (complication vs 
observation, refer to 17.1.2 for defintions).  
Primary Efficacy Endpoint #1 
The Model 4798 LV lead has sixteen (16) programmable pacing vectors.  The endpoint for the primary 
efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing 
capture voltage thresholds less than or equal to 2.5V.  This endpoint will be measured at the 6-month 
post implant follow-up visit. 
Primary Efficacy Endpoint #2 
The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing 
capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the 
primary efficacy endpoint #1.  This endpoint will be measured at 6-month post implant follow-up visit. 
11.2.2 Secondary Endpoints 
To summarize implant procedure related information 
Implant procedure related endpoints will include implant success rate and procedure durations.  
To estimate 6-month reliability 
The Model 4798 LV lead 6-month reliability endpoint is Model 4798 lead related complications.  
To estimate electrical measurement values (Pacing Capture Thresholds (PCTs) and Lead 
Impedance) at 6 months post-implant 

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The electrical measurements are pacing capture thresholds and impedance values for the four extended 
bipolar (CRT-D) vectors (i.e. LV1 to RVCoil, LV2 to RV Coil, LV3 to RV Coil, LV4 to RV Coil) or the unipolar 
(CRT-P) vectors (i.e. LV1 to Can, LV2 to Can, LV3 to Can, LV4 to Can) (refer to 15.8.2.3 for the testing 
procedure requirements). 
12. Study Design  
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, 
Investigational Device Exemption (IDE), interventional clinical study.  The purpose of this clinical study is 
to evaluate the safety and efficacy of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) in 
patients indicated for a de novo LV lead implant.  This will be assessed through a primary safety and 
primary efficacy endpoints. 
All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or 
CRT-D device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).  Compatible market 
released Medtronic RA and Medtronic RV leads will be required.  For subjects enrolled who are receiving 
an upgrade to a CRT system, existing non-Medtronic RV and/or existing non-Medtronic RA leads that are 
not recalled, market withdrawn, and/or have a medical alert may be used.   
Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads 
implanted with 6 months post implant follow up visits (assuming 15% attrition).  For the secondary 
endpoint of individual lead failure modes, Bayesian methods utilizing data from up to 37 historical 
patients will be used.  All other objectives will be analyzed using only patients enrolled in this study.  
After a successful implant, threshold testing will occur to show one LV vector with pacing capture 
threshold (PCT) ≤ 2.5 V @ 0.5ms and with sufficient safety margin was programmed.  Subjects will then 
be followed at implant, three months, six months and every six months thereafter until FDA approval is 
obtained or until study closure, whichever comes first. 
See Figure 1 and Section 15 for further detail on study procedures and data collection as well as time-
points for data collection.  

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Figure 1: Study Visits 
Enrollment/Baseline Visit
De novo LV Lead (Attain Stability 
Quad MRI SureScan LV lead) 
Implant
(Implant/PHD visit)
Follow-up @ 3 months
(in office or remote visit)
Follow-up @ 6 months
(in office visit)
Follow-up 12 months
(in office visit)
Exit if unsuccessful Attain Stability 
Quad MRI SureScan LV lead 
implant
Follow-up every 6 months 
thereafter
(in office or remote visit)
 
The study is expected to be conducted at up to 56 sites worldwide.  Participating geographies are 
expected to include, but are not limited to: the United States, Canada, EMEA, Malaysia, and Hong Kong.  
To ensure a widespread distribution of data and to minimize site bias in the study results, the maximum 
number of subjects allowed at a single site is 50 subjects.  
12.1. Duration 
The study duration is expected to be approximately 19 months.  This represents 13 months for subject 
enrollment and 6 months for subject follow-up for the last subject enrolled.  Subjects are anticipated to 
be in the study for on average 12 months.  The first enrollment is projected to occur in May 2017.  
Subjects will complete visits at enrollment/baseline, implant, 3 months, 6 months, and then every 6 
months thereafter.  Subjects will not be replaced with newly enrolled subjects upon early exit.  As 
described in Section 19, the sample size accounts for attrition.  
12.2. Rationale 
Upon market release, this Attain Stability Quad MRI SureScan LV Lead (Model 4798) will provide 
physicians an alternative option to actively fixate the lead utilizing a side helix feature to achieve stability.  
The Attain Stability Quad Clinical Study is designed to demonstrate that the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is safe and effective.  See Section 19 for further background information 
and evaluation of clinical data.  See Section 10 for further background on the study design. 

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12.3. Study Oversight 
The study will utilize a Steering Committee (SC).  The SC is responsible for the scientific content of the 
study and for providing input for the execution of the study.  Members of the SC may be study site 
investigators.  The purpose of the SC is to provide unbiased opinions and expertise to the Attain Stability 
Quad Clinical Study design and process.  The SC will support the execution of the Attain Stability Quad 
Clinical Study and provide guidance, feedback and direction to the clinical study.  The SC is comprised of 
the members as indicated in Table 4 below.   
Table 4: Steering Committee Members 
Committee Member  
Contact information 
George H. Crossley III, MD  
Steering Committee Co-Chair 
Electrophysiology 
Fellowship Program Director 
Vanderbilt University Medical Center 
1211 Medical Center Drive 
Nashville, TN 37232 
United States 
(615) 322-5000 
george.crossley@vanderbilt.edu 
Kevin P. Jackson, MD  
Steering Committee Co-Chair 
Electrophysiologist 
Duke Cardiology of Raleigh 
Medical Office Building 6 
3320 Wake Forest Road 
2nd Floor, Suite 200 
Raleigh, NC 27609 
United States 
(919) 862-5100 
k.j@duke.edu 
Dr. Maria Grazia Bongiorni 
Electrophysiologist 
University Hospital of Pisa 
Lungarno Antonio Pacinotti 
43, 56126  
Pisa PI Italia 
+39 050 221 2111 
m.g.bongiorni@med.unipi.it 
Prof. Svein Faerestrand 
Electrophysiologist 
University of Bergen 
Jonas Liesvei 65  
Bergen, Norway 5021 
+47 55 97 67 04 
svein.faerestrand@helse-bergen.no 
Dr. Axel Kloppe 
Electrophysiologist 
Berufsgenossenschaftliches Universitätsklinikum  
Bergmannsheil GmbH,  
Bürkle-de-la-Camp-Platz 1,  
44789 Bochum, Germany  
+49 234 3026050 
axel.kloppe@bergmannsheil.de 

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Melissa Kong, MD 
Electrophysiologist 
Silicon Valley Cardiology 
1300 Stockbridge Ave   
Redwood City, CA 94061 
United States 
(650) 363-5262 
mhkong1@gmail.com 
Raymond Yee, MD 
Electrophysiologist 
London Health Sciences Centre  
339 Windemere Road  
London, ON N6A 5A5 
Canada 
(519) 663-3671 
ryee@uwo.ca 
Francois Philippon, MD 
Electrophysiologist 
Institut Universitaire de Cardiologie et de Pneumologie de Quebec  
2725 Chemin Ste-Foy 
Quebec G1V 4G5 
Canada 
(418) 656-8711 
francois.philippon@fmed.ulaval.ca 
 
The study will also utilize a Clinical Events Committee (CEC) who will be responsible for adjudicating 
adverse events and deaths, including procedure and/or system-related complications.  Further details for 
the CEC are provided in Section 18.1. 
13. Product Description 
13.1. General 
The Medtronic Attain Stability Quad MRI SureScan (Model 4798) is a steroid-eluting, quadripolar 
electrode, transvenous, over-the-wire (OTW), IS4-LLLL compatible, active fixation, cardiac vein pacing LV 
lead.  This lead is similar to the Attain Performa family of quadripolar leads (Models 4298, 4398, and 
4598) but also has a side helix for active fixation which is similar to the Attain Stability bipolar lead 
(Model 20066/4796) (available outside of the United States).  Figure 2 is a drawing of the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) illustrating the specifications and location of the four 
electrodes in comparison to the side helix. 

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Figure 2: Attain Stability Quad MRI SureScan LV Lead (Model 4798) Specifications Drawing 
 
 
Table 5 provides compares of the Attain Performa family of leads design features to the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798). 
 

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Table 5: Comparison of Medtronic Quadripolar LV Leads 
 
Attain Performa 
Attain Stability 
Quad 
Design Feature 
Model 4298 
Model 4398 
Model 4598 
Model 4798 
Shape 
Double Canted 
Straight 
S-Shaped 
Single Canted 
Implant Method 
Guide wire, 
stylet, or hybrid 
guide wire via 
Medtronic 
Delivery System 
Same as 4298 
Same as 4298 
Guide wire, 
stylet, or hybrid 
guide wire via 
Medtronic 
Delivery System 
and active 
fixation 
Delivery System 
Inner Diameter 
≥ 5.7 Fr ID 
Same as 4298 
Same as 4298 
Same as 4298 
Lead Body 
Diameter 
5.3 Fr 
proximal/3.9 Fr 
distal 
Same as 4298 
Same as 4298 
4.4 Fr 
proximal/3.9 Fr 
distal 
Lead Body 
Conductor 
Single Quadfilar 
Coil 
(Multiconductor) 
Same as 4298 
Same as 4298 
Same as 4298 
Conductor 
Material 
Ag core-low 
Titanium 
MP35Ncoil 
Same as 4298 
Same as 4298 
Same as 4298 
Insulation 
(Outer/Inner) 
Polyurethane 
55D SI-PI 
Same as 4298 
Same as 4298 
Same as 4298 
Polarity 
Selectable Quad-
electrode 
Same as 4298 
Same as 4298 
Same as 4298 
Electrode 
Material 
PT/Ir* alloy with 
TiN coating 
Same as 4298 
Same as 4298 
Same as 4298 
Fixation Helix 
Material 
N/A 
N/A 
N/A 
Pt/Ir** alloy 
Electrode 
Spacing 
21mm/ 1.3mm/ 
21mm 
Same as 4298 
Same as 4298 
Same as 4298 
Surface Area per 
5.8 
Same as 4298 
Same as 4298 
Same as 4298 

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Electrode (mm2) 
Steroid and Dose 
/  MCRD 
Dexamethasone 
acetate 
Each (4) Ring 
72µg 
Same as 4298 
Same as 4298 
Same as 4298 
Total Target 
Dose 
288 µg/lead 
Same as 4298 
Same as 4298 
Same as 4298 
*90/10 Platinum Iridium 
**80/20 Platinum Iridium 
Similar to the Attain Performa family of leads, the Attain Stability Quad MRI SureScan LV Lead (Model 
4798) contains 4 electrodes with surface area of 5.8 mm2 per electrode and is designed to function as 
cathodes or anodes, depending on how the device LV pacing vector is programmed:  
• 
electrode LV1, the distal electrode, positioned near the distal tip of the lead  
• 
electrode LV2, positioned 21 mm proximal to electrode LV1 
• 
electrode LV3, positioned 1.3 mm proximal to electrode LV2 
• 
electrode LV4, the proximal electrode, positioned 21 mm proximal to electrode LV3 
The electrode spacing on the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is identical to the 
approved Attain Performa family of leads.  This includes a non-uniform electrode spacing consisting of a 
reduced electrode spacing configuration (LV2-LV3) that alters the size of the electric field that is 
generated when stimulating the heart tissue.  This close electrode spacing is designed to reduce the 
likelihood of stimulating the phrenic nerve while still allowing for optimal lead placement and acceptable 
pacing capture thresholds.  
Similar to Attain Performa, each electrode contains a Monolithic Controlled Release Device (MCRD) for 
elution of steroid to reduce inflammatory response within the cardiac vein.  The MCRDs contain a 
combined-total target dosage of 288 μg of dexamethasone acetate steroid.  The target dose of the 
steroid is 72 μg at each MCRD.  Upon exposure to body fluids, the steroid elutes from the MCRDs.  The 
steroid suppresses the inflammatory response that is believed to cause threshold rise typically associated 
with implanted pacing electrodes.  
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) has the same lead body conductor (Single 
Quadfilar Coil (Multiconductor), conductor material (Ag core-low Titanium MP35N coil), insulation 
(outer/inner) (Polyurethane 55D SI-PI), and requires a similar delivery system inner diameter as the 
Attain Performa family of leads (≥ 5.7 Fr ID). 
Unlike the Attain Performa family of leads, the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
has a slightly smaller lead body diameter.  The lead body diameter of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is 4.4 Fr proximal (compared to 5.3 Fr on the Attain Performa family of 
leads) and 3.9 French distal (same as Attain Performa family of leads).  This slightly smaller lead body 
tubing diameter is designed to enhance torquability and steerability to facilitate adherence of the side helix 
in the target location. 
Figure 3 is a visual comparison between the Attain Perform leads and the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) illustrating the similar electrode location but different lead body diameter. 
 

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Figure 3: Comparison of Attain Performa Leads and the Attain Stability Lead Model 4798 
 
A detailed comparison of the Attain Stability bipolar lead (Model 4796) and Attain Stability Quad lead 
(Model 4798) is presented in Table 6. 
Table 6: Comparison of Medtronic Attain Stability Bipolar and Quadripolar LV Leads 
 
Attain Stability 
Attain Stability Quad 
Design Feature 
Model 4796/20066 
Model 4798 
Shape 
Single Canted 
Same as 4796/20066 
Implant Method 
Guide wire, Stylet, or 
hybrid guide wire via 
Medtronic Delivery 
System and active 
fixation 
Same as 4796/20066 
Delivery System 
Inner Diameter 
> 5.7 Fr ID 
Same as 4796/20066 
Lead body 
diameter 
3.9 Fr proximal / 3.4 Fr 
distal 
4.4 Fr proximal /3.9 Fr 
distal 
Lead Body 
Conductor 
Single 2 Filar Coil 
(Multiconductor) 
Single Quadfilar Coil 
(Multiconductor) 
Conductor Material 
Ag core-low Titanium 
MP35N coil 
Same as 4796/20066 

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Attain Stability 
Attain Stability Quad 
Design Feature 
Model 4796/20066 
Model 4798 
Shape 
Single Canted 
Same as 4796/20066 
Insulation 
(Outer/Inner) 
Polyurethane 55D 
SI-PI 
Same as 4796/20066 
Polarity 
bipolar 
Selectable Quad-
electrode 
Electrode Material 
Pt/Ir* alloy with TiN 
coating 
Same as 4796/20066 
Fixation Helix 
Material 
Pt/Ir** alloy 
 
Same as 4796/20066 
Electrode Spacing 
21 mm 
21mm / 1.3mm / 21mm 
Surface Area per 
electrode  (mm2) 
5.8 
Same as 4796/20066 
Steroid and Dose /  
MCRD 
Dexamethasone acetate 
Tip 160µg , Ring 72µg 
Dexamethasone acetate 
Each (4) Ring 72µg 
Total Target Dose 
232µg/lead 
288 µg/lead 
Molded Tip Seal 
Silicone (with steroid), 
pierced hole 
Silicone (without 
steroid), cross-cut hole 
Fixation Method 
Helix 
Same as 4796/20066 
Connector 
IS-1 B1 
IS4-LLLL 
Length (cm) 
88 cm only 
78 and 88 cm 
*90/10 Platinum Iridium 
**80/20 Platinum Iridium 
The non-electrically active side fixation helix component is similar to the Attain Stability Bipolar LV lead 
(Model 20066/4796) and is designed to enable active fixation in the cardiac vein.  The Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) side helix is positioned between the LV3 and LV4 electrode; 
specifically 10 mm proximal from the LV3 electrode (see Figure 2).   
A mechanical stop component is located at the base of the helix to prevent wedging of the endothelial 
tissue in the helix and to prevent tissue ingrowth.  The helix component is platinum (Pt) iridium (Ir) alloy 
(Pt/Ir 80/20).  This same Pt/Ir material is also used in the market released right ventricular active 
fixation lead Models 5076, 3830, and 4076.  Both the helix and mechanical stop components are identical 
to those used on the CE Mark approved Medtronic Attain Stability model 20066/4796 active fixation lead 
and are shown in Figure 4.  

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The Model 4798 lead has one distal curve/cant.  This distal curve geometry (angle) is identical to the 
Attain Performa model 4298, as well as Attain Ability models 4196 and 4296 most distal cant.  The 
single distal cant is also identical to the CE Mark approved model 20066/4796 active fixation lead 
(Figure 4). The purpose of the distal cant is to provide physicians the ability to “steer” the distal tip of 
the lead when navigating difficult vein anatomy or acute vasculature angulation by rotating the lead 
(counterclockwise) and aligning the distal tip towards the desired direction.  The distal cant for the 
Model 4798 lead is not intended, or necessary, to provide any fixation of the implanted lead as any 
retention force from the cant would be negligible compared to the stability provided by the properly 
implanted and verified fixated helix.  
Figure 4: Attain Stability Bipolar (Model 20066/4796) & Attain Stability Quad MRI SureScan 
(Model 4798) Active Fixation Leads 
 
 
The Attain Stability Quad Clinical Study will be conducted to evaluate the safety and efficacy of the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) in combination with CRT system components 
mentioned in Table 7. 

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Table 7: Study Component Information 
Component  
US/Canada 
EMEA/Hong Kong/Malaysia 
Attain Stability Quad MRI 
SureScan LV Lead (Model 
4798) 
Investigational 
Market-released 
Medtronic CRT-P or 
Medtronic CRT-D (with 
VectorExpress capabilities) 
Market-released 
Market-released 
Medtronic RV lead (non-
Medtronic and non-
recalled/non-market 
withdrawaled/non-safety 
alerted lead acceptable for 
upgrades) 
Market-released 
Market-released 
Medtronic RA lead (optional) 
(non-Medtronic and non-
recalled/non-market 
withdrawn/non-safety 
alerted lead acceptable for 
upgraded systems) 
Market-released 
Market-released 
 
Given the similarities between the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the 
Attain Performa family of leads, the proposed indications for use are the same.  The indications are as 
follows: 
Proposed Indication Statement for Use for the Attain Stability Quad Lead: 
The Attain Stability Quad MRI SureScan 4798 steroid-eluting, quadripolar electrode, IS4 transvenous lead 
is indicated for chronic pacing in the left ventricle via the cardiac vein, when used with a compatible 
Medtronic Cardiac Resynchronization Therapy (CRT) System.  Extended bipolar pacing is available using 
this lead in combination with a compatible market approved CRT-D system and RV lead. 
Market-Released Right Atrial Lead 
Commercially available Medtronic RA lead models with an IS-1 connector are required when an RA lead is 
implanted with de novo CRT systems.  An RA lead is not required to be implanted in circumstances 
determined appropriate per physician’s medical assessment.  Medtronic commercially available RA leads 
with an IS-1 connector are recommended but compatible non-Medtronic leads are permissible in enrolled 
patients receving a CRT system upgrades.   
Medtronic Market-Released Right Ventricular Lead 
Commercially available Medtronic RV defibrillation leads with a DF4 connector are required for de novo 
CRT systems.  Medtronic RV defibrillation leads with DF1 connectors may be incorporated in the study as 
DF1-compatible CRT-P and CRT-D devices are made available for the study.  A non-Medtronic RV lead is 
permissible in enrolled patients receving a CRT system upgrades. 

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13.2. Manufacturer 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is manufactured by Medtronic, Inc.  
13.3. Packaging 
Packaging and labeling for all market approved system components can be found with each package 
insert.  Manuals can be found on http://manuals.medtronic.com.  For CE Marked devices the labeling is in 
the appropriate local language. 
For investigational products (e.g. in the US and Canada), the language of labeling and clinical manuals 
will be in English and/or local language where it is required.  Investigational products will be clearly 
labeled e.g. “exclusively for clinical investigation.”   
In Canada, each investigational device will be labelled with the statements “Investigational Device”; “To 
be Used by Qualified Investigators Only”; “Instrument de recherche” and “Réservé uniquement à l’usage 
de chercheurs compétents”. 
13.4. Intended Population 
In the Attain Stability Quad Clinical Study, the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
is to be used in subjects where a de novo LV lead is indicated.  The Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) is intended to be used in conjunction with a market released Medtronic CRT-P or 
CRT-D device, a Medtronic (for de novo CRT implants) RV lead, and a Medtronic (for de novo CRT 
implants) RA lead (optional).    
A complete SureScan system is required for use in the MRI environment.  Before performing an MRI 
scan, refer to the SureScan MRI technical manual for MRI-specific warnings and precautions. 
13.5. Equipment 
All commercially available equipment will be used according to their approved intended use. 
Medtronic CareLink (2090) Programmer 
The Medtronic approved CRT-P or CRT-D devices will be programmed and interrogated using a Medtronic 
CareLink (2090) programmer.  Medtronic may incorporate additional programmers as they receive 
regulatory approval. 
Medtronic CareLink Home Monitor 2490C and Network 
The CareLink Monitor Model 2490C is an external monitor that is indicated for use in the transfer of 
patient and device data from implanted Medtronic devices.  The CareLink Monitor Model 2490C 
interrogates implanted devices and temporarily stores these data, collaborates with the appropriate 
Medtronic server to confirm the establishment of an Internet connection with server, performs any 
required file translation functions necessary for data transfer, executes data file transfer, and collaborates 
with the appropriate Medtronic server to confirm data file transfer through the Internet connection with 
the server.  The CareLink Monitor 2490C is not a programmer and cannot be used to program implanted 
device parameters.  CareLink monitors are not a substitute for appropriate medical attention in the event 
of an emergency and should only be used as directed by a physician.  Approved Medtronic CRT-P and 
CRT-D devices used in this study qualify for use with the Medtronic CareLink Monitor and Medtronic 

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CareLink Network.  Medtronic may incorporate additional home monitors as they receive regulatory 
approval. 
Pacing System Analyzer 
Medtronic’s commercially available Model 2290 Analyzer must be available at each center during the 
implant procedure to determine acceptable electrical parameters.  Medtronic may incorporate additional 
analyzers as they receive regulatory approval. 
13.6. Product Use 
See Section 13 Product Description. 
13.7. Product Receipt, Tracking, and Accountability 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered investigational in 
geographies where the product is not available commercially and will be labeled for clinical use only.  
These geographies include but are not limited to the US and Canada.  Investigational Attain Stability 
Quad Leads will be distributed to a site only when Medtronic has received all required documentation 
(including but not limited to Ethic Committee approval, a signed Clinical Trial Agreement and 
documentation of training) and has notified the site of site readiness.   
Distribution of the investigational product to study sites will be managed by Medtronic and investigational 
products can only be ordered by Medtronic personnel.  Sites with these clinically labeled Attain Stability 
Quad MRI SureScan LV Leads (Model 4798) will track disposition upon receipt or return of the lead but 
also upon implant or explant of the lead.  Disposition logs will be available within the electronic data 
management system and shall be maintained at each site in all geographies to track investigational 
product information.  The logs should be updated when an investigational product is received, opened, 
implanted explanted, disposed of or returned to Medtronic.  The logs will track the following 
investigational lead data (but are not limited to) model and serial numbers of devices delivered to the 
site, subject IDs of the subjects, implanted, received dates of devices, implant/used dates, explant dates, 
returned-to-sponsor dates and reasons, initials of all persons who received, used or disposed each 
device, and method of disposal.  Medtronic will perform periodic reconciliation of investigational product 
to ensure traceability. 
For geographies where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is not considered 
investigational, commercially approved devices will be used.  Sites that use commercially available Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) will track device disposition upon implant or explant 
of the lead on the CRFs. 
13.8. Product Storage 
All investigational products must be stored in a secure location at the site.  It is the responsibility of the 
investigator to correctly handle, store and track the investigational products.  Further details may be 
found in the Clinical Manual or User Manual (dependent on each geography’s commercial release of the 
product). 

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13.9. Product Return 
All explanted, open but unused, and defective products (devices or leads, etc.) should be returned to 
Medtronic for analysis whenever possible and when permissible by local laws and regulations.  If the 
products are explanted but not returned, a justification is required to be reported on the appropriate case 
report form(s) or disposition log(s) (note that this is not considered a study deviation).  In geographies 
where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is considered investigational, the 
Disposition Log must be updated in the event of an explant.  To receive a Returned Product Mailer Kit, 
please contact your local Medtronic field personnel or representative.  All unused investigational products 
must be returned to Medtronic upon study closure at the site. 
14. Selection of Subjects 
14.1. Study Population 
Patients of both genders that are 18 years of age and older (or of legal age to give informed consent per 
local and national law) that are indicated for a de novo LV lead implantation and who meet all inclusion 
and no exclusion criteria are eligible for an Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implant attempt.  There will be no control group for this study. 
14.2. Subject Enrollment 
Patients who meet all of the inclusion and none of the exclusion criteria (see sections 14.3 and 14.4) are 
eligible to be enrolled in this study.  Upon signing and dating the Informed Consent Form (ICF), the 
patient is considered a subject enrolled in the study. 

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14.3. Inclusion Criteria 
• 
Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy  
• 
Patient (or legally authorized representative) has signed and dated the study-specific Informed 
Consent Form 
• 
Patient is 18 years of age or older, or is of legal age to give informed consent per local and 
national law 
• 
Patient is expected to remain available for follow-up visits 
14.4. Exclusion Criteria 
• 
Patient has had a previous unsuccessful LV lead implant attempt 
• 
Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial) 
• 
Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA 
and/or RV lead  
• 
Patient has known coronary venous vasculature that is inadequate for lead placement 
• 
Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the 
past 30 days 
• 
Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary 
angioplasty (PTCA) within the past 90 days 
• 
Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right 
heart valve) 
• 
Patient has had a heart transplant (patients waiting for heart transplants are allowed in the 
study) 
• 
Patient has known renal insufficiency that would prevent them from receiving an occlusive 
venogram during the implant procedure 
• 
Patient is contraindicated for <1mg dexamethasone acetate 
• 
Patient is enrolled in any concurrent drug and/or device study that may confound the results of 
this study 
• 
Patient has a terminal illness and is not expected to survive more than six months 
• 
Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.) 
• 
Patient is unable to tolerate an urgent thoracotomy 
14.5. Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias.  
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
• 
Subjects will be evaluated at baseline to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria  
• 
Subject demographics and medical history will be collected at baseline and differences that may 
affect primary endpoints will be identified 
• 
To ensure widespread distribution of data between sites, the maximum number of subjects 
allowed per site is 50 
• 
All implanters in the study will be experienced in the implant of CRT-P and/or CRT-D systems 
• 
Data collection requirements and study procedures will be standardized across all sites and 
geographies 

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• 
All study site personnel and Medtronic personnel will be trained on their respective aspects of the 
study using standardized training materials, and required to follow the CIP 
• 
Per the specifications in the Monitoring Plan, monitoring visits will be conducted for adherence to 
the CIP and to verify the CRF data against source data 
• 
Pre-defined statistical methods specified in the CIP and the Statistical Analysis Plan (SAP) will be 
followed 
• 
The SC members will not have influence on the treatment decisions by study site investigators 
during the trial 
• 
An independent and blinded CEC will regularly review and adjudicate reported adverse events 
and deaths (per Section 18.1) 
• 
Registration of the trial on ClinicalTrials.gov and the publication plan will ensure that study results 
will be reported 
• 
All study investigators are required to meet 21 CFR Part 54, Financial Disclosure by Clinical 
Investigators, to identify potential bias due to financial interest in the outcome of the study  
In summary, potential sources of bias that may be encountered in this Attain Stability Quad Clinical Study 
have been considered and minimized by careful study design. 
15. Study Procedures  
Prior to performing study related procedures, all sites must have Ethics Committee (EC) and associated 
regulatory authority approval if applicable (e.g., Competent Authority approval) as well as documentation 
from Medtronic of site readiness. 
Medtronic representatives may perform the following activities at the study sites during the study, if 
appropriately trained and under supervision of the Principal Investigator: 
• 
Study training relevant and pertinent to the involvement of personnel conducting study activities 
and investigator responsibilities 
• 
Technical support at all visits (e.g. programming of the CRT-P or CRT-D device according to 
study requirements, performing device interrogations/save-to-media, etc.), but no CRF data entry 
shall be performed by Medtronic personnel  
• 
Monitoring activities 
15.1. Study Personnel Requirements 
Site personnel training and delegation will be completed prior to participation in the Attain Stability Quad 
Clinical Study.  The site personnel training consists of required training topics (CIP, Informed Consent 
Form, CRFs, regulations).  Members of the study site team will receive training on the applicable clinical 
study requirements relevant to their role before contributing to the clinical study. 
All Principal Investigators shall: 

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• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
• 
Be qualified practitioners and experienced in the diagnosis, management, and treatment of HF 
subjects with CRT devices 
• 
Be experienced in the field of application and trained in the use of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) 
• 
Disclose potential conflicts of interest, including financial that interfere with the conduct of the 
clinical investigation or interpretation of results 
• 
Be knowledgeable with the method of obtaining an informed consent 
In addition, the Principal Investigator shall be able to demonstrate that the proposed investigational site: 
• 
Has an experienced CRT implanter who is experienced and trained in the handling/implanting of 
CRT-P and/or CRT-D devices 
• 
Has the required number of eligible subjects needed within the agreed recruitment period 
• 
Has one or more qualified investigators, a qualified investigation site team and adequate facilities 
for the foreseen duration of the clinical investigation  
15.2. Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train site personnel on the CIP, 
the implant procedure, relevant standards and regulations, informed consent process, and on data 
collection and reporting tools.  If new members join the study site team, they will receive training on the 
applicable clinical study requirements relevant to their role before contributing to the clinical study.  For 
new members, local Ethics Committee notification requirements must be met, as well as Medtronic 
requirements noted on the training and delegation form.  
A Clinical Trial Agreement (CTA) shall be entered into effect by Medtronic, the participating investigation 
site and/or the principal clinical investigator at each investigational site as per local legal requirements, 
and returned, fully executed, to Medtronic prior to the commencement of any study activities.  Financial 
aspects of conducting and reporting a study will be specified in the agreement.  By signing and dating the 
agreement the investigator indicates approval of the CIP. 
Prior to performing study related activities, all sites must have Ethics Committee approval, as applicable 
for that geography. 
All local and regional regulatory requirements will be fulfilled prior to site activation and enrollment of 
subjects into the study.  Each study site must have written documentation from Medtronic of site and 
investigator readiness before beginning any study-related activities.  Requirements for activation vary by 
geography, and may include, but are not limited to the following:  
• 
Written documentation of Ethics Committee approval of the current version of the CIP and 
ICF, subject materials (e.g. Global Assessment and KCCQ), and voting list (as required by 
local law)   
• 
Regulatory authority approval or notification (as required per local law)  
• 
Fully executed CTA on file with the sponsor  
• 
Financial Disclosure (for Principal Investigators and Co-Investigators)   
• 
Current Curriculum Vitae (CV) (signed and dated as required by local law) of investigators 
and key members (as required by local law) of the investigation site team on file with the 
sponsor  
• 
Documentation of delegated tasks 

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• 
Documentation of study site personnel training  
Additional requirements imposed by the Ethics Committee and regulatory authority shall be followed, if 
applicable.  
Medtronic will provide each study site with documentation of study site readiness; this letter must be sent 
prior to subject enrollment. 
15.3. Equipment Requirements 
The following equipment must be available at each site to support study activities: 
• 
Medtronic 2290 Analyzer (or latest market released Medtronic analyzer) 
• 
Medtronic 2090 programmer (or latest market released Medtronic programmer) 
• 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) (either clinically labeled product or 
commercial released product located at the site or carried to the implant by the Medtronic 
representative) 
• 
Computer with high speed internet access using a web browser compatible with the electronic 
data management system for electronic database entry  
The equipment necessary for the assessment for the study includes the Medtronic 2290 Analyzer and 
Medtronic 2090 programmer.  The maintenance and calibration of the equipment used for this study will 
be assessed outside of this clinical study.  Sites are responsible for maintaining and calibrating non-
analyzer/programmer equipment used in the course of this study in accordance with established site 
practice or local regulation.  Records should be kept and able to be provided upon request by the 
Sponsor or regulatory agency.   
15.4. Schedule of Events 
Clinical data will be collected at the study milestones detailed in Table 8.  Data will be collected via 
electronic case report forms (eCRFs), still cine images, analyzer/programmer print-outs, and interrogation 
files.  Post-implant follow-ups apply only to those subjects in whom an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) was successfully implanted or an implant was attempted.  Subject visits 
will occur at enrollment, baseline, implant/pre-hospital discharge (PHD), 3 months post-implant, 6 
months post-implant, and every 6 months thereafter until PMA approval of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) implanted or study termination, whichever comes first.  Medtronic 
personnel may assist study personnel during implant and study visits.

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Table 8: Data Collection and Study Procedure Requirements at Subject Visits 
STUDY PROCEDURE 
Enrollment
/Baseline 
Implant/
PHD 
3 months 
post-implant 
(remote or 
inoffice visit) 
6 months 
post-
implant 
(inoffice 
visit) 
12 
months 
post-
implant 
(inoffice 
visit) 
Recurring 6 
month 
follow-ups 
(remote or 
inoffice 
visit) 
Exit 
Subject Informed Consent 
 
 
 
 
 
 
 
Inclusion / Exclusion criteria 
verified 
 
 
 
 
 
 
 
Subject demographics 
 
 
 
 
 
 
 
Cardiovascular medications 
 
 
 
 
 
 
 
Cardiovascular medical history 
 
 
 
 
 
 
 
NYHA classification 
 
 
 
 
 
 
 
Patient Global Assessment 
 
 
 
 
 
 
 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
 
 
 
 
 
 
 
Occlusive venogram with pre-
determined pacing location 
identified 
 
 
 
 
 
 
 
Analyzer PCT data collection (pre 
and post slitting the cannulation 
catheter) 
 
 
(Implant) 
 
 
 
 
 
Investigator Lead Handling 
Assessment 
 
 
(Implant) 
 
 
 
 
 
System and procedure 
information 
 
 
 
 
 
 
 
Lead Impedance (all 16 vectors) 
 
 
 (final 
programmed  
vector only) 
 
 
 (final 
programmed  
vector only) 
 
Pacing Capture Thresholds (all 
16 vectors) 
 
 
 (final 
programmed  
vector only) 
 
 
 (final 
programmed  
vector only) 
 
Phrenic Nerve Stimulation (final 
programmed vector) 
 
 
 (inoffice visit 
only) 
 
 
 
 
 
Phrenic Nerve Stimulation 
(vectors LV1 to RVcoil/Can, LV2 
to RVcoil/Can, LV3 to 
RVcoil/Can, LV4 to RVcoil/Can) 
 
 
 
 
 
 
 
Rationale for selecting specific 
LV lead pacing vector for final 
programming 
 
 
 
 
 
 
 
Final device interrogation/save-
to-media 
 
 
 (CareLink 
transmission is 
acceptable for 
remote visits) 
 
 
 (CareLink 
transmission 
is acceptable 
for remote 
visits) 
 (required 
only if subject 
exits prior to 6 
months post-
implant visit; 
CareLink 
transmission is 
acceptable) 
AE Assessment 
 
 
 
 
 
 
 
Exit Subject 
 
 
 
 
 
 
 
Adverse Events (incl. AE with 
outcome of death) 
As they occur 
Device Deficiencies 
System Modifications 
Study Deviations 

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Table 9 below specifies permitted time windows for the required subject visits.  Subject visit target dates 
and windows for each follow-up will be made available to the study site.  Should a subject miss a visit or 
the visit falls outside the pre-specified window, a study deviation must be reported and the original 
follow-up schedule maintained for subsequent visits.  Data analyses will include follow-up visits, 
regardless of whether the visit occurs within the window.  Therefore, a late visit is preferred over a 
missed visit but must be accompanied by a deviation.  
Table 9: Visit Windows 
Visit 
Window 
Implant 
0-30 days since Baseline 
Assessment 
  
(days since implant) 
Pre-hospital discharge 
0-7 
3-month 
76 - 106 
6-month 
183 - 213 
12-month 
350 - 380 
18-month 
518 - 578 
24-month 
701 - 761 
 
15.5. Subject Consent 
Informed consent (IC) is defined as a legally effective documented confirmation of a subject’s voluntary 
agreement to participate in a particular clinical study after information has been given to the subject on 
all aspects of the clinical study that are relevant to the subject’s decision to participate (ISO 14155:2011).  
This process includes obtaining IC and an Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language (data protection authorization; i.e. HIPAA in 
the US) as required by law.  Informed Consent Forms are required to be approved by the study site’s 
Institutional Review Board (IRB) or Ethics Committee (EC) and Medtronic, and signed and dated by the 
subject and the Principal Investigator.  A subject may only consent after information has been given to 
the subject on all aspects of the clinical study that are relevant to the subject’s decision to participate.  
Prior to enrolling subjects, each site must have documented IRB/EC approval of the IC Form (ICF) and 
the data protection authorization as required by law.  Any changes to a previously approved ICF 
throughout the course of the study must be reviewed and approved by Medtronic and the IRB/EC 
reviewing the application before being used to consent or re-consent a study subject.  The document(s) 
must be controlled (i.e. versioned and dated) to ensure it is clear which version(s) was approved by 
Medtronic and the IRB/EC.  All important new information should be provided in written form to new and 
existing subjects throughout the study.  If relevant, all affected subjects must be asked to confirm their 
continuing IC in writing.   

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Prior to initiation of any study-specific procedures, IC must be obtained from the subject (or legally 
authorized representative).  Likewise, privacy or health information protection regulation may require 
subjects to sign additional forms to authorize sites to submit subject information to the study sponsor.  
The IC process must be conducted by the principal investigator or an authorized designee, and the ICF 
and data protection authorization, as required by law, must be given to the subject in a language he/she 
is able to read and understand.  
The process of obtaining informed consent shall: 
• 
Ensure that the principal investigator or an authorized designee conducts the IC process. 
• 
Include all aspects of the Attain Stability Quad Clinical Study that are relevant to the subject's 
decision to participate throughout the clinical study. 
• 
Avoid any coercion or undue improper influence on, or inducement of the subject to participate. 
• 
Not waive or appear to waive the subject’s legal rights. 
• 
Ensure the ICF and data protection authorization, as required by law, are given to the subject in 
a non-technical language the subject is able to read and understand. 
• 
Provide ample time and opportunity for the subject to read and understand the ICF to inquire 
about details of the study, and to consider participation.  All questions about the study should be 
answered to the satisfaction of the subject. 
• 
Include a personally dated signature of the subject acknowledging that their participation in the 
study is voluntary. 
• 
Include a personally dated signature by the principal investigator or authorized designee 
responsible for conducting the IC process, as required by local law. 
• 
Include any other locally required signatories, such as witnesses, as indicated by country-specific 
legislations. 
• 
Provide the subject with a copy of the ICF, the data protection authorization, as required by law, 
and any other written information, signed and dated if required by local law. 
• 
Ensure subjects are notified of any significant new findings about the study that become 
available during the course of the study which are pertinent to the safety and well-being of the 
subject, as this could impact a subject’s willingness to participate in the study. 
If IC is obtained the same day the subject begins participating in study-related procedures, it must be 
documented that consent was obtained prior to participation in any study-related procedures.  It is best 
practice for the IC process to be documented in the subject’s case history, regardless of circumstance. 
In the event the subject cannot read and/or write, witnessed (impartial third party) IC will be allowed, 
provided detailed documentation of the process is recorded in the subject’s case history and the witness 
signs and dates the ICF.  Informed consent shall be obtained through a supervised oral process.  An 
independent witness must be present throughout the process.  The ICF and any other information must 
be read aloud and explained to the prospective subject, if allowed by local law.  The witness signs and 
personally dates the ICF, attesting that the information was accurately explained and that informed 
consent was freely given.  The subject should “make his mark” (sign or otherwise physically mark the 
document so as to indicate consent) on the ICF as well.  The ICF should document the method used for 
communication with the prospective subject and the specific means by which the prospective subject 
communicated agreement to participate in the study.  
The original of the signed ICF must be filed in the hospital/clinical chart and/or with the subject’s study 
documents.  A second signed original or a copy should be given to the subject for their records (if 
applicable). 

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The ICF and data protection authorization, as required by law, must be available for monitoring, auditing 
and regulatory inspections.  
Geography specific ICF Templates will be provided under separate cover.  
15.6. Enrollment 
The point of enrollment is defined as the time at which a patient has signed and dated the ICF.  The date 
the subject signed (or legally authorized representative) the ICF and data protection authorization, as 
required by law, must be documented in the subject’s medical records.  At that point, the patient is 
considered a subject in the study, a study subject ID number will be assigned, and the subject must be 
followed for the duration of the study unless the subject exits the study prior to study closure.  Each 
investigational center will be responsible for maintaining subject identification records (e.g. subject 
identification log) according to ISO 14155.  
Enrollment will occur on the same day as the baseline visit.  Once IC is obtained, report AEs/deaths, 
study deviations and subject exits as they occur.  To accurately track subject enrollment, Medtronic 
should be notified of the enrollment as soon as possible after a patient has signed the ICF. 
15.7. Baseline 
The baseline visit can be a stand-alone visit or can occur on the same day as, but not later than, the 
implant visit.  The following procedures will be completed/data will be collected at the baseline visit: 
o 
Subject Informed Consent  
o 
Inclusion/Exclusion criteria verified 
o 
Subject demographics  
o 
Cardiovascular medications 
o 
Cardiovascular medical history 
o 
NYHA classification 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ)  
Cardiovascular medications include ACE inhibitors, ARBs, antiarrhythmic, anti-coagulants, antithrombotics, 
and antiplatelet, antihypertensive, antilipidemics (statins), beta blockers, calcium channel blockers, 
diuretics, digitalis, inotropes, nitrates, digoxin, and vasodilators. 
If implant does not occur within 30 days of enrollment, verification of all inclusion and all exclusion 
criteria must be repeated before an implant attempt. 
15.8. Implant/PHD 
Information collected at Implant/PHD will include data from the day of the implant procedure until 
released from the hospital.  The implant CRF will be used to collect data at implant.  Implantation of the 
CRT device and right heart leads should be performed according to the Instruction for Use (IFU) in 
geographies where the devices are commercially available. 
Any Medtronic commercially released right atrial (RA) and any Medtronic commercially released right 
ventricular (RV) lead may be implanted.  Existing non-Medtronic RV and/or RA leads that are not recalled, 
market withdrawn, and/or have a medical alert may be used in enrolled who are receiving an upgrade to 

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a CRT system.  The right-heart leads should be implanted according to the labeling provided with the 
applicable lead. 
The implanted system device must include a Medtronic commercially released CRT device which can be 
programmed to utilize all electrodes, allowing upgrades from implantable pulse generators (IPGs) and 
implantable cardioverter defibrillators (ICDs).  Device and lead requirements are as follows: 
• 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
• 
For de novo CRT implants, any Medtronic commercially released transvenous (active or passive 
fixation) RA pacing lead (unless medical justification to exclude this lead) and any Medtronic 
commercially released transvenous (active or passive fixation) RV lead 
• 
For upgrades to a CRT system, existing non-Medtronic RV and/or non-Medtronic RA leads that 
are not recalled, market withdrawn, and/or have a medical alert may be used in enrolled who are 
receiving an upgrade to a CRT system  
• 
Medtronic commercially released CRT devices that measure discrete LV electrical values from all 
four electrodes (i.e. Vector Express) 
15.8.1. 
Final System Configuration 
For information on the requirements for the implanted system refer to Section 13.  The system is 
successfully implanted when the Medtronic CRT device is successfully connected to the RA, RV and the 
LV lead (except if a medical condition such as chronic atrial fibrillation excludes the need for an RA lead).  
The configuration of the successfully implanted system components will be collected.  This will include 
the serial number of each implanted component (CRT-D or CRT-P device, and leads), and the location of 
lead placement. 
15.8.2. 
Implant Procedure 
Implantation of the CRT device and cardiac leads must be performed by a trained clinical study 
investigator and according to the manufacturer’s instructions for use.  It is recommended to use 
Medtronic catheters that are compatible with the Attain Stability Quad MRI SureScan LV Lead (Model 
4798) (e.g., > 7 Fr) during the implant for gaining access to the coronary sinus (CS).   
For complete information regarding the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and 
the implant procedure, reference the Clinical Manual in the US and Canada or the Instructions for 
Intended Use (Technical Manual in EMEA, Hong Kong, and Malaysia).  These documents are located 
under a separate cover. 
15.8.2.1. Venogram 
An occlusive venogram is required for venous visualization of the subject’s coronary vasculature and will 
be used to pre-determine a desired target pacing location prior to placing the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798).  Once the pre-determined target pacing location is determined, a 
venous image will be collected.  A copy of the venous image will be submitted to Medtronic and kept on 
file at the center.  
15.8.2.2. Implanting the LV lead 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be implanted according to the implant 
instructions found within the lead packaging.  The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) can be positioned with the aid of a guide wire (0.36 mm to 0.46 mm or 0.014 inches to 0.018 

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inches in diameter), stylet, an inner catheter, or an inner catheter plus hybrid guide wire.  If a stylet is 
used for lead positioning, only use the stylets packaged with the lead or in a stylet kit (downsized knob).   
Always use a stylet that is 3 cm shorter than the lead length listed on the IS4 connector label.  Other 
stylets may extend beyond the lead tip causing injury or perforation of the cardiac vein or heart.  If using 
a Medtronic integrated valve system (e.g. SureValve), rotate the helix counterclockwise to allow safe 
passage of the helix when inserting the lead into the delivery system to prevent the side helix from 
inadvertently attaching to the valve.  Rust stylets are not recommended with this lead due to the risk of 
conductor coil/insulation perforation. 
Follow the Attain Stability Quad MRI SureScan LV Lead (Model 4798) package insert carefully for fixating 
the side helix to the vein.  Consider using a J-shaped stylet if fixation is unsuccessful.  An overview of the 
key implanting tips includes: 
• 
Rotate the lead counterclockwise when inserting the lead through the SureValve to prevent the 
helix from attaching to the valve 
• 
Refrain from wedging the lead into the vessel so that the lead can easily rotate during fixation 
allowing torque to transfer from the proximal end to the distal end of the lead 
• 
To fixate the side helix in the desired location, rotate the lead clockwise with the guidewire 
inserted in the lead which will provide extra stiffness to the lead 
• 
Ensure the guidewire is removed to allow for lead pliability to visualize and confirm lead fixation 
during the Push Test and the Pull Test  
• 
To reposition the lead, insert the guidewire and rotate the lead counterclockwise without applying 
tension to the lead to unfixate 
Information on surgical data, such as tool use, and implant times, etc. will be collected during the implant 
procedure. 
In an event that one Attain Stability Quad MRI SureScan LV Lead (Model 4798) is determined to be not 
suitable for a patient after the initial lead insertion; the implanting physician must assess the onset of any 
potential AEs.  A second Attain Stability Quad MRI SureScan LV Lead (Model 4798) may only be 
introduced upon confirmation that no system-related AEs resulted from the first Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) implant attempt.  Any LV lead related AE observed during the initial LV 
lead attempt prohibits an attempt of a second Attain Stability Quad MRI SureScan LV Lead (Model 4798). 
If the subject does not have a successful Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implant at the conclusion of the initial implant procedure, the subject should be followed until procedure 
or system related AEs are resolved or are unresolved with no further actions planned, whichever occurs 
later. 
If an attempt to implant the Attain Stability Quad MRI SureScan LV Lead (Model 4798) does not occur, or 
if the Model 4798 LV lead cannot be implanted, the reasons why the lead was not attempted or 
attempted but not implanted must be documented on the Implant and Study Exit CRF.  See additional 
definitions below. 
No Attain Stability Quad MRI SureScan LV Lead (Model 4798) Attempted (lead not inserted 
into the body) 
An Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt is defined as any time a Model 
4798 lead is introduced into the body.  Subjects that do not have an Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) implant attempted will be exited from the study following their implant procedure 

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unless another Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt is scheduled.  Adverse 
events, device deficiencies and deviations must be documented before the subject is exited. 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) Attempted but Not Implanted 
An Attain Stability Quad MRI SureScan LV Lead (Model 4798) that is inserted into the body that is not 
successfully placed will be considered an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 
4798) attempt.  Note: An unsuccessful implant itself is not considered an AE.  Adverse Events occurring 
during an unsuccessful implant (e.g. dissection, perforation) will be recorded and classified.  Subjects 
with an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt will be followed 
until procedure or system related AEs have been resolved or are deemed unresolvable with no further 
action planned. 
15.8.2.3. CRT System Testing and Programming During Implant 
Prior to connecting the leads to the CRT can, initial electrical measurements will be taken using the 
Analyzer (Model 2290 or market released equivalent) to confirm adequate pacing thresholds (PCTs) prior 
to closing the pocket per the site’s standard testing method.  These PCTs will be collected on the same 
vector, at two timepoints once the lead is fixated and prior to connecting the leads to the can using the 
Analyzer.  The timepoints are as follows; 
1.) Prior to slitting the cannulation catheter – Collect the first PCT using the Analyzer after the 
lead is fixated and the guidewire/stylet has been pulled back proximal to the helix and electrodes.  
2.) Post slitting the cannulation catheter – Collect the second PCT using the Anlyzer after the lead 
is fixated and following slitting of the cannulation catheter.   
These PCT measurements will be collected on the CRF.  This data will only be collected if an Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) is successfully placed. 
Pacing voltage thresholds are measured to determine whether the underlying myocardium will respond 
effectively to pacing and to evaluate lead stability in the cardiac vein.  It is required to perform LV pacing 
threshold measurements during implant using the pacing threshold test at a 0.5ms pulse width.  It is 
recommended to begin at 2.5 Volts and decrease amplitude after at least 3 pulses until capture is lost.  If 
there is no capture at 2.5 V; stop the test and repeat at a higher voltage using the 0.5ms pulse width.  
The lowest amplitude where capture consistently occurs is the pacing threshold value.  Collect data using 
the Analyzer (Model 2290 or market released equivalent). 
It is recommended that physicians locate a final LV pacing site that can be captured using less than or 
equal to 2.5 V at 0.5ms, R-wave sensing of at least 4.0 mV, and does not cause diaphragmatic 
stimulation at 10V at 0.5ms.  For additional details regarding the left ventricular leads and implant tools, 
refer to the respective technical manuals provided with each product.  
Individual patient venous anatomies as well as pathologies present in the left ventricular myocardium are 
factors that will influence LV lead placement.  Therefore, the best cardiac vein lead electrode location to 
stimulate the LV may vary for each patient.  
15.8.2.4. Final Lead Placement Data Collection 
Following fixation and once the final position of the lead is determined, collect a venous image of the final 
placement of the lead.  A copy of the venous image will be submitted to Medtronic and kept on file at the 
center.  

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15.8.2.5. Pre-Hospital Discharge CRT System Testing and Programming  
The following electrical testing will be performed using the implanted CRT-P or CRT-D device and the 
device programmer once the leads are connected to the CRT-P or CRT-D and pre-hospital discharge: 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors 
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors  LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
Other data collected prior to hospital discharge following the implant includes; 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies  
15.9. 3 Months Post-Implant (remote or in office visit) 
The 3 month scheduled follow-ups may be done remotely or inoffice.  For remote visits, CareLink 
transmissions may substitute device interrogations.  The following procedures will be completed and data 
will be collected at the 3 month Follow-up visit; 
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the final programmed vector 
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 

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o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media (or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.10. 
6 Months Post-Implant (in office visit) 
The following procedures will be completed and data will be collected during the 6 months in office 
Follow-up visit. 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If at any tested vector PNS is present at 8.0V at 0.5ms, measure the PNS 
threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
 
 

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Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.11. 
12 Months Post-Implant (in office visit) 
The following procedures will be completed and data will be collected during the 12 month in office 
Follow-up visit. 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 

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o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.12. 
Recurring 6 Month Follow-ups (remote or inoffice visit) 
After the 12 Month Follow-Up visit, subjects will be seen every 6 months. These scheduled follow-ups are 
considered “Recurring 6 month follow-up visits”.  These scheduled follow-ups may be done remotely or 
inoffice.  For remote visits, CareLink transmissions may substitute device interrogations.  The following 
procedures will be completed during these visits: 
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the final programmed vector  
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Retain printouts at the site 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media (or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.13. 
Device Interrogation/Save-to-Media 
For the implant and follow-up visits, a final “Interrogate All” device interrogation file (.pdd) must be 
obtained and saved in a digital format (Save-to-Media).  Store one copy of the save-to-media at the site 
and send a copy to Medtronic.  Do not clear device data.  
A device interrogation (final “Interrogate All”) and Save-to-Media should also be completed at the time of 
study exit (prior to 6 month visit), a system modification (initial and final “Interrogate All”), and in the 
case of a death (where possible).   
15.14. 
System Modifications 
A system modification will be reported in the event the device and/or leads require invasive modification 
(e.g. generator or lead explant, generator or lead replacement, lead repositioning, etc.).  In the event of 
a system modification, regardless of outcome of the modification, subjects should remain in the study 

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when possible and the follow-up visit schedule for the subject will remain unchanged.  For a system 
modification the following information/activities are required to be collected: 
o 
Modification or replace/explant date 
o 
Reason for modification  
o 
Information on device or lead modified   
o 
Information on any replacement device(s) 
o 
Final device interrogation/save-to-media  
o 
Study deviations 
o 
AEs and device deficiencies (as applicable) 
It is recommended that all explanted Medtronic products (device, leads, etc.) are returned to Medtronic 
for analysis per local process and when permissible by local laws and regulations. 
In the event that subject has a re-attempt after a previous unsuccessful system modification, the 
subsequent attempt(s) must be reported via CRF as separate system modifications.    
Attain Stability Quad MRI SureScan LV Lead (Model 4798) repositioned or replaced with 
another Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is repositioned or replaced, the following 
LV lead electrical tests and data collection must be completed:  
Lead Impedance 
o 
Obtain  LV Lead Impedance Test for the final programmed vector 
o 
Perform a manual test for a missing value 
o 
NOTE: Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain a PCT at 0.5ms pulse width using Vector Express on the final programmed vector 
o 
Perform a manual test for a missing value  
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
NOTE: Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
o 
Record the reason why the final configuration was selected for final programming 
o 
Record any programming changes to the LV lead apart from the LV lead pacing vector 
since the last visit and provide rationale for the change(s) 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) capped or explanted without 
replacement with another Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is capped or explanted without 
replacement while the subject is in the study, subjects will continue to be followed per their original 
follow-up schedule for safety monitoring until study closure.  LV lead electrical testing and interrogation 
files will not be required at follow-ups for subjects without the full protocol required system implanted. 

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Explant of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the Medtronic 
CRT-P or CRT-D device without replacement with another Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) and Medtronic CRT-P or CRT-D device 
Subjects who have their Attain Stability Quad MRI SureScan LV Lead (Model 4798) and Medtronic CRT-P 
or CRT-D device explanted without replacement during a system modification procedure should be exited 
from the study as soon as all system related and/or system modification procedure related AEs are 
resolved.  If no system or procedure related AEs are present at the conclusion of such a system 
modification procedure, the subject should be exited immediately. 
Medtronic CRT-P or CRT-D device explanted without replacement, Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) remains implanted 
If the Medtronic CRT-P or CRT-D device is explanted and a replacement device will be implanted, all 
attempts should be made to replace with another Medtronic CRT-P or CRT-D device.  In the event that an 
explanted Medtronic CRT-P or CRT-D device cannot be replaced with a new Medtronic CRT-P or CRT-D 
device, subjects who still have an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted 
will continued to be followed for safety monitoring in person per their original follow-up schedule until 
study closure.  Events related to the Attain Stability Quad MRI SureScan LV Lead (Model 4798) should be 
reported.  Left ventricular lead electrical testing will not be required at follow-ups for subjects without the 
full protocol required system implanted.  In an event that a second Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) was implanted as a result of an Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) related complication, the subject will be followed for safety, however the second implanted 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) will not be included for the analyses of study 
objectives except reportable system related adverse events. 
15.15. 
Study Exit  
Study Exit is defined as the moment when a subject officially stops participating in the study.  Date and 
reason for subject exit must be reported to Medtronic at the earliest opportunity. 
Subjects will be exited from the study for any of the following situations: 
• Study completed 
• Subject lost to follow-up 
• Subject did not meet eligibility criteria and was not yet implanted with an Attain Stability Quad 
MRI SureScan LV Lead (Model 4798)    
• Subject did not have a successful implant and no attempt at re-implant is made 
• Subject did not provide consent or data protection authorization, as required by law 
• Subject chooses to exit (i.e. revokes consent) 
• Investigator withdraws subject  
Prior to exiting a subject from the study, it is recommended to follow the subject until all ongoing system- 
and procedure-related AEs are resolved, unresolved with no further actions planned, or 30 days post the 
6 month visit, whichever occurs first.  Following exit, subjects will continue to receive standard medical 
care.  There will be no further required study-related follow-up visits for these subjects.  All data through 
the time of the subject’s exit will be available for data analyses. 
If possible, the following procedures should be performed / data collected at the exit visit: 

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o 
Report the reason for exit 
o 
Final interrogation file (or CareLink transmission) for exits occurring prior to the 6 month visit 
o 
Study deviations 
o 
AEs and device deficiencies (as applicable) 
After subjects are exited from the study they should receive standard medical care and should be 
managed and followed per physician discretion.  
15.15.1. Study Completed 
All subjects will be followed until FDA Pre-Market Approval (PMA) of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798).  Medtronic will notify sites when the study is complete.  Upon exiting 
subjects, if the current follow-up visit and exit visit are combined, then both the follow-up CRF and a 
Study Exit CRF need to be completed but only one device interrogation/save-to-media needs to be 
completed and collected.  If AEs are unresolved at time of exit, it should be noted on the AE CRF that the 
AE is unresolved at time of study exit.   
15.15.2. Lost to Follow-up 
In the case that the subject is determined to be lost to follow-up, details of a minimum of two attempts 
and the method of attempt (e.g., one letter and one phone record or two letters) to contact the subject 
must be recorded.  In addition, follow the regulations set forth by the governing IRB or EC. 
15.15.3. Study Exit Upon Sponsor Request 
A subject must be exited from the study if the sponsor suspends study enrollment and a subject has 
signed the ICF but no implant attempt of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
has occurred (see Section 15.8.2.2). 
15.16. 
Subject Withdrawal or Discontinuation  
15.16.1. Subject Chooses to Exit (i.e. revokes consent) 
A subject can withdraw from the study at any time.  If the subject wishes to exit from the study (i.e. the 
subject revokes consent), the site is required to document the reason for exit on the Exit CRF.  In 
addition, study sites shall follow the regulations set forth by the governing Ethics Committee.  For 
countries following ISO 14155, permission may be requested to follow up with the patient outside of the 
study due to withdrawal based on problems related to the investigational feature safety or performance.  
If possible, the following data should be collected prior to subject withdrawal: 
• 
Report the reason for subject withdrawal 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
15.16.2. Investigator Withdraws Subject 
No subjects should be withdrawn by investigators unless compelling medical justification is present.  It is 
recommended investigators discuss any withdrawals with the study sponsor prior to exiting subjects.  If 

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an Investigator withdrawal is necessary, the following data should be collected prior to subject 
withdrawal if possible: 
• 
Report the reason for subject withdrawal 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
 The following are reasons for investigator-initiated subject withdrawal; 
Medical Necessity 
A subject may be exited from the study if an investigator feels it is necessary to withdraw the subject 
from the study due to a medical condition or other reason.  In such cases, the subject will be notified and 
provided an explanation regarding the reasons for the study exit. 
Explant of Medtronic CRT-P or CRT-D Device and Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) 
Subjects in which the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the Medtronic CRT-P 
or CRT-D device are explanted without replacement (i.e., subject no longer has a Medtronic CRT-P or 
CRT-D device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted) shall be 
exited from the study (refer to Section 15.8.2.2).  Subjects exposed to an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) through a lead attempt must be followed through at least one month or 
until all implant related AEs (system-, and/or procedure-related) have resolved or are unresolved with no 
further actions planned.  Subjects who have either an Attain Stability Quad MRI SureScan LV Lead (Model 
4798) (active or not active) or a Medtronic CRT-P or CRT-D device implanted will continued to be 
followed for safety until study completion. 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) Not Implanted 
Subjects that are not anticipated to have an implant attempt (e.g. do not meet inclusion/exclusion 
criteria) must be exited from the study.  Subjects that have a CRT system implant attempt, but who do 
not have an Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempted (See Section 15.8.2.2 
for definition) will be exited from the study following their procedure unless an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) attempt is scheduled.  If this attempt is more than 30 days from the 
baseline assessment, verification of the baseline data must be completed prior to a subsequent implant 
attempt. 
Subjects with an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant attempt 
will be followed at pre hospital discharge and one month unless there are ongoing implant related AEs 
(system- and/or procedure related), in which case they will be followed beyond one month until the 
implant related (i.e., system-, and/or procedure related) AEs have been resolved or are considered 
unresolved with no further actions planned.  The subjects may be followed via a clinic visit or by phone 
contact.  In geographies where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is market-
released, subjects will be exited from the study after the assessment of implant procedure or CRT system 
related AEs if the initial attempt of one Attain Stability Quad MRI SureScan LV Lead (Model 4798) model 
was unsuccessful.  The subject may undergo implant attempts with any market released LV lead that 
provides the best benefit to the patient, but data collection on these subsequent attempts will not be 
required as these subjects will be considered exited from the study. 

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15.17. 
Assessment of Efficacy 
The primary efficacy objective is based on the pacing capture threshold data collected as discussed in 
Section 19.1.  
15.18. 
Assessment of Safety  
The primary safety objective is based on the Adverse Event data collected.  Further information on the 
collection of Adverse Events is discussed in Section 17.1.1.  
15.19. 
Recording Data 
The study will collect data using Oracle Clinical, an electronic data management system for clinical 
studies.  Sites will enter data onto CRFs within the Oracle Clinical database.  
Data reported on the CRFs shall be derived from source documents, which may include worksheets, 
patient medical records, programmer printouts and device interrogation/save-to-media files.  These 
source documents must be created and maintained by the investigational site team.  Further detail on 
data management is provided in Section 21.2. 
15.20. 
Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the Clinical 
Investigation Plan or the Clinical Trial Agreement.  
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, or 
makes a conscious decision to deviate.  In all geographies, prior approval is not required when a 
deviation is necessary to protect the safety, rights or well-being of a subject in an emergency or in 
unforeseen situations beyond the investigator’s control (e.g. subject failure to attend scheduled follow-up 
visits, inadvertent loss of data due to computer malfunction, inability to perform required procedures due 
to subject illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward.   
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis).  However, 
prior approval from Medtronic is required for such situations.  
All study deviations must be reported to Medtronic regardless of whether they are medically justifiable, 
pre-approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
The deviation must be recorded in Oracle Clinical with an explanation for the deviations.  In the 
occurrence of a corrupted device interrogation/save-to-media file, Medtronic will request a deviation to 
document that a readable device interrogation/save-to-media file is unavailable.  
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the IRB/EC as well as 
Medtronic as soon as possible but no later than five (5) working days, or according to local requirements.  
Reporting of all other study deviations should comply with IRB/EC policies and/or local laws and 
deviations must be reported to Medtronic as soon as possible upon the site becoming aware of the 
deviation.    

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Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, and 
terminate the study).  Repetitive or serious investigator compliance issues may result in initiation of a 
corrective action plan with the investigator and site, and in some cases, necessitate suspending 
enrollment until the problem is resolved or ultimately terminating the investigator's participation in the 
study.  Medtronic may provide site-specific reports to investigators summarizing information on deviations 
that occurred at the investigational site on a periodic basis. 
16. Risks and Benefits 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of the product, 
from the research and development phase through the study phase and market release.  The risk 
analysis process for the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is being performed in 
accordance with ISO 14971, and will ensure that the level of risk has been reduced as low as possible 
and is acceptable prior to starting the Attain Stability Quad Clinical Study.   
Potential Risks 
Standard risks associated with the medical device used in this study, an analysis of Adverse Device 
Effects and a history of modification or recall of device under investigation or equivalent devices are listed 
in the Instruction for Use Manual or Clinical Manual. 
The potential adverse events (listed in alphabetical order) related to the use of transvenous leads inlcude, 
but are not limited to, the following conditions: 

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• 
Air embolism 
• 
Avulsion or other damage to the endocardium, valve, or vein (particularly in fragile hearts) 
• 
Cardiac dissection or perforation 
• 
Cardiac tamponade 
• 
Coronary sinus dissection  
• 
Death 
• 
Endocarditis or pericarditis 
• 
Erosion through the skin 
• 
Extracardiac muscle or nerve stimulation 
• 
Fibrillation or other arrhythmias 
• 
Heart Block 
• 
Heart wall or vein wall rupture 
• 
Hematoma/seroma 
• 
Infection 
• 
Lead conductor fracture or insulation failure 
• 
Lead dislodgement 
• 
Myocardial irritability 
• 
Myopotential sensing 
• 
Pericardial effusion or rub 
• 
Pneumothorax 
• 
Rejection phenomena (local tissue reaction, fibrotic tissue formation) 
• 
Threshold elevation or exit block 
• 
Thrombosis 
• 
Thrombotic embolism 
Additional potential adverse events related to the lead and the programmed paramenters include, but are 
not limited to, the following: 
Table 10: Additional adverse events related to the lead and programmed parameters 
Potential adverse event 
Indicator of potential 
adverse event 
Corrective actions to 
consider 
Lead dislodgementi 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Reprogram the LV pacing 
polarity. Reposition the lead. 
Lead dislodgementi 
Intermittent or continuous 
oversensing 
Reprogram the LV pacing 
polarity. Reposition the lead. 
Lead conductor fracture 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Replace the lead. Reprogram the 
LV pacing polarity. 
Lead conductor insulation failure 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Replace the lead. Reprogram the 
LV pacing polarity. 
Threshold elevation or exit block 
Loss of capturei 
Adjust the implantable device 
output. Reprogram the LV pacing 
polarity. Replace or reposition 
the lead. 
I Transient loss of capture or LV EGM signal integrity (including sensing) may occur following surgery until 
lead stabilization takes place. If stabilization does not occur, lead dislodgement may be suspected. 

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Implant techniques that may damage the lead include, but are not limited to, the following techniques: 
Table 11: Implant Techniques that may damage the lead 
Implant techniques that may 
damage the lead 
Possible effects on the lead 
Corrective action to consider 
Forcing the lead through the 
introducer/delivery system 
Electrode, conductor coil, or 
insulation damage 
Replace the lead. 
Use of too medial of an approach 
with venous introducer resulting 
in clavicle and first rib binding 
Conductor coil fracture, insulation 
damage 
Replace the lead. 
Using too stiff a stylet 
Conductor coil/insulation 
perforation 
Replace the lead. 
Puncturing the periosteum or 
tendon when using subclavian 
introducer approach resulting in 
binding 
Conductor coil fracture, insulation 
damage 
Replace the lead. 
Advancing the lead through the 
non-coronary central access 
veins without the stylet or guide 
wire fully inserted 
Tip distortion or insulation 
perforation 
Replace the lead. 
Inserting the proximal end of the 
guide wire through the lead tip 
seal without using the guide wire 
insertion tool 
Lead tip seal damage or 
conductor coil/insulation damage 
Replace the lead. 
 
Subjects who are pregnant may be at increased risk (e.g., radiation exposure, and other unforeseen risk 
to the fetus), and are excluded from participation in the study.  If a subject becomes pregnant during the 
study, she must notify the physician immediately.  The subject will remain in the study for intention to 
treat analysis, but the investigator will avoid any procedures that may be determined harmful. 
There may be other discomforts and risks related to the CRT-P or CRT-D device, the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798), and/or this study that are not foreseen at this time.  Interactions 
with concomitant medical treatment are not expected. 
The adverse event collection requirements in this study will ensure that risks associated with the study 
device and the Attain Stability Quad MRI SureScan LV Lead (Model 4798) are adequately monitored.  
16.2. Risk Minimization 
Medtronic has minimized the risks to the subject by the following: 
• 
Performing required laboratory and pre-clinical testing prior to the Attain Stability Quad Clinical 
Study; this information is available under  separate cover in the RPI with the FDA IDE submission 
and the CER with the CE-Mark 
• 
Implementing quality control measures into development and production processes 
• 
Providing guidelines for subject selection and evaluation, and subject inclusion and exclusion 
criteria 
• 
Providing adequate instructions via the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
User Manual, training, and labeling 

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• 
Selecting implanters that have demonstrated previous experience with implanting CRT-P or CRT-
D devices and specifically LV leads 
• 
Selecting investigators that have demonstrated previous experience with the programming, 
interrogating, and monitoring of CRT-P or CRT-D devices 
• 
After enrollment in the Attain Stability Quad Clinical Study, at each protocol required follow-up, 
the investigator must interrogate the study device to verify appropriate study device function and 
to evaluate the subject’s health and assess for any AEs 
16.3. Potential Benefits 
The potential benefits of having the Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted 
are similar to other LV leads currently available to the public.  The Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) is expected to increase lead stability and reduce the need for patients to undergo an 
additional procedure to replace a dislodged/displaced lead.  Due to the active fixation helix, it may be 
possible to place the lead in veins of various sizes.  There is a possibility that the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) may offer no additional benefit over similar LV leads.  The 
information gained from this study could result in the improved management of other CRT patients. 
16.4. Risk-Benefit Rationale 
The risk-benefit analysis has shown that there are no major additional risks associated with the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798), other than those associated with the implant, while 
benefits to the patient are possible.  Any residual risk associated with this study is considered low and 
acceptable. 
17. Adverse Event Assessments 
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are crucial 
for the protection of subjects.  Reporting and analysis of safety data are mandated by regulatory 
authorities worldwide.  Medtronic has established procedures in conformity with worldwide regulatory 
requirements to ensure appropriate reporting of safety information.  This study is conducted in 
accordance with these procedures and regulations. 
Data collected in this study may be used in support of global regulatory approvals.  Since the safety 
reporting requirements and classification systems vary for each regulatory agency, requirements from all 
geographies are taken into account for the collection and reporting of safety information.  Adverse Events 
and Device Deficiencies will be reported in all geographies. 
17.1. Adverse Event and Device Deficiency Assessment 
17.1.1. 
Adverse Events 
Adverse Event definitions are provided in Table 12.   The following AEs will be collected throughout the 
study duration, starting at the time the informed consent form is signed:  

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• 
All procedure related AEs  
• 
All system related AEs 
• 
All accessory related AEs 
• 
All cardiovascular related AEs  
• 
All Serious Adverse Events (SAEs), regardless of relatedness  
Reporting of these events to Medtronic will occur on an AE Form, including date of AE, treatment, 
resolution, assessment of both the seriousness of the AE and the relatedness to the investigational device 
or procedure.  Each AE must be recorded on a separate AE eCRF.  Documented pre-existing conditions 
are not considered AEs unless the nature or severity of the condition has worsened.  In addition, AEs 
impacting users or other persons, Non-subject Adverse Events, (reportable per ISO 14155) will be 
collected.  
In all geographies, Unavoidable AEs, listed in Table 12, need not be reported unless the AE worsens or is 
present outside the stated timeframe post-implant.  
For AEs that require immediate reporting (see Table 14), initial reporting may be done by contacting the 
study sponsor per the sponsor contact information.  The original completed AE CRF must be submitted to 
Medtronic as soon as possible.   
Any medication, whether cardiovascular or not, associated with the treatment of an AE must be reported.  
Medication changes that are not related to adverse events will not be collected.  
Subject deaths are also required to be reported.  Refer to Section 17.4 for Subject Death collection and 
reporting requirements.  
17.1.2. 
Device Deficiencies 
Device deficiency (DD) information will be collected throughout the study and reported to Medtronic. 
Note that DDs that result in an Adverse Device Effect (ADE) to the subject should be captured as an AE 
only.  Device Deficiencies that did not lead to an AE but could have led to a Serious Adverse Device Effect 
(SADE) (i.e., if suitable action had not been taken, if intervention had not been made, or if the 
circumstances had been less fortunate) require immediate reporting (see Table 14).  For DDs that require 
immediate reporting, initial reporting may be done by contacting the study sponsor per the sponsor 
contact information. 
17.1.3. 
Event Updates and Resolution 
For any changes in status of a previously reported AE (i.e. change in actions taken, change in outcome, 
change in relatedness), information needs to be updated on, or added to the original AE form.  All AEs 
must be followed until the AE has been resolved, is unresolved with no further actions planned, the 
subject dies or exits the study, or until study closure, whichever occurs first.  
In the event that a subject is exited from the study prior to their 6 month visit, all efforts should be made 
to continue following the subject until all unresolved system or procedure related adverse events, as 
classified by the investigator, are resolved or unresolved with no further actions planned.  
At the time of study exit, all collected AEs with an outcome of ”Unresolved” must be reviewed and an 
update to the original AE must be reported.  At a minimum, if there are no changes to the description, 
relatedness, test and procedures or actions taken, the outcome must be updated to reflect “Unresolved 
at time of study exit”. 

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17.2. Definitions/Classifications 
Where the definition indicates “device”, it refers to any device used in the study.  This might be the 
device under investigation, or any market released component of the system, and includes but is not 
restricted to: the CRT-P or CRT-D  device, the RA, RV or LV leads, the programmer, and implant tools.   
Table 12: Adverse Event and Device Deficiency Definitions 
General 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
 
NOTE 1: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the 
procedures involved. 
NOTE 3: For users or other persons, this definition is 
restricted to events related to investigational medical 
devices. 
(ISO 14155:2011, 3.2) 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational 
medical device 
 
NOTE 1: This definition includes adverse events resulting 
from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from 
an error use or from intentional misuse of the 
investigational medical device. (ISO 14155:2011, 3.1) 
Device Deficiency (DD) 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance.  
 
NOTE: Device deficiencies include malfunctions, use errors 
and inadequate labeling (ISO 14155:2011, 3.15) 
Relatedness 
Procedure Related 
An Adverse Event that is directly related to the implantation 
or surgical modification of the system.  
 
NOTE: In general, this excludes events that are inherent to 
any surgical procedure (e.g. anesthesia complications) as 
well as indirect subsequent consequences of the procedure 
(e.g. reaction to pain medication). 

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System Related 
 
 
(includes all implantable 
components and features, 
associated introduction tools, 
operational and installed software 
and programmers as defined in the 
Clinical Investigation Plan) 
An adverse event that results from the presence or 
performance of any component of the system. 
 
Device-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the 
device.  
RA lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the RA 
lead.  
RV lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the RV 
lead.  
LV lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the LV 
lead.  
a) LV Lead Fixation-related: An adverse event that 
results from the presence or performance of the 
side-helix. 
 
Accessory Related 
Programmer Related:  An adverse event that results from 
the presence or performance (intended or otherwise) of the 
programmer 
 
Implant tool-related: An adverse event that results from 
the presence or performance (intended or otherwise) of the 
implant tool.  
Cardiovascular Related 
An Adverse Event relating to the heart and the blood 
vessels or the circulation (e.g. Atrial Fibrillation, Myocardial 
Infarction, stroke, perivascular disease) 
Heart Failure Related 
An adverse event related to worsening heart failure signs 
and symptoms such as hypervolemic and hypovolemic 
status requiring the administration, alteration, adjustment 
or augmentation of HF therapy (diuretics, inotropes and/or 
vasodilators etc.) or the utilization of ultrafiltration devices. 
MRI Related 
An adverse event which is caused by the interaction 
between the pacing system and the MRI system that occurs 
during the MRI procedure and up through the one-month 
post-MRI/waiting period follow-up visit. 

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Not Related 
Relationship to the device or procedures can be excluded 
when: 
 
The event is not a known side effect of the product 
category the device belongs to or of similar devices 
and procedures; 
 
The event has no temporal relationship with the 
use of the device or the procedures; 
 
The serious event does not follow a known 
response pattern to the medical device (if the 
response pattern is previously known) and is 
biologically implausible; 
 
The discontinuation of medical device application or 
the reduction of the level of activation/exposure – 
when clinically feasible – and reintroduction of its 
use (or increase of the level of activation/exposure) 
do not impact the serious event; 
 
The event involves a body-site or an organ not 
expected to be affected by the device or 
procedure; 
 
The serious event can be attributed to another 
cause (e.g., an underlying or concurrent 
illness/clinical condition, an effect of another 
device, drug, treatment, or other risk factors); 
 
The event does not depend on a false result given 
by the device used for diagnosis (when applicable); 
 
Harms to the subject are not clearly due to use 
error; 
 
In order to establish the non-relatedness, not all 
the criteria listed above might be met at the same 
time, depending on the type of device/procedures 
and the event. 
Unlikely 
The relationship with the use of the device seems not 
relevant and/or the event can be reasonably explained by 
another cause, but additional information may be obtained. 
Possible 
The relationship with the use of the investigational device is 
weak but cannot be ruled out completely. Alternative 
causes are also possible (e.g. an underlying or concurrent 
illness/ clinical condition or/and an effect of another device, 
drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also 
be classified as possible. 

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Probable 
The relationship with the use of the investigational device 
seems relevant and/or the event cannot reasonably 
explained by another cause, but additional information may 
be obtained.  
Causal Relationship 
The event is associated with the device or study procedures 
beyond reasonable doubt when: 
 
The event is a known side effect of the product 
category the device belongs to or of similar devices 
and procedures; 
 
The event has a temporal relationship with device 
use/application or procedures; 
 
The event involves a body-site or organ that the 
device or procedures are applied to or the device or 
procedures have an effect on; 
 
The serious event follows a known response 
pattern to the medical device (if the response 
pattern is previously known); 
 
The discontinuation of medical device application 
(or reduction of the level of activation/exposure) 
and reintroduction of its use (or increase of the 
level of activation/exposure) impact on the serious 
event (when clinically feasible); 
 
Other possible causes (e.g., an underlying or 
concurrent illness/clinical condition or/and an effect 
of another device, drug, or treatment) have been 
adequately ruled out; 
 
Harm to the subject is due to error in use; 
 
The event depends on a false result given by the 
device used for diagnosis (when applicable); 
 
In order to establish the relatedness, not all the 
criteria listed above might be met at the same 
time, depending on the type of device/procedures 
and the serious event. 
 
 
 
 
 
 
 
 

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Seriousness 
Serious Adverse Event (SAE) 
 
Adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the 
subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or 
a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-
threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c) led to fetal distress, fetal death or a congenital 
abnormality or birth defect 
 
NOTE 1: Planned hospitalization for a pre-existing 
condition, or a procedure required by the CIP, without 
serious deterioration in health, is not considered a serious 
adverse event. 
(ISO 14155:2011, 3.37)  
Serious Adverse Device Effect 
(SADE)  
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
(ISO 14155:2011, 3.36)  
Unanticipated Adverse Device Effect 
(UADE) 
 
Any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated 
with, a device, if that effect, problem, or death, was not 
previously identified in a nature, severity, or degree of 
incidence in the investigational plan or application 
(including a supplementary plan or application), or any 
other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of 
subjects. (21 CFR 812.3(s)) 
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in 
the current version of the risk analysis report 
 
NOTE 1: Anticipated serious adverse device effect (ASADE) 
is an effect which by its nature, incidence, severity or 
outcome has been identified in the risk analysis report. 
(ISO 14155:2011, 3.42)  

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Complication 
An adverse event that includes the following is considered a 
complication:  
• 
Results in death,  
• 
Involves any termination of significant device 
function, or  
• 
Requires an invasive intervention  
 
Non-invasive (21 CFR 812.3 (k)): when applied to a 
diagnostic device or procedure, means one that does not 
by design or intention:  Penetrate or pierce the skin or 
mucous membranes of the body, the ocular cavity, or the 
urethra, or enter the ear beyond the external auditory 
canal, the nose beyond the nares, the mouth beyond the 
pharynx, the anal canal beyond the rectum, or the vagina 
beyond the cervical os 
 
Note (FDA): Blood sampling that involves simple 
venipuncture is considered noninvasive, and the use of 
surplus samples of body fluids or tissues that are left over 
from samples taken for non-investigational purposes is also 
considered noninvasive. 
 
*** Only system or procedure related AEs will be classified 
as complication or observation 
Observation 
Any Adverse Event that is not a complication. 
 
*** Only system or procedure related AEs will be classified 
as complication or observation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Other 
Unavoidable Adverse Event 
An Adverse Event inherent to a surgical procedure that is 
expected to occur in all subjects for a projected duration 
according to the Investigator’s opinion, including, but not 
limited to:  
 
Event Description 
Timeframe 
(hours) 
from the 
Surgical 
Procedure 
Anesthesia related nausea / vomiting  
24 
Low-grade fever (<100°F or 37.8°C) 
48 
Pocket site / Incisional pain 
72 
Mild to moderate bruising / ecchymosis 
168 
Sleep problems (insomnia) 
72 
Back pain related to laying on table 
72 
Shoulder pain/discomfort/stiffness 
related to shoulder immobilization 
during procedure 
72 
17.3. Reporting of Adverse Events 
17.3.1. 
Adverse Events and Device Deficiency Classification 
All reported AEs and DDs will be reviewed by a Medtronic representative.  Adverse Events will be 
classified according to the definitions provided. 
Upon receipt of AEs at Medtronic, a Medtronic representative will review the AE/DD for completeness and 
accuracy and when necessary will request clarification and/or additional information from the 
Investigator.  Medtronic will utilize the Medical Dictionary for Regulatory Activities (MedDRA), to assign a 
MedDRA term for each AE based on the information provided by the investigator.  
Regulatory reporting of AEs and DDs that could have led to an SADE will be completed according to local 
regulatory requirements.  Refer to Table 14 for a list of required investigator and Medtronic reporting 
requirements and timeframes.  It is the responsibility of the investigator to abide by any additional AE 
reporting requirements stipulated by the IRB/EC responsible for oversight of the study. 
APPENDIX 1 contains the Foreseeable Adverse Event List (FAL), which is a list of adverse events related 
to the system or procedure that have been observed in previous studies and may be experienced by 
subjects.  This list may help to assess if an AE is unanticipated in nature.   
For emergency contact regarding a UADE, SAE and/or SADE, contact a Attain Stability Quad Clinical Study 
representative immediately (refer to the study contact list provided in the site’s study documents 
binder/investigator site file or refer to the Sponsor Contact Information section provided in the CIP). 
Adverse Events and Deaths will be classified according to the standard definitions as outlined below:  

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Table 13: Adverse Event Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Relatedness 
Investigator 
Device, RA Lead, RV Lead, LV Lead, Implant Tool(s), 
Programmer, Procedure, Cardiovascular, Heart Failure, 
MRI 
Sponsor 
Device, RA Lead, RV Lead, LV Lead, Implant Tool(s), 
Programmer, Procedure 
Seriousness 
Investigator 
SAE  
Sponsor 
SAE, UADE/USADE, Device Deficiency with SADE potential 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided by 
Investigator 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-Cardiac, 
Unknown 
An independent Clinical Events Committee (CEC) will review and adjudicate, at a minimum, all events 
classified by the investigator or Medtronic as procedure or system related to determine relatedness and 
complication or observation classifications.    In addition, the CEC will also review and adjudicate all 
Adverse Events resulting in death. 
17.3.2. 
Adverse Events and Device Deficiency Reporting Requirements 
Regulatory reporting of AEs and device deficiencies will be recorded and reported according to local 
regulatory requirements.  It is the responsibility of the Investigator to abide by the adverse event 
reporting requirements stipulated by local law and the site’s IRB/EC.  
Table 14: Reporting Requirements 
Serious Adverse Events (SAEs) 
Investigator submit to: 
Medtronic 
Canada: Investigators are required to report SAEs to the sponsor immediately except for 
those SAEs that the protocol or other document (e.g. Investigator’s Brochure (IB)) identifies 
as not needing immediate reporting.   The immediate reports should be followed promptly by 
detailed, written reports.  
Medical Devices Regulations, sections 59-61.  A guidance for “immediately” is within 72 hours 
of the investigator becoming aware of the event;  Report to sponsor, without unjustified 
delay ISO 14155:2011, sec 9.8.b). 
EMEA: Immediately after the investigator first learns of the event or new information in 
relation with an already reported event.  
All geographies: Report to the sponsor, without unjustified delay, all serious adverse 
events. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies:  Submit to Ethics Committee per local reporting requirement. 

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Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Adverse Device Effects (ADEs),  
Investigator submit to: 
Medtronic 
EMEA: Immediately after the investigator first learns of the event or new information in 
relation with an already reported event. 
All geographies: Submit in a timely manner after the investigator first learns of the effect. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Serious Adverse Device Effects (SADEs), Unanticipated Adverse Device Effects (UADEs), 
Unanticipated Serious Adverse Device Effects (USADEs),  
Investigator submit to: 
Medtronic 
US: Submit as soon as possible, but no later than within 10 working days after the 
investigator first learns of the event.  (21 CFR 812.150(a)(1)) 
Canada: SADEs on the patient, the user or any other person must be reported to the 
Sponsor within 72 hours after it comes to the attention of the qualified investigator. 
It is recommended for the investigator to report safety events as soon as possible but no 
longer than 15 calendar days.”  
All geographies:  Immediately after the investigator learns of the event or of new 
information in relation to an already reported event. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement 
Ethics 
Committee 
All geographies: Submit to Ethics Committees per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies:  Submit to Ethics Committee per local reporting requirement. 
Investigators All geographies: Submit per local reporting requirement. 

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All other reportable Adverse Events  
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the event. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Device Deficiencies with SADE potential 
Investigator submit to: 
Medtronic 
Canada: DDs that have resulted in any of the consequences characteristic of an SAE on the 
patient, the user or any other person or could do so were it to reoccur must be reported to 
the Sponsor within 72 hours after it comes to the attention of the qualified investigator 
EMEA: Immediately after the investigator first learns of the deficiency or of new information 
in relation with an already reported deficiency. 
All other geographies: Submit or report as required per local reporting requirements. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
All other Device Deficiencies 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the 
deficiency. 
Regulatory 
authorities 
Canada: any DD that: 
a. 
has resulted in any of the consequences characteristic of an SAE on the patient, 
the user or any other person; These must be reported by Medtronic to the 
Regulator within 10 days from the date Medtronic becomes aware. 
or 
b. 
could do so were it to reoccur.  These must be reported by Medtronic to the 
Regulator within 30 days from the date Medtronic becomes aware. 
 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 

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17.4. Subject Death 
17.4.1. 
Death Data Collection 
All subject deaths must be reported by the investigator to Medtronic on an AE form (AE with outcome of 
death) as soon as possible after the investigator first learns of the death.  In case of death, there should 
be one SAE with the outcome of death reported.  
In the event of a subject’s death, it is recommended that the implanted system be explanted and 
returned to Medtronic for analysis whenever possible per local process.  Local laws and procedures must 
be followed where applicable. 
System Interrogation Data Recommendations: 
• 
After the subject has died but prior to explant, it is strongly recommended that the system be 
interrogated and a full summary interrogation (Interrogate All) performed when possible, and 
saved in a digital format (Save-to-Media).  Store one copy of the save-to-media at the site and 
send a copy to Medtronic.   
• 
Make the device interrogation/save-to-media file before any programming to prevent overwriting 
information in the device’s memory and/or distinguishing between events detected during versus 
before the explant procedure. 
• 
Recommend obtaining the exact date and time of death as lower temperatures after death can 
cause ERI and other “event flags” to be stored in the device memory. 
If the system is not interrogated, an explanation must be entered on the AE form.  For ICD systems, the 
ventricular tachycardia (VT) and ventricular fibrillation (VF) detection capabilities must be disabled to 
avoid inadvertent shocks.  If any system component is returned to Medtronic, internal return product 
reporting systems may be used to gather additional information about the returned device/component. 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic Attain Stability Quad Clinical Study team.  When a death occurs in a hospital, a copy of the 
death summary report and all relevant hospital records should be sent to the Medtronic Attain Stability 
Quad Clinical Study team, if available.  If an autopsy is conducted, the autopsy report should also be sent 
to the Medtronic Attain Stability Quad Clinical Study team if available and allowed by state/local law.  
When the death occurs at a remote site, it is the investigative site’s responsibility to attempt retrieval of 
information about the death.  Additionally, device disposition information should be updated.  In 
summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death  
• 
Relatedness to system and/or procedure 
• 
Device interrogation and Save-to-Media (if available) 
• 
Device disposition information 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and allowed by state/local law) 

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17.4.2. 
Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. The Investigator 
shall classify each subject death per the following definitions: 
Cardiac Death: A death directly related to the electrical or mechanical dysfunction of the heart. 
Sudden Cardiac Death (SCD): Natural death due to cardiac causes, indicated by abrupt loss of 
consciousness within one hour of the onset of acute symptoms; preexisting heart disease may have been 
known to be present, but the time and mode of death are unexpected. If time of onset cannot be 
determined, SCD will alternatively be defined as any unexpected cardiac death occurring out of the 
hospital or in the emergency room as dead on arrival. 
Non-sudden Cardiac Death: All cardiac deaths that are not classified as sudden deaths, including all 
cardiac deaths of hospitalized subjects on inotropic support. 
Non-cardiac Death: A death not classified as a cardiac death. 
Unknown Classification: Unknown death classification is intended for use only when there is insufficient or 
inadequate information to classify the death. 
Table 15: Subject Death Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-cardiac, 
Unknown 
The Clinical Events Committee will review all deaths and provide a final adjudication of the death 
classification.  
Regulatory reporting of Subject Deaths will be completed according to local regulatory requirements.  
17.5. Product Complaint Reporting 
Product complaint reporting and vigilance reporting are applicable and AEs related to any market-
released device during the study must be reported.  The reporting of product complaints is not part of 
the Attain Stability Quad Clinical Study and should be done in addition to the AE reporting requirements.  
Refer to local regulations for reporting requirements.  
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that has 
been placed on the market. 
• 
Abuse: Abnormal use (definition acc. #4.1 of Meddev 2.12-1 rev8) 
• 
Misuse: Use error (definition acc. #4.20 of Meddev 2.12-1 rev8) 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse of 
the product.  Reporting must be done immediately and via the regular channels for market-released 
products.  The reporting of product complaints by the clinical team must be done according to the local 
Standard Operating Procedures.  Medtronic will notify the regulatory authorities (e.g. Competent 
Authority) as applicable for the following incidents immediately upon learning of them: 

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• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as 
any inadequacy in the labeling or instructions for use which led or might have led to the death or 
serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
• 
Any serious deterioration in the state of health, including: 
o 
Life-threatening illness or injury 
o 
Permanent impairment of a body function or permanent damage to a body structure 
o 
A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 
18. Data Review Committees  
18.1. Clinical Events Committee 
The study will utilize a Clinical Events Committee (CEC). At regular intervals, an independent CEC will 
review events and adjudicate at a minimum all system, and procedure-related events.  Additionally, the 
CEC will provide an adjudication of the death classification for all reported deaths. 
The CEC will consist of a minimum of three (3) non-Medtronic-employed physicians that are not 
participating investigators for the study, including a CEC chairperson.  
Medtronic personnel may facilitate and participate in CEC meetings but will be non-voting members. 
For AEs and deaths reviewed by the CEC, Medtronic will provide the CEC with the Investigator’s 
description and classification and supportive documentation (when available).  The CEC is responsible for 
reviewing the Investigator’s assessment and supportive documentation (when available), reviewing 
applicable definitions, and determining final classifications for all adjudication parameters. For AEs, 
classification includes system/procedure relatedness and complication or observation.  Additionally, the 
CEC will provide an adjudication for all reported deaths, including system/procedure relatedness and 
cardiac relatedness. 
If the CEC disagrees with the investigator’s classification of the event, the difference will be provided to 
the investigator.  If the investigator agrees with the CEC’s adjudication, the CRF documenting the AE will 
be updated accordingly. 
If the investigator does not agree with the CEC’s adjudication classification, both determinations will be 
provided within the final report; however the CEC’s adjudication will be used for data analysis.  The 
disagreement will also be included in reporting to ethics committees and regulatory authorities, if 
required. 
 
 

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18.2. Data Monitoring Committee 
A Data Monitoring Committee (DMC) will not be utilized for this study considering: 
 
• 
An independent CEC will be formed to adjudicate at minimum all system and procedure related 
events and all deaths. 
• 
This study does not meet FDA’s recommended criteria (Guidance for Clinical Trial Sponsors: 
Establishment and Operation of Clinical Trial Data Monitoring Committees) for when a study 
should use a DMC, primarily because the study is not evaluating the effectiveness of a treatment 
intended to prolong life or reduce the risk of a major adverse health outcome. 
• 
As a result of risk analysis and mitigation efforts as outlined in Section 16, any residual risk 
associated with this study is considered low and acceptable. 
• 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is a modification of the currently 
market approved Attain Performa lead Models 4298, 4398, and 4598 is a modification of the 
currently market approved Model 4396 LV lead.  The Attain Stability Quad lead Model 4798 has a 
similar electrode spacing as the Attain Performa lead Models 4298, 4398, and 4598.  
• 
Study will be conducted under FDA oversight via an investigational device exemption (IDE). 
19. Statistical Design and Methods 
This section presents statistical considerations for the study design and provides a high-level description 
of planned analysis and reporting.  More details will be given in a separate Statistical Analysis Plan (SAP) 
that will be completed before data freeze for the primary objective analysis.  Any deviation to the pre-
specified statistical analyses will be noted in the study report.  The analysis of the study objectives will be 
completed when the sample size requirements (see Table 18) for all the study primary and secondary 
objectives are met.  An interim analysis will be conducted when 360 subjects are enrolled in the study.  
This interim analysis is specifically designed for one of the secondary objectives (details in Section 
19.2.2). 
19.1. Primary Objectives 
19.1.1. 
Primary Safety Objective 
Objective 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered safe if the probability of 
subjects free of Model 4798 lead-related complications at 6 months post-implant is greater than 87% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 87%). 
Hypothesis: 
H0: S(6-month) ≤ 87% 
H1: S(6-month) > 87% 
where S6-month is the probability that a subject remains free from Model 4798 lead related complications 
through 6 months since implant. 
Endpoint Justification 
The study primary safety endpoint is Attain Stability Quad MRI SureScan LV Lead (Model 4798) related 
complications.  All reported system and procedure-related AEs will be reviewed by an event review 
committee  for LV lead relatedness and severity (see Section 18.1).  

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Utilizing lead related complication free survival probability to evaluate lead safety performance is widely 
accepted across cardiac device manufacturers and in the medical literature.  Current already market-
released Quadripolar LV lead 6-month safety performance is summarized in Table 16.  The population 
performance of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is expected to be similar to 
the Medtronic Attain Performa Model 4298 lead. 
Table 16: Safety Performance of Market Released Quadripolar Lead 
 
Medtronic  
Attain Performa 
St. Jude Medical 
Quartet22  
Boston Scientific 
ACUITY X423 
6-month LV 
Lead 
Complication 
Free 
Survival 
Probability 
Estimate 
Model 4298 (Canted): 96.0% 
Model 4398 (Straight): 98.8% 
Model 4598 (S-shape): 96.2% 
96% at 3 months 
Straight: 96.5%  
Spiral: 98.5%  
Statistical Analysis Methods  
The primary objective will be analyzed using the time-to-first event Kaplan-Meier survival analysis 
method.  Time 0 will be the day a subject undergoes the implant procedure of a Attain Stability Quad 
MRI SureScan LV Lead (Model 4798), which will be independent of success status of this implant 
procedure. Event date is the onset date of a subject’s first complication that is related to the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) according to CEC adjudication.  Subjects who 
undergo an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant attempt and do not 
experience any LV lead related complications will be censored at the time of their last known exposure to 
the Attain Stability Quad MRI SureScan LV Lead (Model 4798) for the survival analysis.  For any lost-to-
follow up subject, the last contact date will be used as the censor date.  The 1-sided 97.5% confidence 
limit lower bound for the survival probability at 6 months (183 days) will be calculated using the log-log 
survival function approach (Kalbfleisch and Prentice 2002).  
Sample Size Consideration 
The primary safety objective performance criterion is set to be identical to Medtronic’s Attain Performa 
Clinical Study (IDE Number: G120213).  Therefore, the sample size calculation assumptions are derived 
based on the Model 4298 lead study results.  The Attain Performa Model 4298 lead reported a 6-month 
complication free survival probably of 96.0%, with 97.5% Confidence Lower Limit of 94.3% (PMA-s 
clinical report).  
The binomial calculation (Z-test) is used for initial sample size estimation.  In order to preserve the 
overall study power, a type II error less than 10% was used for the sample size calculation.  A sample 
size of 170 subjects completing their 6-month visit achieves greater than 90% power to detect a 
difference of 7% using the one-sided binomial test.  The target significance level is 0.025.  These results 
assume that the population proportion under the null hypothesis is 87% with an expected value of 94% 
(Figure 5). To account for 15% attrition, the enrollment size for this objective is 200. 

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Figure 5: Primary Safety Objective Sample Size Consideration by Difference Performance 
Assumption 
 
Determination of Patients / Data for Analysis 
All consented subjects who undergo an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant 
attempt will be included in the analysis cohort.  If a patient experiences multiple Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) implant procedures during the study, the analysis cohort will only 
consider the first procedure.  In the event multiple complications occur, the survival analysis endpoint is 
reached when the first Attain Stability Quad MRI SureScan LV Lead (Model 4798) related complication 
occurs. 
19.1.2. 
Primary Efficacy Objective #1 
Objective 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet the first primary efficacy 
objective if the proportion of subjects with at least one Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) pacing vector having a pacing capture threshold (PCT) less than or equal to 2.5 V at 0.5ms 
pulse width at 6 months post-implant is greater than 80% (i.e., the lower bound of the one-sided 97.5% 
confidence interval must be greater than 80%). 
Hypothesis 
H0: P16-month ≤ 80% 
HA: P16-month > 80%, 
where P16-month is the proportion of subjects with pacing voltage thresholds ≤ 2.5V at 0.5ms  at 6 months 
follow-up visit post-implant for at least one LV lead pacing vector. 
Endpoint Justification 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is equipped with the identical four 
electrodes to the Attain Performa LV leads.  At the same time, the unique fixation mechanism may cause 
the distal end of the lead (tip) to be implanted away from the apical region of the heart, and therefore 
90.3% 
90.8% 
60.0%
65.0%
70.0%
75.0%
80.0%
85.0%
90.0%
95.0%
100.0%
170
180
190
200
210
220
Power 
Sample Size at 6 months 
0.93
0.94
0.95
0.96

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the PCT may be slightly higher than the values observed in other Quadripolar LV leads.  Therefore, we 
simulated the lead pacing threshold values based on the Attain Performa IDE study data, but excluding 
the PCT values collected at the most distal electrode.  The simulation estimated that 89% of the subjects 
will achieve this endpoint (Figure 6). 
Figure 6: Simulated PCT Distribution 
 
 
Statistical Analysis Methods 
All subjects with valid pacing thresholds measured at the 6 month follow-up visit will be included in this 
analysis.  The proportion of subjects having at least one LV lead pacing vector with voltage thresholds 
less than or equal to 2.5V will be calculated.  The lower bound of the 1-sided 97.5% Confidence Interval 
will be calculated using the Exact binomial method.  Any subject in which no valid pacing threshold value 
is measured  or who has an unable-to-capture result via all LV lead pacing vectors will be reviewed and 
adjudicated for a possible lead related AE but will not be included for this evaluation if the occurrence is 
deemed to be a system related event (e.g. lead dislodgement). However, this event may be counted 
against the safety primary endpoint based on the CEC’s final classification. 
Sample Size 
The primary efficacy endpoint will be analyzed using the Exact binomial method.  In order to preserve the 
overall study power, a type II error less than 10% was used for the sample size calculation.  A sample 
size of 145 subjects achieves 91% power to detect a difference of 0.1 using a one-sided binomial test at 
a target significance level of 0.025.  These results assume that the population proportion under the null 
hypothesis is 80%, with an expected proportion of 90%.  
 
 

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Determination of Patients / Data for Analysis 
All subjects enrolled into this study satisfying the following conditions will be included in this analysis: 
• 
Successfully implanted with a Medtronic Quad CRT-P or CRT-D  device and Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) 
• 
Completed 6-month follow-up visit  
• 
Initially implanted Attain Stability Quad MRI SureScan LV Lead (Model 4798) is active at the 6–
month follow-up visit 
• 
At least one available and valid pacing threshold at the 6-month follow-up visit 
19.1.3. 
Primary Efficacy Objective # 2 
Objective 
The Attain Stability Quad lead will meet the second primary efficacy objective if the proportion of subjects 
with at least one additional (or second) LV lead pacing vector having a pacing capture threshold less than 
or equal to 4.0 V at 0.5ms pulse width at 6 months post-implant is greater than 80% (i.e., the one-sided 
97.5% lower confidence bound must be greater than 80%).  
Hypothesis 
H0: P26-month ≤ 80% 
HA: P26-month > 80%, 
where P26-month is the proportion of subjects with at least one additional LV lead pacing vector with pacing 
voltage thresholds ≤ 4.0V at 0.5ms at 6 months post-implant follow-up visit. 
Endpoint Justification 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) has 16 LV programmable pacing vectors .  
Subjects may have the pacing configuration programmed or reprogrammed at each clinic visit.  A pacing 
threshold of 4.0 V will allow an adequate safety margin for programming LV pacing output.  The 
maximum pacing amplitude of the CRT-P or CRT-D devices capable of programming pacing output to any 
LV lead pacing vector is 8.0V.  In actual clinical practice, a less than 3V safety margin is used for the 
programmed LV lead pacing output in 99% of the patients.  
Statistical Analysis Methods  
The efficacy endpoint #2 will be analyzed using the Exact binomial method.  The proportion of subjects 
with at least 2 LV lead pacing vectors  having voltage thresholds less than or equal to 4.0V at 0.5ms will 
be calculated.  The lower bound of the 1-sided 97.5% Confidence Interval will be calculated using the 
Exact binomial method.  Any subject in which no valid pacing threshold values are measured  or with an  
Unable-to-capture result via all LV lead  pacing vectors  will be reviewed and adjudicated for possible lead 
related complications, and therefore may be counted against the study safety endpoint.  However, it will 
be counted as a failure if there is not any additional LV lead pacing vectors  (excluding the vector that is 
already include for the efficacy endpoint #1) are unable to capture with no lead related events reported. 
Sample Size 
The Attain Performa Model 4298 LV lead observed 97.7% subjects who were able to obtain a non-
programmed pacing vector with PCT less than or equal to 4 volts.  A sample size of 50 subjects 
completing the 6 month visit achieves 98% power to detect a difference of 0.18 using a one-sided 
binomial test at a target significance level of 0.025.  These results assume that the population proportion 
under the null hypothesis is 80%, with the expected proportion of 97%.  

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Determination of Patients / Data for Analysis 
All subjects enrolled into this study satisfying the following conditions will be included in this analysis: 
• 
Successfully implanted with a Medtronic Quad CRT-P or CRT-D  device and Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) 
• 
Completed 6-month follow-up visit  
• 
Initially implanted Attain Stability Quad MRI SureScan LV Lead (Model 4798) lead is active at the 
6–month follow-up visit 
• 
At least one available and valid pacing threshold at the 6-month follow-up visit. In the event a 
subject failed to provide more than one valid pacing threshold value, that subject will be 
considered as not having at least one additional LV lead pacing with PCT ≤ 4.0V at 0.5ms at 6 
months post-implant follow-up visit 
19.2. Secondary Objectives  
19.2.1. 
Secondary Objective # 1 
Objective - Implant procedure related information: success rate, implant related times 
The Attain Stability Quad LV lead implant success rate will be estimated as the number of subjects with 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) successfully implanted divided by the total 
number of subjects who had a Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant 
attempt.  A 2-sided 95% Confidence Interval will be calculated using the Exact Binomial method. 
The distribution of implant related times will be summarized through statistical summaries such as mean, 
standard deviation, minimum, median and maximum.  Only subjects with the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) successfully implanted will be included in this calculation.  The total 
implant time is defined as time from initial incision to final skin closure.  Fluoroscopy time is defined as 
the total time the fluoroscope is imaging.  Cannulation time is defined as the time from insertion of the 
first CS cannulation catheter to the first successful CS cannulation.  Successful lead placement time is 
defined as the time from lead insertion of the successfully placed lead to the time when the lead is placed 
in its first acceptable pacing location.   
19.2.2. 
Secondary Objective # 2 
Objective - 6-month reliability: post implant lead failure modes  
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is a composite of two existing market 
released Medtronic products.  The helix fixation is identical to the Attain Stability LV Lead Model 
20066/4796 (market released outside of the US).  The remainder of the lead is similar to the Attain 
Performa LV Lead Model 4298, released worldwide.   
Historical datasets will be used as informative priors for lead related complications.  More specifically, 
analysis of all complications related to fixation (helix performance) will use data from the Attain Stability 
(Model 20066/4796) research study, conducted outside of the US.  Analysis of all other lead related 
complications will use data from the Attain Performa clinical study, conducted globally.  Credible intervals 
will be constructed for each individual failure mode within the two groups. 
 
 

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Historical Data (for secondary endpoints only) 
o 
Fixation-related LV lead complications - Data from the 37 patients who completed 6-
month follow up with a successfully implanted 20066 lead in the Attain Stability study will 
be used as an informative prior.  
o 
All other LV lead-related complications - Data from the 401 patients who completed 6-
month follow up in the Attain Performa 4298 study will be used as an informative prior. 
These historical datasets will be downweighted such that their effective sample size will not exceed the 
9% of the total sample size (i.e at most 37 subjects at 6 months). 
Statistical Analysis Methods 
The weighted historical data will be incorporated using the power prior method24.  The weight of the 
historical data will be adjusted using a loss function25, which scales from 0 to 1 according to the similarity 
of the historical and observed data.  This loss function adjusts the amount of weight the prior receives.  
The comparison between historical and observed data will be performed twice, once for each group of 
complications (fixation-related and all other).  The objective of using a loss function with the power prior 
method is to reduce the influence of an informative prior in the parameter estimation, when the historical 
data does not agree with the current study data.  
If analysis of failure rate shows a high level of agreement between historical and current study data or 
there is better performance for Attain Stability Quad MRI SureScan LV Lead (Model 4798) compared to 
historical data, the historical data will be weighted at or near a maximum level (9% of total effective 
sample size).  If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) performs worse than 
historical data, the historical data will receive very little or zero weight.  Note that there will be two loss 
function weights, one for fixation-related complications and one for all other complications.  Credible 
interval calculations will be done separately for individual failure modes within the two groups of 
complications (fixation and all other).  
Denote by 𝜃𝜃𝑐𝑐 and 𝜃𝜃ℎ the probabilities of lead complication for the current and historical studies 
respectively.  The posterior distributions of 𝜃𝜃𝑐𝑐 and 𝜃𝜃ℎ respectively, both with minimally informative priors 
are: 
𝜃𝜃𝑐𝑐= 𝑏𝑏𝑏𝑏𝑏𝑏𝑎𝑎(𝑦𝑦𝑐𝑐+ 1, 𝑛𝑛𝑐𝑐−𝑦𝑦𝑐𝑐+ 1) 
𝜃𝜃ℎ= 𝑏𝑏𝑒𝑒𝑡𝑡𝑡𝑡(𝑦𝑦ℎ+ 1, 𝑛𝑛ℎ−𝑦𝑦ℎ+ 1) 
These posterior distributions are then stochastically compared using a posterior Bayesian p-value26 as: 
𝑝𝑝= 𝑃𝑃(𝜃𝜃𝑐𝑐≤𝜃𝜃ℎ) 
The desired characteristics for the loss function are: 
1. For 𝑝𝑝≥~0.5, there is a high level of agreement between current and historical data, therefore 
the loss function should allow a0 to be close to 1, allowing for full weight of historical data.  
2. Conversely, for 𝑝𝑝< ~0.5, there begins to be evidence of disagreement between current and 
historical data, and a0 should start to down-weight the prior, i.e. a0 approaches zero as 𝑝𝑝 
approaches zero. 
The Weibull cumulative distribution function (CDF) meets these criteria: 
𝑎𝑎0 = 1 −𝑒𝑒−(𝑝𝑝∗5)2 

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Note that for the case where the number of samples in the prior is different than the effective number, a 
scaling factor will be applied, where 𝑛𝑛ℎ is the desired effective number of prior samples and 𝑁𝑁ℎ is the 
actual number of prior samples: 
𝑎𝑎0 = 𝑛𝑛ℎ
𝑁𝑁ℎ
ൣ1 −𝑒𝑒−(𝑝𝑝∗5)2൧ 
Sample values are listed in Table 17 below and illustrated in Figure 7.  The comparison between current 
and historical data will be performed for all LV lead fixation related complications using Attain Stability 
(Model 20066) historical data and for all other LV lead related complications using Attain Performa 
historical data. 
Table 17: Prior weight from Attain Stability (Model 20066) and prior weight from Attain 
Performa as a function of the posterior Bayesian p-value (𝒑𝒑) 
 
Prior weight from Attain 
Stability (Model 20066) 
Prior weight from Attain 
Performa 
𝒑𝒑 
𝑎𝑎0 = 1 −𝑒𝑒−(𝑝𝑝∗5)2 
𝑎𝑎0 = 37
401 ൣ1 −𝑒𝑒−(𝑝𝑝∗5)2൧ 
0.01 
0.002 
0.000 
0.05 
0.061 
0.006 
0.1 
0.221 
0.020 
0.2 
0.632 
0.058 
0.5 
0.998 
0.092 
 
Figure 7: Loss Function 𝒂𝒂𝟎𝟎= 𝟏𝟏−𝒆𝒆−(𝒑𝒑∗𝟓𝟓)𝟐𝟐 
 
 
 

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Note that the loss function proposed here does not reduce the strength of the prior when the current 
study outperforms the historical data.  This implementation of the loss function is only concerned with 
negative impacts to patients, i.e. it penalizes an optimistic prior while not penalizing a pessimistic prior. 
Also, note that this function is selected for the shape of the CDF rather than due to conventional 
statistical properties of the Weibull distribution.  
Figure 8 illustrates the effect of the power prior coupled with the loss function.  The figure shows credible 
intervals in scenarios where the prior is optimistic (better performance than current study), in agreement 
(similar performance to the current study), and pessimistic (worse performance than the clinical study).  
Note that the prior data source in Figure 8 is the Attain Performa study, with 401 patients.  As will be 
discussed later, these data are scaled to represent a maximum of 37 patients (i.e. 9% weight).   
Figure 8: Credible Intervals for Scenarios of Agreement Between Historical and Current Data 
 
The prior data set in Figure 8 has 401 samples.  However, the maximum effective historical data sample 
size is 𝑛𝑛ℎ= 37, for a maximum weight of 9%.  Therefore, the prior will be scaled by a factor of (37/401).  
As an example, illustrated in the middle panel above, if the effective sample size is 34 out of 37, the prior 
has received 89% of the maximum weight, or 8.5%. 
The panels in Figure 8 can be interpreted as follows:  

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• 
Top panel: The current data shows lower performance than the prior.  The loss function 
produces a substantial penalty resulting in almost no weight to the prior (1%).  The posterior 
(final estimate) is essentially the same as the current study.   
• 
Middle panel: The current data is very similar to the prior.  The loss function penalty is small, 
resulting in a prior weight of 8.5% (recall that the maximum weight is 9.2%).  Because the 
agreement is good, the posterior(final estimate) is similar to both the prior and current study.   
• 
Bottom panel: The current data is very similar, with slightly better performance than the prior.  
The loss function produces a weight very close to the maximum of 9.2%.  The posterior (final 
estimate) is a balance between the prior and current study.  
Sample Size 
A Bayesian adaptive design is set up to enroll patients until a sufficient sample size is achieved to have 
high probability of meeting the required effective sample size of 𝑛𝑛𝑒𝑒= 400.  The number of enrolled 
patients in the study may vary from 363 to 400 subjects due to the adaptations to the trial.  This study 
follows methods from Berry, et.al.27  
The interim analysis will take place after 360 subjects have been enrolled into the study.   
The Adaptive Bayesian sample size algorithm will stop or continue enrollment accordingly to the 
following: 
1.) If the predictive probability of 𝑛𝑛𝑒𝑒≥400 is larger than 80% then enrollment will stop. 
2.) If the predictive probability of 𝑛𝑛𝑒𝑒≥400 is less than 80%, enroll sufficient additional patients to 
make the probability of 𝑛𝑛𝑒𝑒≥400 at least 80%.   
At the time of the interim analysis, some patients will not have completed the full evaluation period.  A 
longitudinal model will be employed to enable final observations to be imputed for those subjects with 
incomplete information.  
There are 3 types of subjects at a given interim analysis: 
1.) Subjects that have complete data 
2.) Subjects that have partial data (censored value at a particular time) 
3.) Subjects that have no information (subjects that have not been enrolled) 
Predictive probabilities for types 2 and 3 will have to be computed.  The predictive probability model that 
will be used is a piecewise exponential.  This will allow the final outcomes for the subjects who have not 
had an event and have not completed 6 month follow up to be simulated. 
Note this Bayesian approach to borrow information from historical datasets will only be used for the 
secondary objective #2. 
19.2.3. 
Secondary Objective # 3  
Objective – Electrical measurements (PCT and Impedance) at follow-ups 
Pacing Capture Threshold (PCT) and impedance data will be collected using VectorExpressTM.  Pacing 
vector changes will be monitored for all implanted patients at follow-up visits. 
Summary statistics for PCT and impedance at each time point (i.e. Implant, 6 months, etc.).  The 
distribution of the electrical measurements at the final programmed pacing vector will be presented as n, 
mean, standard deviation, minimum, median and maximum.  In the event of a replacement of a 
Medtronic Quad CRT-P or CRT-D  device and/or the implanted LV lead, only measurements from the 

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Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted at the initial implant procedure will 
be included in the analysis cohort for this objective. 
19.3. Additional Analysis  
19.3.1. 
Poolability Analysis 
Additional analysis will be conducted to summarize study primary objectives by patient characteristics, 
such as gender, age group,  race and study site geography.  The purpose of the poolability analysis is to 
identify if there is any clinical meaningful difference in a subgroup of patients.  These analyses will not be 
statistically powered, and there is no pre-specified statistical significance level for these analyses. 
19.3.2. 
Sensitivity Analysis 
All subjects enrolled into this study and successfully implanted with a Medtronic Quad CRT-P or CRT-D  
device and Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be included in the primary 
efficacy analysis datasets (efficacy objectives #1 and #2).  Sensitivity analysis such as the Tipping Point 
method or similar will be conducted to investigate the influence of subjects who were successfully 
implanted with the required system however missed a 6 month post implant follow-up test(s) (due to 
reasons such as missing in-office visit, subject exit, death and/or the initial implanted lead was 
deactivated).  For this purpose, all subjects with successful implant who do not meet analysis cohort 
requirements, will be considered as the worst case scenario (i.e. failure to meet the efficacy 
endpoints).The results will be submitted as part of the clinical reports.   
19.3.3. 
Additional Data Collection 
Heart failure clinical outcomes will be assessed. The measurements, including NYHA classification, death, 
heart failure related hospitalization, heart failure related study exits and subject self-reported global 
assessment for each subject will be obtained at 6 months post-implant.  Summary statistics will be 
provided.  
19.3.3. 
Overall Study Sample Size Requirements 
The sample size requirement  at 6-months for each of the study objectives is displayed in Table 18. The 
first row does not account for attrition, while the second row is inflated by 15% attrition. The sample size 
for Secondary Objective #2 assumes the conservative case that the interim look results in, no borrowing 
of historical data. Therefore, the overall sample size for the study is 471.  
Table 18: Required Sample Size by Study Objective  
 
Primary 
Safety 
Objective 
Primary 
Efficacy 
Objective 
#1 
Primary 
Efficacy 
Objective 
#2 
Secondary 
Objective 
#1  
Secondary 
Objective 
#2 (post-
implant 
failure 
modes) 
Secondary 
Objective 
#3 
Overall 
Number 
needed at 
6-months 
170 
145 
50 
NA 
400 
NA 
400 
Number of 
enrollments 
200 
171 
59 
NA 
471 
NA 
471  
 

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20. Ethics 
20.1. Statement(s) of Compliance  
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as good clinical practice (GCP).  Good Clinical Practice includes review and approval by an 
independent IRB/EC before initiating a study, continuing review of an ongoing study by an IRB/EC, and 
obtaining and documenting the freely given IC of a subject before initiating the study. 
The clinical investigation shall not begin until all required approvals and documents from the IRB/EC and 
a regulatory authority, if needed, have been received.  Any additional requirements imposed by the 
IRB/EC or regulatory authority shall be followed, if appropriate. 
The Attain Stability Quad Clinical Study was designed to reflect the GCP principles outlined in ISO 
14155:2011 and other international clinical requirements outlined below. These include the protection of 
the rights, safety and well-being of human subjects, controls to ensure the scientific conduct and 
credibility of the clinical investigation and the definition of responsibilities of the sponsor and 
investigators.  In accordance with ISO 14155:2011, the sponsor shall avoid improper influence on, or 
inducement of, the subject, monitor, any investigator(s) or other parties participating in, or contributing 
to, the clinical investigation.  All investigators shall avoid improper influence on or inducement of the 
subject, sponsor, monitor, other investigator(s) or other parties participating in or contributing to the 
clinical investigation.  Adverse Event and Device Deficiency handling in the Attain Stability Quad Clinical 
Study is ISO 14155:2011 compliant for all participating geographies with the exception  that only those 
AEs which are related to the subject’s system, procedure, accessory, or are cardiovascular-related, and all 
Serious AEs, will be collected. This ensures any AEs which could potentially be relevant will be collected. 
The scope and duration of the Attain Stability Quad Clinical Study would make collection of all AEs to be 
a significant burden for investigators and investigative sites. Therefore, only a subset of AEs will be 
collected in this study, including any that could be potentially relevant. 
The principles of the Declaration of Helsinki have been implemented through the IC process, IRB/EC 
approval, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment and 
publication policy.  
Ultimately, all sites in all geographies will follow and comply with: 
• 
Principles of Declaration of Helsinki 
• 
21 CFR Part 11 (Electronic Records, Electronic Signatures) (per local law) 
• 
21 CFR Part 54 (Financial Disclosure by Clinical Investigators) 
• 
The Clinical Trial Agreement 
• 
The procedures described within this CIP 
• 
Local Ethics Board Requirements 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to:  

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• 
In the United States, the study will be conducted under an FDA IDE in compliance with 21 CFR 
Parts: 
o 
50: Protection of Human Subjects 
o 
56: Institutional Review Boards 
o 
812: Investigational Device Exemptions 
• 
In Canada, SOR/98-282, Section 59-88 will be followed and Mandatory Problem Reporting 59(1), 
59(2), 60 (1)). 
• 
In EMEA the study will be conducted in compliance with the Active Implantable Medical Device 
Directive (AIMDD) and Declaration of Helsinki version 2013.  
• 
In Hong Kong and Malaysia, the study will be conducted in compliance with the Declaration of 
Helsinki version 2013.   
• 
In EMEA, an IB is not required for this study as it is a post market study 
The study will be publicly registered prior to first enrollment in accordance with the 2007 Food and Drug 
Administration Amendments Act FDAAA and Declaration of Helsinki on http://clinicaltrials.gov (PL 110-85, 
section 810(a)).  In addition, the study may be registered in local regulatory databases where required by 
local law.  
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law/regulations) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical ethics committee or institutional review board. 
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above 
mentioned groups prior to implementation of the revised CIP at the site.  
21. Study Administration 
21.1. Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this Attain Stability Quad Clinical 
Study.  Trained Medtronic personnel or delegates appointed by Medtronic may perform study monitoring 
at the study site in order to ensure that the study is conducted in accordance with the CIP, the CTA, and 
applicable regulatory and local requirements.  Medtronic, or delegates, must therefore be allowed access 
to the subjects’ case histories (clinic and hospital records, and other source data/documentation) upon 
request as per the Subject IC, Data Protection Authorization (where applicable) and CTA.  The principal 
investigator should also be available during monitoring visits.  
Monitoring for the study, including site initiation visits, interim monitoring visits, and closeout visits, will 
be done in accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess site study progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to IRB/EC approval and review of 
the study, maintenance of records and reports, and review of source documents against subject CRFs.  
Monitors review site regulatory and study compliance by identifying findings of non-compliance and 
communicating those findings along with recommendations for preventative/corrective actions to site 
personnel.  Monitors may work with study personnel to determine appropriate corrective action 

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recommendations and to identify trends within the study or at a particular site.  Regulatory documents 
may be reviewed at each study site.   
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, findings from previous monitoring visits 
and any suspected inconsistency in data that requires investigation. 
21.2. Data Management 
Data will be collected using Oracle Clinical, an electronic data management system for clinical studies.  
CRF data will be stored in a secure, password-protected database which will be backed up nightly.  Data 
will be reviewed using programmed and manual data checks.  Data queries will be made available to sites 
for resolution.  Study management reports may be generated to monitor data quality and study progress.  
At the end of the study, the data will be frozen and will be retained indefinitely by Medtronic. 
Only authorized persons can complete CRFs.  CRFs shall be signed by the Principle Investigator.  The 
Principle Investigator can delegate the CRF sign off task to Sub-Investigators only.  Delegation of 
authority will be specified on the appropriate documentation. 
All records and other information about subjects participating in this study will be treated as confidential.  
Data will be transferred and processed by Medtronic or a third party designated by Medtronic in a key 
coded form, unless it’s impossible to make it anonymous, for instance, where the subject’s name cannot 
be removed from the data carrier.     
Procedures in the CIP require source documentation.  Source documentation will be maintained at the 
site.  Source documents, which may include worksheets, patient medical records, programmer printouts 
and device interrogation files, must be created and maintained by the investigational site team.  For 
source documentation, the investigational site study team must sign and date any copies or printouts of 
original source documents with a statement that this is a complete and true reproduction of the original 
source document. 
The data reported on the CRFs shall be derived from source documents and be consistent with these 
source documents, and any discrepancies shall be explained in writing.  The CRF may be considered 
source for the following data collection elements recorded directly on the CRFs: 
• 
Enrollment Notification 
o 
Site assigned patient reference 
• 
Baseline 
o 
Administrative information 
• 
Adverse Event eCRF 
o 
Date study site became aware of event 
o 
Relatedness of adverse event 
• 
Device Deficiency eCRF 
o 
Date study site became aware of event 
• 
Subject Death 
o 
Date study site became aware of death 
o 
Relatedness of death 
• 
System Modification 
o 
Justification for explanted product not being returned to Medtronic 
• 
Deviations 

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o 
Reason for deviation 
• 
Investigational product Disposition Log 
o 
Date the Investigational Attain Stability Quad lead was implanted/explanted  
Even when the CRF may be considered as source, an alternate method of source documentation is 
always strongly encouraged. 
Save-to-media data collected at office visits will be sent to Medtronic.  Upon receipt, device data will be 
maintained within a Medtronic device database and retrieved for analysis and reporting. 
21.3. Direct Access to Source Data/Documents  
The sponsor or a regulatory authority may audit or inspect the study site to evaluate the conduct of the 
study.  The clinical investigator(s)/institution(s) shall allow study related monitoring, audits, IRB/EC 
review and regulatory inspection.  
21.4. Confidentiality 
All records and other information about subjects participating in this study will be treated as confidential.  
21.5. CIP Amendments 
Approval of subsequent revisions to the CIP is required at each study site from the following groups prior 
to implementation of the revised CIP at the site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical ethics committee or institutional review board. 
If a CIP amendment occurs, site personnel will need to be re-trained as necessary, and will need to 
submit any changes to their IRB/EC as required by the committee.  Protocol amendments will also be 
reported to and approved by the FDA, or regulatory authority. 
21.6. Warranty/Insurance Information 
21.6.1. 
Warranty 
Warranty information is provided in the product packaging for the commercially released CRT-P or CRT-D 
devices and leads, and additional copies are available upon request. 
21.6.2. 
Insurance (EMEA) 
Medtronic Bakken Research Center B.V. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical study liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the EC 
and/or Competent Authority (CA). 

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21.6.3. 
Insurance (Canada) 
Medtronic of Canada  is a wholly owned subsidiary of Medtronic, which as the parent company of such 
entity maintains appropriate general liability insurance coverage as required under applicable laws and 
regulations and will comply with applicable local law and custom concerning specific insurance coverage.  
If required, a General Liability insurance statement/certificate will be provided to the Ethics Committee. 
21.6.4. 
Insurance (Malaysia) 
Medtronic International Ltd. is a wholly owned subsidiary of Medtronic, which as the parent company of 
such entity maintains appropriate clinical trial liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the Ethics 
Committee. 
21.6.5. 
Insurance (Hong Kong) 
Medtronic Hong Kong Medical Ltd.   Ltd. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical trial liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the 
Ethics Committee. 
21.7. Record Retention 
21.7.1. 
Investigator Records 
The investigator is responsible for the preparation and retention of the records including, but not limited 
to, those cited below.  All of the below records, with the exception of case history records and case 
report forms, should be kept in the Investigator Site File (e.g., the study binder provided to the 
investigator) or Subject Study Binder.  Case Report Forms must be maintained and signed electronically 
by an investigator within the electronic data capture system during the study.  The following records are 
subject to inspection and must be retained for a period of two years (or longer as local law/regulation or 
hospital administration requires) after product approval.  Measures shall be taken to avoid loss or 
premature destruction. 
• 
All correspondence between the IRB/EC, sponsor, monitor, regulatory authority and/or the 
investigator that pertains to the investigation, including required reports.  
• 
Subject’s case history records, including:  
o 
Signed and dated informed consent form, in accordance with local requirements  
o 
Observations of adverse events/adverse device effects/device deficiencies 
o 
Medical history 
o 
Baseline, Implant and follow-up data (if applicable) 
o 
Documentation of the dates and rationale for any deviation from the protocol 
• 
Electronically signed and dated eCRFs and a blank set of CRFs where required by local law 
• 
All approved versions of the CIP, IC  
• 
Fully executed Clinical Trial Agreement 
• 
Ethics Committee approval documentation.  Written information that the investigator or other 
study staff, when member of the Ethics Committee, did not participate in the approval process. 

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Approval documentation must include the Ethics Board composition, where required per local 
law.   
• 
Regulatory authority notification, correspondence and approval, where required per local law. 
• 
List of investigation sites: This list is not yet final at the time of CIP development. The list will be 
provided under separate cover and will be maintained by the sponsor. 
• 
Financial disclosure (investigators) 
• 
Enrollment Log (for sites following ISO 14155) 
• 
For sites where the Attain Stability Quad lead is considered investigational, device disposition logs 
containing Model and serial numbers of devices implanted, subject IDs of the subjects implanted, 
implant/used dates, explant dates, returned-to-sponsor dates and reasons and method of 
disposal/destruction 
• 
Current curriculum vitae (signed and dated in EMEA only) of principal investigators and key 
members of investigation site team (as required by local law) 
• 
Documentation of delegated tasks 
• 
Study training records for investigation site team 
• 
Assurance certificates (EMEA, Hong Kong, and Malaysia) 
• 
Any other records that FDA and local regulatory agencies require to be maintained (e.g. Ethics 
Committee Roster, study equipment calibration information) 
• 
Final Study Report including the statistical analysis 
21.7.2. 
Investigator Reports 
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all CRFs, AEs and ADEs (reported per the country-specific collection requirements), DDs, deaths, 
crossovers and any deviations from the CIP.  If any action is taken by an IRB/EC with respect to this 
Attain Stability Quad Clinical Study, copies of all pertinent documentation must be forwarded to Medtronic 
in a timely manner.  Reports are subject to inspection and to the retention requirements as described 
above for investigator records.  
Investigator reporting requirements for safety data are listed in Section 17.3).  
Table 19: Investigator Reports Applicable for All Geographies per Medtronic Requirements 
Report  
Submit to 
Description/Constraints 
Withdrawal of Ethics 
Committee approval 
Sponsor and 
Relevant 
Authorities 
The investigator must report a withdrawal of approval by 
the reviewing Ethics Committee of the investigator’s part of 
the investigation within 5 working days. 
Study Deviations  
Sponsor and 
Ethics Committee 
Any deviation from the clinical investigation plan shall be 
recorded together with the explanation of the deviation. 
Notice of deviations from the CIP to protect the life or 
physical well-being of a subject in an emergency shall be 
given as soon as possible, but no later than 5 working days 
after the emergency occurred.  Except in such emergency, 
prior approval is required for changes in the plan or 
deviations.  
Failure to obtain 
informed consent 
Sponsor and 
Ethics Committee 
Informed consent shall be obtained in writing and 
documented before a subject is enrolled into the Attain 
Stability Quad Clinical Study 
Final Report 
Ethics Committee 
and  
Relevant 
Authorities 
This report must be submitted within 3 months of study 
completion or termination. 

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21.7.3. 
Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records that includes, but is not 
limited to: 
• 
All correspondence which pertains to the Attain Stability Quad Clinical Study 
• 
Executed Clinical Trial Agreement 
• 
Financial disclosures (investigators) 
• 
Current curriculum vitae (signed and dated in EMEA only) of principal investigators and key 
members of investigation site team (as required by local law) 
• 
Device Disposition Logs containing Model and serial numbers of devices implanted, subject IDs of 
the subjects implanted, implant/used dates, explant dates, returned-to-sponsor dates and 
reasons and method of disposal/destruction 
• 
Electronically signed and dated eCRFs 
• 
All approved informed consent templates, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all Ethics Committee approval letters and relevant Ethics Committee correspondence 
and Ethics Committee voting list/roster/letter of assurance 
• 
List of names, addresses, and professional position of the clinical investigators and coordinating 
clinical, if appointed.  
• 
Names and addresses of the institutions in which the Attain Stability Quad Clinical Study will be 
conducted: This list is not yet final at the time of CIP development. The list will be provided 
under separate cover and will be maintained by the sponsor. 
• 
Regulatory authorities correspondence, notification and approval as required by national 
legislation 
• 
Insurance certificates (EMEA, Hong Kong, and Malaysia)  
• 
Names/contact addresses of monitors 
• 
Monitoring reports (interim monitoring visit reports, follow-up letters and close-out visit reports) 
• 
Site qualification visit reports 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the Attain Stability Quad Clinical Study 
• 
The approved Clinical Investigation Plan and study related reports, and revisions 
• 
Documentation of delegated tasks 
• 
Study training records for site personnel and Medtronic personnel involved in the study 
• 
Sample of CRFs 
• 
Any other records that local regulatory agencies require to be maintained 
21.7.4. 
Sponsor Reports 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in the 
tables below (by geography).  In addition to the reports listed below, Medtronic shall, upon request of 
reviewing Ethics Committee, regulatory agency or FDA, provide accurate, complete and current 
information about any aspect of the Attain Stability Quad Clinical Study.  Safety data Medtronic reporting 
requirements are listed in Section 17.3). 
 
 
 

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Table 20: Sponsor Reports for Canada 
Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities, and  
Head of the 
Institution 
Provide prompt notification of termination or suspension 
and reason(s).  
Recall and device 
disposition 
Investigators, 
Ethics Committee 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, 
or otherwise dispose of any devices.   
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  
Site specific study deviations will be submitted to 
investigators periodically.   
Table 21: Sponsor Reports for EMEA, Malaysia, Hong Kong 
Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities and 
Head of the 
Institution 
Provide prompt notification of termination or suspension 
and reason(s) per local law.  (ISO 14155:2011) 
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics Committee 
and relevant 
authorities 
Investigators and other Ethics Committees will be notified 
only if required by local laws or by the Ethics Committee. 
Withdrawal of CA 
approval 
Investigators, 
Ethics 
Committee, and 
relevant 
authorities 
Investigators, Ethics Committees and relevant authorities 
will be notified only if required by local laws or by the Ethics 
Committee. 
Progress Reports 
Ethics Committee 
and 
regulatory 
authorities 
This will be submitted to the Ethics Committee and 
regulatory authorities only if required by local law. 
Final report 
Investigators, 
Ethics 
Committee, and 
Regulatory 
authorities upon 
request 
• 
The investigator shall have the opportunity to review 
and comment on the final report.   
• 
If a clinical investigator does not agree with the final 
report, his/her comments shall be communicated to the 
other investigator(s).   
• 
The signature of the principal Investigator in each 
site should be obtained. 
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  (ISO 
14155:2011) 
Site specific study deviations will be submitted to 
investigators periodically.   

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Table 22: Sponsor Reports for the United States 
Report  
Submit to 
Description/Constraints 
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics 
Committee, 
FDA, and 
relevant 
authorities 
Notification within five working days.  (21 CFR 
812.150(b)(2))   
Withdrawal of FDA 
approval 
Investigators, 
Ethics 
Committee, and 
relevant 
authorities 
Notification within five working days.  (21 CFR 
812.150(b)(3)) 
Investigator List 
FDA 
Submit at 6-month intervals, a current list of the names and 
addresses of all investigators participating in the 
investigation.  (21 CFR 812.150(b)(4)) 
Progress Reports 
Ethics Committee 
and  
FDA 
Progress reports will be submitted at least annually.  (21 
CFR 812.150(b)(5), 812.36(f)   
Recall and device 
disposition 
Investigators, 
Head of 
Institution, 
Ethics 
Committee, 
relevant 
authorities, and  
FDA 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, 
or otherwise dispose of any devices.  (21 CFR 
812.150(b)(6)) 
Failure to obtain 
informed consent  
FDA 
Investigator’s report will be submitted to FDA within five 
working days of notification.  (21 CFR 812.150(b)(8)) 
Final report 
Investigators, 
Ethics 
Committee,  
Regulatory 
authorities upon 
request, and FDA 
Medtronic will notify FDA within 30 working days of the 
completion or termination of the investigation.   A final 
report will be submitted to the FDA, investigators, and 
IRBs/MECs within six months after completion or 
termination of this study.  (21 CFR 812.150(b)(7)) 
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  
Site specific study deviations will be submitted to 
investigators periodically.   
Other 
IRB, FDA 
Accurate, complete, and current information about any 
aspect of the investigation.  (21 CFR 812.150(b)(10)) 
 
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in secured file cabinets at Medtronic 
during the course of this study.  After closure of the study Medtronic will archive records and reports as 
required by applicable regulations. 
21.8. Publication and Use of Information 
Publications from the Attain Stability Quad Clinical Study will be handled according to Medtronic Policies 
and Standard Operating Procedures and as indicated in the CTA. 

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21.8.1. 
Publication Committee 
The Attain Stability Quad Clinical Study will utilize a Publication Committee which will include the Steering 
Committee members as well as Medtronic personnel.  This committee will manage study publications with 
the goal of publishing findings from the data.  The Publication Committee will develop the final 
Publication Plan as a separate document. 
The Publication Committee’s role is to:  
• 
Manage elements addressed in the publication plan as outlined in this section 
• 
Develop the final Publication Plan under separate cover 
• 
Execute the Publication Plan 
• 
Oversee the publication of primary, secondary and ancillary study results 
• 
Review and prioritize publication proposals 
• 
Provide input on publication content, and  
• 
Determine authorship 
In addition, the committee will apply and reinforce the authorship guidelines set forth in the Publication 
Plan.  Membership in the Publication Committee does not guarantee authorship.  The committee will 
meet as needed. 
21.8.2. 
Management of Primary, Secondary, and Ancillary Publications 
The Publication Committee reviews, prioritizes and manages all publications including primary, secondary 
and ancillary publications.  Primary and secondary publications are those that address analyses of any or 
all primary objectives or secondary/ancillary objectives, respectively, as specified in the Clinical 
Investigation Plan.  An ancillary publication is any publication that does not address the study objectives 
identified in the Clinical Investigation Plan.  They include publications proposed and developed by other 
Medtronic departments or entities, clinicians participating in this Attain Stability Quad Clinical Study and 
clinicians not participating in this Attain Stability Quad Clinical Study.  The committee will work with 
Medtronic to ensure that requests do not present conflicts with other proposals, are not duplicative and 
to determine which ancillary publication proposals, if any, will be supported. 
The committee may decide that no publications, including abstracts, will be published prior to the end of 
the study or with individual site data.  Requests for publications on study objectives utilizing subset data 
(e.g., regional) will be evaluated for scientific validity and the ability of Medtronic to provide resources.  
21.8.3. 
Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical Journal 
Editors (ICMJE), Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org).  Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data 
• 
Drafting the article or revising it critically for important intellectual content 
• 
Final approval of the version to be published 
Decisions regarding authorship and contributor-ship will be made by the publication committee.  The 
selected authors will be responsible for drafting the publication.  All selected authors must fulfill the 

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authorship conditions stated above to be listed as authors, and all contributors who fulfill the conditions 
must be listed as authors. 
All investigators not listed as co-authors will be acknowledged as the “Medtronic Attain Stability Quad 
Clinical Study Investigators” and will be individually listed according to the guidelines of the applicable 
scientific journal when possible.  Any other contributors will be acknowledged by name with their specific 
contribution indicated. 
21.8.4. 
Transparency 
Transparency of study results will be maintained by the following means: 
• 
A final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, IRB/ECs and Competent Authorities of participating countries when required by 
local law 
• 
Registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated  
• 
Submitting for publication the primary study results after the study ends  
• 
Disclosing conflicts of interest (e.g. financial) of the co-authors of publications according to the 
policies set forth by the corresponding journals and conferences  
• 
Making an individual sites study data accessible to the corresponding investigator after the 
completion of the study, if requested  
21.9. Suspension or Early Termination 
21.9.1. 
Planned Study Closure 
Study Closure is a process initiated by distribution of a study closure letter.  Study closure is defined as 
closure of a clinical study that occurs when Medtronic and/or regulatory requirements have been satisfied 
per the CIP and/or by a decision by Medtronic or regulatory authority, whichever occurs first.  The study 
closure process is complete upon distribution of the Final Report or after final payments, whichever 
occurs last.  Ongoing IRB/EC oversight is required until the overall study closure process is complete.  
Upon study closure, subjects should be managed and followed per physician discretion. 
21.9.2. 
Early Termination or Suspension 
Early Termination of the Study is the closure of a clinical study that occurs prior to meeting defined 
endpoints.  This is possible for the whole study or a single site.  Study Suspension is a temporary 
postponement of study activities related to enrollment and distribution of the product.  This is possible for 
the whole study or a single site.  In the event the whole study or a single site is terminated, subjects will 
be exited.  
Study-Wide Termination or Suspension 
Possible reasons for considering study suspension or termination of the study include but are not limited 
to: 
• 
Adverse events associated with the system or product under investigation which might endanger 
the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or regulatory body (where the study is operating under regulatory body 
authority)  

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• 
Technical issues during the manufacturing process 
Investigator/Site Termination or Suspension 
Possible reasons for clinical investigator or site termination or suspension include but are not limited to: 
• 
Failure to obtain initial IRB/EC approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups)  
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring findings in a timely manner, etc.)  
• 
Institutional Review Board/Ethics Committee suspension of the site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)  
• 
Investigator request (e.g. no longer able to support the study)  
21.9.3. 
Procedures for Termination or Suspension 
Medtronic-Initiated and Regulatory Authority-Initiated 
• 
Medtronic will promptly inform the clinical investigators of the (early) termination or suspension 
and the reasons and inform the regulatory authority(s) where required 
• 
In the case of study termination or suspension for reasons other than a temporary IRB/EC 
approval lapse, the investigator will promptly inform the IRB/EC  
• 
In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare 
Investigator-Initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension 
• 
The investigator will promptly inform the institution (where required per regulatory requirements)  
• 
The investigator will promptly inform the IRB/EC 
• 
The investigator will promptly inform the regulatory authorities (for regions following ISO only) 
• 
The investigator will promptly inform the subjects and/or the personal physician of the subjects 
to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare 
Institutional Review Board Ethics Committee-Initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days 
• 
Subject enrollment must stop until the suspension is lifted 
• 
Subjects already enrolled should continue to be followed in accordance with IRB/EC policy or its 
determination that an overriding safety concern or ethical issue is involved 
• 
The investigator will inform his/her institution (where required per local requirements)  

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• 
The investigator will promptly inform the subjects, and/or the personal physician of the subjects, 
with the rationale for the study termination or suspension 
• 
The investigator will promptly inform the regulatory authorities (for regions following ISO 14155 
only) 
 
 

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22. Appendices 
APPENDIX 1: Foreseeable Adverse Event List 
The information provided in this section pertains to foreseeable AEs that may be observed in study 
subjects and may collectively assist in identifying those events that are unexpected in nature.  The 
foreseeable adverse events information consists of three parts: (1) listing of potential adverse events 
associated with implantation of CRT system and transvenous leads, (2) rates of AEs reported from 
previous Medtronic studies evaluating CRT systems and transvenous leads, and (3) AEs rates reported in 
published literature for procedures similar to the CRT system implant procedure.  This information will be 
used in combination with device labeling, current event reporting information, and other published data 
to assess for an unexpected occurrence.  
The implantation of the study device, CRT-P or CRT-D, involves surgery, therefore, standard AEs 
associated with a surgical procedure may be experienced (e.g. anesthesia complications, injury, 
infections, bleeding, exacerbation of pre-existing conditions, healing complications, etc.).  The focus of 
this section is to specifically address in more detail, those events that are foreseeable due to the use, 
performance, and/or presence of the system under investigation.  
Additional potential risks associated with the implantation of the CRT system and the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798), as well as risk minimization are discussed within Section 16. 
Treatment required for procedure and/or system related adverse events that are experienced may 
include medication, device reprogramming, device modification (e.g. repositioning, surgical 
abandonment, surgical removal), or other surgical and medical remedies.  The AEs associated with the 
use of transvenous leads, pacing and defibrillation systems include, but are not limited to, the following: 

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Table 23: Listing of Potential Adverse Events Associated with System Implant 
• 
acceleration of tachyarrhythmias (caused by device) 
• 
air embolism 
• 
bleeding 
• 
body rejection phenomena, including local tissue reaction 
• 
cardiac dissection 
• 
cardiac perforation 
• 
cardiac tamponade 
• 
chronic nerve damage 
• 
constrictive pericarditis 
• 
death 
• 
device migration 
• 
endocarditis 
• 
erosion 
• 
excessive fibrotic tissue growth 
• 
extrusion 
• 
fibrillation or other arrhythmias 
• 
fluid accumulation 
• 
formation of hematomas/seromas or cysts 
• 
heart block 
• 
heart wall or vein wall rupture 
• 
hemothorax 
• 
infection 
• 
keloid formation 
• 
lead abrasion and discontinuity 
• 
lead migration/dislodgment 
• 
complications and mortality due to inability to deliver appropriate and intended therapy 
• 
muscle and/or nerve stimulation 
• 
myocardial damage 
• 
myocardial irritability 
• 
myopotential sensing 
• 
pericardial effusion 
• 
pericardial rub 
• 
pneumothorax 
• 
poor connection of the lead to the device, which may lead to oversensing, undersensing, or a 
loss of therapy 
• 
stroke 
• 
threshold elevation 
• 
thrombotic embolism 
• 
thrombosis 
• 
tissue necrosis 
• 
valve damage (particularly in fragile hearts) 
• 
venous occlusion 
• 
venous perforation 

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An additional potential AE associated with the use of transvenous left ventricular pacing leads is coronary 
sinus dissection. 
Additional potential AEs associated with the use of ICD systems include, but are not limited to, the 
following events: 
• 
inappropriate shocks 
• 
potential mortality due to inability to defibrillate 
• 
shunting current or insulating myocardium during defibrillation 
Patients susceptible to frequent shocks despite medical management could develop psychological 
intolerance to an ICD system that might include the following conditions: 
• 
dependency 
• 
depression 
• 
fear of premature battery depletion 
• 
fear of shocking while conscious 
• 
fear that shocking capability may be lost 
• 
imagined shocking (phantom shock) 
Adverse Events Reported in Previous Medtronic Studies 
The listing below provides an example of reported system and procedure related AEs in recent Medtronic 
studies.  This table includes a summary of combined system or procedure related AEs as reported in the 
Concerto-AT, Insync III US, 4194, 4195, 4196, 4396, Adaptive CRT, and Attain Performa studies along 
with their incidence.  The observed rate is based on the study populations that included a total of 3,246 
subjects.  In total, there were 1749 system or procedure related events.  This includes both serious and 
non-serious events.  The rate is calculated as number of subjects that experience the event, not 
accounting for duration of follow-up. 
Table 24: System or procedure-related adverse events from previous clinical studies 
MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Abdominal pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Acidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Acute respiratory failure 
4 
4 
0.12% 
(0.03%, 0.32%) 
Adverse drug reaction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Air embolism 
1 
1 
0.03% 
(0.00%, 0.17%) 
Alcohol withdrawal syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Alpha haemolytic streptococcal 
infection 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Anaemia 
7 
7 
0.22% 
(0.09%, 0.44%) 
Anaemia postoperative 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anaphylactic shock 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anticoagulation drug level below 
therapeutic 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anxiety 
3 
3 
0.09% 
(0.02%, 0.27%) 
Application site rash 
2 
2 
0.06% 
(0.01%, 0.22%) 
Arterial haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arteriovenous fistula 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arteriovenous fistula operation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arthralgia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arthritis bacterial 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ascites 
1 
1 
0.03% 
(0.00%, 0.17%) 
Atelectasis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Atrial fibrillation 
19 
19 
0.59% 
(0.35%, 0.91%) 
Atrial flutter 
4 
4 
0.12% 
(0.03%, 0.32%) 
Atrial tachycardia 
5 
4 
0.12% 
(0.03%, 0.32%) 
Atrioventricular block 
16 
16 
0.49% 
(0.28%, 0.80%) 
Back pain 
3 
3 
0.09% 
(0.02%, 0.27%) 
Bacteraemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac arrest 
8 
8 
0.25% 
(0.11%, 0.49%) 
Cardiac failure 
46 
43 
1.32% 
(0.96%, 1.78%) 
Cardiac failure chronic 
5 
5 
0.15% 
(0.05%, 0.36%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Cardiac pacemaker battery 
replacement 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac perforation 
8 
8 
0.25% 
(0.11%, 0.49%) 
Cardiac sarcoidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac tamponade 
3 
3 
0.09% 
(0.02%, 0.27%) 
Cardiac vein dissection 
38 
37 
1.14% 
(0.80%, 1.57%) 
Cardiac vein perforation 
5 
5 
0.15% 
(0.05%, 0.36%) 
Cardiogenic shock 
3 
3 
0.09% 
(0.02%, 0.27%) 
Cardiomyopathy 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiovascular disorder 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cellulitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Cerebral infarction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cerebrovascular accident 
3 
3 
0.09% 
(0.02%, 0.27%) 
Chest discomfort 
4 
4 
0.12% 
(0.03%, 0.32%) 
Chest pain 
8 
8 
0.25% 
(0.11%, 0.49%) 
Chronic obstructive pulmonary 
disease 
3 
3 
0.09% 
(0.02%, 0.27%) 
Circulatory collapse 
1 
1 
0.03% 
(0.00%, 0.17%) 
Colitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Complication of device insertion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Complication of device removal 
4 
4 
0.12% 
(0.03%, 0.32%) 
Constipation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Contusion 
2 
2 
0.06% 
(0.01%, 0.22%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Cough 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cystitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Decubitus ulcer 
1 
1 
0.03% 
(0.00%, 0.17%) 
Deep vein thrombosis 
14 
14 
0.43% 
(0.24%, 0.72%) 
Dehydration 
1 
1 
0.03% 
(0.00%, 0.17%) 
Delirium 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device alarm issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device battery issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device capturing issue 
30 
29 
0.89% 
(0.60%, 1.28%) 
Device computer issue 
19 
19 
0.59% 
(0.35%, 0.91%) 
Device connection issue 
19 
19 
0.59% 
(0.35%, 0.91%) 
Device damage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device dislocation 
125 
107 
3.30% 
(2.71%, 3.97%) 
Device electrical impedance issue 
12 
12 
0.37% 
(0.19%, 0.64%) 
Device extrusion 
2 
1 
0.03% 
(0.00%, 0.17%) 
Device failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device lead damage 
13 
13 
0.40% 
(0.21%, 0.68%) 
Device lead issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device misuse 
9 
9 
0.28% 
(0.13%, 0.53%) 
Device pacing issue 
69 
67 
2.06% 
(1.60%, 2.61%) 
Device psychogenic complication 
7 
7 
0.22% 
(0.09%, 0.44%) 
Device related infection 
3 
3 
0.09% 
(0.02%, 0.27%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Device signal detection issue 
2 
2 
0.06% 
(0.01%, 0.22%) 
Device stimulation issue 
443 
349 
10.75% 
(9.71%, 11.87%) 
Diabetes 
1 
1 
0.03% 
(0.00%, 0.17%) 
Diarrhea 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dizziness 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dressler's syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Drug hypersensitivity 
3 
3 
0.09% 
(0.02%, 0.27%) 
Dysarthria 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dyspnoea 
2 
2 
0.06% 
(0.01%, 0.22%) 
Dyspnoea exertional 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dyspnoea paroxysmal nocturnal 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ecchymosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Electromagnetic interference 
1 
1 
0.03% 
(0.00%, 0.17%) 
Endocarditis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Endocarditis staphylococcal 
1 
1 
0.03% 
(0.00%, 0.17%) 
Erythema multiforme 
1 
1 
0.03% 
(0.00%, 0.17%) 
Fatigue 
5 
5 
0.15% 
(0.05%, 0.36%) 
Fluid overload 
1 
1 
0.03% 
(0.00%, 0.17%) 
Gastroenteritis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Gastrointestinal haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Haematoma 
2 
2 
0.06% 
(0.01%, 0.22%) 
Haematuria 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Haemoptysis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Haemothorax 
4 
4 
0.12% 
(0.03%, 0.32%) 
Hot flush 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hydrothorax 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyperglycaemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyperkalaemia 
4 
4 
0.12% 
(0.03%, 0.32%) 
Hypersensitivity 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hypertension 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyponatraemia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Hypotension 
20 
20 
0.62% 
(0.38%, 0.95%) 
Hypovolaemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ileus 
1 
1 
0.03% 
(0.00%, 0.17%) 
Impaired healing 
2 
2 
0.06% 
(0.01%, 0.22%) 
Implant site bruising 
2 
2 
0.06% 
(0.01%, 0.22%) 
Implant site cellulitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site effusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site erosion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site erythema 
6 
6 
0.18% 
(0.07%, 0.40%) 
Implant site haematoma 
98 
96 
2.96% 
(2.40%, 3.60%) 
Implant site haemorrhage 
6 
6 
0.18% 
(0.07%, 0.40%) 
Implant site hypoaesthesia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site infection 
44 
44 
1.36% 
(0.99%, 1.82%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Implant site inflammation 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site irritation 
5 
5 
0.15% 
(0.05%, 0.36%) 
Implant site oedema 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site pain 
72 
64 
1.97% 
(1.52%, 2.51%) 
Implant site rash 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site swelling 
4 
4 
0.12% 
(0.03%, 0.32%) 
Implant site warmth 
1 
1 
0.03% 
(0.00%, 0.17%) 
Incision site complication 
1 
1 
0.03% 
(0.00%, 0.17%) 
Incision site haemorrhage 
5 
5 
0.15% 
(0.05%, 0.36%) 
Incision site pain 
4 
4 
0.12% 
(0.03%, 0.32%) 
Incisional drainage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Infection 
2 
2 
0.06% 
(0.01%, 0.22%) 
Infusion site extravasation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Intracardiac thrombus 
6 
6 
0.18% 
(0.07%, 0.40%) 
Lead dislodgement 
33 
30 
0.92% 
(0.62%, 1.32%) 
Leukocytosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Localized oedema 
1 
1 
0.03% 
(0.00%, 0.17%) 
Mediastinal effusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Medical device discomfort 
3 
3 
0.09% 
(0.02%, 0.27%) 
Medical device site reaction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Monoparesis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Muscle spasms 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Muscle twitching 
1 
1 
0.03% 
(0.00%, 0.17%) 
Musculoskeletal chest pain 
2 
2 
0.06% 
(0.01%, 0.22%) 
Musculoskeletal pain 
42 
40 
1.23% 
(0.88%, 1.67%) 
Musculoskeletal stiffness 
1 
1 
0.03% 
(0.00%, 0.17%) 
Myocardial infarction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nausea 
1 
1 
0.03% 
(0.00%, 0.17%) 
Neck pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nephrosclerosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Neuropathy peripheral 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nodal rhythm 
2 
2 
0.06% 
(0.01%, 0.22%) 
Non-cardiac chest pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Oedema peripheral 
12 
12 
0.37% 
(0.19%, 0.64%) 
Oliguria 
1 
1 
0.03% 
(0.00%, 0.17%) 
Operative haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Orthostatic hypotension 
2 
2 
0.06% 
(0.01%, 0.22%) 
Oversensing 
34 
33 
1.02% 
(0.70%, 1.42%) 
Oxygen saturation decreased 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pacemaker generated arrhythmia 
6 
6 
0.18% 
(0.07%, 0.40%) 
Pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pain in extremity 
1 
1 
0.03% 
(0.00%, 0.17%) 
Palpitations 
9 
9 
0.28% 
(0.13%, 0.53%) 
Paraesthesia 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Pericardial effusion 
16 
15 
0.46% 
(0.26%, 0.76%) 
Pericarditis 
4 
4 
0.12% 
(0.03%, 0.32%) 
Phantom shocks 
4 
3 
0.09% 
(0.02%, 0.27%) 
Phlebitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Pleural effusion 
21 
21 
0.65% 
(0.40%, 0.99%) 
Pneumonia 
9 
9 
0.28% 
(0.13%, 0.53%) 
Pneumothorax 
43 
43 
1.32% 
(0.96%, 1.78%) 
Pocket erosion 
4 
4 
0.12% 
(0.03%, 0.32%) 
Post procedural haemorrhage 
2 
2 
0.06% 
(0.01%, 0.22%) 
Presyncope 
3 
3 
0.09% 
(0.02%, 0.27%) 
Procedural haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Procedural headache 
2 
2 
0.06% 
(0.01%, 0.22%) 
Procedural pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pruritus 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pruritus generalized 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulmonary embolism 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulmonary oedema 
3 
3 
0.09% 
(0.02%, 0.27%) 
Pulmonary sepsis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulseless electrical activity 
2 
2 
0.06% 
(0.01%, 0.22%) 
Pyrexia 
5 
5 
0.15% 
(0.05%, 0.36%) 
Rash 
8 
8 
0.25% 
(0.11%, 0.49%) 
Rash generalized 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Renal failure 
8 
8 
0.25% 
(0.11%, 0.49%) 
Renal failure acute 
2 
2 
0.06% 
(0.01%, 0.22%) 
Renal impairment 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory acidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory distress 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sepsis 
3 
3 
0.09% 
(0.02%, 0.27%) 
Sepsis syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Septic shock 
4 
4 
0.12% 
(0.03%, 0.32%) 
Sinus arrest 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sinus bradycardia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sinus tachycardia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Staphylococcal infection 
2 
2 
0.06% 
(0.01%, 0.22%) 
Stitch abscess 
1 
1 
0.03% 
(0.00%, 0.17%) 
Subclavian vein thrombosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Subcutaneous emphysema 
1 
1 
0.03% 
(0.00%, 0.17%) 
Subcutaneous haematoma 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sudden cardiac death 
10 
10 
0.31% 
(0.15%, 0.57%) 
Superior vena cava stenosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Supraventricular extrasystoles 
1 
1 
0.03% 
(0.00%, 0.17%) 
Supraventricular tachycardia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Syncope 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Tachycardia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Thrombophlebitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Thrombosis 
8 
8 
0.25% 
(0.11%, 0.49%) 
Thrombotic stroke 
1 
1 
0.03% 
(0.00%, 0.17%) 
Toxicity to various agents 
1 
1 
0.03% 
(0.00%, 0.17%) 
Twiddler's syndrome 
5 
5 
0.15% 
(0.05%, 0.36%) 
Undersensing 
7 
7 
0.22% 
(0.09%, 0.44%) 
Urinary retention 
2 
2 
0.06% 
(0.01%, 0.22%) 
Vena cava thrombosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Venous occlusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular dyssynchrony 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular extrasystoles 
2 
2 
0.06% 
(0.01%, 0.22%) 
Ventricular fibrillation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular tachycardia 
11 
11 
0.34% 
(0.17%, 0.61%) 
Vomiting 
3 
3 
0.09% 
(0.02%, 0.27%) 
Weaning failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Weight decreased 
1 
1 
0.03% 
(0.00%, 0.17%) 
Wound dehiscence 
1 
1 
0.03% 
(0.00%, 0.17%) 
Adverse Events in Literature 
The potential AEs associated with the implantation of CRT-P or CRT-D  systems have been documented 
in various articles in medical scientific literature.  A summary of those events and their published 
incidence are included below. 
1. Ahsan SY, Saberwal B, Lambiase PD, Chaubey S, Segal OR, Gopalamurugan AB, McCready J, 
Rogers DP, Lowe MD, and Chow AWC.  An 8-year single-centre experience of cardiac 

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resynchronization therapy: procedural success, early and late complications, and left ventricular 
lead performance.  Europace 2013;15:711-717. 
Retrospective data were analyzed for all acute and chronic complications occurring over 490 consecutive 
CRT device procedures in 402 patients, from 2000 through 2008.  Associated complications were 
reported by timeframe. 
Table 25: Complications reported in Ahsan et al. 
 
 
2. Dickstein K, Bogale N, Priori S, Auricchio A, Cleland JG, Gitt A, Limbourg T, Linde C, van 
Veldhuisen DJ, Brugada J; Scientific Committee; National Coordinators.  The European Cardiac 
Resynchronization Therapy Survey.  European Heart Journal 2009; 30:2450–2460. 
The primary aim of this survey was to describe current European practice associated with CRT 
implantations.  A total of 140 centers from 13 European countries contributed data from consecutive 
patients successfully implanted with a CRT device with or without an ICD between November 2008 and 
June 2009.  The total number of patients enrolled was 2438. 
Table 26: Complications reported in Dickstein et al. 
Event 
Incidence (%) 
Peri-procedural complications 
10 
Bleeding 
1 
Pocket haematoma 
3 
Pneumothorax 
1 
Pericardial tamponade 
0.3 
Coronary sinus dissection 
1 
Phrenic nerve pacing 
2 
Lead dislocation 
3 

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Post–implantation device related complications 
4 
Lead displacement 
2 
Lead malfunction 
0 
Phrenic nerve stimulation 
2 
 
3. Kirkfeldt R.E., Johansen J.B., Nohr E.A., Jorgensen O.D., Nielsen J.C. Complications after cardiac 
implantable electronic device implantations: An analysis of a complete, nationwide cohort in 
Denmark.  European Heart Journal 2014 35:18 1186-1194. 
This was a population-based cohort study in all Danish patients who underwent a Cardiac Implantable 
Electronic Device (CIED) procedure from May 2010 to April 2011.  The study population consisted of 5918 
consecutive patients.  Total of 562 patients (9.5%) experienced at least one complication. 
Table 27: Complications reported by Kirkfeldt et al. shows cumulative incidence of complications at 6 
monthsa. 
Table 27: Complications reported by Kirkfeldt et al. 
Complication type 
All (n=5918) 
New Implant 
(n=4335) 
Generator 
replacement 
(n=1136) 
Upgrade/Lead 
revision (n=427) 
Any complication 
562 (9.5; 8.7–
10.2) 
432 (9.9; 9.0–
10.8) 
67 (5.9; 4.5–7.3) 
63 (14.8; 11.4–
18.1) 
Any major complicationb 
329 (5.6; 5.0–
6.1) 
253 (5.8; 5.1–
6.5) 
40 (3.5; 2.4–4.6) 
36 (8.4; 5.8–11.1) 
Any minor complicationc 
250 (4.2; 3.7–
4.7) 
189 (4.3; 3.7–
4.9) 
30 (2.6; 1.7–3.6) 
31 (7.3; 4.8–9.7) 
Major complications 
 
Lead related re-intervention 
143 (2.4; 2.0–
2.8) 
120 (2.8; 2.3–
3.2) 
10 (0.9; 0.3–1.4) 
13 (3.0; 1.4–4.7) 
Infection 
49 (0.8; 0.6–1.1) 
24 (0.6; 0.3–0.8) 
17 (1.5; 0.8–2.2) 
8 (1.9; 0.6–3.2) 
Local infection 
22 (0.4; 0.2–0.5) 
10 (0.2; 0.1–0.4) 
8 (0.7; 0.2–1.1) 
4 (1.0; 0.0–1.9) 
Systemic 
infection/endocarditis 
27 (0.5; 0.3–0.6) 
14 (0.3; 0.2–0.5) 
9 (0.8; 0.3–1.3) 
4 (0.9; 0.0–1.9) 
Pneumothorax requiring 
drainage 
51 (0.9; 0.6–1.1) 
45 (1.0; 0.7–1.3) 
0 
6 (1.4; 0.3–2.5) 
Cardiac perforation 
38 (0.6; 0.4–0.8) 
35 (0.8; 0.5–1.1) 
0 
3 (0.7; 0.0–1.5) 

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Cardiac perforation (No 
intervention) 
21 (0.4; 0.2–0.5) 
18 (0.4; 0.2–0.6) 
0 
3 (0.7; 0.0–1.5) 
Cardiac perforation 
(Intervention) 
17 (0.3; 0.2–0.4) 
17 (0.4; 0.2–0.6) 
0 
0 
Pocket revision because of pain 
25 (0.4; 0.3–0.6) 
10 (0.2; 0.1–0.4) 
9 (0.8; 0.3–1.3) 
6 (1.4; 0.3–2.5) 
Generator-lead interface 
problem with re-intervention 
7 (0.1; 0.0–0.2) 
3 (0.1; 0.0–0.1) 
4 (0.4; 0.0–0.7) 
0 
Haematoma requiring re-
intervention 
10 (0.2; 0.1–0.3) 
9 (0.2; 0.1–0.3) 
1 (0.1; 0.0–0.3) 
0 
Otherd 
16 (0.3; 0.1–0.4) 
16 (0.4; 0.2–0.5) 
0 
0 
Minor complications 
 
Haematomae 
138 (2.3; 1.9–
2.7) 
104 (2.4; 1.9–
2.8) 
20 (1.8; 1.0–2.5) 
14 (3.3; 1.6–5.0) 
Wound infection treated with 
antibiotics 
69 (1.2; 0.9–1.4) 
47 (1.1; 0.8–1.4) 
12 (1.0; 0.5–1.7) 
10 (2.3; 0.9–3.8) 
Pneumothorax conservatively 
treated 
39 (0.7; 0.5–0.9) 
32 (0.7; 0.5–1.0) 
0 
7 (1.6; 0.4–2.8) 
Lead dislodgement without re-
intervention 
10 (0.2; 0.1–0.3) 
9 (0.2; 0.1–0.3) 
0 
1 (0.2; 0.0–0.7) 
aReported as absolute frequencies and percentages with 95% CIs in parenthesis. 
bAll re-interventions were categorized as major complications due to their inherently higher risk of infections e.g. local CIED 
infections requiring re-intervention, systemic infections, pocket revisions etc. 
cMinor complications included haematomas resulting in a prolonged hospital stay, hospital re-admissions, or additional out-patient 
visits, wound infections treated with antibiotics, pneumothorax conservatively treated, and lead dislodgements without re-
intervention. 
dDeep venous thrombosis (n=8), Twiddler’s syndrome (n=3), wound revision (n=3), stroke (n=1), myocardial infarction (n=1) 
eResulting in prolonged hospital stay, hospital re-admission, or additional out-patient visit. 
 
 

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23. References 
                                               
 
1 Model 8040 InSync MIRACLE Study (IDE # G980219). 
 
2 Model 7272 InSync ICD Study (IDE # G990176). 
 
3 Thackray S, Coletta A, Jones P, Dunn A, Clark AL, Cleland, JGF.  Clinical trials update:  highlights of the 
scientific sessions of heart failure 2001, a meeting of the working group of heart failure of the European 
Society of Cardiology.  European Journal of Heart Failure 3 (2001): 491-494. 
 
4 Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood 
G, Santini M, Bailleul C, Daubert J.  Effects of multisite biventricular pacing in patients with heart failure 
and intraventricular conduction delay.  New England Journal of Medicine 344 (2001):873-880. 
 
5 Stellbrink C, Breithardt, O, Franke A, Sack S, Bakker P, Auticchio A, et al.  Impact of cardiac 
resynchronization therapy using hemodynamically optimized pacing on left ventricular remodeling in 
patients with congestive heart failure and ventricular conduction disturbances.  Journal of American 
College of Cardioliolgy 38 (2001): 1957-1965. 
 
6 Salukhe TV, Francis, DP, Sutton R.  Comparison of medical therapy, pacing and defibrillation in heart 
failure (COMPANION) trial terminated early; combines biventricular pacemaker defibrillators reduce all-
cause mortality and hospitalization.  International Journal of Cardiology 87 (2003): 119-120. 
 
7 MOSS AJ, Jackson Hall W, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NAM, Foster E, 
Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Silber D, ZarebaW, for the MADIT-CRT Trial 
Investigators.  Cardiac resynchronization therapy for the prevention of heart failure events.  New England 
Journal of Medicine (2009); 
 
8 Cleland JFG, Daubert J-C, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L, for the Cardiac 
Resynchronization-Heart Failure (CARE-HF) Study Investigators.  The effect of cardiac resynchronization 
on morbidity and mortality in heart failure.  New England Journal of Medicine 352 (2005): 1539-1549. 
 
9 Mozzafarian D, Benjamin EJ, Go AS, et al.  On behalf of the American Heart Association Statistics 
Committee and Stroke Statistics Subcommittee.  Heart disease and stroke statistics-2016 update: a report 
from the American Heart Association.  Circulation 133 ( 2016): e38-e360. 
 
10 Abraham, William T., et al.  “Cardiac resynchronization in chronic heart failure.” New England Journal 
of Medicine 346.24 (2002): 1845-1853. 
 
11 Higgins, Steven L., et al.  “Cardiac resynchronization therapy for the treatment of heart failure in 
patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias.” Journal of 
American College of Cardiology 42.8 (2003): 1454-1559. 
 
12 Tang, Anthony SL, et al.  “Cardiac-resynchronization therapy for mild-to-moderate heart failure.” New 
England Journal of Medicine 363.25 (2010): 2385-2395. 
 
 

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13 Moss, Arthur J., et al.  “Cardiac-resynchronization therapy for the prevention of heart-failure events.” 
New England Journal of Medicine 361.14 (2009): 1329-1338. 
 
14 Bristow, Michael R., et al.  “Cardiac-resynchronization therapy with or without an implantable 
defibrillator in advanced chronic heart failure.” New England Journal of Medicine 350.21 (2004): 2140-
2150. 
 
15 Sutton, Martin G. St John, et al.  “Effect of cardiac resynchronization therapy on left ventricular size 
and function in chronic heart failure.” Circulation 107.15 (2003): 1985-1990. 
 
16 Saxon, Leslie A., et al.  “Effects of long-term biventricular stimulation for resynchronization on 
echocardiographic measures of remodeling.” Circulation 105.11 (2002): 1304-1310. 
 
17 Auricchio, Angelo, et al.  “Long-term clinical effect of hemodynamically optimized cardiac 
resynchronization therapy in patients with heart failure and ventricular conduction delay.” Journal of 
American College of Cardiology 39.12 (2002): 2026-2033. 
 
18 Linde, Cecilia, et al.  “Randomized trial of cardiac resynchronization in mildly symptomatic heart failure 
patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure 
symptoms.” Journal of American College of Cardiology 52.23 (2008): 1834-1843. 
 
19 Cleland John GF, et al.  The effect of cardiac resynchronization on morbidity and mortality in heart 
failure.” New England Journal of Medicine 352.15 (2005): 1539-1549. 
 
20 Crossley, George H., et al.  “Performance of a novel left ventricular lead with short bipolar spacing for 
cardiac resynchronization therapy: primary results of the Attain Performa Quadripolar Left Ventricular 
Lead Study.” Heart Rhythm 12.4 (2015): 751-758. 
 
21 Yee, Raymond, et al. “Novel active fixation mechanism permits precise placement of a left ventricular 
lead: early results from a multicenter clinical study.” Heart Rhythm 11.7 (2014): 1150-1155. 
 
22 Tomassoni G, Baker J et.al.  Postoperative Performance of the Quartet Left Ventricular Heart Lead, J 
Cardiovasc Electrophysiology, Vol 24, pp. 449-456, April 2013 
 
23 Mittal S, Nair D, et.al,, Performance of Anatomically Designed Quadripolar Left Ventricular Leads: 
Results from the NAVIGATE X4 Clinical Trial, J Cardiovasc Electrophysiology, DOI: 10.1111/jce.13044 
 
24 J. G. Ibrahim and M.-H. Chen, "Power prior distributions for regression models," Statistical Science, vol. 
15, no. 1, pp. 46-60, 2000. 
 
25 T. Haddad, A. Himes, L. Thompson, T. Irony, R. Nair, "Incorporation of stochastic engineering models 
as prior information in Bayesian medical device trials", Draft manuscript 
 
26 A. Gelman, J. Carlin, H. Stern and D. Rubin, Bayesian Data Analysis, Boca Raton: Chapman & Hall / 
CRC, 2004. 
 
27 S.M. Berry, B.P. Carlin, J.J. Lee, P. Muller, Bayesian adaptive methods for clinical trials. CRC press, 
2010. 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Attain StabilityTM Quad Clinical Study 
Study Product Name Attain StabilityTM Quad MRI SureScan Left 
Ventricular Lead (Model 4798) 
Sponsor/Local Sponsor Sponsor: 
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 U.S.A.  
1-800-328-2518 
Local Sponsors: 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
+1-905-460-3800 
 
Europe, Middle East, Africa (EMEA) Medtronic, 
Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
 
Hong Kong 
Medtronic Hong Kong Medical Ltd. 1104-11, 11/F, 
Tower 1,  
The Gateway,  
Harbour City, Kowloon,  
Hong Kong SAR, China 
+852-2919-1300 
 
Malaysia 
Medtronic International Ltd (Malaysia) 
B-23-1 Level 23, The Ascent, Paradigm  
No 1 Jalan SS7/26A Kelena Jaya 46301 Petaling 
Jaya 
Selangor 
Malaysia 
+603 7883 8000 
Document Version Version 3.0; 20/MAR/2017 
 

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Lead Principal Investigators Dr. George H. Crossley III, MD (Co-Chair) 
Associate Professor of Medicine; Electrophysiologist 
Fellowship Program Director 
Vanderbilt University Medical Center 
1211 Medical Center Drive 
Nashville, TN 37232 
(615) 322-5000 
 
Dr. Kevin Jackson, MD (Co-Chair) 
Assistant  Professor of Medicine; Electrophysiologist 
Director, Duke Cardiac Resynchronization Therapy 
Center 
Medical Director, Electrophysiology Services 
Duke University Medical Center Rm 7451-D 
Durham, North Carolina 27710 
(919) 681-5441 
 
  
 
 
 
 
 

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1. Sponsor Contact 
Medtronic, Inc. is sponsoring the Attain Stability Quad Clinical Study.  Regional contact information is 
provided below.  This information may be subject to change during the course of the Attain Stability 
Quad Clinical Study.  Periodic updates to study contact information will be sent to sites as needed.  
Table 1: Study Sponsor Contact Information 
Study Contacts 
Worldwide Clinical Study Leader  
 
Melissa Thalin, Principal Clinical Research 
Specialist 
 
melissa.a.thalin@medtronic.com 
United States 
 
Ann Vacca, Prin. Customer Specialist  
 
ann.vacca@medtronic.com 
Canada 
 
Mary McCann, Sr. Clinical Research Specialist 
 
mary.mccann@medtronic.com  
Europe, the Middle East and Africa (EMEA) 
 
Rinie Peters, Associate Clinical Research 
Specialist 
  
rinie.peters@medtronic.com 
Hong Kong 
 
Grace Wong, Clinical Research Supervisor 
 
grace.wong@medtronic.com 
Malaysia 
 
Sheikh Abdul Aziz, Sr. Clinical Research 
Specialist 
 
sheikh.hafiz@medtronic.com 
Study Monitors and Contacts 
Worldwide Monitoring Leader 
 
Taryn Randall, Clinical Monitoring Manager 
Direct Phone: (+1-763) 250-0785  
Direct Fax: (+1-651) 367-0759 
taryn.randall@medtronic.com  
Monitoring Leader EMEA, Hong Kong, Malaysia 
 
Anja Hesse, CRHF Portfolio Specialist CRHF 
Direct Phone: +49215981490 
Direct Fax: +4921027069069 
anja.hesse@medtronic.com 
Sponsor’s Medical Expert 
David Steinhaus, M.D., VP & GM Heart Failure and Medical Director CRHF 
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure 
8200 Coral Sea Street N.E., MVC42 
Mounds View, MN 55112 
United States 
Phone: (+1-763) 526-1250 
Fax: (+1-651) 367-0671 
david.m.steinhaus@medtronic.com 
 

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2. CROs/Core Laboratories 
This information may be subject to change during the course of the Attain Stability Quad Clinical Study.  
Periodic updates to study contact information will be sent to sites as needed. 
Table 2: CRO and Core Laboratory Information 
Contact Information 
Role 
Cognizant Technology Solutions 
500 Frank W. Burr Blvd. 
Teaneck, NJ 07666 
United States 
Direct Phone: (201) 801-0233 
Direct Fax: (201) 801-0243 
Review of electronic case report forms and 
management of discrepancies 
 
 

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3. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
o 
Initial Release 
Melissa Thalin, Principal Clinical 
Research Specialist 
 
Rinie Peters, Associate Clinical 
Research Specialist 
 
Ann Vacca, Principal Customer 
Specialist 
 
Shelby Li, Senior Principal 
Statistician 
 
Joao Monteiro, Senior Statistician 
2.0 
o 
Added slitting information for Implant 
analyzer PCT at synopsis and table 8 
o 
Remote visits:  
 
Changed wording to clarify 
required actions 
 
Removed manual PCT test  
 
Deleted rationale for final 
vector programmed  
o 
Recurring 6 mth FU: 
 
Removed PNS test 
 
Removed Patient Global 
Assessment 
o 
System Modification 
 
Reduced electrical testing 
requirements 
o 
Patient Global Assessment 
 
Added to Glossary 
 
Removed from Baseline and 
3 month visits 
o 
Vectors 
 
Added additional 4 CRT-P 
vectors (LV to Can) 
throughout  
o 
Investigator Lead Handling 
Assessment 
 
Added to Implant visit 
o 
Adjusted # of participating centers 
o 
Updated exclusion criteria #2 
o 
Updates to grammar, version ,and 
footers 
Melissa Thalin, Principal Clinical 
Research Specialist 
 
Rinie Peters, Associate Clinical 
Research Specialist 

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3.0 
o 
Modified Primary Efficacy 
objectives/endpoints to include PNS 
testing 
o 
Added reference to inclusion criteria 
that US patients should meet CRT 
device indications per the 
HRS/ACC/AHA guidelines 
o 
Added reference to exclusion criteria 
that subjects with significant allergy 
to contrast dye will be excluded 
o 
Added statement that EU will be full 
ISO 14155 compliant 
o 
Broadened the 3rd secondary 
endpoint definition to include 
summary statistics on all PCTs and 
lead impedances collected 
Melissa Thalin, Principal Clinical 
Research Specialist 
 

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4. Investigator Statement 
Investigators will be provided with a separate investigator agreement to document their obligation and 
commitment with respect to study conduct.  
 
 

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5. Index 
 
1. 
Sponsor Contact ............................................................................................................ 3 
2. 
CROs/Core Laboratories .............................................................................................. 4 
3. 
Version History ............................................................................................................. 5 
4. 
Investigator Statement .................................................................................................. 7 
5. 
Index ............................................................................................................................. 8 
6. 
List of Tables .............................................................................................................. 11 
7. 
List of Figures ............................................................................................................. 12 
8. 
Glossary ....................................................................................................................... 12 
9. 
Synopsis ...................................................................................................................... 16 
10. 
Introduction ................................................................................................................ 28 
10.1. 
Background ................................................................................................................... 28 
10.2. 
Purpose .......................................................................................................................... 29 
11. 
Objectives and Endpoints ........................................................................................... 29 
11.1. 
Objectives ..................................................................................................................... 29 
11.1.1. 
Primary Objective(s) ....................................................................................................... 29 
11.1.2. 
Secondary Objective(s) .................................................................................................. 30 
11.2. 
Endpoints ...................................................................................................................... 30 
12. 
Study Design ............................................................................................................... 31 
12.1. 
Duration ......................................................................................................................... 32 
12.2. 
Rationale ....................................................................................................................... 32 
12.3. 
Study Oversight ........................................................................................................... 33 
13. 
Product Description .................................................................................................... 34 
13.1. 
General .......................................................................................................................... 34 
13.2. 
Manufacturer ................................................................................................................ 42 
13.3. 
Packaging ...................................................................................................................... 42 
13.4. 
Intended Population .................................................................................................. 42 
13.5. 
Equipment ..................................................................................................................... 42 
13.6. 
Product Use .................................................................................................................. 43 
13.7. 
Product Receipt, Tracking, and Accountability ................................................... 43 
13.8. 
Product Storage ........................................................................................................... 43 
13.9. 
Product Return ............................................................................................................ 44 
14. 
Selection of Subjects .................................................................................................... 44 
14.1. 
Study Population ......................................................................................................... 44 
14.2. 
Subject Enrollment ..................................................................................................... 44 
14.3. 
Inclusion Criteria ........................................................................................................ 45 
14.4. 
Exclusion Criteria ........................................................................................................ 45 
14.5. 
Minimization of Bias ................................................................................................... 45 

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15. 
Study Procedures......................................................................................................... 46 
15.1. 
Study Personnel Requirements ............................................................................... 46 
15.2. 
Site Activation .............................................................................................................. 47 
15.3. 
Equipment Requirements ......................................................................................... 48 
15.4. 
Schedule of Events ..................................................................................................... 48 
15.5. 
Subject Consent .......................................................................................................... 50 
15.6. 
Enrollment .................................................................................................................... 52 
15.7. 
Baseline ......................................................................................................................... 52 
15.8. 
Implant/PHD ................................................................................................................ 52 
15.8.1. 
Final System Configuration ............................................................................................ 53 
15.8.2. 
Implant Procedure ........................................................................................................... 53 
15.8.2.1. 
Venogram...................................................................................................................... 53 
15.8.2.2. 
Implanting the LV lead ............................................................................................... 53 
15.8.2.3. 
CRT System Testing and Programming During Implant ........................................ 55 
15.8.2.4. 
Final Lead Placement Data Collection ....................................................................... 55 
15.8.2.5. 
Pre-Hospital Discharge CRT System Testing and Programming ........................... 56 
15.9. 
3 Months Post-Implant (remote or in office visit) ............................................. 56 
15.10. 
6 Months Post-Implant (in office visit) .............................................................. 57 
15.11. 
12 Months Post-Implant (in office visit) ........................................................... 58 
15.12. 
Recurring 6 Month Follow-ups (remote or in office visit) ............................. 59 
15.13. 
Device Interrogation/Save-to-Media ................................................................. 59 
15.14. 
System Modifications.............................................................................................. 59 
15.15. 
Study Exit .................................................................................................................. 61 
15.15.1. 
Study Completed ......................................................................................................... 62 
15.15.2. 
Lost to Follow-up ......................................................................................................... 62 
15.15.3. 
Study Exit Upon Sponsor Request ............................................................................ 62 
15.16. 
Subject Withdrawal or Discontinuation ............................................................. 62 
15.16.1. 
Subject Chooses to Exit (i.e. revokes consent) ....................................................... 62 
15.16.2. 
Investigator Withdraws Subject ................................................................................ 62 
15.17. 
Assessment of Efficacy ........................................................................................... 64 
15.18. 
Assessment of Safety ............................................................................................. 64 
15.19. 
Recording Data ......................................................................................................... 64 
15.20. 
Deviation Handling .................................................................................................. 64 
16. 
Risks and Benefits ....................................................................................................... 65 
16.1. 
Potential Risks ............................................................................................................. 65 
16.2. 
Risk Minimization ........................................................................................................ 67 
16.3. 
Potential Benefits ....................................................................................................... 68 
16.4. 
Risk-Benefit Rationale ............................................................................................... 68 
17. 
Adverse Event Assessments ........................................................................................ 68 
17.1. 
Adverse Event and Device Deficiency Assessment ............................................. 68 
17.1.1. 
Adverse Events ................................................................................................................ 68 
17.1.2. 
Device Deficiencies.......................................................................................................... 69 
17.1.3. 
Event Updates and Resolution ...................................................................................... 69 
17.2. 
Definitions/Classifications ....................................................................................... 70 
17.3. 
Reporting of Adverse Events .................................................................................... 76 
17.3.1. 
Adverse Events and Device Deficiency Classification ................................................. 76 

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17.3.2. 
Adverse Events and Device Deficiency Reporting Requirements ............................. 77 
17.4. 
Subject Death .............................................................................................................. 80 
17.4.1. 
Death Data Collection ..................................................................................................... 80 
17.4.2. 
Death Classification and Reporting ............................................................................... 81 
17.5. 
Product Complaint Reporting .................................................................................. 81 
18. 
Data Review Committees ............................................................................................ 82 
18.1. 
Clinical Events Committee ........................................................................................ 82 
18.2. 
Data Monitoring Committee ..................................................................................... 83 
19. 
Statistical Design and Methods................................................................................... 83 
19.1. 
Primary Objectives ..................................................................................................... 83 
19.1.1. 
Primary Safety Objective ................................................................................................ 83 
19.1.2. 
Primary Efficacy Objective #1 ....................................................................................... 85 
19.1.3. 
Primary Efficacy Objective # 2 ...................................................................................... 87 
19.2. 
Secondary Objectives ................................................................................................ 88 
19.2.1. 
Secondary Objective # 1 ................................................................................................ 88 
19.2.2. 
Secondary Objective # 2 ................................................................................................ 88 
19.2.3. 
Secondary Objective # 3 ................................................................................................ 92 
19.3. 
Additional Analysis ..................................................................................................... 93 
19.3.1. 
Poolability Analysis .......................................................................................................... 93 
19.3.2. 
Sensitivity Analysis .......................................................................................................... 93 
19.3.3. 
Additional Data Collection .............................................................................................. 93 
19.3.3. 
Overall Study Sample Size Requirements .................................................................... 93 
20. 
Ethics .......................................................................................................................... 94 
20.1. 
Statement(s) of Compliance .................................................................................... 94 
21. 
Study Administration .................................................................................................. 95 
21.1. 
Monitoring .................................................................................................................... 95 
21.2. 
Data Management ....................................................................................................... 96 
21.3. 
Direct Access to Source Data/Documents ............................................................ 97 
21.4. 
Confidentiality ............................................................................................................. 97 
21.5. 
CIP Amendments ........................................................................................................ 97 
21.6. 
Warranty/Insurance Information .......................................................................... 97 
21.6.1. 
Warranty ........................................................................................................................... 97 
21.6.2. 
Insurance (EMEA) ........................................................................................................... 97 
21.6.3. 
Insurance (Canada) ........................................................................................................ 98 
21.6.4. 
Insurance (Malaysia) ...................................................................................................... 98 
21.6.5. 
Insurance (Hong Kong) .................................................................................................. 98 
21.7. 
Record Retention ........................................................................................................ 98 
21.7.1. 
Investigator Records ....................................................................................................... 98 
21.7.2. 
Investigator Reports ....................................................................................................... 99 
21.7.3. 
Sponsor Records ............................................................................................................ 100 
21.7.4. 
Sponsor Reports ............................................................................................................ 100 
21.8. 
Publication and Use of Information ..................................................................... 102 
21.8.1. 
Publication Committee .................................................................................................. 103 
21.8.2. 
Management of Primary, Secondary, and Ancillary Publications ........................... 103 
21.8.3. 
Criteria for Determining Authorship ........................................................................... 103 

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21.8.4. 
Transparency ................................................................................................................. 104 
21.9. 
Suspension or Early Termination .......................................................................... 104 
21.9.1. 
Planned Study Closure .................................................................................................. 104 
21.9.2. 
Early Termination or Suspension ................................................................................ 104 
21.9.3. 
Procedures for Termination or Suspension ............................................................... 105 
22. 
Appendices ................................................................................................................ 107 
23. 
References ................................................................................................................. 123 
 
6. List of Tables 
Table 1: Study Sponsor Contact Information ............................................................................................. 3 
Table 2: CRO and Core Laboratory Information ......................................................................................... 4 
Table 3: Glossary of Terms ................................................................................................................. 12 
Table 4: Steering Committee Members ................................................................................................... 33 
Table 5: Comparison of Medtronic Quadripolar LV Leads .......................................................................... 36 
Table 6: Comparison of Medtronic Attain Stability Bipolar and Quadripolar LV Leads ....................................... 38 
Table 7: Study Component Information ................................................................................................. 41 
Table 8: Data Collection and Study Procedure Requirements at Subject Visits .................................................. 49 
Table 9: Visit Windows ...................................................................................................................... 50 
Table 10: Additional adverse events related to the lead and programmed parameters .......................................... 66 
Table 11: Implant Techniques that may damage the lead ............................................................................. 67 
Table 12: Adverse Event and Device Deficiency Definitions ........................................................................ 70 
Table 13: Adverse Event Classification Responsibilities .............................................................................. 77 
Table 14: Reporting Requirements ........................................................................................................ 77 
Table 15: Subject Death Classification Responsibilities ............................................................................... 81 
Table 16: Safety Performance of Market Released Quadripolar Lead .............................................................. 84 
Table 17: Prior weight from Attain Stability (Model 20066) and prior weight from Attain Performa as a function of the 
posterior Bayesian p-value (࢖) .............................................................................................................. 90 
Table 18: Required Sample Size by Study Objective ................................................................................... 93 
Table 19: Investigator Reports Applicable for All Geographies per Medtronic Requirements ................................ 99 
Table 20: Sponsor Reports for Canada ................................................................................................. 101 
Table 21: Sponsor Reports for EMEA, Malaysia, Hong Kong .................................................................... 101 
Table 22: Sponsor Reports for the United States ..................................................................................... 102 
Table 23: Listing of Potential Adverse Events Associated with System Implant ............................................... 108 
Table 24: System or procedure-related adverse events from previous clinical studies ......................................... 109 
Table 25: Complications reported in Ahsan et al. ..................................................................................... 120 

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Table 26: Complications reported in Dickstein et al. ................................................................................. 120 
Table 27: Complications reported by Kirkfeldt et al. ................................................................................. 121 
 
7. List of Figures 
Figure 1: Study Visits ......................................................................................................................... 32 
Figure 2: Attain Stability Quad MRI SureScan LV Lead (Model 4798) Specifications Drawing .............................. 35 
Figure 3: Comparison of Attain Performa Leads and the Attain Stability Lead Model 4798 .................................. 38 
Figure 4: Attain Stability Bipolar (Model 20066/4796) & Attain Stability Quad MRI SureScan (Model 4798) Active 
Fixation Leads ................................................................................................................................. 40 
Figure 5: Primary Safety Objective Sample Size Consideration by Difference Performance Assumption .................. 85 
Figure 6: Simulated PCT Distribution .................................................................................................... 86 
Figure 7: Loss Function ࢇ૙ൌ૚െࢋെ࢖∗૞૛ ........................................................................................ 90 
Figure 8: Credible Intervals for Scenarios of Agreement Between Historical and Current Data .............................. 91 
 
8. Glossary 
Table 3: Glossary of Terms 
Term 
Definition 
2090 
Medtronic CareLink Programmer with the 
application software installed.   
2290 
Medtronic Analyzer 
Medtronic Attain Stability Quad MRI SureScan 
(Model 4798) LV Lead 
The quadripolar LV lead being studied 
(investigational in the United States/Canada, 
commercially available in EMEA, Hong Kong, and 
Malaysia).   
Active Fixation Helix 
A non-electrically active side helix, positioned 
between the LV 3 and LV 4 electrodes that will 
allow fixation of the Attain Stability Quad MRI 
SureScan (Model 4798) LV Lead in the cardiac vein.  
ADE 
Adverse Device Effect 
AE 
Adverse Event 
Ag 
Silver 
CABG 
Coronary Artery Bypass Graft 

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Term 
Definition 
CAD 
Coronary Artery Disease 
CDF 
Cumulative Distribution Function 
CEC 
Clinical Events Committee 
CIP 
Clinical Investigation Protocol 
CRF 
Case Report Form 
CRT 
Cardiac Resynchronization Therapy: Established 
pacing therapy for patients with heart failure 
CRT-D 
Cardiac Resynchronization Therapy - Defibrillator 
CRT-P 
Cardiac Resynchronization Therapy - Pacemaker 
CS 
Coronary Sinus 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DEKRA 
Deutscher Kraftfahrzeug-Überwachungs-Verein 
(German Motor Vehicle Inspections Association) 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
EMEA 
Europe, the Middle East, and Africa 
eCRF 
Electronic Case Report Form 
MEC/IRB/HREB/Ethics Board 
Ethics Committee 
FAL 
Foreseeable Adverse Event List 
FDA 
Food and Drug Administration 
Fr 
French 
GCP 
Good Clinical Practice 

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Term 
Definition 
HF 
Heart Failure 
HTN 
Hypertension 
IC 
Informed Consent 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigation Device Exemption 
Ir 
Iridium 
IRB 
Institutional Review Board 
LAR 
Legally Authorized Representative 
LBBB 
Left Bundle Branch Block 
LV 
Left Ventricular 
LVEF 
Left Ventricular Ejection Fraction 
MCRD 
Monolithic Controlled Release Device which is 
located on the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) electrodes which elutes 
steroid to reduce inflammatory response within the 
cardiac vein. 
Mechanical Stop 
A component on the Attain Stability Quad MRI 
SureScan (Model 4798) LV Lead located at the 
base of the helix to prevent wedging of endothelial 
tissue in the helix and to prevent tissue ingrowth. 
MedDRA 
Medical Dictionary for Regulatory Activities 
OC 
Oracle Clinical (database management system) 
OTW 
Over-the-wire 
PCT 
Pacing Capture Threshold 
Patient Global Assessment 
Self-reported assessment to provide information on 
patient condition compared to previous heart 
failure status 

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Term 
Definition 
PHD 
Pre-Hospital Discharge means the point at which a 
subject has been released from the hospital post 
implant procedure. 
PMA 
Premarket Approval 
PNS 
Phrenic Nerve Stimulation 
POR 
Power On Reset 
Pt 
Platinum 
PTCA 
Percutaneous Transluminal Coronary Angioplasty 
QOL 
Quality of Life 
RA 
Right Atrial 
RRT 
Recommended Replacement Time 
RV 
Right Ventricular 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SC 
Steering Committee 
SDN 
Software Distribution Network 
TÜV 
Technischer Überwachungsverein (German safety 
validation organization) 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
USADE 
Unanticipated Serious Adverse Device Effect 
VF 
Ventricular Fibrillation 
VT 
Ventricular Tachycardia 
 
 

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9. Synopsis 
Title 
Attain StabilityTM Quad Clinical Study 
Product Name 
Attain StabilityTM Quad MRI SureScan Left Ventricular Lead 
(Model 4798) 
Sponsor  
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 U.S.A. 
1-800-328-2518 
Local Sponsor 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
+1-905-460-3800 
 
EMEA 
Medtronic, Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
 
Hong Kong 
Medtronic Hong Kong Medical Ltd. 
1104-11, 11/F, Tower 1,  
The Gateway,  
Harbour City, Kowloon,  
Hong Kong SAR, China 
+852-2919-1300 
 
Malaysia 
Medtronic International Ltd (Malaysia) 
B-23-1 Level 23, The Ascent, Paradigm, No 1 Jalan 
SS7/26A Kelena Jaya 46301 Petaling Jaya 
Selangor 
Malaysia 
+603 7883 8000 
Indication under investigation  
All subjects included in the study will be implanted with a 
Medtronic market released de novo CRT-P or CRT-D 
device, compatible market released Medtronic RA and 
Medtronic RV leads and an Attain Stability Quad SureScan 
LV lead (Model 4798). For subjects enrolled who are 
receiving an upgrade to a CRT system, existing non-
Medtronic RV and/or existing non-Medtronic RA leads that 
are not recalled, market withdrawn, and/or have a medical 
alert may be used.   

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Given the vast similarities between the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) and the Attain 
Performa family of leads, the proposed indications for use 
are the same.  The indications are as follows: 
The Attain Stability Quad MRI SureScan 4798 steroid-
eluting, quadripolar electrode, IS4 transvenous lead is 
indicated for chronic pacing in the left ventricle via the 
cardiac vein, when used with a compatible Medtronic 
Cardiac Resynchronization Therapy (CRT) system.  
Extended bipolar pacing is available using this lead in 
combination with a compatible market approved CRT-D 
system and RV defibrillation lead. 
Investigation Purpose 
The Attain Stability Quad Clinical Study is a prospective, 
non-randomized, multi-site, global, Investigational Device 
Exemption (IDE) interventional clinical study.  The 
purpose of this clinical study is to evaluate the safety and 
efficacy of the Attain Stability Quad MRI SureScan LV lead 
(Model 4798).  This study will not be considered 
investigational in geographies with CE Mark of the Attain 
Stability Quadripolar LV lead (4798).  However, data 
collected from all study subjects will be represented in the 
final report and the PMA Supplement (PMA-S) to the 
Model 4196 Original PMA.  
Product Status 
The Attain Stability Quad Clinical Study will be conducted 
using a research system composed of an approved 
Medtronic CRT-D or CRT-P System and an Attain Stability 
Quad MRI SureScan LV Lead (Model 4798).  The Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) is an 
active fixation quadripolar LV lead based on the Attain 
Performa lead family models (4298, 4398, and 4598).  The 
lead incorporates an active fixation helix similar to the 
Attain Stability bipolar LV lead (Model 20066/4796) which 
is designed to allow an implanter more options in lead 
location.   
The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) will be considered investigational in geographies 
where the product is not available commercially and will 
be labeled for clinical use only.  These geographies include 
but are not limited to the US and Canada.  Investigational 
Attain Stability Quad MRI SureScan LV Leads (Model 4798) 
will be distributed to a site only when Medtronic has 
received all required documentation (including but not 
limited to Ethic Committee approval, a signed Clinical Trial 
Agreement and documentation of training) and has 

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notified the site of site readiness.  Distribution of the 
investigational product to study sites will be managed by 
Medtronic and can only be ordered by Medtronic 
personnel.  Sites with these clinically labeled Attain 
Stability Quad MRI SureScan LV Leads (Model 4798) will 
track disposition upon receipt or return of the lead but 
also upon implant or explant of the lead. Disposition logs 
will be available within the electronic data management 
system and shall be maintained at each site in all 
geographies to track investigational product information.  
For geographies where the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is not considered 
investigational, commercially approved devices will be 
used.  Sites that use commercially available Attain Stability 
Quad MRI SureScan LV Leads (Model 4798) will track 
device disposition upon implant or explant on the lead 
CRFs. 
The Medtronic approved CRT-P or CRT-D devices will be 
programmed and interrogated using a Medtronic CareLink 
(2090) programmer.  Medtronic may incorporate 
additional programmers as they receive regulatory 
approval. 
The CareLink Monitor Model 2490C is an external monitor 
that is indicated for use in the transfer of patient and 
device data from implanted Medtronic devices.  The 
CareLink Monitor Model 2490C interrogates implanted 
devices and temporarily stores these data, collaborates 
with the appropriate Medtronic server to confirm the 
establishment of an Internet connection with server, 
performs any required file translation functions necessary 
for data transfer, executes data file transfer, and 
collaborates with the appropriate Medtronic server to 
confirm data file transfer through the Internet connection 
with the server.  The CareLink Monitor 2490C is not a 
programmer and cannot be used to program implanted 
device parameters.  CareLink monitors are not a substitute 
for appropriate medical attention in the event of an 
emergency and should only be used as directed by a 
physician. 
Approved Medtronic CRT-P and CRT-D devices used in this 
study qualify for use with the Medtronic CareLink Monitor 
and Medtronic CareLink Network.  
Medtronic may incorporate additional home monitors as 
they receive regulatory approval. 

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Medtronic’s commercially available Model 2290 Analyzer 
must be available at each center during the implant 
procedure to determine acceptable electrical parameters.  
Medtronic may incorporate additional analyzers as they 
receive regulatory approval. 
Primary Objective(s) 
Primary Safety Objective: Lead complication-free 
rate at 6 months 
The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) will be considered safe if the probability of subjects 
free of Model 4798 lead-related complications at 6 months 
post-implant is greater than 87% (i.e., the lower bound of 
a one-sided 97.5% confidence interval must be greater 
than 87%). 
The study primary safety endpoint is Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) related complications 
through 6 months post implant.  All reported system and 
procedure-related AEs will be reviewed by an event review 
committee for LV lead relatedness and severity 
(complication vs observation, refer to 17.1.2 for 
definitions).  
Primary Efficacy Objectives: Lead pacing capture 
thresholds at 6 months 
To demonstrate the effectiveness of the Attain Stability 
Quad MRI SureScan LV lead (Model 4798) the study will 
evaluate the likelihood that there are at least two 
programmable vectors for each patient post implant.  The 
effectiveness of this lead will be evaluated based on two 
primary efficacy objectives.  More specifically, both 
primary efficacy objectives must be met simultaneously.   
Primary Efficacy Objective #1 
The Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) will meet the objective if the 
proportion of subjects with at least one LV lead 
pacing vector having a pacing capture threshold 
less than or equal to 2.5 V at 0.5ms pulse width 
(with absence of Phrenic Nerve Stimulation (PNS) 
at 5.0 V) at 6 months post-implant is greater than 
80% (i.e., the lower bound of a one-sided 97.5% 
confidence interval must be greater than 80%). 
The endpoint for the primary efficacy objective is 
whether or not there is at least one Model 4798 
LV lead pacing vector with pacing capture voltage 
thresholds less than or equal to 2.5V (with 

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absence of PNS at 5.0 V).  This endpoint will be 
measured at the 6-month post implant follow-up 
visit. 
Primary Efficacy Objective #2 
The Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) will meet the objective if the 
proportion of subjects with at least one additional 
LV lead pacing vector having a pacing capture 
threshold less than or equal to 4.0 V at 0.5ms 
pulse width (with absence of PNS at 5.0 V) at 6 
months post-implant is greater than 80% (i.e., the 
lower bound of a one-sided 97.5% confidence 
interval must be greater than 80%).  
The co-primary efficacy endpoint is whether or not 
a second Model 4798 lead configuration has a 
pacing capture threshold less than or equal to 4V 
(with absence of PNS at 5.0 V), excluding the 
pacing vector that is already counted to the 
primary efficacy endpoint #1. This endpoint will 
be measured at 6-month post implant follow-up 
visit. 
Secondary  
Objective(s) 
The secondary objectives are descriptive in nature and are 
intended to provide additional information about the Attain 
Stability Quad Model 4798 LV lead. There will be no 
established performance requirements for these secondary 
objectives. 
o 
Implant procedure related information: success 
rate, implant related times 
o 
Endpoints will include implant success rate 
and procedure durations.  
o 
6-month reliability: post implant lead failure 
modes (i.e. complication rate) 
o 
Endpoint is Model 4798 lead related 
complications. 
o 
Electrical measurements (PCT and Impedance) at 
follow-ups 
o 
Endpoints are the electrical measurements 
(pacing capture thresholds and impedance 
values) for the four extended bipolar 
(CRT-D) or unipolar (CRT-P) vectors, i.e. 

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LV1 to RVCoil/Can, LV2 to RV Coil/Can, 
LV3 to RV Coil/Can and LV4 to RV 
Coil/Can (refer to 15.8.2.3 for the testing 
procedure requirements) 
Study Design 
The Attain Stability Quad Clinical Study is a prospective, 
non-randomized, multi-site, global, Investigational Device 
Exemption (IDE) interventional clinical study.  The 
purpose of this clinical study is to evaluate the safety and 
efficacy of the Attain Stability Quad MRI SureScan LV lead 
(Model 4798) in patients indicated for a de novo LV lead 
implant.  This will be assessed through primary safety and 
primary efficacy endpoints. 
All subjects included in the study will be implanted with a 
Medtronic market released de novo CRT-P or CRT-D 
device and an Attain Stability Quad MRI SureScan LV Lead 
(Model 4798).  Compatible market released Medtronic RA 
and Medtronic RV leads will be required.  For subjects 
enrolled who are receiving an upgrade to a CRT system, 
existing non-Medtronic RV and/or existing non-Medtronic 
RA leads that are not recalled, market withdrawn, and/or 
have a medical alert may be used.   
Up to 471 subjects will be enrolled into the study and up 
to 471 Attain Stability Quad MRI SureScan LV Leads 
(Model 4798) implanted, to ensure a minimum effective 
sample size of 400 Model 4798 leads implanted with 6 
months post implant follow up visits (assuming 15% 
attrition).  For the secondary endpoint of individual lead 
failure modes, Bayesian methods utilizing data from up to 
37 historical patients will be used.  All other objectives will 
be analyzed using only patients enrolled in this study.   
After a successful implant, threshold testing will occur per 
protocol requirement.  Subjects will then be followed at 
implant, three months, six months and every six months 
thereafter until FDA approval is obtained or until study 
closure, whichever comes first. 
The study duration is expected to be approximately 19 
months.  This represents an estimated 13 months for 
subject enrollment and 6 months for subject follow-up for 
the last subject enrolled.  Subjects are anticipated to be in 
the study for on average 12 months.  The first enrollment 
is projected to occur in May 2017.   
Sample Size 
Up to 471 subjects will be enrolled into the study, to 
ensure a minimum effective sample size of 400 Model 

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4798 leads implanted with 6 months post implant follow 
up visits (assuming 15% attrition) at up to 56 sites 
worldwide. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
• 
Patient meets CRT implant criteria as determined 
by local regulatory and/or hospital policy (i.e. US 
subjects should meet CRT device indications per 
the HRS/ACC/AHA guidelines) 
• 
Patient (or legally authorized representative) has 
signed and dated the study-specific 
Consent Form 
• 
Patient is 18 years of age or older, or is of legal 
age to give informed consent per local and 
national law 
• 
Patient is expected to remain available for follow-
up visits 
Exclusion Criteria: 
• 
Patient has had a previous unsuccessful LV lead 
implant attempt 
• 
Patient has a previous CRT system or LV lead 
implanted (for example, transvenous or epicardial) 
• 
Patient is currently implanted with a recalled (i.e. 
market-withdrawn, recalled or safety alert) RA 
and/or RV lead  
• 
Patient has known coronary venous vasculature 
that is inadequate for lead placement 
• 
Patient has unstable angina pectoris or has had an 
acute myocardial infarction (MI) within the past 30 
days 
• 
Patient has had a coronary artery bypass graft 
(CABG) or percutaneous transluminal coronary 
angioplasty (PTCA) within the past 90 days 
• 
Patient has contraindications for standard 
transvenous cardiac pacing (e.g., mechanical right 
heart valve) 
• 
Patient has had a heart transplant (patients 
waiting for heart transplants are allowed in the 
study) 
• 
Patient has known renal insufficiency and/or 
significant allergy to contrast dye that would 
prevent them from receiving an occlusive 
venogram during the implant procedure 
• 
Patient is contraindicated for <1mg 
dexamethasone acetate 
• 
Patient is enrolled in any concurrent drug and/or 
device study that may confound the results of this 
study 

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• 
Patient has a terminal illness and is not expected 
to survive more than six months 
• 
Patient meets exclusion criteria required by local 
law (e.g. age, pregnancy, breast feeding, etc.) 
• 
Patient is unable to tolerate an urgent 
thoracotomy 
Study Procedures and Assessments 
Clinical data will be collected at the study milestones: at 
enrollment, baseline, implant/PHD, 3M, 6M, thereafter 
every occurring 6M and study exit visits: 
Enrollment/Baseline:  
o 
Subject Informed Consent  
o 
Inclusion/Exclusion criteria verified 
o 
Subject demographics  
o 
Cardiovascular medications 
o 
Cardiovascular medical history 
o 
NYHA classification 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
Implant:  
o 
Occlusive venogram with pre-determined 
target vessel location identified 
o 
Analyzer PCT data collection post lead 
fixation and prior to connecting the leads 
to the CRT-P/D device: 
1. Pre-slitting the cannulation 
catheter and following guide 
wire/stylet has been pulled back 
proximal to the helix and 
electrodes 
2. Post slitting the cannulation 
catheter 
o 
Investigator Lead Handling Assessment 
o 
System and procedure information 
PHD CRT System Testing and Programming using the 
implanted CRT-P or CRT-D device and the device 
programmer: 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors  
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  

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o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors  
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
3 Month (remote or in office visit):  
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the 
final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the 
final programmed vector 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 

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measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media 
(or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
6 Month:  
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors 
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors  LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors  
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
 
NOTE: If PNS is present at 8.0V 
at 0.5ms, measure the PNS 
threshold at 0.5ms 
o 
Test for presence of PNS at 5.0V at 0.5ms 

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on the two efficacy endpoints (one vector 
with PCT ≤ 2.5 V and an additional vector 
with PCT ≤ 4.0 V)  
o 
NOTE: PNS observed during any PNS 
testing will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
12 Month:  
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors 
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 

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o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
Recurring 6 Month follow-ups (remote or in office 
visit):  
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the 
final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the 
final programmed vector 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Retain printouts at the site 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media 
(or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
Study Exit:  
o 
Report the reason for exit 
o 
Final Interrogation file (or CareLink 
transmissions) for exits occurring prior to 
the 6 month visit) 
o 
Study Deviations 
o 
AEs  
o 
Device Deficiencies 
Safety Assessments 
Adverse Event and Device Deficiency handling in the 
Attain Stability Quad Clinical Study is ISO 14155:2011 
compliant for all participating geographies with the 

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exception that only those AEs which are related to the 
subject’s system, procedure, accessory, or are 
cardiovascular-related, heart failure-related, MRI-related, 
and all Serious AEs, will be collected (refer to Section 17 
for AE assessment).  This ensures any AEs which could 
potentially be relevant will be collected.  Reporting of these 
events to Medtronic will occur on an Adverse Event (AE) 
Form, including date of AE, treatment, resolution, 
assessment of both the seriousness of the AE and the 
relatedness to the investigational device or procedure.  
Each AE must be recorded on a separate AE eCRF.  
Documented pre-existing conditions are not considered 
AEs unless the nature or severity of the condition has 
worsened. 
 Statistics 
The primary objective will be analyzed using the time-to-
first event Kaplan-Meier survival analysis method.  A 
minimum number of subjects who have completed their 6 
months post-implant visits will be required.  Time 0 will be 
the day a subject undergoes the implant procedure of an 
Attain Stability Quad MRI SureScan LV Lead (Model 4798), 
which will be independent of success status of this implant 
procedure.  Event date is the onset date of a subject’s first 
complication that is related to the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) according to CEC 
adjudication.  Subjects who undergo an Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) implant 
attempt and do not experience any LV lead related 
complications, will be censored at the time of their last 
known exposure to the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) for the survival analysis.  For any 
lost-to-follow up subject, the last contact date will be used 
as the censor date.  The 1-sided 97.5% confidence limit 
lower bound for the survival probability at 6 months (183 
days) will be calculated using the log-log survival function 
approach (Kalbfleisch and Prentice 2002). 
 
10. Introduction  
10.1. Background 
Several clinical trials (including MIRCLE1, MIRACLE-ICD2, CONTAK-CD3, MUSTIC4, PATH-CHF5, 
COMPANION6, MADIT CRT7, and CARE-HF8) have demonstrated the benefit of cardiac resynchronization 
therapy (CRT) among patients with moderate to severe heart failure (HF) with a prolonged QRS duration 
and depressed Left Ventricular (LV) function.   

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Approximately 5.7 million people in the United States (US) are living with HF9.  Heart Failure may be a 
chronic condition which causes the heart to not pump oxygenated blood efficiently through the body due 
to stiffening of the heart muscle.  Heart Failure may affect one or both sides of the heart.  It is most 
often caused by coronary artery disease (CAD) or uncontrolled hypertension (HTN).  Patients who suffer 
from HF experience a variety of different symptoms including most often fatigue, cough, shortness of 
breath, swollen feet (edema) and weight gain. 
Heart Failure is treated with medications and sometimes cardiac devices (i.e. pacemaker or defibrillator 
with CRT).  Medications work to relieve symptoms and reverse the effects of HF.  Cardiac 
Resynchronization Therapy devices treat HF by synchronizing the left and right ventricles of the heart 
which improves the heart’s ability to pump oxygenated blood to the body.10 11 12 13 14 15 16 17 18 19 20 21 
Cardiac Resynchronization Therapy devices are primarily made up of 4 main components; the can or 
battery, a Right Atrial (RA) lead, a Right Ventricular (RV) lead, and a Left Ventricular (LV) lead. 
The LV lead specifically is important at maintaining ventricular synchrony.  In 2014, Medtronic released 
the Attain® PerformaTM family of LV leads (models 4298, 4398 and 4598).  The three different shapes of 
these leads (double canted, straight, and S-shaped) were designed to enable the lead to be passively 
fixed within different anatomies of coronary vessels.  In addition, the 4 strategically placed electrodes on 
the lead were designed to offer 16 different electrical vector programming configurations.  
Medtronic also released the Attain Stability bipolar LV lead (Model 20066/4796) (CE Mark approved in 
September 30, 2013) in Europe.  This lead has a side helix which enables it to be actively fixated to the 
vessel wall.  The active fixation is an advantageous component in vessels that are wide or have short 
take-offs.  The next generation of LV lead is known as the Attain StabilityTM Quad MRI SureScan LV lead 
(Model 4798).  This is a quadripolar lead similar to its Attain Performa predecessor leads and has a side 
helix for active fixation like the Attain Stability bipolar lead.   
10.2. Purpose 
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, 
Investigational Device Exemption (IDE), interventional clinical study.  The purpose of this clinical study is 
to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798).  
This study will not be considered investigational in geographies with CE Mark of the Attain Stability™ 
Quad MRI SureScan LV lead (Model 4798).  However, data collected from all study subjects will be 
represented in the final clinical report and the PMA Supplement (PMA-S) to the Attain Ability Model 4196 
Original PMA (P080006, approved April 7, 2009).  Subjects successfully implanted with the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) will be followed at implant, three months, six months and 
every six months thereafter until FDA approval is obtained or until study closure, whichever comes first. 
11. Objectives and Endpoints 
11.1. Objectives 
11.1.1. 
Primary Objective(s) 
Primary Safety Objective: Lead complication-free rate at 6 months 

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The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered safe if the probability of 
subjects free of Model 4798 lead-related complications at 6 months post-implant is greater than 87% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 87%). 
Primary Efficacy Objectives: Lead pacing capture thresholds at 6 months 
To demonstrate the effectiveness of the Attain Stability Quad MRI SureScan LV Lead (Model 4798), the 
study will evaluate the likelihood that there are at least two programmable vectors for each patient post 
implant.  The effectiveness of this lead will be evaluated based on two primary efficacy objectives.  More 
specifically, both primary efficacy objectives must be met simultaneously.   
Primary Efficacy Objective #1 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet this objective if the 
proportion of subjects with at least one LV lead pacing vector having a pacing capture threshold 
less than or equal to 2.5 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation 
(PNS) at 5.0 V) at 6 months post-implant is greater than 80% (i.e., the lower bound of a one-
sided 97.5% confidence interval must be greater than 80%). 
Primary Efficacy Objective #2 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet this objective if the 
proportion of subjects with at least one additional (or second) LV lead pacing vector having a 
pacing capture threshold less than or equal to 4.0 V at 0.5 ms pulse width (with absence of PNS 
at 5.0 V) at 6 months post-implant is greater than 80% (i.e., the lower bound of a one-sided 
97.5% confidence interval must be greater than 80%).  
11.1.2. 
Secondary Objective(s)  
The secondary objectives are descriptive in nature and are intended to provide additional information 
about the Attain Stability Quad MRI SureScan LV Lead (Model 4798).  There will be no established 
performance requirements for these secondary objectives. 
o 
To summarize implant procedure related information: success rate, implant related times 
o 
To estimate 6-month reliability: post implant lead failure modes (i.e. complication rate)  
o 
To estimate electrical measurement values (Pacing Capture Thresholds (PCTs) and Lead 
Impedance) at 6 months post-implant 
11.2. Endpoints 
11.2.1 Primary Endpoints 
Primary Safety Endpoint 
The study primary safety endpoint is Attain Stability Quad MRI SureScan LV Lead (Model 4798) related 
complications through 6 months post implant.  All reported system and procedure-related AEs will be 
reviewed by an event review committee for LV lead relatedness and severity (complication vs 
observation, refer to 17.1.2 for definitions).  
Primary Efficacy Endpoint #1 
The Model 4798 LV lead has sixteen (16) programmable pacing vectors.  The endpoint for the primary 
efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing 

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capture voltage thresholds less than or equal to 2.5V (with absence of PNS at 5.0 V).  This endpoint will 
be measured at the 6-month post implant follow-up visit. 
Primary Efficacy Endpoint #2 
The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing 
capture threshold less than or equal to 4V (with absence of PNS at 5.0 V), excluding the pacing vector 
that is already counted to the primary efficacy endpoint #1.  This endpoint will be measured at 6-month 
post implant follow-up visit. 
11.2.2 Secondary Endpoints 
To summarize implant procedure related information 
Implant procedure related endpoints will include implant success rate and procedure durations.  
To estimate 6-month reliability 
The Model 4798 LV lead 6-month reliability endpoint is Model 4798 lead related complications.  
To estimate electrical measurement values (Pacing Capture Thresholds (PCTs) and Lead 
Impedance) at 6 months post-implant 
The electrical measurements endpoints are pacing capture thresholds and impedance values collected at 
each time point (i.e. Implant, 6 months, etc.) (refer to 15.8.2.3 for the testing procedure requirements). 
12. Study Design  
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, 
Investigational Device Exemption (IDE), interventional clinical study.  The purpose of this clinical study is 
to evaluate the safety and efficacy of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) in 
patients indicated for a de novo LV lead implant.  This will be assessed through a primary safety and 
primary efficacy endpoints. 
All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or 
CRT-D device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).  Compatible market 
released Medtronic RA and Medtronic RV leads will be required.  For subjects enrolled who are receiving 
an upgrade to a CRT system, existing non-Medtronic RV and/or existing non-Medtronic RA leads that are 
not recalled, market withdrawn, and/or have a medical alert may be used.   
Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads 
implanted with 6 months post implant follow up visits (assuming 15% attrition).  For the secondary 
endpoint of individual lead failure modes, Bayesian methods utilizing data from up to 37 historical 
patients will be used.  All other objectives will be analyzed using only patients enrolled in this study.  
After a successful implant, threshold testing should occur to show at least one LV vector with pacing 
capture threshold (PCT) ≤ 2.5 V @ 0.5ms and with sufficient safety margin was programmed.  Subjects 
will then be followed at implant, three months, six months and every six months thereafter until FDA 
approval is obtained or until study closure, whichever comes first. 
See Figure 1 and Section 15 for further detail on study procedures and data collection as well as time-
points for data collection.  

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Figure 1: Study Visits 
 
The study is expected to be conducted at up to 56 sites worldwide.  Participating geographies are 
expected to include, but are not limited to: the United States, Canada, EMEA, Malaysia, and Hong Kong.  
To ensure a widespread distribution of data and to minimize site bias in the study results, the maximum 
number of subjects allowed at a single site is 50 subjects.  
12.1. Duration 
The study duration is expected to be approximately 19 months.  This represents an estimated 13 months 
for subject enrollment and 6 months for subject follow-up for the last subject enrolled.  Subjects are 
anticipated to be in the study for on average 12 months.  The first enrollment is projected to occur in 
May 2017.  Subjects will complete visits at enrollment/baseline, implant, 3 months, 6 months, and then 
every 6 months thereafter.  Subjects will not be replaced with newly enrolled subjects upon early exit.  As 
described in Section 19, the sample size accounts for attrition.  
12.2. Rationale 
Upon market release, this Attain Stability Quad MRI SureScan LV Lead (Model 4798) will provide 
physicians an alternative option to actively fixate the lead utilizing a side helix feature to achieve stability.  
The Attain Stability Quad Clinical Study is designed to demonstrate that the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is safe and effective.  See Section 19 for further background information 
and evaluation of clinical data.  See Section 10 for further background on the study design. 

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12.3. Study Oversight 
The study will utilize a Steering Committee (SC).  The SC is responsible for the scientific content of the 
study and for providing input for the execution of the study.  Members of the SC may be study site 
investigators.  The purpose of the SC is to provide unbiased opinions and expertise to the Attain Stability 
Quad Clinical Study design and process.  The SC will support the execution of the Attain Stability Quad 
Clinical Study and provide guidance, feedback and direction to the clinical study.  The SC is comprised of 
the members as indicated in Table 4 below.   
Table 4: Steering Committee Members 
Committee Member  
Contact information 
George H. Crossley III, MD  
Steering Committee Co-Chair 
Electrophysiology 
Fellowship Program Director 
Vanderbilt University Medical Center 
1211 Medical Center Drive 
Nashville, TN 37232 
United States 
(615) 322-5000 
george.crossley@vanderbilt.edu 
Kevin P. Jackson, MD  
Steering Committee Co-Chair 
Electrophysiologist 
Duke Cardiology of Raleigh 
Medical Office Building 6 
3320 Wake Forest Road 
2nd Floor, Suite 200 
Raleigh, NC 27609 
United States 
(919) 862-5100 
k.j@duke.edu 
Dr. Maria Grazia Bongiorni 
Electrophysiologist 
University Hospital of Pisa 
Lungarno Antonio Pacinotti 
43, 56126  
Pisa PI Italia 
+39 050 221 2111 
m.g.bongiorni@med.unipi.it 
Prof. Svein Faerestrand 
Electrophysiologist 
University of Bergen 
Jonas Liesvei 65  
Bergen, Norway 5021 
+47 55 97 67 04 
svein.faerestrand@helse-bergen.no 
Dr. Axel Kloppe 
Electrophysiologist 
Berufsgenossenschaftliches Universitätsklinikum  
Bergmannsheil GmbH,  
Bürkle-de-la-Camp-Platz 1,  
44789 Bochum, Germany  
+49 234 3026050 
axel.kloppe@bergmannsheil.de 

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Melissa Kong, MD 
Electrophysiologist 
Silicon Valley Cardiology 
1300 Stockbridge Ave   
Redwood City, CA 94061 
United States 
(650) 363-5262 
mhkong1@gmail.com 
Raymond Yee, MD 
Electrophysiologist 
London Health Sciences Centre  
339 Windemere Road  
London, ON N6A 5A5 
Canada 
(519) 663-3671 
ryee@uwo.ca 
Francois Philippon, MD 
Electrophysiologist 
Institut Universitaire de Cardiologie et de Pneumologie de Quebec  
2725 Chemin Ste-Foy 
Quebec G1V 4G5 
Canada 
(418) 656-8711 
francois.philippon@fmed.ulaval.ca 
 
The study will also utilize a Clinical Events Committee (CEC) who will be responsible for adjudicating 
adverse events and deaths, including procedure and/or system-related complications.  Further details for 
the CEC are provided in Section 18.1. 
13. Product Description 
13.1. General 
The Medtronic Attain Stability Quad MRI SureScan (Model 4798) is a steroid-eluting, quadripolar 
electrode, transvenous, over-the-wire (OTW), IS4-LLLL compatible, active fixation, cardiac vein pacing LV 
lead.  This lead is similar to the Attain Performa family of quadripolar leads (Models 4298, 4398, and 
4598) but also has a side helix for active fixation which is similar to the Attain Stability bipolar lead 
(Model 20066/4796) (available outside of the United States).  Figure 2 is a drawing of the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) illustrating the specifications and location of the four 
electrodes in comparison to the side helix. 

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Figure 2: Attain Stability Quad MRI SureScan LV Lead (Model 4798) Specifications Drawing 
 
 
Table 5 provides compares of the Attain Performa family of leads design features to the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798). 
 

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Table 5: Comparison of Medtronic Quadripolar LV Leads 
 
Attain Performa 
Attain Stability 
Quad 
Design Feature 
Model 4298 
Model 4398 
Model 4598 
Model 4798 
Shape 
Double Canted 
Straight 
S-Shaped 
Single Canted 
Implant Method 
Guide wire, 
stylet, or hybrid 
guide wire via 
Medtronic 
Delivery System 
Same as 4298 
Same as 4298 
Guide wire, 
stylet, or hybrid 
guide wire via 
Medtronic 
Delivery System 
and active 
fixation 
Delivery System 
Inner Diameter 
≥ 5.7 Fr ID 
Same as 4298 
Same as 4298 
Same as 4298 
Lead Body 
Diameter 
5.3 Fr 
proximal/3.9 Fr 
distal 
Same as 4298 
Same as 4298 
4.4 Fr 
proximal/3.9 Fr 
distal 
Lead Body 
Conductor 
Single Quadfilar 
Coil 
(Multiconductor) 
Same as 4298 
Same as 4298 
Same as 4298 
Conductor 
Material 
Ag core-low 
Titanium 
MP35Ncoil 
Same as 4298 
Same as 4298 
Same as 4298 
Insulation 
(Outer/Inner) 
Polyurethane 
55D SI-PI 
Same as 4298 
Same as 4298 
Same as 4298 
Polarity 
Selectable Quad-
electrode 
Same as 4298 
Same as 4298 
Same as 4298 
Electrode 
Material 
PT/Ir* alloy with 
TiN coating 
Same as 4298 
Same as 4298 
Same as 4298 
Fixation Helix 
Material 
N/A 
N/A 
N/A 
Pt/Ir** alloy 
Electrode 
Spacing 
21mm/ 1.3mm/ 
21mm 
Same as 4298 
Same as 4298 
Same as 4298 
Surface Area per 
5.8 
Same as 4298 
Same as 4298 
Same as 4298 

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Electrode (mm2) 
Steroid and Dose 
/  MCRD 
Dexamethasone 
acetate 
Each (4) Ring 
72µg 
Same as 4298 
Same as 4298 
Same as 4298 
Total Target 
Dose 
288 µg/lead 
Same as 4298 
Same as 4298 
Same as 4298 
*90/10 Platinum Iridium 
**80/20 Platinum Iridium 
Similar to the Attain Performa family of leads, the Attain Stability Quad MRI SureScan LV Lead (Model 
4798) contains 4 electrodes with surface area of 5.8 mm2 per electrode and is designed to function as 
cathodes or anodes, depending on how the device LV pacing vector is programmed:  
• 
electrode LV1, the distal electrode, positioned near the distal tip of the lead  
• 
electrode LV2, positioned 21 mm proximal to electrode LV1 
• 
electrode LV3, positioned 1.3 mm proximal to electrode LV2 
• 
electrode LV4, the proximal electrode, positioned 21 mm proximal to electrode LV3 
The electrode spacing on the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is identical to the 
approved Attain Performa family of leads.  This includes a non-uniform electrode spacing consisting of a 
reduced electrode spacing configuration (LV2-LV3) that alters the size of the electric field that is 
generated when stimulating the heart tissue.  This close electrode spacing is designed to reduce the 
likelihood of stimulating the phrenic nerve while still allowing for optimal lead placement and acceptable 
pacing capture thresholds.  
Similar to Attain Performa, each electrode contains a Monolithic Controlled Release Device (MCRD) for 
elution of steroid to reduce inflammatory response within the cardiac vein.  The MCRDs contain a 
combined-total target dosage of 288 μg of dexamethasone acetate steroid.  The target dose of the 
steroid is 72 μg at each MCRD.  Upon exposure to body fluids, the steroid elutes from the MCRDs.  The 
steroid suppresses the inflammatory response that is believed to cause threshold rise typically associated 
with implanted pacing electrodes.  
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) has the same lead body conductor (Single 
Quadfilar Coil (Multiconductor), conductor material (Ag core-low Titanium MP35N coil), insulation 
(outer/inner) (Polyurethane 55D SI-PI), and requires a similar delivery system inner diameter as the 
Attain Performa family of leads (≥ 5.7 Fr ID). 
Unlike the Attain Performa family of leads, the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
has a slightly smaller lead body diameter.  The lead body diameter of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is 4.4 Fr proximal (compared to 5.3 Fr on the Attain Performa family of 
leads) and 3.9 French distal (same as Attain Performa family of leads).  This slightly smaller lead body 
tubing diameter is designed to enhance torquability and steerability to facilitate adherence of the side helix 
in the target location. 
Figure 3 is a visual comparison between the Attain Perform leads and the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) illustrating the similar electrode location but different lead body diameter. 
 

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Figure 3: Comparison of Attain Performa Leads and the Attain Stability Lead Model 4798 
 
A detailed comparison of the Attain Stability bipolar lead (Model 4796) and Attain Stability Quad lead 
(Model 4798) is presented in Table 6. 
Table 6: Comparison of Medtronic Attain Stability Bipolar and Quadripolar LV Leads 
 
Attain Stability 
Attain Stability Quad 
Design Feature 
Model 4796/20066 
Model 4798 
Shape 
Single Canted 
Same as 4796/20066 
Implant Method 
Guide wire, Stylet, or 
hybrid guide wire via 
Medtronic Delivery 
System and active 
fixation 
Same as 4796/20066 
Delivery System 
Inner Diameter 
> 5.7 Fr ID 
Same as 4796/20066 
Lead body 
diameter 
3.9 Fr proximal / 3.4 Fr 
distal 
4.4 Fr proximal /3.9 Fr 
distal 
Lead Body 
Conductor 
Single 2 Filar Coil 
(Multiconductor) 
Single Quadfilar Coil 
(Multiconductor) 
Conductor Material 
Ag core-low Titanium 
MP35N coil 
Same as 4796/20066 

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Attain Stability 
Attain Stability Quad 
Design Feature 
Model 4796/20066 
Model 4798 
Shape 
Single Canted 
Same as 4796/20066 
Insulation 
(Outer/Inner) 
Polyurethane 55D 
SI-PI 
Same as 4796/20066 
Polarity 
bipolar 
Selectable Quad-
electrode 
Electrode Material 
Pt/Ir* alloy with TiN 
coating 
Same as 4796/20066 
Fixation Helix 
Material 
Pt/Ir** alloy 
 
Same as 4796/20066 
Electrode Spacing 
21 mm 
21mm / 1.3mm / 21mm 
Surface Area per 
electrode  (mm2) 
5.8 
Same as 4796/20066 
Steroid and Dose /  
MCRD 
Dexamethasone acetate 
Tip 160µg , Ring 72µg 
Dexamethasone acetate 
Each (4) Ring 72µg 
Total Target Dose 
232µg/lead 
288 µg/lead 
Molded Tip Seal 
Silicone (with steroid), 
pierced hole 
Silicone (without 
steroid), cross-cut hole 
Fixation Method 
Helix 
Same as 4796/20066 
Connector 
IS-1 B1 
IS4-LLLL 
Length (cm) 
88 cm only 
78 and 88 cm 
*90/10 Platinum Iridium 
**80/20 Platinum Iridium 
The non-electrically active side fixation helix component is similar to the Attain Stability Bipolar LV lead 
(Model 20066/4796) and is designed to enable active fixation in the cardiac vein.  The Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) side helix is positioned between the LV3 and LV4 electrode; 
specifically 10 mm proximal from the LV3 electrode (see Figure 2).   
A mechanical stop component is located at the base of the helix to prevent wedging of the endothelial 
tissue in the helix and to prevent tissue ingrowth.  The helix component is platinum (Pt) iridium (Ir) alloy 
(Pt/Ir 80/20).  This same Pt/Ir material is also used in the market released right ventricular active 
fixation lead Models 5076, 3830, and 4076.  Both the helix and mechanical stop components are identical 
to those used on the CE Mark approved Medtronic Attain Stability model 20066/4796 active fixation lead 
and are shown in Figure 4.  

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The Model 4798 lead has one distal curve/cant.  This distal curve geometry (angle) is identical to the 
Attain Performa model 4298, as well as Attain Ability models 4196 and 4296 most distal cant.  The 
single distal cant is also identical to the CE Mark approved model 20066/4796 active fixation lead 
(Figure 4). The purpose of the distal cant is to provide physicians the ability to “steer” the distal tip of 
the lead when navigating difficult vein anatomy or acute vasculature angulation by rotating the lead 
(counterclockwise) and aligning the distal tip towards the desired direction.  The distal cant for the 
Model 4798 lead is not intended, or necessary, to provide any fixation of the implanted lead as any 
retention force from the cant would be negligible compared to the stability provided by the properly 
implanted and verified fixated helix.  
Figure 4: Attain Stability Bipolar (Model 20066/4796) & Attain Stability Quad MRI SureScan 
(Model 4798) Active Fixation Leads 
 
 
The Attain Stability Quad Clinical Study will be conducted to evaluate the safety and efficacy 
of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) in combination with CRT 
system components mentioned in  
Table 7. 

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Table 7: Study Component Information 
Component  
US/Canada 
EMEA/Hong Kong/Malaysia 
Attain Stability Quad MRI 
SureScan LV Lead (Model 
4798) 
Investigational 
Market-released 
Medtronic CRT-P or 
Medtronic CRT-D (with 
Vector Express capabilities) 
Market-released 
Market-released 
Medtronic RV lead (non-
Medtronic and non-
recalled/non-market 
withdrawn/non-safety 
alerted lead acceptable for 
upgrades) 
Market-released 
Market-released 
Medtronic RA lead (optional) 
(non-Medtronic and non-
recalled/non-market 
withdrawn/non-safety 
alerted lead acceptable for 
upgraded systems) 
Market-released 
Market-released 
 
Given the similarities between the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the 
Attain Performa family of leads, the proposed indications for use are the same.  The indications are as 
follows: 
Proposed Indication Statement for Use for the Attain Stability Quad Lead: 
The Attain Stability Quad MRI SureScan 4798 steroid-eluting, quadripolar electrode, IS4 transvenous lead 
is indicated for chronic pacing in the left ventricle via the cardiac vein, when used with a compatible 
Medtronic Cardiac Resynchronization Therapy (CRT) System.  Extended bipolar pacing is available using 
this lead in combination with a compatible market approved CRT-D system and RV lead. 
Market-Released Right Atrial Lead 
Commercially available Medtronic RA lead models with an IS-1 connector are required when an RA lead is 
implanted with de novo CRT systems.  An RA lead is not required to be implanted in circumstances 
determined appropriate per physician’s medical assessment.  Medtronic commercially available RA leads 
with an IS-1 connector are recommended but compatible non-Medtronic leads are permissible in enrolled 
patients receiving a CRT system upgrades.   
Medtronic Market-Released Right Ventricular Lead 
Commercially available Medtronic RV defibrillation leads with a DF4 connector are required for de novo 
CRT systems.  Medtronic RV defibrillation leads with DF1 connectors may be incorporated in the study as 
DF1-compatible CRT-P and CRT-D devices are made available for the study.  A non-Medtronic RV lead is 
permissible in enrolled patients receiving a CRT system upgrades. 

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13.2. Manufacturer 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is manufactured by Medtronic, Inc.  
13.3. Packaging 
Packaging and labeling for all market approved system components can be found with each package 
insert.  Manuals can be found on http://manuals.medtronic.com.  For CE Marked devices the labeling is in 
the appropriate local language. 
For investigational products (e.g. in the US and Canada), the language of labeling and clinical manuals 
will be in English and/or local language where it is required.  Investigational products will be clearly 
labeled e.g. “exclusively for clinical investigation.”   
In Canada, each investigational device will be labelled with the statements “Investigational Device”; “To 
be Used by Qualified Investigators Only”; “Instrument de recherche” and “Réservé uniquement à l’usage 
de chercheurs compétents”. 
13.4. Intended Population 
In the Attain Stability Quad Clinical Study, the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
is to be used in subjects where a de novo LV lead is indicated.  The Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) is intended to be used in conjunction with a market released Medtronic CRT-P or 
Medtronic CRT-D device, a Medtronic (for de novo CRT implants) RV lead, and a Medtronic (for de novo 
CRT implants) RA lead (optional).    
A complete SureScan system is required for use in the MRI environment.  Before performing an MRI 
scan, refer to the SureScan MRI technical manual for MRI-specific warnings and precautions. 
13.5. Equipment 
All commercially available equipment will be used according to their approved intended use. 
Medtronic CareLink (2090) Programmer 
The Medtronic approved CRT-P or CRT-D devices will be programmed and interrogated using a Medtronic 
CareLink (2090) programmer.  Medtronic may incorporate additional programmers as they receive 
regulatory approval. 
Medtronic CareLink Home Monitor 2490C and Network 
The CareLink Monitor Model 2490C is an external monitor that is indicated for use in the transfer of 
patient and device data from implanted Medtronic devices.  The CareLink Monitor Model 2490C 
interrogates implanted devices and temporarily stores these data, collaborates with the appropriate 
Medtronic server to confirm the establishment of an Internet connection with server, performs any 
required file translation functions necessary for data transfer, executes data file transfer, and collaborates 
with the appropriate Medtronic server to confirm data file transfer through the Internet connection with 
the server.  The CareLink Monitor 2490C is not a programmer and cannot be used to program implanted 
device parameters.  CareLink monitors are not a substitute for appropriate medical attention in the event 
of an emergency and should only be used as directed by a physician.  Approved Medtronic CRT-P and 
CRT-D devices used in this study qualify for use with the Medtronic CareLink Monitor and Medtronic 

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CareLink Network.  Medtronic may incorporate additional home monitors as they receive regulatory 
approval. 
Pacing System Analyzer 
Medtronic’s commercially available Model 2290 Analyzer must be available at each center during the 
implant procedure to determine acceptable electrical parameters.  Medtronic may incorporate additional 
analyzers as they receive regulatory approval. 
13.6. Product Use 
See Section 13 Product Description. 
13.7. Product Receipt, Tracking, and Accountability 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered investigational in 
geographies where the product is not available commercially and will be labeled for clinical use only.  
These geographies include but are not limited to the US and Canada.  Investigational Attain Stability 
Quad Leads will be distributed to a site only when Medtronic has received all required documentation 
(including but not limited to Ethic Committee approval, a signed Clinical Trial Agreement and 
documentation of training) and has notified the site of site readiness.   
Distribution of the investigational product to study sites will be managed by Medtronic and investigational 
products can only be ordered by Medtronic personnel.  Sites with these clinically labeled Attain Stability 
Quad MRI SureScan LV Leads (Model 4798) will track disposition upon receipt or return of the lead but 
also upon implant or explant of the lead.  Disposition logs will be available within the electronic data 
management system and shall be maintained at each site in all geographies to track investigational 
product information.  The logs should be updated when an investigational product is received, opened, 
implanted explanted, disposed of or returned to Medtronic.  The logs will track the following 
investigational lead data (but are not limited to) model and serial numbers of devices delivered to the 
site, subject IDs of the subjects, implanted, received dates of devices, implant/used dates, explant dates, 
returned-to-sponsor dates and reasons, initials of all persons who received, used or disposed each 
device, and method of disposal.  Medtronic will perform periodic reconciliation of investigational product 
to ensure traceability. 
For geographies where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is not considered 
investigational, commercially approved devices will be used.  Sites that use commercially available Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) will track device disposition upon implant or explant 
of the lead on the CRFs. 
13.8. Product Storage 
All investigational products must be stored in a secure location at the site.  It is the responsibility of the 
investigator to correctly handle, store and track the investigational products.  Further details may be 
found in the Clinical Manual or User Manual (dependent on each geography’s commercial release of the 
product). 

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13.9. Product Return 
All explanted, open but unused, and defective products (devices or leads, etc.) should be returned to 
Medtronic for analysis whenever possible and when permissible by local laws and regulations.  If the 
products are explanted but not returned, a justification is required to be reported on the appropriate case 
report form(s) or disposition log(s) (note that this is not considered a study deviation).  In geographies 
where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is considered investigational, the 
Disposition Log must be updated in the event of an explant.  To receive a Returned Product Mailer Kit, 
please contact your local Medtronic field personnel or representative.  All unused investigational products 
must be returned to Medtronic upon study closure at the site. 
14. Selection of Subjects 
14.1. Study Population 
Patients of both genders that are 18 years of age and older (or of legal age to give informed consent per 
local and national law) that are indicated for a de novo LV lead implantation and who meet all inclusion 
and no exclusion criteria are eligible for an Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implant attempt.  There will be no control group for this study. 
14.2. Subject Enrollment 
Patients who meet all of the inclusion and none of the exclusion criteria (see sections 14.3 and 14.4) are 
eligible to be enrolled in this study.  Upon signing and dating the Informed Consent Form (ICF), the 
patient is considered a subject enrolled in the study. 

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14.3. Inclusion Criteria 
• 
Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy (i.e. 
US subjects should meet CRT device indications per the HRS/ACC/AHA guidelines) 
• 
Patient (or legally authorized representative) has signed and dated the study-specific Informed 
Consent Form 
• 
Patient is 18 years of age or older, or is of legal age to give informed consent per local and 
national law 
• 
Patient is expected to remain available for follow-up visits 
14.4. Exclusion Criteria 
• 
Patient has had a previous unsuccessful LV lead implant attempt 
• 
Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial) 
• 
Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA 
and/or RV lead  
• 
Patient has known coronary venous vasculature that is inadequate for lead placement 
• 
Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the 
past 30 days 
• 
Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary 
angioplasty (PTCA) within the past 90 days 
• 
Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right 
heart valve) 
• 
Patient has had a heart transplant (patients waiting for heart transplants are allowed in the 
study) 
• 
Patient has known renal insufficiency and/or significant allergy to contrast dye that would prevent 
them from receiving an occlusive venogram during the implant procedure 
• 
Patient is contraindicated for <1mg dexamethasone acetate 
• 
Patient is enrolled in any concurrent drug and/or device study that may confound the results of 
this study 
• 
Patient has a terminal illness and is not expected to survive more than six months 
• 
Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.) 
• 
Patient is unable to tolerate an urgent thoracotomy 
14.5. Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias.  
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
• 
Subjects will be evaluated at baseline to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria  
• 
Subject demographics and medical history will be collected at baseline and differences that may 
affect primary endpoints will be identified 
• 
To ensure widespread distribution of data between sites, the maximum number of subjects 
allowed per site is 50 
• 
All implanters in the study will be experienced in the implant of CRT-P and/or CRT-D systems 
• 
Data collection requirements and study procedures will be standardized across all sites and 
geographies 

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• 
All study site personnel and Medtronic personnel will be trained on their respective aspects of the 
study using standardized training materials, and required to follow the CIP 
• 
Per the specifications in the Monitoring Plan, monitoring visits will be conducted for adherence to 
the CIP and to verify the CRF data against source data 
• 
Pre-defined statistical methods specified in the CIP and the Statistical Analysis Plan (SAP) will be 
followed 
• 
The SC members will not have influence on the treatment decisions by study site investigators 
during the trial 
• 
An independent and blinded CEC will regularly review and adjudicate reported adverse events 
and deaths (per Section 18.1) 
• 
Registration of the trial on ClinicalTrials.gov and the publication plan will ensure that study results 
will be reported 
• 
All study investigators are required to meet 21 CFR Part 54, Financial Disclosure by Clinical 
Investigators, to identify potential bias due to financial interest in the outcome of the study  
In summary, potential sources of bias that may be encountered in this Attain Stability Quad Clinical Study 
have been considered and minimized by careful study design. 
15. Study Procedures  
Prior to performing study related procedures, all sites must have Ethics Committee (EC) and associated 
regulatory authority approval if applicable (e.g., Competent Authority approval) as well as documentation 
from Medtronic of site readiness. 
Medtronic representatives may perform the following activities at the study sites during the study, if 
appropriately trained and under supervision of the Principal Investigator: 
• 
Study training relevant and pertinent to the involvement of personnel conducting study activities 
and investigator responsibilities 
• 
Technical support at all visits (e.g. programming of the CRT-P or CRT-D device according to 
study requirements, performing device interrogations/save-to-media, etc.), but no CRF data entry 
shall be performed by Medtronic personnel  
• 
Monitoring activities 
15.1. Study Personnel Requirements 
Site personnel training and delegation will be completed prior to participation in the Attain Stability Quad 
Clinical Study.  The site personnel training consists of required training topics (CIP, Informed Consent 
Form, CRFs, regulations).  Members of the study site team will receive training on the applicable clinical 
study requirements relevant to their role before contributing to the clinical study. 
All Principal Investigators shall: 

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• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
• 
Be qualified practitioners and experienced in the diagnosis, management, and treatment of HF 
subjects with CRT devices 
• 
Be experienced in the field of application and trained in the use of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) 
• 
Disclose potential conflicts of interest, including financial that interfere with the conduct of the 
clinical investigation or interpretation of results 
• 
Be knowledgeable with the method of obtaining an informed consent 
In addition, the Principal Investigator shall be able to demonstrate that the proposed investigational site: 
• 
Has an experienced CRT implanter who is experienced and trained in the handling/implanting of 
CRT-P and/or CRT-D devices 
• 
Has the required number of eligible subjects needed within the agreed recruitment period 
• 
Has one or more qualified investigators, a qualified investigation site team and adequate facilities 
for the foreseen duration of the clinical investigation  
15.2. Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train site personnel on the CIP, 
the implant procedure, relevant standards and regulations, informed consent process, and on data 
collection and reporting tools.  If new members join the study site team, they will receive training on the 
applicable clinical study requirements relevant to their role before contributing to the clinical study.  For 
new members, local Ethics Committee notification requirements must be met, as well as Medtronic 
requirements noted on the training and delegation form.  
A Clinical Trial Agreement (CTA) shall be entered into effect by Medtronic, the participating investigation 
site and/or the principal clinical investigator at each investigational site as per local legal requirements, 
and returned, fully executed, to Medtronic prior to the commencement of any study activities.  Financial 
aspects of conducting and reporting a study will be specified in the agreement.  By signing and dating the 
agreement the investigator indicates approval of the CIP. 
Prior to performing study related activities, all sites must have Ethics Committee approval, as applicable 
for that geography. 
All local and regional regulatory requirements will be fulfilled prior to site activation and enrollment of 
subjects into the study.  Each study site must have written documentation from Medtronic of site and 
investigator readiness before beginning any study-related activities.  Requirements for activation vary by 
geography, and may include, but are not limited to the following:  
• 
Written documentation of Ethics Committee approval of the current version of the CIP and 
ICF, subject materials (e.g. Global Assessment and KCCQ), and voting list (as required by 
local law)   
• 
Regulatory authority approval or notification (as required per local law)  
• 
Fully executed CTA on file with the sponsor  
• 
Financial Disclosure (for Principal Investigators and Co-Investigators)   
• 
Current Curriculum Vitae (CV) (signed and dated as required by local law) of investigators 
and key members (as required by local law) of the investigation site team on file with the 
sponsor  
• 
Documentation of delegated tasks 

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• 
Documentation of study site personnel training  
Additional requirements imposed by the Ethics Committee and regulatory authority shall be followed, if 
applicable.  
Medtronic will provide each study site with documentation of study site readiness; this letter must be sent 
prior to subject enrollment. 
15.3. Equipment Requirements 
The following equipment must be available at each site to support study activities: 
• 
Medtronic 2290 Analyzer (or latest market released Medtronic analyzer) 
• 
Medtronic 2090 programmer (or latest market released Medtronic programmer) 
• 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) (either clinically labeled product or 
commercial released product located at the site or carried to the implant by the Medtronic 
representative) 
• 
Computer with high speed internet access using a web browser compatible with the electronic 
data management system for electronic database entry  
The equipment necessary for the assessment for the study includes the Medtronic 2290 Analyzer and 
Medtronic 2090 programmer.  The maintenance and calibration of the equipment used for this study will 
be assessed outside of this clinical study.  Sites are responsible for maintaining and calibrating non-
analyzer/programmer equipment used in the course of this study in accordance with established site 
practice or local regulation.  Records should be kept and able to be provided upon request by the 
Sponsor or regulatory agency.   
15.4. Schedule of Events 
Clinical data will be collected at the study milestones detailed in Table 8.  Data will be collected via 
electronic case report forms (eCRFs), still cine images, analyzer/programmer print-outs, and interrogation 
files.  Post-implant follow-ups apply only to those subjects in whom an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) was successfully implanted or an implant was attempted.  Subject visits 
will occur at enrollment, baseline, implant/pre-hospital discharge (PHD), 3 months post-implant, 6 
months post-implant, and every 6 months thereafter until PMA approval of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) implanted or study termination, whichever comes first.  Medtronic 
personnel may assist study personnel during implant and study visits.

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Table 8: Data Collection and Study Procedure Requirements at Subject Visits 
STUDY PROCEDURE 
Enrollment/
Baseline 
Implant/ 
PHD 
3 months 
post-implant 
(remote or in 
office visit) 
6 months 
post-
implant 
(in office 
visit) 
12 months 
post-
implant 
(in office 
visit) 
Recurring 6 
month 
follow-ups 
(remote or in 
office visit) 
Exit 
Subject Informed Consent 
 
 
 
 
 
 
 
Inclusion / Exclusion criteria 
verified 
 
 
 
 
 
 
 
Subject demographics 
 
 
 
 
 
 
 
Cardiovascular medications 
 
 
 
 
 
 
 
Cardiovascular medical history 
 
 
 
 
 
 
 
NYHA classification 
 
 
 
 
 
 
 
Patient Global Assessment 
 
 
 
 
 
 
 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
 
 
 
 
 
 
 
Occlusive venogram with pre-
determined pacing location 
identified 
 
 
 
 
 
 
 
Analyzer PCT data collection (pre 
and post slitting the cannulation 
catheter) 
 
 
(Implant) 
 
 
 
 
 
Investigator Lead Handling 
Assessment 
 
 
(Implant) 
 
 
 
 
 
System and procedure 
information 
 
 
 
 
 
 
 
Lead Impedance (all 16 vectors) 
 
 
 (final 
programmed  
vector only) 
 
 
 (final 
programmed  
vector only) 
 
Pacing Capture Thresholds (all 16 
vectors) 
 
 
 (final 
programmed  
vector only) 
 
 
 (final 
programmed  
vector only) 
 
Phrenic Nerve Stimulation (final 
programmed vector) 
 
 
 (in office 
visit only) 
 
 
 
 
 
Phrenic Nerve Stimulation 
(vectors LV1 to RVcoil/Can, LV2 
to RVcoil/Can, LV3 to RVcoil/Can, 
LV4 to RVcoil/Can) 
 
 
 
 
 
 
 
Phrenic Nerve Stimulation 
(Primary Endpoint vectors) 
 
 
 
 
 
 
 
Rationale for selecting specific LV 
lead pacing vector for final 
programming 
 
 
 
 
 
 
 
Final device interrogation/save-
to-media 
 
 
 (CareLink 
transmission 
is acceptable 
for remote 
visits) 
 
 
 (CareLink 
transmission 
is acceptable 
for remote 
visits) 
 (required only if 
subject exits prior to 
6 months post-
implant visit; 
CareLink 
transmission is 
acceptable) 
AE Assessment 
 
 
 
 
 
 
 
Exit Subject 
 
 
 
 
 
 
 
Adverse Events (incl. AE with 
outcome of death) 
As they occur 
Device Deficiencies 
System Modifications 
Study Deviations 

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Table 9 below specifies permitted time windows for the required subject visits.  Subject visit target dates 
and windows for each follow-up will be made available to the study site.  Should a subject miss a visit or 
the visit falls outside the pre-specified window, a study deviation must be reported and the original 
follow-up schedule maintained for subsequent visits.  Data analyses will include follow-up visits, 
regardless of whether the visit occurs within the window.  Therefore, a late visit is preferred over a 
missed visit but must be accompanied by a deviation.  
Table 9: Visit Windows 
Visit 
Window 
Implant 
0-30 days since Baseline 
Assessment 
  
(days since implant) 
Pre-hospital discharge 
0-7 
3-month 
76 - 106 
6-month 
183 - 213 
12-month 
350 - 380 
18-month 
518 - 578 
24-month 
701 - 761 
 
15.5. Subject Consent 
Informed consent (IC) is defined as a legally effective documented confirmation of a subject’s voluntary 
agreement to participate in a particular clinical study after information has been given to the subject on 
all aspects of the clinical study that are relevant to the subject’s decision to participate (ISO 14155:2011).  
This process includes obtaining IC and an Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language (data protection authorization; i.e. HIPAA in 
the US) as required by law.  Informed Consent Forms are required to be approved by the study site’s 
Institutional Review Board (IRB) or Ethics Committee (EC) and Medtronic, and signed and dated by the 
subject and the Principal Investigator.  A subject may only consent after information has been given to 
the subject on all aspects of the clinical study that are relevant to the subject’s decision to participate.  
Prior to enrolling subjects, each site must have documented IRB/EC approval of the IC Form (ICF) and 
the data protection authorization as required by law.  Any changes to a previously approved ICF 
throughout the course of the study must be reviewed and approved by Medtronic and the IRB/EC 
reviewing the application before being used to consent or re-consent a study subject.  The document(s) 
must be controlled (i.e. versioned and dated) to ensure it is clear which version(s) was approved by 
Medtronic and the IRB/EC.  All important new information should be provided in written form to new and 
existing subjects throughout the study.  If relevant, all affected subjects must be asked to confirm their 
continuing IC in writing.   

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Prior to initiation of any study-specific procedures, IC must be obtained from the subject (or legally 
authorized representative).  Likewise, privacy or health information protection regulation may require 
subjects to sign additional forms to authorize sites to submit subject information to the study sponsor.  
The IC process must be conducted by the principal investigator or an authorized designee, and the ICF 
and data protection authorization, as required by law, must be given to the subject in a language he/she 
is able to read and understand.  
The process of obtaining informed consent shall: 
• 
Ensure that the principal investigator or an authorized designee conducts the IC process. 
• 
Include all aspects of the Attain Stability Quad Clinical Study that are relevant to the subject's 
decision to participate throughout the clinical study. 
• 
Avoid any coercion or undue improper influence on, or inducement of the subject to participate. 
• 
Not waive or appear to waive the subject’s legal rights. 
• 
Ensure the ICF and data protection authorization, as required by law, are given to the subject in 
a non-technical language the subject is able to read and understand. 
• 
Provide ample time and opportunity for the subject to read and understand the ICF to inquire 
about details of the study, and to consider participation.  All questions about the study should be 
answered to the satisfaction of the subject. 
• 
Include a personally dated signature of the subject acknowledging that their participation in the 
study is voluntary. 
• 
Include a personally dated signature by the principal investigator or authorized designee 
responsible for conducting the IC process, as required by local law. 
• 
Include any other locally required signatories, such as witnesses, as indicated by country-specific 
legislations. 
• 
Provide the subject with a copy of the ICF, the data protection authorization, as required by law, 
and any other written information, signed and dated if required by local law. 
• 
Ensure subjects are notified of any significant new findings about the study that become 
available during the course of the study which are pertinent to the safety and well-being of the 
subject, as this could impact a subject’s willingness to participate in the study. 
If IC is obtained the same day the subject begins participating in study-related procedures, it must be 
documented that consent was obtained prior to participation in any study-related procedures.  It is best 
practice for the IC process to be documented in the subject’s case history, regardless of circumstance. 
In the event the subject cannot read and/or write, witnessed (impartial third party) IC will be allowed, 
provided detailed documentation of the process is recorded in the subject’s case history and the witness 
signs and dates the ICF.  Informed consent shall be obtained through a supervised oral process.  An 
independent witness must be present throughout the process.  The ICF and any other information must 
be read aloud and explained to the prospective subject, if allowed by local law.  The witness signs and 
personally dates the ICF, attesting that the information was accurately explained and that informed 
consent was freely given.  The subject should “make his mark” (sign or otherwise physically mark the 
document so as to indicate consent) on the ICF as well.  The ICF should document the method used for 
communication with the prospective subject and the specific means by which the prospective subject 
communicated agreement to participate in the study.  
The original of the signed ICF must be filed in the hospital/clinical chart and/or with the subject’s study 
documents.  A second signed original or a copy should be given to the subject for their records (if 
applicable). 

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The ICF and data protection authorization, as required by law, must be available for monitoring, auditing 
and regulatory inspections.  
Geography specific ICF Templates will be provided under separate cover.  
15.6. Enrollment 
The point of enrollment is defined as the time at which a patient has signed and dated the ICF.  The date 
the subject signed (or legally authorized representative) the ICF and data protection authorization, as 
required by law, must be documented in the subject’s medical records.  At that point, the patient is 
considered a subject in the study, a study subject ID number will be assigned, and the subject must be 
followed for the duration of the study unless the subject exits the study prior to study closure.  Each 
investigational center will be responsible for maintaining subject identification records (e.g. subject 
identification log) according to ISO 14155.  
Enrollment will occur on the same day as the baseline visit.  Once IC is obtained, report AEs/deaths, 
study deviations and subject exits as they occur.  To accurately track subject enrollment, Medtronic 
should be notified of the enrollment as soon as possible after a patient has signed the ICF. 
15.7. Baseline 
The baseline visit can be a stand-alone visit or can occur on the same day as, but not later than, the 
implant visit.  The following procedures will be completed/data will be collected at the baseline visit: 
o 
Subject Informed Consent  
o 
Inclusion/Exclusion criteria verified 
o 
Subject demographics  
o 
Cardiovascular medications 
o 
Cardiovascular medical history 
o 
NYHA classification 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ)  
Cardiovascular medications include ACE inhibitors, ARBs, antiarrhythmic, anti-coagulants, antithrombotics, 
and antiplatelet, antihypertensive, antilipidemics (statins), beta blockers, calcium channel blockers, 
diuretics, digitalis, inotropes, nitrates, digoxin, and vasodilators. 
If implant does not occur within 30 days of enrollment, verification of all inclusion and all exclusion 
criteria must be repeated before an implant attempt. 
15.8. Implant/PHD 
Information collected at Implant/PHD will include data from the day of the implant procedure until 
released from the hospital.  The implant CRF will be used to collect data at implant.  Implantation of the 
CRT device and right heart leads should be performed according to the Instruction for Use (IFU) in 
geographies where the devices are commercially available. 
Any Medtronic commercially released right atrial (RA) and any Medtronic commercially released right 
ventricular (RV) lead may be implanted.  Existing non-Medtronic RV and/or RA leads that are not recalled, 
market withdrawn, and/or have a medical alert may be used in enrolled who are receiving an upgrade to 

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a CRT system.  The right-heart leads should be implanted according to the labeling provided with the 
applicable lead. 
The implanted system device must include a Medtronic commercially released CRT device which can be 
programmed to utilize all electrodes, allowing upgrades from implantable pulse generators (IPGs) and 
implantable cardioverter defibrillators (ICDs).  Device and lead requirements are as follows: 
• 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
• 
For de novo CRT implants, any Medtronic commercially released transvenous (active or passive 
fixation) RA pacing lead (unless medical justification to exclude this lead) and any Medtronic 
commercially released transvenous (active or passive fixation) RV lead 
• 
For upgrades to a CRT system, existing non-Medtronic RV and/or non-Medtronic RA leads that 
are not recalled, market withdrawn, and/or have a medical alert may be used in enrolled who are 
receiving an upgrade to a CRT system  
• 
Medtronic commercially released CRT devices that measure discrete LV electrical values from all 
four electrodes (i.e. Vector Express) 
15.8.1. 
Final System Configuration 
For information on the requirements for the implanted system refer to Section 13.  The system is 
successfully implanted when the Medtronic CRT device is successfully connected to the RA, RV and the 
LV lead (except if a medical condition such as chronic atrial fibrillation excludes the need for an RA lead).  
The configuration of the successfully implanted system components will be collected.  This will include 
the serial number of each implanted component (CRT-D or CRT-P device, and leads), and the location of 
lead placement. 
15.8.2. 
Implant Procedure 
Implantation of the CRT device and cardiac leads must be performed by a trained clinical study 
investigator and according to the manufacturer’s instructions for use.  It is recommended to use 
Medtronic catheters that are compatible with the Attain Stability Quad MRI SureScan LV Lead (Model 
4798) (e.g., > 7 Fr) during the implant for gaining access to the coronary sinus (CS).   
For complete information regarding the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and 
the implant procedure, reference the Clinical Manual in the US and Canada or the Instructions for 
Intended Use (Technical Manual in EMEA, Hong Kong, and Malaysia).  These documents are located 
under a separate cover. 
15.8.2.1. Venogram 
An occlusive venogram is required for venous visualization of the subject’s coronary vasculature and will 
be used to pre-determine a desired target pacing location prior to placing the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798).  Once the pre-determined target pacing location is determined, a 
venous image will be collected.  A copy of the venous image will be submitted to Medtronic and kept on 
file at the center.  
15.8.2.2. Implanting the LV lead 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be implanted according to the implant 
instructions found within the lead packaging.  The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) can be positioned with the aid of a guide wire (0.36 mm to 0.46 mm or 0.014 inches to 0.018 

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inches in diameter), stylet, an inner catheter, or an inner catheter plus hybrid guide wire.  If a stylet is 
used for lead positioning, only use the stylets packaged with the lead or in a stylet kit (downsized knob).   
Always use a stylet that is 3 cm shorter than the lead length listed on the IS4 connector label.  Other 
stylets may extend beyond the lead tip causing injury or perforation of the cardiac vein or heart.  If using 
a Medtronic integrated valve system (e.g. SureValve), rotate the helix counterclockwise to allow safe 
passage of the helix when inserting the lead into the delivery system to prevent the side helix from 
inadvertently attaching to the valve.  Rust stylets are not recommended with this lead due to the risk of 
conductor coil/insulation perforation. 
Follow the Attain Stability Quad MRI SureScan LV Lead (Model 4798) package insert carefully for fixating 
the side helix to the vein.  Consider using a J-shaped stylet if fixation is unsuccessful.  An overview of the 
key implanting tips includes: 
• 
Rotate the lead counterclockwise when inserting the lead through the SureValve to prevent the 
helix from attaching to the valve 
• 
Refrain from wedging the lead into the vessel so that the lead can easily rotate during fixation 
allowing torque to transfer from the proximal end to the distal end of the lead 
• 
To fixate the side helix in the desired location, rotate the lead clockwise with the guidewire 
inserted in the lead which will provide extra stiffness to the lead 
• 
Ensure the guidewire is removed to allow for lead pliability to visualize and confirm lead fixation 
during the Push Test and the Pull Test  
• 
To reposition the lead, insert the guidewire and rotate the lead counterclockwise without applying 
tension to the lead to unfixate 
Information on surgical data, such as tool use, and implant times, etc. will be collected during the implant 
procedure. 
In an event that one Attain Stability Quad MRI SureScan LV Lead (Model 4798) is determined to be not 
suitable for a patient after the initial lead insertion; the implanting physician must assess the onset of any 
potential AEs.  A second Attain Stability Quad MRI SureScan LV Lead (Model 4798) may only be 
introduced upon confirmation that no system-related AEs resulted from the first Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) implant attempt.  Any LV lead related AE observed during the initial LV 
lead attempt prohibits an attempt of a second Attain Stability Quad MRI SureScan LV Lead (Model 4798). 
If the subject does not have a successful Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implant at the conclusion of the initial implant procedure, the subject should be followed until procedure 
or system related AEs are resolved or are unresolved with no further actions planned, whichever occurs 
later. 
If an attempt to implant the Attain Stability Quad MRI SureScan LV Lead (Model 4798) does not occur, or 
if the Model 4798 LV lead cannot be implanted, the reasons why the lead was not attempted or 
attempted but not implanted must be documented on the Implant and Study Exit CRF.  See additional 
definitions below. 
No Attain Stability Quad MRI SureScan LV Lead (Model 4798) Attempted (lead not inserted 
into the body) 
An Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt is defined as any time a Model 
4798 lead is introduced into the body.  Subjects that do not have an Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) implant attempted will be exited from the study following their implant procedure 

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unless another Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt is scheduled.  Adverse 
events, device deficiencies and deviations must be documented before the subject is exited. 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) Attempted but Not Implanted 
An Attain Stability Quad MRI SureScan LV Lead (Model 4798) that is inserted into the body that is not 
successfully placed will be considered an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 
4798) attempt.  Note: An unsuccessful implant itself is not considered an AE.  Adverse Events occurring 
during an unsuccessful implant (e.g. dissection, perforation) will be recorded and classified.  Subjects 
with an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt will be followed 
until procedure or system related AEs have been resolved or are deemed unresolvable with no further 
action planned. 
15.8.2.3. CRT System Testing and Programming During Implant 
Prior to connecting the leads to the CRT can, initial electrical measurements will be taken using the 
Analyzer (Model 2290 or market released equivalent) to confirm adequate pacing thresholds (PCTs) prior 
to closing the pocket per the site’s standard testing method.  These PCTs will be collected on the same 
vector, at two time points once the lead is fixated and prior to connecting the leads to the can using the 
Analyzer.  The time points are as follows; 
1.) Prior to slitting the cannulation catheter – Collect the first PCT using the Analyzer after the 
lead is fixated and the guidewire/stylet has been pulled back proximal to the helix and electrodes.  
2.) Post slitting the cannulation catheter – Collect the second PCT using the Analyzer after the 
lead is fixated and following slitting of the cannulation catheter.   
These PCT measurements will be collected on the CRF.  This data will only be collected if an Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) is successfully placed. 
Pacing voltage thresholds are measured to determine whether the underlying myocardium will respond 
effectively to pacing and to evaluate lead stability in the cardiac vein.  It is required to perform LV pacing 
threshold measurements during implant using the pacing threshold test at a 0.5ms pulse width.  It is 
recommended to begin at 2.5 Volts and decrease amplitude after at least 3 pulses until capture is lost.  If 
there is no capture at 2.5 V; stop the test and repeat at a higher voltage using the 0.5ms pulse width.  
The lowest amplitude where capture consistently occurs is the pacing threshold value.  Collect data using 
the Analyzer (Model 2290 or market released equivalent). 
It is recommended that physicians locate a final LV pacing site that can be captured using less than or 
equal to 2.5 V at 0.5ms, R-wave sensing of at least 4.0 mV, and does not cause diaphragmatic 
stimulation at 10V at 0.5ms.  For additional details regarding the left ventricular leads and implant tools, 
refer to the respective technical manuals provided with each product.  
Individual patient venous anatomies as well as pathologies present in the left ventricular myocardium are 
factors that will influence LV lead placement.  Therefore, the best cardiac vein lead electrode location to 
stimulate the LV may vary for each patient.  
15.8.2.4. Final Lead Placement Data Collection 
Following fixation and once the final position of the lead is determined, collect a venous image of the final 
placement of the lead.  A copy of the venous image will be submitted to Medtronic and kept on file at the 
center.  

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15.8.2.5. Pre-Hospital Discharge CRT System Testing and Programming  
The following electrical testing will be performed using the implanted CRT-P or CRT-D device and the 
device programmer once the leads are connected to the CRT-P or CRT-D and pre-hospital discharge: 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors 
o 
NOTE: A onetime manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors  LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
Other data collected prior to hospital discharge following the implant includes; 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies  
15.9. 3 Months Post-Implant (remote or in office visit) 
The 3 month scheduled follow-ups may be done remotely or in office.  For remote visits, CareLink 
transmissions may substitute device interrogations.  The following procedures will be completed and data 
will be collected at the 3 month Follow-up visit; 
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the final programmed vector 
o 
NOTE: A onetime manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 

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o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media (or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.10. 
6 Months Post-Implant (in office visit) 
The following procedures will be completed and data will be collected during the 6 months in office 
Follow-up visit. 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
o 
NOTE: A onetime manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
 
NOTE: If at any tested vector PNS is present at 8.0V at 0.5ms, measure the PNS 
threshold at 0.5ms 
o 
Test for presence of PNS at 5.0V at 0.5ms on the two efficacy endpoints (one vector with 
PCT ≤ 2.5 V and an additional vector with PCT ≤ 4.0 V)  
o 
NOTE: PNS observed during any PNS testing will not be considered an AE 
 
 

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Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.11. 
12 Months Post-Implant (in office visit) 
The following procedures will be completed and data will be collected during the 12 month in office 
Follow-up visit. 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
o 
NOTE: A onetime manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 

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o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.12. 
Recurring 6 Month Follow-ups (remote or in office visit) 
After the 12 Month Follow-Up visit, subjects will be seen every 6 months. These scheduled follow-ups are 
considered “Recurring 6 month follow-up visits”.  These scheduled follow-ups may be done remotely or in 
office.  For remote visits, CareLink transmissions may substitute device interrogations.  The following 
procedures will be completed during these visits: 
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the final programmed vector  
o 
NOTE: A onetime manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Retain printouts at the site 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media (or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.13. 
Device Interrogation/Save-to-Media 
For the implant and follow-up visits, a final “Interrogate All” device interrogation file (.pdd) must be 
obtained and saved in a digital format (Save-to-Media).  Store one copy of the save-to-media at the site 
and send a copy to Medtronic.  Do not clear device data.  
A device interrogation (final “Interrogate All”) and Save-to-Media should also be completed at the time of 
study exit (prior to 6 month visit), a system modification (initial and final “Interrogate All”), and in the 
case of a death (where possible).   
15.14. 
System Modifications 
A system modification will be reported in the event the device and/or leads require invasive modification 
(e.g. generator or lead explant, generator or lead replacement, lead repositioning, etc.).  In the event of 
a system modification, regardless of outcome of the modification, subjects should remain in the study 

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when possible and the follow-up visit schedule for the subject will remain unchanged.  For a system 
modification the following information/activities are required to be collected: 
o 
Modification or replace/explant date 
o 
Reason for modification  
o 
Information on device or lead modified   
o 
Information on any replacement device(s) 
o 
Final device interrogation/save-to-media  
o 
Study deviations 
o 
AEs and device deficiencies (as applicable) 
It is recommended that all explanted Medtronic products (device, leads, etc.) are returned to Medtronic 
for analysis per local process and when permissible by local laws and regulations. 
In the event that subject has a re-attempt after a previous unsuccessful system modification, the 
subsequent attempt(s) must be reported via CRF as separate system modifications.    
Attain Stability Quad MRI SureScan LV Lead (Model 4798) repositioned or replaced with 
another Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is repositioned or replaced, the following 
LV lead electrical tests and data collection must be completed:  
Lead Impedance 
o 
Obtain  LV Lead Impedance Test for the final programmed vector 
o 
Perform a manual test for a missing value 
o 
NOTE: Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain a PCT at 0.5ms pulse width using Vector Express on the final programmed vector 
o 
Perform a manual test for a missing value  
o 
NOTE: A onetime manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
NOTE: Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
o 
Record the reason why the final configuration was selected for final programming 
o 
Record any programming changes to the LV lead apart from the LV lead pacing vector 
since the last visit and provide rationale for the change(s) 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) capped or explanted without 
replacement with another Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is capped or explanted without 
replacement while the subject is in the study, subjects will continue to be followed per their original 
follow-up schedule for safety monitoring until study closure.  LV lead electrical testing and interrogation 
files will not be required at follow-ups for subjects without the full protocol required system implanted. 

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Explant of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the Medtronic 
CRT-P or CRT-D device without replacement with another Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) and Medtronic CRT-P or CRT-D device 
Subjects who have their Attain Stability Quad MRI SureScan LV Lead (Model 4798) and Medtronic CRT-P 
or CRT-D device explanted without replacement during a system modification procedure should be exited 
from the study as soon as all system related and/or system modification procedure related AEs are 
resolved.  If no system or procedure related AEs are present at the conclusion of such a system 
modification procedure, the subject should be exited immediately. 
Medtronic CRT-P or CRT-D device explanted without replacement, Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) remains implanted 
If the Medtronic CRT-P or CRT-D device is explanted and a replacement device will be implanted, all 
attempts should be made to replace with another Medtronic CRT-P or CRT-D device.  In the event that an 
explanted Medtronic CRT-P or CRT-D device cannot be replaced with a new Medtronic CRT-P or CRT-D 
device, subjects who still have an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted 
will continued to be followed for safety monitoring in person per their original follow-up schedule until 
study closure.  Events related to the Attain Stability Quad MRI SureScan LV Lead (Model 4798) should be 
reported.  Left ventricular lead electrical testing will not be required at follow-ups for subjects without the 
full protocol required system implanted.  In an event that a second Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) was implanted as a result of an Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) related complication, the subject will be followed for safety, however the second implanted 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) will not be included for the analyses of study 
objectives except reportable system related adverse events. 
15.15. 
Study Exit  
Study Exit is defined as the moment when a subject officially stops participating in the study.  Date and 
reason for subject exit must be reported to Medtronic at the earliest opportunity. 
Subjects will be exited from the study for any of the following situations: 
• Study completed 
• Subject lost to follow-up 
• Subject did not meet eligibility criteria and was not yet implanted with an Attain Stability Quad 
MRI SureScan LV Lead (Model 4798)    
• Subject did not have a successful implant and no attempt at re-implant is made 
• Subject did not provide consent or data protection authorization, as required by law 
• Subject chooses to exit (i.e. revokes consent) 
• Investigator withdraws subject  
Prior to exiting a subject from the study, it is recommended to follow the subject until all ongoing system- 
and procedure-related AEs are resolved, unresolved with no further actions planned, or 30 days post the 
6 month visit, whichever occurs first.  Following exit, subjects will continue to receive standard medical 
care.  There will be no further required study-related follow-up visits for these subjects.  All data through 
the time of the subject’s exit will be available for data analyses. 
If possible, the following procedures should be performed / data collected at the exit visit: 

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o 
Report the reason for exit 
o 
Final interrogation file (or CareLink transmission) for exits occurring prior to the 6 month visit 
o 
Study deviations 
o 
AEs and device deficiencies (as applicable) 
After subjects are exited from the study they should receive standard medical care and should be 
managed and followed per physician discretion.  
15.15.1. Study Completed 
All subjects will be followed until FDA Pre-Market Approval (PMA) of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798).  Medtronic will notify sites when the study is complete.  Upon exiting 
subjects, if the current follow-up visit and exit visit are combined, then both the follow-up CRF and a 
Study Exit CRF need to be completed but only one device interrogation/save-to-media needs to be 
completed and collected.  If AEs are unresolved at time of exit, it should be noted on the AE CRF that the 
AE is unresolved at time of study exit.   
15.15.2. Lost to Follow-up 
In the case that the subject is determined to be lost to follow-up, details of a minimum of two attempts 
and the method of attempt (e.g., one letter and one phone record or two letters) to contact the subject 
must be recorded.  In addition, follow the regulations set forth by the governing IRB or EC. 
15.15.3. Study Exit Upon Sponsor Request 
A subject must be exited from the study if the sponsor suspends study enrollment and a subject has 
signed the ICF but no implant attempt of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
has occurred (see Section 15.8.2.2). 
15.16. 
Subject Withdrawal or Discontinuation  
15.16.1. Subject Chooses to Exit (i.e. revokes consent) 
A subject can withdraw from the study at any time.  If the subject wishes to exit from the study (i.e. the 
subject revokes consent), the site is required to document the reason for exit on the Exit CRF.  In 
addition, study sites shall follow the regulations set forth by the governing Ethics Committee.  For 
countries following ISO 14155, permission may be requested to follow up with the patient outside of the 
study due to withdrawal based on problems related to the investigational feature safety or performance.  
If possible, the following data should be collected prior to subject withdrawal: 
• 
Report the reason for subject withdrawal 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
15.16.2. Investigator Withdraws Subject 
No subjects should be withdrawn by investigators unless compelling medical justification is present.  It is 
recommended investigators discuss any withdrawals with the study sponsor prior to exiting subjects.  If 

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an Investigator withdrawal is necessary, the following data should be collected prior to subject 
withdrawal if possible: 
• 
Report the reason for subject withdrawal 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
 The following are reasons for investigator-initiated subject withdrawal; 
Medical Necessity 
A subject may be exited from the study if an investigator feels it is necessary to withdraw the subject 
from the study due to a medical condition or other reason.  In such cases, the subject will be notified and 
provided an explanation regarding the reasons for the study exit. 
Explant of Medtronic CRT-P or CRT-D Device and Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) 
Subjects in which the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the Medtronic CRT-P 
or CRT-D device are explanted without replacement (i.e., subject no longer has a Medtronic CRT-P or 
CRT-D device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted) shall be 
exited from the study (refer to Section 15.8.2.2).  Subjects exposed to an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) through a lead attempt must be followed through at least one month or 
until all implant related AEs (system-, and/or procedure-related) have resolved or are unresolved with no 
further actions planned.  Subjects who have either an Attain Stability Quad MRI SureScan LV Lead (Model 
4798) (active or not active) or a Medtronic CRT-P or CRT-D device implanted will continued to be 
followed for safety until study completion. 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) Not Implanted 
Subjects that are not anticipated to have an implant attempt (e.g. do not meet inclusion/exclusion 
criteria) must be exited from the study.  Subjects that have a CRT system implant attempt, but who do 
not have an Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempted (See Section 15.8.2.2 
for definition) will be exited from the study following their procedure unless an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) attempt is scheduled.  If this attempt is more than 30 days from the 
baseline assessment, verification of the baseline data must be completed prior to a subsequent implant 
attempt. 
Subjects with an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant attempt 
will be followed at pre hospital discharge and one month unless there are ongoing implant related AEs 
(system- and/or procedure related), in which case they will be followed beyond one month until the 
implant related (i.e., system, and/or procedure related) AEs have been resolved or are considered 
unresolved with no further actions planned.  The subjects may be followed via a clinic visit or by phone 
contact.  In geographies where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is market-
released, subjects will be exited from the study after the assessment of implant procedure or CRT system 
related AEs if the initial attempt of one Attain Stability Quad MRI SureScan LV Lead (Model 4798) model 
was unsuccessful.  The subject may undergo implant attempts with any market released LV lead that 
provides the best benefit to the patient, but data collection on these subsequent attempts will not be 
required as these subjects will be considered exited from the study. 

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15.17. 
Assessment of Efficacy 
The primary efficacy objective is based on the pacing capture threshold data collected as discussed in 
Section 19.1.  
15.18. 
Assessment of Safety  
The primary safety objective is based on the Adverse Event data collected.  Further information on the 
collection of Adverse Events is discussed in Section 17.1.1.  
15.19. 
Recording Data 
The study will collect data using Oracle Clinical, an electronic data management system for clinical 
studies.  Sites will enter data onto CRFs within the Oracle Clinical database.  
Data reported on the CRFs shall be derived from source documents, which may include worksheets, 
patient medical records, programmer printouts and device interrogation/save-to-media files.  These 
source documents must be created and maintained by the investigational site team.  Further detail on 
data management is provided in Section 21.2. 
15.20. 
Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the Clinical 
Investigation Plan or the Clinical Trial Agreement.  
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, or 
makes a conscious decision to deviate.  In all geographies, prior approval is not required when a 
deviation is necessary to protect the safety, rights or well-being of a subject in an emergency or in 
unforeseen situations beyond the investigator’s control (e.g. subject failure to attend scheduled follow-up 
visits, inadvertent loss of data due to computer malfunction, inability to perform required procedures due 
to subject illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward.   
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis).  However, 
prior approval from Medtronic is required for such situations.  
All study deviations must be reported to Medtronic regardless of whether they are medically justifiable, 
pre-approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
The deviation must be recorded in Oracle Clinical with an explanation for the deviations.  In the 
occurrence of a corrupted device interrogation/save-to-media file, Medtronic will request a deviation to 
document that a readable device interrogation/save-to-media file is unavailable.  
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the IRB/EC as well as 
Medtronic as soon as possible but no later than five (5) working days, or according to local requirements.  
Reporting of all other study deviations should comply with IRB/EC policies and/or local laws and 
deviations must be reported to Medtronic as soon as possible upon the site becoming aware of the 
deviation.    

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Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, and 
terminate the study).  Repetitive or serious investigator compliance issues may result in initiation of a 
corrective action plan with the investigator and site, and in some cases, necessitate suspending 
enrollment until the problem is resolved or ultimately terminating the investigator's participation in the 
study.  Medtronic may provide site-specific reports to investigators summarizing information on deviations 
that occurred at the investigational site on a periodic basis. 
16. Risks and Benefits 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of the product, 
from the research and development phase through the study phase and market release.  The risk 
analysis process for the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is being performed in 
accordance with ISO 14971, and will ensure that the level of risk has been reduced as low as possible 
and is acceptable prior to starting the Attain Stability Quad Clinical Study.   
Potential Risks 
Standard risks associated with the medical device used in this study, an analysis of Adverse Device 
Effects and a history of modification or recall of device under investigation or equivalent devices are listed 
in the Instruction for Use Manual or Clinical Manual. 
The potential adverse events (listed in alphabetical order) related to the use of transvenous leads include, 
but are not limited to, the following conditions: 

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• 
Air embolism 
• 
Avulsion or other damage to the endocardium, valve, or vein (particularly in fragile hearts) 
• 
Cardiac dissection or perforation 
• 
Cardiac tamponade 
• 
Coronary sinus dissection  
• 
Death 
• 
Endocarditis or pericarditis 
• 
Erosion through the skin 
• 
Extracardiac muscle or nerve stimulation 
• 
Fibrillation or other arrhythmias 
• 
Heart Block 
• 
Heart wall or vein wall rupture 
• 
Hematoma/seroma 
• 
Infection 
• 
Lead conductor fracture or insulation failure 
• 
Lead dislodgement 
• 
Myocardial irritability 
• 
Myopotential sensing 
• 
Pericardial effusion or rub 
• 
Pneumothorax 
• 
Rejection phenomena (local tissue reaction, fibrotic tissue formation) 
• 
Threshold elevation or exit block 
• 
Thrombosis 
• 
Thrombotic embolism 
Additional potential adverse events related to the lead and the programmed parameters include, but are 
not limited to, the following: 
Table 10: Additional adverse events related to the lead and programmed parameters 
Potential adverse event 
Indicator of potential 
adverse event 
Corrective actions to 
consider 
Lead dislodgementi 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Reprogram the LV pacing 
polarity. Reposition the lead. 
Lead dislodgementi 
Intermittent or continuous 
oversensing 
Reprogram the LV pacing 
polarity. Reposition the lead. 
Lead conductor fracture 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Replace the lead. Reprogram the 
LV pacing polarity. 
Lead conductor insulation failure 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Replace the lead. Reprogram the 
LV pacing polarity. 
Threshold elevation or exit block 
Loss of capturei 
Adjust the implantable device 
output. Reprogram the LV pacing 
polarity. Replace or reposition 
the lead. 
I Transient loss of capture or LV EGM signal integrity (including sensing) may occur following surgery until 
lead stabilization takes place. If stabilization does not occur, lead dislodgement may be suspected. 

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Implant techniques that may damage the lead include, but are not limited to, the following techniques: 
Table 11: Implant Techniques that may damage the lead 
Implant techniques that may 
damage the lead 
Possible effects on the lead 
Corrective action to consider 
Forcing the lead through the 
introducer/delivery system 
Electrode, conductor coil, or 
insulation damage 
Replace the lead. 
Use of too medial of an approach 
with venous introducer resulting 
in clavicle and first rib binding 
Conductor coil fracture, insulation 
damage 
Replace the lead. 
Using too stiff a stylet 
Conductor coil/insulation 
perforation 
Replace the lead. 
Puncturing the periosteum or 
tendon when using subclavian 
introducer approach resulting in 
binding 
Conductor coil fracture, insulation 
damage 
Replace the lead. 
Advancing the lead through the 
non-coronary central access 
veins without the stylet or guide 
wire fully inserted 
Tip distortion or insulation 
perforation 
Replace the lead. 
Inserting the proximal end of the 
guide wire through the lead tip 
seal without using the guide wire 
insertion tool 
Lead tip seal damage or 
conductor coil/insulation damage 
Replace the lead. 
 
Subjects who are pregnant may be at increased risk (e.g., radiation exposure, and other unforeseen risk 
to the fetus), and are excluded from participation in the study.  If a subject becomes pregnant during the 
study, she must notify the physician immediately.  The subject will remain in the study for intention to 
treat analysis, but the investigator will avoid any procedures that may be determined harmful. 
There may be other discomforts and risks related to the CRT-P or CRT-D device, the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798), and/or this study that are not foreseen at this time.  Interactions 
with concomitant medical treatment are not expected. 
The adverse event collection requirements in this study will ensure that risks associated with the study 
device and the Attain Stability Quad MRI SureScan LV Lead (Model 4798) are adequately monitored.  
16.2. Risk Minimization 
Medtronic has minimized the risks to the subject by the following: 
• 
Performing required laboratory and pre-clinical testing prior to the Attain Stability Quad Clinical 
Study; this information is available under  separate cover in the RPI with the FDA IDE submission 
and the CER with the CE-Mark 
• 
Implementing quality control measures into development and production processes 
• 
Providing guidelines for subject selection and evaluation, and subject inclusion and exclusion 
criteria 
• 
Providing adequate instructions via the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
User Manual, training, and labeling 

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• 
Selecting implanters that have demonstrated previous experience with implanting CRT-P or CRT-
D devices and specifically LV leads 
• 
Selecting investigators that have demonstrated previous experience with the programming, 
interrogating, and monitoring of CRT-P or CRT-D devices 
• 
After enrollment in the Attain Stability Quad Clinical Study, at each protocol required follow-up, 
the investigator must interrogate the study device to verify appropriate study device function and 
to evaluate the subject’s health and assess for any AEs 
16.3. Potential Benefits 
The potential benefits of having the Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted 
are similar to other LV leads currently available to the public.  The Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) is expected to increase lead stability and reduce the need for patients to undergo an 
additional procedure to replace a dislodged/displaced lead.  Due to the active fixation helix, it may be 
possible to place the lead in veins of various sizes.  There is a possibility that the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) may offer no additional benefit over similar LV leads.  The 
information gained from this study could result in the improved management of other CRT patients. 
16.4. Risk-Benefit Rationale 
The risk-benefit analysis has shown that there are no major additional risks associated with the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798), other than those associated with the implant, while 
benefits to the patient are possible.  Any residual risk associated with this study is considered low and 
acceptable. 
17. Adverse Event Assessments 
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are crucial 
for the protection of subjects.  Reporting and analysis of safety data are mandated by regulatory 
authorities worldwide.  Medtronic has established procedures in conformity with worldwide regulatory 
requirements to ensure appropriate reporting of safety information.  This study is conducted in 
accordance with these procedures and regulations. 
Data collected in this study may be used in support of global regulatory approvals.  Since the safety 
reporting requirements and classification systems vary for each regulatory agency, requirements from all 
geographies are taken into account for the collection and reporting of safety information.  Adverse Events 
and Device Deficiencies will be reported in all geographies. 
17.1. Adverse Event and Device Deficiency Assessment 
17.1.1. 
Adverse Events 
Adverse Event definitions are provided in Table 12.   The following AEs will be collected throughout the 
study duration, starting at the time the informed consent form is signed:  

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• 
All procedure related AEs  
• 
All system related AEs 
• 
All accessory related AEs 
• 
All cardiovascular related AEs  
• 
All Serious Adverse Events (SAEs), regardless of relatedness  
Reporting of these events to Medtronic will occur on an AE Form, including date of AE, treatment, 
resolution, assessment of both the seriousness of the AE and the relatedness to the investigational device 
or procedure.  Each AE must be recorded on a separate AE eCRF.  Documented pre-existing conditions 
are not considered AEs unless the nature or severity of the condition has worsened.  In addition, AEs 
impacting users or other persons, Non-subject Adverse Events, (reportable per ISO 14155) will be 
collected.  
In all geographies, Unavoidable AEs, listed in Table 12, need not be reported unless the AE worsens or is 
present outside the stated timeframe post-implant.  
For AEs that require immediate reporting (see Table 14), initial reporting may be done by contacting the 
study sponsor per the sponsor contact information.  The original completed AE CRF must be submitted to 
Medtronic as soon as possible.   
Any medication, whether cardiovascular or not, associated with the treatment of an AE must be reported.  
Medication changes that are not related to adverse events will not be collected.  
Subject deaths are also required to be reported.  Refer to Section 17.4 for Subject Death collection and 
reporting requirements.  
17.1.2. 
Device Deficiencies 
Device deficiency (DD) information will be collected throughout the study and reported to Medtronic. 
Note that DDs that result in an Adverse Device Effect (ADE) to the subject should be captured as an AE 
only.  Device Deficiencies that did not lead to an AE but could have led to a Serious Adverse Device Effect 
(SADE) (i.e., if suitable action had not been taken, if intervention had not been made, or if the 
circumstances had been less fortunate) require immediate reporting (see Table 14).  For DDs that require 
immediate reporting, initial reporting may be done by contacting the study sponsor per the sponsor 
contact information. 
17.1.3. 
Event Updates and Resolution 
For any changes in status of a previously reported AE (i.e. change in actions taken, change in outcome, 
change in relatedness), information needs to be updated on, or added to the original AE form.  All AEs 
must be followed until the AE has been resolved, is unresolved with no further actions planned, the 
subject dies or exits the study, or until study closure, whichever occurs first.  
In the event that a subject is exited from the study prior to their 6 month visit, all efforts should be made 
to continue following the subject until all unresolved system or procedure related adverse events, as 
classified by the investigator, are resolved or unresolved with no further actions planned.  
At the time of study exit, all collected AEs with an outcome of ”Unresolved” must be reviewed and an 
update to the original AE must be reported.  At a minimum, if there are no changes to the description, 
relatedness, test and procedures or actions taken, the outcome must be updated to reflect “Unresolved 
at time of study exit”. 

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17.2. Definitions/Classifications 
Where the definition indicates “device”, it refers to any device used in the study.  This might be the 
device under investigation, or any market released component of the system, and includes but is not 
restricted to: the CRT-P or CRT-D  device, the RA, RV or LV leads, the programmer, and implant tools.   
Table 12: Adverse Event and Device Deficiency Definitions 
General 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
 
NOTE 1: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the 
procedures involved. 
NOTE 3: For users or other persons, this definition is 
restricted to events related to investigational medical 
devices. 
(ISO 14155:2011, 3.2) 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational 
medical device 
 
NOTE 1: This definition includes adverse events resulting 
from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from 
an error use or from intentional misuse of the 
investigational medical device. (ISO 14155:2011, 3.1) 
Device Deficiency (DD) 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance.  
 
NOTE: Device deficiencies include malfunctions, use errors 
and inadequate labeling (ISO 14155:2011, 3.15) 
Relatedness 
Procedure Related 
An Adverse Event that is directly related to the implantation 
or surgical modification of the system.  
 
NOTE: In general, this excludes events that are inherent to 
any surgical procedure (e.g. anesthesia complications) as 
well as indirect subsequent consequences of the procedure 
(e.g. reaction to pain medication). 

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System Related 
 
 
(includes all implantable 
components and features, 
associated introduction tools, 
operational and installed software 
and programmers as defined in the 
Clinical Investigation Plan) 
An adverse event that results from the presence or 
performance of any component of the system. 
 
Device-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the 
device.  
RA lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the RA 
lead.  
RV lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the RV 
lead.  
LV lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the LV 
lead.  
a) LV Lead Fixation-related: An adverse event that 
results from the presence or performance of the 
side-helix. 
 
Accessory Related 
Programmer Related:  An adverse event that results from 
the presence or performance (intended or otherwise) of the 
programmer 
 
Implant tool-related: An adverse event that results from 
the presence or performance (intended or otherwise) of the 
implant tool.  
Cardiovascular Related 
An Adverse Event relating to the heart and the blood 
vessels or the circulation (e.g. Atrial Fibrillation, Myocardial 
Infarction, stroke, perivascular disease) 
Heart Failure Related 
An adverse event related to worsening heart failure signs 
and symptoms such as hypervolemic and hypovolemic 
status requiring the administration, alteration, adjustment 
or augmentation of HF therapy (diuretics, inotropes and/or 
vasodilators etc.) or the utilization of ultrafiltration devices. 
MRI Related 
An adverse event which is caused by the interaction 
between the pacing system and the MRI system that occurs 
during the MRI procedure and up through the one-month 
post-MRI/waiting period follow-up visit. 

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Not Related 
Relationship to the device or procedures can be excluded 
when: 
 
The event is not a known side effect of the product 
category the device belongs to or of similar devices 
and procedures; 
 
The event has no temporal relationship with the 
use of the device or the procedures; 
 
The serious event does not follow a known 
response pattern to the medical device (if the 
response pattern is previously known) and is 
biologically implausible; 
 
The discontinuation of medical device application or 
the reduction of the level of activation/exposure – 
when clinically feasible – and reintroduction of its 
use (or increase of the level of activation/exposure) 
do not impact the serious event; 
 
The event involves a body-site or an organ not 
expected to be affected by the device or 
procedure; 
 
The serious event can be attributed to another 
cause (e.g., an underlying or concurrent 
illness/clinical condition, an effect of another 
device, drug, treatment, or other risk factors); 
 
The event does not depend on a false result given 
by the device used for diagnosis (when applicable); 
 
Harm to the subject are not clearly due to use 
error; 
 
In order to establish the non-relatedness, not all 
the criteria listed above might be met at the same 
time, depending on the type of device/procedures 
and the event. 
Unlikely 
The relationship with the use of the device seems not 
relevant and/or the event can be reasonably explained by 
another cause, but additional information may be obtained. 
Possible 
The relationship with the use of the investigational device is 
weak but cannot be ruled out completely. Alternative 
causes are also possible (e.g. an underlying or concurrent 
illness/ clinical condition or/and an effect of another device, 
drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also 
be classified as possible. 

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Probable 
The relationship with the use of the investigational device 
seems relevant and/or the event cannot reasonably 
explained by another cause, but additional information may 
be obtained.  
Causal Relationship 
The event is associated with the device or study procedures 
beyond reasonable doubt when: 
 
The event is a known side effect of the product 
category the device belongs to or of similar devices 
and procedures; 
 
The event has a temporal relationship with device 
use/application or procedures; 
 
The event involves a body-site or organ that the 
device or procedures are applied to or the device or 
procedures have an effect on; 
 
The serious event follows a known response 
pattern to the medical device (if the response 
pattern is previously known); 
 
The discontinuation of medical device application 
(or reduction of the level of activation/exposure) 
and reintroduction of its use (or increase of the 
level of activation/exposure) impact on the serious 
event (when clinically feasible); 
 
Other possible causes (e.g., an underlying or 
concurrent illness/clinical condition or/and an effect 
of another device, drug, or treatment) have been 
adequately ruled out; 
 
Harm to the subject is due to error in use; 
 
The event depends on a false result given by the 
device used for diagnosis (when applicable); 
 
In order to establish the relatedness, not all the 
criteria listed above might be met at the same 
time, depending on the type of device/procedures 
and the serious event. 
 
 
 
 
 
 
 
 

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Seriousness 
Serious Adverse Event (SAE) 
 
Adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the 
subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or 
a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-
threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c) led to fetal distress, fetal death or a congenital 
abnormality or birth defect 
 
NOTE 1: Planned hospitalization for a pre-existing 
condition, or a procedure required by the CIP, without 
serious deterioration in health, is not considered a serious 
adverse event. 
(ISO 14155:2011, 3.37)  
Serious Adverse Device Effect 
(SADE)  
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
(ISO 14155:2011, 3.36)  
Unanticipated Adverse Device Effect 
(UADE) 
 
Any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated 
with, a device, if that effect, problem, or death, was not 
previously identified in a nature, severity, or degree of 
incidence in the investigational plan or application 
(including a supplementary plan or application), or any 
other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of 
subjects. (21 CFR 812.3(s)) 
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in 
the current version of the risk analysis report 
 
NOTE 1: Anticipated serious adverse device effect (ASADE) 
is an effect which by its nature, incidence, severity or 
outcome has been identified in the risk analysis report. 
(ISO 14155:2011, 3.42)  

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Complication 
An adverse event that includes the following is considered a 
complication:  
• 
Results in death,  
• 
Involves any termination of significant device 
function, or  
• 
Requires an invasive intervention  
 
Non-invasive (21 CFR 812.3 (k)): when applied to a 
diagnostic device or procedure, means one that does not 
by design or intention:  Penetrate or pierce the skin or 
mucous membranes of the body, the ocular cavity, or the 
urethra, or enter the ear beyond the external auditory 
canal, the nose beyond the nares, the mouth beyond the 
pharynx, the anal canal beyond the rectum, or the vagina 
beyond the cervical os 
 
Note (FDA): Blood sampling that involves simple 
venipuncture is considered noninvasive, and the use of 
surplus samples of body fluids or tissues that are left over 
from samples taken for non-investigational purposes is also 
considered noninvasive. 
 
*** Only system or procedure related AEs will be classified 
as complication or observation 
Observation 
Any Adverse Event that is not a complication. 
 
*** Only system or procedure related AEs will be classified 
as complication or observation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Other 
Unavoidable Adverse Event 
An Adverse Event inherent to a surgical procedure that is 
expected to occur in all subjects for a projected duration 
according to the Investigator’s opinion, including, but not 
limited to:  
 
Event Description 
Timeframe 
(hours) 
from the 
Surgical 
Procedure 
Anesthesia related nausea / vomiting  
24 
Low-grade fever (<100°F or 37.8°C) 
48 
Pocket site / Incisional pain 
72 
Mild to moderate bruising / ecchymosis 
168 
Sleep problems (insomnia) 
72 
Back pain related to laying on table 
72 
Shoulder pain/discomfort/stiffness 
related to shoulder immobilization 
during procedure 
72 
 
17.3. Reporting of Adverse Events 
17.3.1. 
Adverse Events and Device Deficiency Classification 
All reported AEs and DDs will be reviewed by a Medtronic representative.  Adverse Events will be 
classified according to the definitions provided. 
Upon receipt of AEs at Medtronic, a Medtronic representative will review the AE/DD for completeness and 
accuracy and when necessary will request clarification and/or additional information from the 
Investigator.  Medtronic will utilize the Medical Dictionary for Regulatory Activities (MedDRA), to assign a 
MedDRA term for each AE based on the information provided by the investigator.  
Regulatory reporting of AEs and DDs that could have led to an SADE will be completed according to local 
regulatory requirements.  Refer to Table 14 for a list of required investigator and Medtronic reporting 
requirements and timeframes.  It is the responsibility of the investigator to abide by any additional AE 
reporting requirements stipulated by the IRB/EC responsible for oversight of the study. 
APPENDIX 1 contains the Foreseeable Adverse Event List (FAL), which is a list of adverse events related 
to the system or procedure that have been observed in previous studies and may be experienced by 
subjects.  This list may help to assess if an AE is unanticipated in nature.   
For emergency contact regarding a UADE, SAE and/or SADE, contact a Attain Stability Quad Clinical Study 
representative immediately (refer to the study contact list provided in the site’s study documents 
binder/investigator site file or refer to the Sponsor Contact Information section provided in the CIP). 
Adverse Events and Deaths will be classified according to the standard definitions as outlined below:  

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Table 13: Adverse Event Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Relatedness 
Investigator 
Device, RA Lead, RV Lead, LV Lead, Implant Tool(s), 
Programmer, Procedure, Cardiovascular, Heart Failure, 
MRI 
Sponsor 
Device, RA Lead, RV Lead, LV Lead, Implant Tool(s), 
Programmer, Procedure 
Seriousness 
Investigator 
SAE  
Sponsor 
SAE, UADE/USADE, Device Deficiency with SADE potential 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided by 
Investigator 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-Cardiac, 
Unknown 
An independent Clinical Events Committee (CEC) will review and adjudicate, at a minimum, all events 
classified by the investigator or Medtronic as procedure or system related to determine relatedness and 
complication or observation classifications.    In addition, the CEC will also review and adjudicate all 
Adverse Events resulting in death. 
17.3.2. 
Adverse Events and Device Deficiency Reporting Requirements 
Regulatory reporting of AEs and device deficiencies will be recorded and reported according to local 
regulatory requirements.  It is the responsibility of the Investigator to abide by the adverse event 
reporting requirements stipulated by local law and the site’s IRB/EC.  
Table 14: Reporting Requirements 
Serious Adverse Events (SAEs) 
Investigator submit to: 
Medtronic 
Canada: Investigators are required to report SAEs to the sponsor immediately except for 
those SAEs that the protocol or other document (e.g. Investigator’s Brochure (IB)) identifies 
as not needing immediate reporting.   The immediate reports should be followed promptly by 
detailed, written reports.  
Medical Devices Regulations, sections 59-61.  A guidance for “immediately” is within 72 hours 
of the investigator becoming aware of the event;  Report to sponsor, without unjustified 
delay ISO 14155:2011, sec 9.8.b). 
EMEA: Immediately after the investigator first learns of the event or new information in 
relation with an already reported event.  
All geographies: Report to the sponsor, without unjustified delay, all serious adverse 
events. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies:  Submit to Ethics Committee per local reporting requirement. 

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Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Adverse Device Effects (ADEs),  
Investigator submit to: 
Medtronic 
EMEA: Immediately after the investigator first learns of the event or new information in 
relation with an already reported event. 
All geographies: Submit in a timely manner after the investigator first learns of the effect. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Serious Adverse Device Effects (SADEs), Unanticipated Adverse Device Effects (UADEs), 
Unanticipated Serious Adverse Device Effects (USADEs),  
Investigator submit to: 
Medtronic 
US: Submit as soon as possible, but no later than within 10 working days after the 
investigator first learns of the event.  (21 CFR 812.150(a)(1)) 
Canada: SADEs on the patient, the user or any other person must be reported to the 
Sponsor within 72 hours after it comes to the attention of the qualified investigator. 
It is recommended for the investigator to report safety events as soon as possible but no 
longer than 15 calendar days.”  
All geographies:  Immediately after the investigator learns of the event or of new 
information in relation to an already reported event. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement 
Ethics 
Committee 
All geographies: Submit to Ethics Committees per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies:  Submit to Ethics Committee per local reporting requirement. 
Investigators All geographies: Submit per local reporting requirement. 

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All other reportable Adverse Events  
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the event. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Device Deficiencies with SADE potential 
Investigator submit to: 
Medtronic 
Canada: DDs that have resulted in any of the consequences characteristic of an SAE on the 
patient, the user or any other person or could do so were it to reoccur must be reported to 
the Sponsor within 72 hours after it comes to the attention of the qualified investigator 
EMEA: Immediately after the investigator first learns of the deficiency or of new information 
in relation with an already reported deficiency. 
All other geographies: Submit or report as required per local reporting requirements. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
All other Device Deficiencies 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the 
deficiency. 
Regulatory 
authorities 
Canada: any DD that: 
a. 
has resulted in any of the consequences characteristic of an SAE on the patient, 
the user or any other person; These must be reported by Medtronic to the 
Regulator within 10 days from the date Medtronic becomes aware. 
or 
b. 
could do so were it to reoccur.  These must be reported by Medtronic to the 
Regulator within 30 days from the date Medtronic becomes aware. 
 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 

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17.4. Subject Death 
17.4.1. 
Death Data Collection 
All subject deaths must be reported by the investigator to Medtronic on an AE form (AE with outcome of 
death) as soon as possible after the investigator first learns of the death.  In case of death, there should 
be one SAE with the outcome of death reported.  
In the event of a subject’s death, it is recommended that the implanted system be explanted and 
returned to Medtronic for analysis whenever possible per local process.  Local laws and procedures must 
be followed where applicable. 
System Interrogation Data Recommendations: 
• 
After the subject has died but prior to explant, it is strongly recommended that the system be 
interrogated and a full summary interrogation (Interrogate All) performed when possible, and 
saved in a digital format (Save-to-Media).  Store one copy of the save-to-media at the site and 
send a copy to Medtronic.   
• 
Make the device interrogation/save-to-media file before any programming to prevent overwriting 
information in the device’s memory and/or distinguishing between events detected during versus 
before the explant procedure. 
• 
Recommend obtaining the exact date and time of death as lower temperatures after death can 
cause ERI and other “event flags” to be stored in the device memory. 
If the system is not interrogated, an explanation must be entered on the AE form.  For ICD systems, the 
ventricular tachycardia (VT) and ventricular fibrillation (VF) detection capabilities must be disabled to 
avoid inadvertent shocks.  If any system component is returned to Medtronic, internal return product 
reporting systems may be used to gather additional information about the returned device/component. 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic Attain Stability Quad Clinical Study team.  When a death occurs in a hospital, a copy of the 
death summary report and all relevant hospital records should be sent to the Medtronic Attain Stability 
Quad Clinical Study team, if available.  If an autopsy is conducted, the autopsy report should also be sent 
to the Medtronic Attain Stability Quad Clinical Study team if available and allowed by state/local law.  
When the death occurs at a remote site, it is the investigative site’s responsibility to attempt retrieval of 
information about the death.  Additionally, device disposition information should be updated.  In 
summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death  
• 
Relatedness to system and/or procedure 
• 
Device interrogation and Save-to-Media (if available) 
• 
Device disposition information 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and allowed by state/local law) 

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17.4.2. 
Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. The Investigator 
shall classify each subject death per the following definitions: 
Cardiac Death: A death directly related to the electrical or mechanical dysfunction of the heart. 
Sudden Cardiac Death (SCD): Natural death due to cardiac causes, indicated by abrupt loss of 
consciousness within one hour of the onset of acute symptoms; preexisting heart disease may have been 
known to be present, but the time and mode of death are unexpected. If time of onset cannot be 
determined, SCD will alternatively be defined as any unexpected cardiac death occurring out of the 
hospital or in the emergency room as dead on arrival. 
Non-sudden Cardiac Death: All cardiac deaths that are not classified as sudden deaths, including all 
cardiac deaths of hospitalized subjects on inotropic support. 
Non-cardiac Death: A death not classified as a cardiac death. 
Unknown Classification: Unknown death classification is intended for use only when there is insufficient or 
inadequate information to classify the death. 
Table 15: Subject Death Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-cardiac, 
Unknown 
The Clinical Events Committee will review all deaths and provide a final adjudication of the death 
classification.  
Regulatory reporting of Subject Deaths will be completed according to local regulatory requirements.  
17.5. Product Complaint Reporting 
Product complaint reporting and vigilance reporting are applicable and AEs related to any market-
released device during the study must be reported.  The reporting of product complaints is not part of 
the Attain Stability Quad Clinical Study and should be done in addition to the AE reporting requirements.  
Refer to local regulations for reporting requirements.  
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that has 
been placed on the market. 
• 
Abuse: Abnormal use (definition acc. #4.1 of Meddev 2.12-1 rev8) 
• 
Misuse: Use error (definition acc. #4.20 of Meddev 2.12-1 rev8) 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse of 
the product.  Reporting must be done immediately and via the regular channels for market-released 
products.  The reporting of product complaints by the clinical team must be done according to the local 
Standard Operating Procedures.  Medtronic will notify the regulatory authorities (e.g. Competent 
Authority) as applicable for the following incidents immediately upon learning of them: 

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• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as 
any inadequacy in the labeling or instructions for use which led or might have led to the death or 
serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
• 
Any serious deterioration in the state of health, including: 
o 
Life-threatening illness or injury 
o 
Permanent impairment of a body function or permanent damage to a body structure 
o 
A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 
18. Data Review Committees  
18.1. Clinical Events Committee 
The study will utilize a Clinical Events Committee (CEC). At regular intervals, an independent CEC will 
review events and adjudicate at a minimum all system, and procedure-related events.  Additionally, the 
CEC will provide an adjudication of the death classification for all reported deaths. 
The CEC will consist of a minimum of three (3) non-Medtronic-employed physicians that are not 
participating investigators for the study, including a CEC chairperson.  
Medtronic personnel may facilitate and participate in CEC meetings but will be non-voting members. 
For AEs and deaths reviewed by the CEC, Medtronic will provide the CEC with the Investigator’s 
description and classification and supportive documentation (when available).  The CEC is responsible for 
reviewing the Investigator’s assessment and supportive documentation (when available), reviewing 
applicable definitions, and determining final classifications for all adjudication parameters. For AEs, 
classification includes system/procedure relatedness and complication or observation.  Additionally, the 
CEC will provide an adjudication for all reported deaths, including system/procedure relatedness and 
cardiac relatedness. 
If the CEC disagrees with the investigator’s classification of the event, the difference will be provided to 
the investigator.  If the investigator agrees with the CEC’s adjudication, the CRF documenting the AE will 
be updated accordingly. 
If the investigator does not agree with the CEC’s adjudication classification, both determinations will be 
provided within the final report; however the CEC’s adjudication will be used for data analysis.  The 
disagreement will also be included in reporting to ethics committees and regulatory authorities, if 
required. 
 
 

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18.2. Data Monitoring Committee 
A Data Monitoring Committee (DMC) will not be utilized for this study considering: 
 
• 
An independent CEC will be formed to adjudicate at minimum all system and procedure related 
events and all deaths. 
• 
This study does not meet FDA’s recommended criteria (Guidance for Clinical Trial Sponsors: 
Establishment and Operation of Clinical Trial Data Monitoring Committees) for when a study 
should use a DMC, primarily because the study is not evaluating the effectiveness of a treatment 
intended to prolong life or reduce the risk of a major adverse health outcome. 
• 
As a result of risk analysis and mitigation efforts as outlined in Section 16, any residual risk 
associated with this study is considered low and acceptable. 
• 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is a modification of the currently 
market approved Attain Performa lead Models 4298, 4398, and 4598 is a modification of the 
currently market approved Model 4396 LV lead.  The Attain Stability Quad lead Model 4798 has a 
similar electrode spacing as the Attain Performa lead Models 4298, 4398, and 4598.  
• 
Study will be conducted under FDA oversight via an investigational device exemption (IDE). 
19. Statistical Design and Methods 
This section presents statistical considerations for the study design and provides a high-level description 
of planned analysis and reporting.  More details will be given in a separate Statistical Analysis Plan (SAP) 
that will be completed before data freeze for the primary objective analysis.  Any deviation to the pre-
specified statistical analyses will be noted in the study report.  The analysis of the study objectives will be 
completed when the sample size requirements (see Table 18) for all the study primary and secondary 
objectives are met.  An interim analysis will be conducted when 360 subjects are enrolled in the study.  
This interim analysis is specifically designed for one of the secondary objectives (details in Section 
19.2.2). 
19.1. Primary Objectives 
19.1.1. 
Primary Safety Objective 
Objective 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered safe if the probability of 
subjects free of Model 4798 lead-related complications at 6 months post-implant is greater than 87% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 87%). 
Hypothesis: 
H0: S(6-month) ≤ 87% 
H1: S(6-month) > 87% 
where S6-month is the probability that a subject remains free from Model 4798 lead related complications 
through 6 months since implant. 
Endpoint Justification 
The study primary safety endpoint is Attain Stability Quad MRI SureScan LV Lead (Model 4798) related 
complications.  All reported system and procedure-related AEs will be reviewed by an event review 
committee  for LV lead relatedness and severity (see Section 18.1).  

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Utilizing lead related complication free survival probability to evaluate lead safety performance is widely 
accepted across cardiac device manufacturers and in the medical literature.  Current already market-
released Quadripolar LV lead 6-month safety performance is summarized in Table 16.  The population 
performance of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is expected to be similar to 
the Medtronic Attain Performa Model 4298 lead. 
Table 16: Safety Performance of Market Released Quadripolar Lead 
 
Medtronic  
Attain Performa20 
St. Jude Medical 
Quartet22  
Boston Scientific 
ACUITY X423 
6-month LV 
Lead 
Complication 
Free 
Survival 
Probability 
Estimate 
Model 4298 (Canted): 96.0% 
Model 4398 (Straight): 98.8% 
Model 4598 (S-shape): 96.2% 
96% at 3 months 
Straight: 96.5%  
Spiral: 98.5%  
Statistical Analysis Methods  
The primary objective will be analyzed using the time-to-first event Kaplan-Meier survival analysis 
method.  Time 0 will be the day a subject undergoes the implant procedure of a Attain Stability Quad 
MRI SureScan LV Lead (Model 4798), which will be independent of success status of this implant 
procedure. Event date is the onset date of a subject’s first complication that is related to the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) according to CEC adjudication.  Subjects who 
undergo an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant attempt and do not 
experience any LV lead related complications will be censored at the time of their last known exposure to 
the Attain Stability Quad MRI SureScan LV Lead (Model 4798) for the survival analysis.  For any lost-to-
follow up subject, the last contact date will be used as the censor date.  The 1-sided 97.5% confidence 
limit lower bound for the survival probability at 6 months (183 days) will be calculated using the log-log 
survival function approach (Kalbfleisch and Prentice 2002).  
Sample Size Consideration 
The primary safety objective performance criterion is set to be identical to Medtronic’s Attain Performa 
Clinical Study (IDE Number: G120213).  Therefore, the sample size calculation assumptions are derived 
based on the Model 4298 lead study results.  The Attain Performa Model 4298 lead reported a 6-month 
complication free survival probably of 96.0%, with 97.5% Confidence Lower Limit of 94.3% (PMA-s 
clinical report).  
The binomial calculation (Z-test) is used for initial sample size estimation.  In order to preserve the 
overall study power, a type II error less than 10% was used for the sample size calculation.  A sample 
size of 170 subjects completing their 6-month visit achieves greater than 90% power to detect a 
difference of 7% using the one-sided binomial test.  The target significance level is 0.025.  These results 
assume that the population proportion under the null hypothesis is 87% with an expected value of 94% 
(Figure 5). To account for 15% attrition, the enrollment size for this objective is 200. 

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Figure 5: Primary Safety Objective Sample Size Consideration by Difference Performance 
Assumption 
 
Determination of Patients / Data for Analysis 
All consented subjects who undergo an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant 
attempt will be included in the analysis cohort.  If a patient experiences multiple Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) implant procedures during the study, the analysis cohort will only 
consider the first procedure.  In the event multiple complications occur, the survival analysis endpoint is 
reached when the first Attain Stability Quad MRI SureScan LV Lead (Model 4798) related complication 
occurs. 
19.1.2. 
Primary Efficacy Objective #1 
Objective 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet the first primary efficacy 
objective if the proportion of subjects with at least one Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) pacing vector having a pacing capture threshold (PCT) less than or equal to 2.5 V at 0.5ms 
pulse width (with absence of PNS at 5.0 V) at 6 months post-implant is greater than 80% (i.e., the lower 
bound of the one-sided 97.5% confidence interval must be greater than 80%). 
Hypothesis 
H0: P16-month ≤ 80% 
HA: P16-month > 80%, 
where P16-month is the proportion of subjects with pacing voltage thresholds ≤ 2.5V at 0.5ms (with 
absence of PNS at 5.0 V) at 6 months follow-up visit post-implant for at least one LV lead pacing vector. 
Endpoint Justification 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is equipped with the identical four 
electrodes to the Attain Performa LV leads.  At the same time, the unique fixation mechanism may cause 
the distal end of the lead (tip) to be implanted away from the apical region of the heart, and therefore 
90.3%
90.8%
60.0%
65.0%
70.0%
75.0%
80.0%
85.0%
90.0%
95.0%
100.0%
170
180
190
200
210
220
Power
Sample Size at 6 months
0.93
0.94
0.95
0.96

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the PCT may be slightly higher than the values observed in other Quadripolar LV leads.  Therefore, we 
simulated the lead pacing threshold values based on the Attain Performa IDE study data, but excluding 
the PCT values collected at the most distal electrode.  The simulation estimated that 89% of the subjects 
will achieve this endpoint (Figure 6). 
Figure 6: Simulated PCT Distribution 
 
 
Statistical Analysis Methods 
All subjects with valid pacing thresholds measured at the 6 month follow-up visit will be included in this 
analysis.  The proportion of subjects having at least one LV lead pacing vector with voltage thresholds 
less than or equal to 2.5V (with absence of PNS at 5.0 V) will be calculated.  The lower bound of the 1-
sided 97.5% Confidence Interval will be calculated using the Exact binomial method.  Any subject in 
which no valid pacing threshold value is measured  or who has an unable-to-capture result via all LV lead 
pacing vectors will be reviewed and adjudicated for a possible lead related AE but will not be included for 
this evaluation if the occurrence is deemed to be a system related event (e.g. lead dislodgement). 
However, this event may be counted against the safety primary endpoint based on the CEC’s final 
classification. 
Sample Size 
The primary efficacy endpoint will be analyzed using the Exact binomial method.  In order to preserve the 
overall study power, a type II error less than 10% was used for the sample size calculation.  A sample 
size of 145 subjects achieves 91% power to detect a difference of 0.1 using a one-sided binomial test at 
a target significance level of 0.025.  These results assume that the population proportion under the null 
hypothesis is 80%, with an expected proportion of 90%.  
 
 

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Determination of Patients / Data for Analysis 
All subjects enrolled into this study satisfying the following conditions will be included in this analysis: 
• 
Successfully implanted with a Medtronic Quad CRT-P or CRT-D  device and Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) 
• 
Completed 6-month follow-up visit  
• 
Initially implanted Attain Stability Quad MRI SureScan LV Lead (Model 4798) is active at the 6–
month follow-up visit 
• 
At least one available and valid pacing threshold at the 6-month follow-up visit 
19.1.3. 
Primary Efficacy Objective # 2 
Objective 
The Attain Stability Quad lead will meet the second primary efficacy objective if the proportion of subjects 
with at least one additional (or second) LV lead pacing vector having a pacing capture threshold less than 
or equal to 4.0 V at 0.5ms pulse width (with absence of PNS at 5.0 V) at 6 months post-implant is greater 
than 80% (i.e., the one-sided 97.5% lower confidence bound must be greater than 80%).  
Hypothesis 
H0: P26-month ≤ 80% 
HA: P26-month > 80%, 
where P26-month is the proportion of subjects with at least one additional LV lead pacing vector with pacing 
voltage thresholds ≤ 4.0V at 0.5ms (with absence of PNS at 5.0 V) at 6 months post-implant follow-up 
visit. 
Endpoint Justification 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) has 16 LV programmable pacing vectors .  
Subjects may have the pacing configuration programmed or reprogrammed at each clinic visit.  A pacing 
threshold of 4.0 V (with absence of PNS at 5.0 V) will allow an adequate safety margin for programming 
LV pacing output.  The maximum pacing amplitude of the CRT-P or CRT-D devices capable of 
programming pacing output to any LV lead pacing vector is 8.0V.  In actual clinical practice, a less than 
3V safety margin is used for the programmed LV lead pacing output in 99% of the patients.  
Statistical Analysis Methods  
The efficacy endpoint #2 will be analyzed using the Exact binomial method.  The proportion of subjects 
with at least 2 LV lead pacing vectors  having voltage thresholds less than or equal to 4.0V at 0.5ms 
(with absence of PNS at 5.0 V) will be calculated.  The lower bound of the 1-sided 97.5% Confidence 
Interval will be calculated using the Exact binomial method.  Any subject in which no valid pacing 
threshold values are measured  or with an  Unable-to-capture result via all LV lead  pacing vectors  will 
be reviewed and adjudicated for possible lead related complications, and therefore may be counted 
against the study safety endpoint.  However, it will be counted as a failure if there is not any additional 
LV lead pacing vectors  (excluding the vector that is already include for the efficacy endpoint #1) are 
unable to capture with no lead related events reported. 
Sample Size 
The Attain Performa Model 4298 LV lead observed 97.7% subjects who were able to obtain a non-
programmed pacing vector with PCT less than or equal to 4 volts (with absence of PNS at 5.0 V).  A 
sample size of 50 subjects completing the 6 month visit achieves 98% power to detect a difference of 

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0.18 using a one-sided binomial test at a target significance level of 0.025.  These results assume that 
the population proportion under the null hypothesis is 80%, with the expected proportion of 97%.  
Determination of Patients / Data for Analysis 
All subjects enrolled into this study satisfying the following conditions will be included in this analysis: 
• 
Successfully implanted with a Medtronic Quad CRT-P or CRT-D  device and Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) 
• 
Completed 6-month follow-up visit  
• 
Initially implanted Attain Stability Quad MRI SureScan LV Lead (Model 4798) lead is active at the 
6–month follow-up visit 
• 
At least one available and valid pacing threshold at the 6-month follow-up visit. In the event a 
subject failed to provide more than one valid pacing threshold value, that subject will be 
considered as not having at least one additional LV lead pacing with PCT ≤ 4.0V at 0.5ms at 6 
months post-implant follow-up visit 
19.2. Secondary Objectives  
19.2.1. 
Secondary Objective # 1 
Objective - Implant procedure related information: success rate, implant related times 
The Attain Stability Quad LV lead implant success rate will be estimated as the number of subjects with 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) successfully implanted divided by the total 
number of subjects who had a Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant 
attempt.  A 2-sided 95% Confidence Interval will be calculated using the Exact Binomial method. 
The distribution of implant related times will be summarized through statistical summaries such as mean, 
standard deviation, minimum, median and maximum.  Only subjects with the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) successfully implanted will be included in this calculation.  The total 
implant time is defined as time from initial incision to final skin closure.  Fluoroscopy time is defined as 
the total time the fluoroscope is imaging.  Cannulation time is defined as the time from insertion of the 
first CS cannulation catheter to the first successful CS cannulation.  Successful lead placement time is 
defined as the time from lead insertion of the successfully placed lead to the time when the lead is placed 
in its first acceptable pacing location.   
19.2.2. 
Secondary Objective # 2 
Objective - 6-month reliability: post implant lead failure modes  
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is a composite of two existing market 
released Medtronic products.  The helix fixation is identical to the Attain Stability LV Lead Model 
20066/4796 (market released outside of the US).  The remainder of the lead is similar to the Attain 
Performa LV Lead Model 4298, released worldwide.   
Historical datasets will be used as informative priors for lead related complications.  More specifically, 
analysis of all complications related to fixation (helix performance) will use data from the Attain Stability 
(Model 20066/4796) research study, conducted outside of the US21.  Analysis of all other lead related 
complications will use data from the Attain Performa clinical study, conducted globally.  Credible intervals 
will be constructed for each individual failure mode within the two groups. 
 
 

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Historical Data (for secondary endpoints only) 
o 
Fixation-related LV lead complications - Data from the 37 patients who completed 6-
month follow up with a successfully implanted 20066 lead in the Attain Stability study will 
be used as an informative prior.  
o 
All other LV lead-related complications - Data from the 401 patients who completed 6-
month follow up in the Attain Performa 4298 study will be used as an informative prior. 
These historical datasets will be down weighted such that their effective sample size will not exceed the 
9% of the total sample size (i.e. at most 37 subjects at 6 months). 
Statistical Analysis Methods 
The weighted historical data will be incorporated using the power prior method24.  The weight of the 
historical data will be adjusted using a loss function25, which scales from 0 to 1 according to the similarity 
of the historical and observed data.  This loss function adjusts the amount of weight the prior receives.  
The comparison between historical and observed data will be performed twice, once for each group of 
complications (fixation-related and all other).  The objective of using a loss function with the power prior 
method is to reduce the influence of an informative prior in the parameter estimation, when the historical 
data does not agree with the current study data.  
If analysis of failure rate shows a high level of agreement between historical and current study data or 
there is better performance for Attain Stability Quad MRI SureScan LV Lead (Model 4798) compared to 
historical data, the historical data will be weighted at or near a maximum level (9% of total effective 
sample size).  If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) performs worse than 
historical data, the historical data will receive very little or zero weight.  Note that there will be two loss 
function weights, one for fixation-related complications and one for all other complications.  Credible 
interval calculations will be done separately for individual failure modes within the two groups of 
complications (fixation and all other).  
Denote by ߠ௖ and ߠ௛ the probabilities of lead complication for the current and historical studies 
respectively.  The posterior distributions of ߠ௖ and ߠ௛ respectively, both with minimally informative priors 
are: 
ߠ௖ൌܾ݁ݐܽሺݕ௖൅1, ݊௖െݕ௖൅1ሻ 
ߠ௛ൌܾ݁ݐܽሺݕ௛൅1, ݊௛െݕ௛൅1ሻ 
These posterior distributions are then stochastically compared using a posterior Bayesian p-value26 as: 
݌ൌܲሺߠ௖൑ߠ௛ሻ 
The desired characteristics for the loss function are: 
1. For ݌൒~0.5, there is a high level of agreement between current and historical data, therefore 
the loss function should allow a଴ to be close to 1, allowing for full weight of historical data.  
2. Conversely, for ݌൏~0.5, there begins to be evidence of disagreement between current and 
historical data, and a଴ should start to down-weight the prior, i.e. a଴ approaches zero as ݌ 
approaches zero. 
The Weibull cumulative distribution function (CDF) meets these criteria: 
ܽ଴ൌ1 െ݁ିሺ௣∗ହሻమ 

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Note that for the case where the number of samples in the prior is different than the effective number, a 
scaling factor will be applied, where ݊௛ is the desired effective number of prior samples and ܰ௛ is the 
actual number of prior samples: 
ܽ଴ൌ݊௛
ܰ௛
ൣ1 െ݁ିሺ௣∗ହሻమ൧ 
Sample values are listed in Table 17 below and illustrated in Figure 7.  The comparison between current 
and historical data will be performed for all LV lead fixation related complications using Attain Stability 
(Model 20066) historical data and for all other LV lead related complications using Attain Performa 
historical data. 
Table 17: Prior weight from Attain Stability (Model 20066) and prior weight from Attain 
Performa as a function of the posterior Bayesian p-value (࢖) 
 
Prior weight from Attain 
Stability (Model 20066) 
Prior weight from Attain 
Performa 
࢖ 
ܽ଴ൌ1 െ݁ିሺ௣∗ହሻమ 
ܽ଴ൌ37
401 ൣ1 െ݁ିሺ௣∗ହሻమ൧ 
0.01 
0.002 
0.000 
0.05 
0.061 
0.006 
0.1 
0.221 
0.020 
0.2 
0.632 
0.058 
0.5 
0.998 
0.092 
 
Figure 7: Loss Function ࢇ૙ൌ૚െࢋିሺ࢖∗૞ሻ૛ 
 
 
 

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Note that the loss function proposed here does not reduce the strength of the prior when the current 
study outperforms the historical data.  This implementation of the loss function is only concerned with 
negative impacts to patients, i.e. it penalizes an optimistic prior while not penalizing a pessimistic prior. 
Also, note that this function is selected for the shape of the CDF rather than due to conventional 
statistical properties of the Weibull distribution.  
Figure 8 illustrates the effect of the power prior coupled with the loss function.  The figure shows credible 
intervals in scenarios where the prior is optimistic (better performance than current study), in agreement 
(similar performance to the current study), and pessimistic (worse performance than the clinical study).  
Note that the prior data source in Figure 8 is the Attain Performa study, with 401 patients.  As will be 
discussed later, these data are scaled to represent a maximum of 37 patients (i.e. 9% weight).   
Figure 8: Credible Intervals for Scenarios of Agreement Between Historical and Current Data 
 
The prior data set in Figure 8 has 401 samples.  However, the maximum effective historical data sample 
size is ݊௛ൌ37, for a maximum weight of 9%.  Therefore, the prior will be scaled by a factor of (37/401).  
As an example, illustrated in the middle panel above, if the effective sample size is 34 out of 37, the prior 
has received 89% of the maximum weight, or 8.5%. 
The panels in Figure 8 can be interpreted as follows:  

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• 
Top panel: The current data shows lower performance than the prior.  The loss function 
produces a substantial penalty resulting in almost no weight to the prior (1%).  The posterior 
(final estimate) is essentially the same as the current study.   
• 
Middle panel: The current data is very similar to the prior.  The loss function penalty is small, 
resulting in a prior weight of 8.5% (recall that the maximum weight is 9.2%).  Because the 
agreement is good, the posterior(final estimate) is similar to both the prior and current study.   
• 
Bottom panel: The current data is very similar, with slightly better performance than the prior.  
The loss function produces a weight very close to the maximum of 9.2%.  The posterior (final 
estimate) is a balance between the prior and current study.  
Sample Size 
A Bayesian adaptive design is set up to enroll patients until a sufficient sample size is achieved to have 
high probability of meeting the required effective sample size of ݊௘ൌ400.  The number of enrolled 
patients in the study may vary from 363 to 400 subjects due to the adaptations to the trial.  This study 
follows methods from Berry, et.al.27  
The interim analysis will take place after 360 subjects have been enrolled into the study.   
The Adaptive Bayesian sample size algorithm will stop or continue enrollment accordingly to the 
following: 
1.) If the predictive probability of ݊௘൒400 is larger than 80% then enrollment will stop. 
2.) If the predictive probability of ݊௘൒400 is less than 80%, enroll sufficient additional patients to 
make the probability of ݊௘൒400 at least 80%.   
At the time of the interim analysis, some patients will not have completed the full evaluation period.  A 
longitudinal model will be employed to enable final observations to be imputed for those subjects with 
incomplete information.  
There are 3 types of subjects at a given interim analysis: 
1.) Subjects that have complete data 
2.) Subjects that have partial data (censored value at a particular time) 
3.) Subjects that have no information (subjects that have not been enrolled) 
Predictive probabilities for types 2 and 3 will have to be computed.  The predictive probability model that 
will be used is a piecewise exponential.  This will allow the final outcomes for the subjects who have not 
had an event and have not completed 6 month follow up to be simulated. 
Note this Bayesian approach to borrow information from historical datasets will only be used for the 
secondary objective #2. 
19.2.3. 
Secondary Objective # 3  
Objective – Electrical measurements (PCT and Impedance) at follow-ups 
Pacing Capture Threshold (PCT) and impedance data will be collected using VectorExpressTM.  Pacing 
vector changes will be monitored for all implanted patients at follow-up visits. 
Summary statistics for PCT and impedance at each time point (i.e. Implant, 6 months, etc.).  The 
distribution of the electrical measurements at the final programmed pacing vector will be presented as n, 
mean, standard deviation, minimum, median and maximum.  In the event of a replacement of a 
Medtronic Quad CRT-P or CRT-D  device and/or the implanted LV lead, only measurements from the 

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Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted at the initial implant procedure will 
be included in the analysis cohort for this objective. 
19.3. Additional Analysis  
19.3.1. 
Poolability Analysis 
Additional analysis will be conducted to summarize study primary objectives by patient characteristics, 
such as gender, age group,  race and study site geography.  The purpose of the poolability analysis is to 
identify if there is any clinical meaningful difference in a subgroup of patients.  These analyses will not be 
statistically powered, and there is no pre-specified statistical significance level for these analyses. 
19.3.2. 
Sensitivity Analysis 
All subjects enrolled into this study and successfully implanted with a Medtronic Quad CRT-P or CRT-D  
device and Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be included in the primary 
efficacy analysis datasets (efficacy objectives #1 and #2).  Sensitivity analysis such as the Tipping Point 
method or similar will be conducted to investigate the influence of subjects who were successfully 
implanted with the required system however missed a 6 month post implant follow-up test(s) (due to 
reasons such as missing in-office visit, subject exit, death and/or the initial implanted lead was 
deactivated).  For this purpose, all subjects with successful implant who do not meet analysis cohort 
requirements, will be considered as the worst case scenario (i.e. failure to meet the efficacy 
endpoints).The results will be submitted as part of the clinical reports.   
19.3.3. 
Additional Data Collection 
Heart failure clinical outcomes will be assessed. The measurements, including NYHA classification, death, 
heart failure related hospitalization, heart failure related study exits and subject self-reported global 
assessment for each subject will be obtained at 6 months post-implant.  Summary statistics will be 
provided.  
19.3.3. 
Overall Study Sample Size Requirements 
The sample size requirement  at 6-months for each of the study objectives is displayed in Table 18. The 
first row does not account for attrition, while the second row is inflated by 15% attrition. The sample size 
for Secondary Objective #2 assumes the conservative case that the interim look results in, no borrowing 
of historical data. Therefore, the overall sample size for the study is 471.  
Table 18: Required Sample Size by Study Objective  
 
Primary 
Safety 
Objective 
Primary 
Efficacy 
Objective 
#1 
Primary 
Efficacy 
Objective 
#2 
Secondary 
Objective 
#1  
Secondary 
Objective 
#2 (post-
implant 
failure 
modes) 
Secondary 
Objective 
#3 
Overall 
Number 
needed at 
6-months 
170 
145 
50 
NA 
400 
NA 
400 
Number of 
enrollments 
200 
171 
59 
NA 
471 
NA 
471  
 

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20. Ethics 
20.1. Statement(s) of Compliance  
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as good clinical practice (GCP).  Good Clinical Practice includes review and approval by an 
independent IRB/EC before initiating a study, continuing review of an ongoing study by an IRB/EC, and 
obtaining and documenting the freely given IC of a subject before initiating the study. 
The clinical investigation shall not begin until all required approvals and documents from the IRB/EC and 
a regulatory authority, if needed, have been received.  Any additional requirements imposed by the 
IRB/EC or regulatory authority shall be followed, if appropriate. 
The Attain Stability Quad Clinical Study was designed to reflect the GCP principles outlined in ISO 
14155:2011 and other international clinical requirements outlined below. These include the protection of 
the rights, safety and well-being of human subjects, controls to ensure the scientific conduct and 
credibility of the clinical investigation and the definition of responsibilities of the sponsor and 
investigators.  In accordance with ISO 14155:2011, the sponsor shall avoid improper influence on, or 
inducement of, the subject, monitor, any investigator(s) or other parties participating in, or contributing 
to, the clinical investigation.  All investigators shall avoid improper influence on or inducement of the 
subject, sponsor, monitor, other investigator(s) or other parties participating in or contributing to the 
clinical investigation.  Adverse Event and Device Deficiency handling in the Attain Stability Quad Clinical 
Study is ISO 14155:2011 compliant for all participating geographies with the exception  that only those 
AEs which are related to the subject’s system, procedure, accessory, or are cardiovascular-related, and all 
Serious AEs, will be collected. This ensures any AEs which could potentially be relevant will be collected. 
The scope and duration of the Attain Stability Quad Clinical Study would make collection of all AEs to be 
a significant burden for investigators and investigative sites. Therefore, only a subset of AEs will be 
collected in this study, including any that could be potentially relevant. 
The principles of the Declaration of Helsinki have been implemented through the IC process, IRB/EC 
approval, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment and 
publication policy.  
Ultimately, all sites in all geographies will follow and comply with: 
• 
Principles of Declaration of Helsinki 
• 
21 CFR Part 11 (Electronic Records, Electronic Signatures) (per local law) 
• 
21 CFR Part 54 (Financial Disclosure by Clinical Investigators) 
• 
The Clinical Trial Agreement 
• 
The procedures described within this CIP 
• 
Local Ethics Board Requirements 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to:  

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• 
In the United States, the study will be conducted under an FDA IDE in compliance with 21 CFR 
Parts: 
o 
50: Protection of Human Subjects 
o 
56: Institutional Review Boards 
o 
812: Investigational Device Exemptions 
• 
In Canada, SOR/98-282, Section 59-88 will be followed and Mandatory Problem Reporting 59(1), 
59(2), 60 (1)). 
• 
In EMEA the study will be conducted in compliance with the Active Implantable Medical Device 
Directive (AIMDD), Declaration of Helsinki version 2013, and full compliance with ISO 14155.  
• 
In Hong Kong and Malaysia, the study will be conducted in compliance with the Declaration of 
Helsinki version 2013.   
• 
In EMEA, an IB is not required for this study as it is a post market study 
The study will be publicly registered prior to first enrollment in accordance with the 2007 Food and Drug 
Administration Amendments Act FDAAA and Declaration of Helsinki on http://clinicaltrials.gov (PL 110-85, 
section 810(a)).  In addition, the study may be registered in local regulatory databases where required by 
local law.  
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law/regulations) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical ethics committee or institutional review board. 
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above 
mentioned groups prior to implementation of the revised CIP at the site.  
21. Study Administration 
21.1. Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this Attain Stability Quad Clinical 
Study.  Trained Medtronic personnel or delegates appointed by Medtronic may perform study monitoring 
at the study site in order to ensure that the study is conducted in accordance with the CIP, the CTA, and 
applicable regulatory and local requirements.  Medtronic, or delegates, must therefore be allowed access 
to the subjects’ case histories (clinic and hospital records, and other source data/documentation) upon 
request as per the Subject IC, Data Protection Authorization (where applicable) and CTA.  The principal 
investigator should also be available during monitoring visits.  
Monitoring for the study, including site initiation visits, interim monitoring visits, and closeout visits, will 
be done in accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess site study progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to IRB/EC approval and review of 
the study, maintenance of records and reports, and review of source documents against subject CRFs.  
Monitors review site regulatory and study compliance by identifying findings of non-compliance and 
communicating those findings along with recommendations for preventative/corrective actions to site 
personnel.  Monitors may work with study personnel to determine appropriate corrective action 

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recommendations and to identify trends within the study or at a particular site.  Regulatory documents 
may be reviewed at each study site.   
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, findings from previous monitoring visits 
and any suspected inconsistency in data that requires investigation. 
21.2. Data Management 
Data will be collected using Oracle Clinical, an electronic data management system for clinical studies.  
CRF data will be stored in a secure, password-protected database which will be backed up nightly.  Data 
will be reviewed using programmed and manual data checks.  Data queries will be made available to sites 
for resolution.  Study management reports may be generated to monitor data quality and study progress.  
At the end of the study, the data will be frozen and will be retained indefinitely by Medtronic. 
Only authorized persons can complete CRFs.  CRFs shall be signed by the Principle Investigator.  The 
Principle Investigator can delegate the CRF sign off task to Sub-Investigators only.  Delegation of 
authority will be specified on the appropriate documentation. 
All records and other information about subjects participating in this study will be treated as confidential.  
Data will be transferred and processed by Medtronic or a third party designated by Medtronic in a key 
coded form, unless it’s impossible to make it anonymous, for instance, where the subject’s name cannot 
be removed from the data carrier.     
Procedures in the CIP require source documentation.  Source documentation will be maintained at the 
site.  Source documents, which may include worksheets, patient medical records, programmer printouts 
and device interrogation files, must be created and maintained by the investigational site team.  For 
source documentation, the investigational site study team must sign and date any copies or printouts of 
original source documents with a statement that this is a complete and true reproduction of the original 
source document. 
The data reported on the CRFs shall be derived from source documents and be consistent with these 
source documents, and any discrepancies shall be explained in writing.  The CRF may be considered 
source for the following data collection elements recorded directly on the CRFs: 
• 
Enrollment Notification 
o 
Site assigned patient reference 
• 
Baseline 
o 
Administrative information 
• 
Adverse Event eCRF 
o 
Date study site became aware of event 
o 
Relatedness of adverse event 
• 
Device Deficiency eCRF 
o 
Date study site became aware of event 
• 
Subject Death 
o 
Date study site became aware of death 
o 
Relatedness of death 
• 
System Modification 
o 
Justification for explanted product not being returned to Medtronic 
• 
Deviations 

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o 
Reason for deviation 
• 
Investigational product Disposition Log 
o 
Date the Investigational Attain Stability Quad lead was implanted/explanted  
Even when the CRF may be considered as source, an alternate method of source documentation is 
always strongly encouraged. 
Save-to-media data collected at office visits will be sent to Medtronic.  Upon receipt, device data will be 
maintained within a Medtronic device database and retrieved for analysis and reporting. 
21.3. Direct Access to Source Data/Documents  
The sponsor or a regulatory authority may audit or inspect the study site to evaluate the conduct of the 
study.  The clinical investigator(s)/institution(s) shall allow study related monitoring, audits, IRB/EC 
review and regulatory inspection.  
21.4. Confidentiality 
All records and other information about subjects participating in this study will be treated as confidential.  
21.5. CIP Amendments 
Approval of subsequent revisions to the CIP is required at each study site from the following groups prior 
to implementation of the revised CIP at the site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical ethics committee or institutional review board. 
If a CIP amendment occurs, site personnel will need to be re-trained as necessary, and will need to 
submit any changes to their IRB/EC as required by the committee.  Protocol amendments will also be 
reported to and approved by the FDA, or regulatory authority. 
21.6. Warranty/Insurance Information 
21.6.1. 
Warranty 
Warranty information is provided in the product packaging for the commercially released CRT-P or CRT-D 
devices and leads, and additional copies are available upon request. 
21.6.2. 
Insurance (EMEA) 
Medtronic Bakken Research Center B.V. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical study liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the EC 
and/or Competent Authority (CA). 

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21.6.3. 
Insurance (Canada) 
Medtronic of Canada  is a wholly owned subsidiary of Medtronic, which as the parent company of such 
entity maintains appropriate general liability insurance coverage as required under applicable laws and 
regulations and will comply with applicable local law and custom concerning specific insurance coverage.  
If required, a General Liability insurance statement/certificate will be provided to the Ethics Committee. 
21.6.4. 
Insurance (Malaysia) 
Medtronic International Ltd. is a wholly owned subsidiary of Medtronic, which as the parent company of 
such entity maintains appropriate clinical trial liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the Ethics 
Committee. 
21.6.5. 
Insurance (Hong Kong) 
Medtronic Hong Kong Medical Ltd.   Ltd. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical trial liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the 
Ethics Committee. 
21.7. Record Retention 
21.7.1. 
Investigator Records 
The investigator is responsible for the preparation and retention of the records including, but not limited 
to, those cited below.  All of the below records, with the exception of case history records and case 
report forms, should be kept in the Investigator Site File (e.g., the study binder provided to the 
investigator) or Subject Study Binder.  Case Report Forms must be maintained and signed electronically 
by an investigator within the electronic data capture system during the study.  The following records are 
subject to inspection and must be retained for a period of two years (or longer as local law/regulation or 
hospital administration requires) after product approval.  Measures shall be taken to avoid loss or 
premature destruction. 
• 
All correspondence between the IRB/EC, sponsor, monitor, regulatory authority and/or the 
investigator that pertains to the investigation, including required reports.  
• 
Subject’s case history records, including:  
o 
Signed and dated informed consent form, in accordance with local requirements  
o 
Observations of adverse events/adverse device effects/device deficiencies 
o 
Medical history 
o 
Baseline, Implant and follow-up data (if applicable) 
o 
Documentation of the dates and rationale for any deviation from the protocol 
• 
Electronically signed and dated eCRFs and a blank set of CRFs where required by local law 
• 
All approved versions of the CIP, IC  
• 
Fully executed Clinical Trial Agreement 
• 
Ethics Committee approval documentation.  Written information that the investigator or other 
study staff, when member of the Ethics Committee, did not participate in the approval process. 

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Approval documentation must include the Ethics Board composition, where required per local 
law.   
• 
Regulatory authority notification, correspondence and approval, where required per local law. 
• 
List of investigation sites: This list is not yet final at the time of CIP development. The list will be 
provided under separate cover and will be maintained by the sponsor. 
• 
Financial disclosure (investigators) 
• 
Enrollment Log (for sites following ISO 14155) 
• 
For sites where the Attain Stability Quad lead is considered investigational, device disposition logs 
containing Model and serial numbers of devices implanted, subject IDs of the subjects implanted, 
implant/used dates, explant dates, returned-to-sponsor dates and reasons and method of 
disposal/destruction 
• 
Current curriculum vitae (signed and dated in EMEA only) of principal investigators and key 
members of investigation site team (as required by local law) 
• 
Documentation of delegated tasks 
• 
Study training records for investigation site team 
• 
Assurance certificates (EMEA, Hong Kong, and Malaysia) 
• 
Any other records that FDA and local regulatory agencies require to be maintained (e.g. Ethics 
Committee Roster, study equipment calibration information) 
• 
Final Study Report including the statistical analysis 
21.7.2. 
Investigator Reports 
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all CRFs, AEs and ADEs (reported per the country-specific collection requirements), DDs, deaths, 
crossovers and any deviations from the CIP.  If any action is taken by an IRB/EC with respect to this 
Attain Stability Quad Clinical Study, copies of all pertinent documentation must be forwarded to Medtronic 
in a timely manner.  Reports are subject to inspection and to the retention requirements as described 
above for investigator records.  
Investigator reporting requirements for safety data are listed in Section 17.3).  
Table 19: Investigator Reports Applicable for All Geographies per Medtronic Requirements 
Report  
Submit to 
Description/Constraints 
Withdrawal of Ethics 
Committee approval 
Sponsor and 
Relevant 
Authorities 
The investigator must report a withdrawal of approval by 
the reviewing Ethics Committee of the investigator’s part of 
the investigation within 5 working days. 
Study Deviations  
Sponsor and 
Ethics Committee 
Any deviation from the clinical investigation plan shall be 
recorded together with the explanation of the deviation. 
Notice of deviations from the CIP to protect the life or 
physical well-being of a subject in an emergency shall be 
given as soon as possible, but no later than 5 working days 
after the emergency occurred.  Except in such emergency, 
prior approval is required for changes in the plan or 
deviations.  
Failure to obtain 
informed consent 
Sponsor and 
Ethics Committee 
Informed consent shall be obtained in writing and 
documented before a subject is enrolled into the Attain 
Stability Quad Clinical Study 
Final Report 
Ethics Committee 
and  
Relevant 
Authorities 
This report must be submitted within 3 months of study 
completion or termination. 

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21.7.3. 
Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records that includes, but is not 
limited to: 
• 
All correspondence which pertains to the Attain Stability Quad Clinical Study 
• 
Executed Clinical Trial Agreement 
• 
Financial disclosures (investigators) 
• 
Current curriculum vitae (signed and dated in EMEA only) of principal investigators and key 
members of investigation site team (as required by local law) 
• 
Device Disposition Logs containing Model and serial numbers of devices implanted, subject IDs of 
the subjects implanted, implant/used dates, explant dates, returned-to-sponsor dates and 
reasons and method of disposal/destruction 
• 
Electronically signed and dated eCRFs 
• 
All approved informed consent templates, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all Ethics Committee approval letters and relevant Ethics Committee correspondence 
and Ethics Committee voting list/roster/letter of assurance 
• 
List of names, addresses, and professional position of the clinical investigators and coordinating 
clinical, if appointed.  
• 
Names and addresses of the institutions in which the Attain Stability Quad Clinical Study will be 
conducted: This list is not yet final at the time of CIP development. The list will be provided 
under separate cover and will be maintained by the sponsor. 
• 
Regulatory authorities correspondence, notification and approval as required by national 
legislation 
• 
Insurance certificates (EMEA, Hong Kong, and Malaysia)  
• 
Names/contact addresses of monitors 
• 
Monitoring reports (interim monitoring visit reports, follow-up letters and close-out visit reports) 
• 
Site qualification visit reports 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the Attain Stability Quad Clinical Study 
• 
The approved Clinical Investigation Plan and study related reports, and revisions 
• 
Documentation of delegated tasks 
• 
Study training records for site personnel and Medtronic personnel involved in the study 
• 
Sample of CRFs 
• 
Any other records that local regulatory agencies require to be maintained 
21.7.4. 
Sponsor Reports 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in the 
tables below (by geography).  In addition to the reports listed below, Medtronic shall, upon request of 
reviewing Ethics Committee, regulatory agency or FDA, provide accurate, complete and current 
information about any aspect of the Attain Stability Quad Clinical Study.  Safety data Medtronic reporting 
requirements are listed in Section 17.3). 
 
 
 

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Table 20: Sponsor Reports for Canada 
Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities, and  
Head of the 
Institution 
Provide prompt notification of termination or suspension 
and reason(s).  
Recall and device 
disposition 
Investigators, 
Ethics Committee 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, 
or otherwise dispose of any devices.   
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  
Site specific study deviations will be submitted to 
investigators periodically.   
Table 21: Sponsor Reports for EMEA, Malaysia, Hong Kong 
Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities and 
Head of the 
Institution 
Provide prompt notification of termination or suspension 
and reason(s) per local law.  (ISO 14155:2011) 
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics Committee 
and relevant 
authorities 
Investigators and other Ethics Committees will be notified 
only if required by local laws or by the Ethics Committee. 
Withdrawal of CA 
approval 
Investigators, 
Ethics 
Committee, and 
relevant 
authorities 
Investigators, Ethics Committees and relevant authorities 
will be notified only if required by local laws or by the Ethics 
Committee. 
Progress Reports 
Ethics Committee 
and 
regulatory 
authorities 
This will be submitted to the Ethics Committee and 
regulatory authorities only if required by local law. 
Final report 
Investigators, 
Ethics 
Committee, and 
Regulatory 
authorities upon 
request 
• 
The investigator shall have the opportunity to review 
and comment on the final report.   
• 
If a clinical investigator does not agree with the final 
report, his/her comments shall be communicated to the 
other investigator(s).   
• 
The signature of the principal Investigator in each 
site should be obtained. 
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  (ISO 
14155:2011) 
Site specific study deviations will be submitted to 
investigators periodically.   

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Table 22: Sponsor Reports for the United States 
Report  
Submit to 
Description/Constraints 
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics 
Committee, 
FDA, and 
relevant 
authorities 
Notification within five working days.  (21 CFR 
812.150(b)(2))   
Withdrawal of FDA 
approval 
Investigators, 
Ethics 
Committee, and 
relevant 
authorities 
Notification within five working days.  (21 CFR 
812.150(b)(3)) 
Investigator List 
FDA 
Submit at 6-month intervals, a current list of the names and 
addresses of all investigators participating in the 
investigation.  (21 CFR 812.150(b)(4)) 
Progress Reports 
Ethics Committee 
and  
FDA 
Progress reports will be submitted at least annually.  (21 
CFR 812.150(b)(5), 812.36(f)   
Recall and device 
disposition 
Investigators, 
Head of 
Institution, 
Ethics 
Committee, 
relevant 
authorities, and  
FDA 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, 
or otherwise dispose of any devices.  (21 CFR 
812.150(b)(6)) 
Failure to obtain 
informed consent  
FDA 
Investigator’s report will be submitted to FDA within five 
working days of notification.  (21 CFR 812.150(b)(8)) 
Final report 
Investigators, 
Ethics 
Committee,  
Regulatory 
authorities upon 
request, and FDA 
Medtronic will notify FDA within 30 working days of the 
completion or termination of the investigation.   A final 
report will be submitted to the FDA, investigators, and 
IRBs/MECs within six months after completion or 
termination of this study.  (21 CFR 812.150(b)(7)) 
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  
Site specific study deviations will be submitted to 
investigators periodically.   
Other 
IRB, FDA 
Accurate, complete, and current information about any 
aspect of the investigation.  (21 CFR 812.150(b)(10)) 
 
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in secured file cabinets at Medtronic 
during the course of this study.  After closure of the study Medtronic will archive records and reports as 
required by applicable regulations. 
21.8. Publication and Use of Information 
Publications from the Attain Stability Quad Clinical Study will be handled according to Medtronic Policies 
and Standard Operating Procedures and as indicated in the CTA. 

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21.8.1. 
Publication Committee 
The Attain Stability Quad Clinical Study will utilize a Publication Committee which will include the Steering 
Committee members as well as Medtronic personnel.  This committee will manage study publications with 
the goal of publishing findings from the data.  The Publication Committee will develop the final 
Publication Plan as a separate document. 
The Publication Committee’s role is to:  
• 
Manage elements addressed in the publication plan as outlined in this section 
• 
Develop the final Publication Plan under separate cover 
• 
Execute the Publication Plan 
• 
Oversee the publication of primary, secondary and ancillary study results 
• 
Review and prioritize publication proposals 
• 
Provide input on publication content, and  
• 
Determine authorship 
In addition, the committee will apply and reinforce the authorship guidelines set forth in the Publication 
Plan.  Membership in the Publication Committee does not guarantee authorship.  The committee will 
meet as needed. 
21.8.2. 
Management of Primary, Secondary, and Ancillary Publications 
The Publication Committee reviews, prioritizes and manages all publications including primary, secondary 
and ancillary publications.  Primary and secondary publications are those that address analyses of any or 
all primary objectives or secondary/ancillary objectives, respectively, as specified in the Clinical 
Investigation Plan.  An ancillary publication is any publication that does not address the study objectives 
identified in the Clinical Investigation Plan.  They include publications proposed and developed by other 
Medtronic departments or entities, clinicians participating in this Attain Stability Quad Clinical Study and 
clinicians not participating in this Attain Stability Quad Clinical Study.  The committee will work with 
Medtronic to ensure that requests do not present conflicts with other proposals, are not duplicative and 
to determine which ancillary publication proposals, if any, will be supported. 
The committee may decide that no publications, including abstracts, will be published prior to the end of 
the study or with individual site data.  Requests for publications on study objectives utilizing subset data 
(e.g., regional) will be evaluated for scientific validity and the ability of Medtronic to provide resources.  
21.8.3. 
Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical Journal 
Editors (ICMJE), Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org).  Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data 
• 
Drafting the article or revising it critically for important intellectual content 
• 
Final approval of the version to be published 
Decisions regarding authorship and contributor-ship will be made by the publication committee.  The 
selected authors will be responsible for drafting the publication.  All selected authors must fulfill the 

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authorship conditions stated above to be listed as authors, and all contributors who fulfill the conditions 
must be listed as authors. 
All investigators not listed as co-authors will be acknowledged as the “Medtronic Attain Stability Quad 
Clinical Study Investigators” and will be individually listed according to the guidelines of the applicable 
scientific journal when possible.  Any other contributors will be acknowledged by name with their specific 
contribution indicated. 
21.8.4. 
Transparency 
Transparency of study results will be maintained by the following means: 
• 
A final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, IRB/ECs and Competent Authorities of participating countries when required by 
local law 
• 
Registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated  
• 
Submitting for publication the primary study results after the study ends  
• 
Disclosing conflicts of interest (e.g. financial) of the co-authors of publications according to the 
policies set forth by the corresponding journals and conferences  
• 
Making an individual sites study data accessible to the corresponding investigator after the 
completion of the study, if requested  
21.9. Suspension or Early Termination 
21.9.1. 
Planned Study Closure 
Study Closure is a process initiated by distribution of a study closure letter.  Study closure is defined as 
closure of a clinical study that occurs when Medtronic and/or regulatory requirements have been satisfied 
per the CIP and/or by a decision by Medtronic or regulatory authority, whichever occurs first.  The study 
closure process is complete upon distribution of the Final Report or after final payments, whichever 
occurs last.  Ongoing IRB/EC oversight is required until the overall study closure process is complete.  
Upon study closure, subjects should be managed and followed per physician discretion. 
21.9.2. 
Early Termination or Suspension 
Early Termination of the Study is the closure of a clinical study that occurs prior to meeting defined 
endpoints.  This is possible for the whole study or a single site.  Study Suspension is a temporary 
postponement of study activities related to enrollment and distribution of the product.  This is possible for 
the whole study or a single site.  In the event the whole study or a single site is terminated, subjects will 
be exited.  
Study-Wide Termination or Suspension 
Possible reasons for considering study suspension or termination of the study include but are not limited 
to: 
• 
Adverse events associated with the system or product under investigation which might endanger 
the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or regulatory body (where the study is operating under regulatory body 
authority)  

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• 
Technical issues during the manufacturing process 
Investigator/Site Termination or Suspension 
Possible reasons for clinical investigator or site termination or suspension include but are not limited to: 
• 
Failure to obtain initial IRB/EC approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups)  
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring findings in a timely manner, etc.)  
• 
Institutional Review Board/Ethics Committee suspension of the site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)  
• 
Investigator request (e.g. no longer able to support the study)  
21.9.3. 
Procedures for Termination or Suspension 
Medtronic-Initiated and Regulatory Authority-Initiated 
• 
Medtronic will promptly inform the clinical investigators of the (early) termination or suspension 
and the reasons and inform the regulatory authority(s) where required 
• 
In the case of study termination or suspension for reasons other than a temporary IRB/EC 
approval lapse, the investigator will promptly inform the IRB/EC  
• 
In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare 
Investigator-Initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension 
• 
The investigator will promptly inform the institution (where required per regulatory requirements)  
• 
The investigator will promptly inform the IRB/EC 
• 
The investigator will promptly inform the regulatory authorities (for regions following ISO only) 
• 
The investigator will promptly inform the subjects and/or the personal physician of the subjects 
to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare 
Institutional Review Board Ethics Committee-Initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days 
• 
Subject enrollment must stop until the suspension is lifted 
• 
Subjects already enrolled should continue to be followed in accordance with IRB/EC policy or its 
determination that an overriding safety concern or ethical issue is involved 
• 
The investigator will inform his/her institution (where required per local requirements)  

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• 
The investigator will promptly inform the subjects, and/or the personal physician of the subjects, 
with the rationale for the study termination or suspension 
• 
The investigator will promptly inform the regulatory authorities (for regions following ISO 14155 
only) 
 
 

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22. Appendices 
APPENDIX 1: Foreseeable Adverse Event List 
The information provided in this section pertains to foreseeable AEs that may be observed in study 
subjects and may collectively assist in identifying those events that are unexpected in nature.  The 
foreseeable adverse events information consists of three parts: (1) listing of potential adverse events 
associated with implantation of CRT system and transvenous leads, (2) rates of AEs reported from 
previous Medtronic studies evaluating CRT systems and transvenous leads, and (3) AEs rates reported in 
published literature for procedures similar to the CRT system implant procedure.  This information will be 
used in combination with device labeling, current event reporting information, and other published data 
to assess for an unexpected occurrence.  
The implantation of the study device, CRT-P or CRT-D, involves surgery, therefore, standard AEs 
associated with a surgical procedure may be experienced (e.g. anesthesia complications, injury, 
infections, bleeding, exacerbation of pre-existing conditions, healing complications, etc.).  The focus of 
this section is to specifically address in more detail, those events that are foreseeable due to the use, 
performance, and/or presence of the system under investigation.  
Additional potential risks associated with the implantation of the CRT system and the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798), as well as risk minimization are discussed within Section 16. 
Treatment required for procedure and/or system related adverse events that are experienced may 
include medication, device reprogramming, device modification (e.g. repositioning, surgical 
abandonment, surgical removal), or other surgical and medical remedies.  The AEs associated with the 
use of transvenous leads, pacing and defibrillation systems include, but are not limited to, the following: 

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Table 23: Listing of Potential Adverse Events Associated with System Implant 
• 
acceleration of tachyarrhythmias (caused by device) 
• 
air embolism 
• 
bleeding 
• 
body rejection phenomena, including local tissue reaction 
• 
cardiac dissection 
• 
cardiac perforation 
• 
cardiac tamponade 
• 
chronic nerve damage 
• 
constrictive pericarditis 
• 
death 
• 
device migration 
• 
endocarditis 
• 
erosion 
• 
excessive fibrotic tissue growth 
• 
extrusion 
• 
fibrillation or other arrhythmias 
• 
fluid accumulation 
• 
formation of hematomas/seromas or cysts 
• 
heart block 
• 
heart wall or vein wall rupture 
• 
hemothorax 
• 
infection 
• 
keloid formation 
• 
lead abrasion and discontinuity 
• 
lead migration/dislodgment 
• 
complications and mortality due to inability to deliver appropriate and intended therapy 
• 
muscle and/or nerve stimulation 
• 
myocardial damage 
• 
myocardial irritability 
• 
myopotential sensing 
• 
pericardial effusion 
• 
pericardial rub 
• 
pneumothorax 
• 
poor connection of the lead to the device, which may lead to oversensing, undersensing, or a 
loss of therapy 
• 
stroke 
• 
threshold elevation 
• 
thrombotic embolism 
• 
thrombosis 
• 
tissue necrosis 
• 
valve damage (particularly in fragile hearts) 
• 
venous occlusion 
• 
venous perforation 

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An additional potential AE associated with the use of transvenous left ventricular pacing leads is coronary 
sinus dissection. 
Additional potential AEs associated with the use of ICD systems include, but are not limited to, the 
following events: 
• 
inappropriate shocks 
• 
potential mortality due to inability to defibrillate 
• 
shunting current or insulating myocardium during defibrillation 
Patients susceptible to frequent shocks despite medical management could develop psychological 
intolerance to an ICD system that might include the following conditions: 
• 
dependency 
• 
depression 
• 
fear of premature battery depletion 
• 
fear of shocking while conscious 
• 
fear that shocking capability may be lost 
• 
imagined shocking (phantom shock) 
Adverse Events Reported in Previous Medtronic Studies 
The listing below provides an example of reported system and procedure related AEs in recent Medtronic 
studies.  This table includes a summary of combined system or procedure related AEs as reported in the 
Concerto-AT, Insync III US, 4194, 4195, 4196, 4396, Adaptive CRT, and Attain Performa studies along 
with their incidence.  The observed rate is based on the study populations that included a total of 3,246 
subjects.  In total, there were 1749 system or procedure related events.  This includes both serious and 
non-serious events.  The rate is calculated as number of subjects that experience the event, not 
accounting for duration of follow-up. 
Table 24: System or procedure-related adverse events from previous clinical studies 
MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Abdominal pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Acidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Acute respiratory failure 
4 
4 
0.12% 
(0.03%, 0.32%) 
Adverse drug reaction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Air embolism 
1 
1 
0.03% 
(0.00%, 0.17%) 
Alcohol withdrawal syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Alpha haemolytic streptococcal 
infection 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Anaemia 
7 
7 
0.22% 
(0.09%, 0.44%) 
Anaemia postoperative 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anaphylactic shock 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anticoagulation drug level below 
therapeutic 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anxiety 
3 
3 
0.09% 
(0.02%, 0.27%) 
Application site rash 
2 
2 
0.06% 
(0.01%, 0.22%) 
Arterial haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arteriovenous fistula 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arteriovenous fistula operation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arthralgia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arthritis bacterial 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ascites 
1 
1 
0.03% 
(0.00%, 0.17%) 
Atelectasis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Atrial fibrillation 
19 
19 
0.59% 
(0.35%, 0.91%) 
Atrial flutter 
4 
4 
0.12% 
(0.03%, 0.32%) 
Atrial tachycardia 
5 
4 
0.12% 
(0.03%, 0.32%) 
Atrioventricular block 
16 
16 
0.49% 
(0.28%, 0.80%) 
Back pain 
3 
3 
0.09% 
(0.02%, 0.27%) 
Bacteraemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac arrest 
8 
8 
0.25% 
(0.11%, 0.49%) 
Cardiac failure 
46 
43 
1.32% 
(0.96%, 1.78%) 
Cardiac failure chronic 
5 
5 
0.15% 
(0.05%, 0.36%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Cardiac pacemaker battery 
replacement 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac perforation 
8 
8 
0.25% 
(0.11%, 0.49%) 
Cardiac sarcoidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac tamponade 
3 
3 
0.09% 
(0.02%, 0.27%) 
Cardiac vein dissection 
38 
37 
1.14% 
(0.80%, 1.57%) 
Cardiac vein perforation 
5 
5 
0.15% 
(0.05%, 0.36%) 
Cardiogenic shock 
3 
3 
0.09% 
(0.02%, 0.27%) 
Cardiomyopathy 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiovascular disorder 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cellulitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Cerebral infarction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cerebrovascular accident 
3 
3 
0.09% 
(0.02%, 0.27%) 
Chest discomfort 
4 
4 
0.12% 
(0.03%, 0.32%) 
Chest pain 
8 
8 
0.25% 
(0.11%, 0.49%) 
Chronic obstructive pulmonary 
disease 
3 
3 
0.09% 
(0.02%, 0.27%) 
Circulatory collapse 
1 
1 
0.03% 
(0.00%, 0.17%) 
Colitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Complication of device insertion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Complication of device removal 
4 
4 
0.12% 
(0.03%, 0.32%) 
Constipation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Contusion 
2 
2 
0.06% 
(0.01%, 0.22%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Cough 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cystitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Decubitus ulcer 
1 
1 
0.03% 
(0.00%, 0.17%) 
Deep vein thrombosis 
14 
14 
0.43% 
(0.24%, 0.72%) 
Dehydration 
1 
1 
0.03% 
(0.00%, 0.17%) 
Delirium 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device alarm issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device battery issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device capturing issue 
30 
29 
0.89% 
(0.60%, 1.28%) 
Device computer issue 
19 
19 
0.59% 
(0.35%, 0.91%) 
Device connection issue 
19 
19 
0.59% 
(0.35%, 0.91%) 
Device damage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device dislocation 
125 
107 
3.30% 
(2.71%, 3.97%) 
Device electrical impedance issue 
12 
12 
0.37% 
(0.19%, 0.64%) 
Device extrusion 
2 
1 
0.03% 
(0.00%, 0.17%) 
Device failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device lead damage 
13 
13 
0.40% 
(0.21%, 0.68%) 
Device lead issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device misuse 
9 
9 
0.28% 
(0.13%, 0.53%) 
Device pacing issue 
69 
67 
2.06% 
(1.60%, 2.61%) 
Device psychogenic complication 
7 
7 
0.22% 
(0.09%, 0.44%) 
Device related infection 
3 
3 
0.09% 
(0.02%, 0.27%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Device signal detection issue 
2 
2 
0.06% 
(0.01%, 0.22%) 
Device stimulation issue 
443 
349 
10.75% 
(9.71%, 11.87%) 
Diabetes 
1 
1 
0.03% 
(0.00%, 0.17%) 
Diarrhea 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dizziness 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dressler's syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Drug hypersensitivity 
3 
3 
0.09% 
(0.02%, 0.27%) 
Dysarthria 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dyspnoea 
2 
2 
0.06% 
(0.01%, 0.22%) 
Dyspnoea exertional 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dyspnoea paroxysmal nocturnal 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ecchymosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Electromagnetic interference 
1 
1 
0.03% 
(0.00%, 0.17%) 
Endocarditis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Endocarditis staphylococcal 
1 
1 
0.03% 
(0.00%, 0.17%) 
Erythema multiforme 
1 
1 
0.03% 
(0.00%, 0.17%) 
Fatigue 
5 
5 
0.15% 
(0.05%, 0.36%) 
Fluid overload 
1 
1 
0.03% 
(0.00%, 0.17%) 
Gastroenteritis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Gastrointestinal haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Haematoma 
2 
2 
0.06% 
(0.01%, 0.22%) 
Haematuria 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Haemoptysis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Haemothorax 
4 
4 
0.12% 
(0.03%, 0.32%) 
Hot flush 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hydrothorax 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyperglycaemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyperkalaemia 
4 
4 
0.12% 
(0.03%, 0.32%) 
Hypersensitivity 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hypertension 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyponatraemia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Hypotension 
20 
20 
0.62% 
(0.38%, 0.95%) 
Hypovolaemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ileus 
1 
1 
0.03% 
(0.00%, 0.17%) 
Impaired healing 
2 
2 
0.06% 
(0.01%, 0.22%) 
Implant site bruising 
2 
2 
0.06% 
(0.01%, 0.22%) 
Implant site cellulitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site effusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site erosion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site erythema 
6 
6 
0.18% 
(0.07%, 0.40%) 
Implant site haematoma 
98 
96 
2.96% 
(2.40%, 3.60%) 
Implant site haemorrhage 
6 
6 
0.18% 
(0.07%, 0.40%) 
Implant site hypoaesthesia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site infection 
44 
44 
1.36% 
(0.99%, 1.82%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Implant site inflammation 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site irritation 
5 
5 
0.15% 
(0.05%, 0.36%) 
Implant site oedema 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site pain 
72 
64 
1.97% 
(1.52%, 2.51%) 
Implant site rash 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site swelling 
4 
4 
0.12% 
(0.03%, 0.32%) 
Implant site warmth 
1 
1 
0.03% 
(0.00%, 0.17%) 
Incision site complication 
1 
1 
0.03% 
(0.00%, 0.17%) 
Incision site haemorrhage 
5 
5 
0.15% 
(0.05%, 0.36%) 
Incision site pain 
4 
4 
0.12% 
(0.03%, 0.32%) 
Incisional drainage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Infection 
2 
2 
0.06% 
(0.01%, 0.22%) 
Infusion site extravasation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Intracardiac thrombus 
6 
6 
0.18% 
(0.07%, 0.40%) 
Lead dislodgement 
33 
30 
0.92% 
(0.62%, 1.32%) 
Leukocytosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Localized oedema 
1 
1 
0.03% 
(0.00%, 0.17%) 
Mediastinal effusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Medical device discomfort 
3 
3 
0.09% 
(0.02%, 0.27%) 
Medical device site reaction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Monoparesis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Muscle spasms 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Muscle twitching 
1 
1 
0.03% 
(0.00%, 0.17%) 
Musculoskeletal chest pain 
2 
2 
0.06% 
(0.01%, 0.22%) 
Musculoskeletal pain 
42 
40 
1.23% 
(0.88%, 1.67%) 
Musculoskeletal stiffness 
1 
1 
0.03% 
(0.00%, 0.17%) 
Myocardial infarction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nausea 
1 
1 
0.03% 
(0.00%, 0.17%) 
Neck pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nephrosclerosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Neuropathy peripheral 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nodal rhythm 
2 
2 
0.06% 
(0.01%, 0.22%) 
Non-cardiac chest pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Oedema peripheral 
12 
12 
0.37% 
(0.19%, 0.64%) 
Oliguria 
1 
1 
0.03% 
(0.00%, 0.17%) 
Operative haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Orthostatic hypotension 
2 
2 
0.06% 
(0.01%, 0.22%) 
Oversensing 
34 
33 
1.02% 
(0.70%, 1.42%) 
Oxygen saturation decreased 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pacemaker generated arrhythmia 
6 
6 
0.18% 
(0.07%, 0.40%) 
Pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pain in extremity 
1 
1 
0.03% 
(0.00%, 0.17%) 
Palpitations 
9 
9 
0.28% 
(0.13%, 0.53%) 
Paraesthesia 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Pericardial effusion 
16 
15 
0.46% 
(0.26%, 0.76%) 
Pericarditis 
4 
4 
0.12% 
(0.03%, 0.32%) 
Phantom shocks 
4 
3 
0.09% 
(0.02%, 0.27%) 
Phlebitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Pleural effusion 
21 
21 
0.65% 
(0.40%, 0.99%) 
Pneumonia 
9 
9 
0.28% 
(0.13%, 0.53%) 
Pneumothorax 
43 
43 
1.32% 
(0.96%, 1.78%) 
Pocket erosion 
4 
4 
0.12% 
(0.03%, 0.32%) 
Post procedural haemorrhage 
2 
2 
0.06% 
(0.01%, 0.22%) 
Presyncope 
3 
3 
0.09% 
(0.02%, 0.27%) 
Procedural haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Procedural headache 
2 
2 
0.06% 
(0.01%, 0.22%) 
Procedural pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pruritus 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pruritus generalized 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulmonary embolism 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulmonary oedema 
3 
3 
0.09% 
(0.02%, 0.27%) 
Pulmonary sepsis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulseless electrical activity 
2 
2 
0.06% 
(0.01%, 0.22%) 
Pyrexia 
5 
5 
0.15% 
(0.05%, 0.36%) 
Rash 
8 
8 
0.25% 
(0.11%, 0.49%) 
Rash generalized 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Renal failure 
8 
8 
0.25% 
(0.11%, 0.49%) 
Renal failure acute 
2 
2 
0.06% 
(0.01%, 0.22%) 
Renal impairment 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory acidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory distress 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sepsis 
3 
3 
0.09% 
(0.02%, 0.27%) 
Sepsis syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Septic shock 
4 
4 
0.12% 
(0.03%, 0.32%) 
Sinus arrest 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sinus bradycardia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sinus tachycardia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Staphylococcal infection 
2 
2 
0.06% 
(0.01%, 0.22%) 
Stitch abscess 
1 
1 
0.03% 
(0.00%, 0.17%) 
Subclavian vein thrombosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Subcutaneous emphysema 
1 
1 
0.03% 
(0.00%, 0.17%) 
Subcutaneous haematoma 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sudden cardiac death 
10 
10 
0.31% 
(0.15%, 0.57%) 
Superior vena cava stenosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Supraventricular extrasystoles 
1 
1 
0.03% 
(0.00%, 0.17%) 
Supraventricular tachycardia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Syncope 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Tachycardia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Thrombophlebitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Thrombosis 
8 
8 
0.25% 
(0.11%, 0.49%) 
Thrombotic stroke 
1 
1 
0.03% 
(0.00%, 0.17%) 
Toxicity to various agents 
1 
1 
0.03% 
(0.00%, 0.17%) 
Twiddler's syndrome 
5 
5 
0.15% 
(0.05%, 0.36%) 
Undersensing 
7 
7 
0.22% 
(0.09%, 0.44%) 
Urinary retention 
2 
2 
0.06% 
(0.01%, 0.22%) 
Vena cava thrombosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Venous occlusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular dyssynchrony 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular extrasystoles 
2 
2 
0.06% 
(0.01%, 0.22%) 
Ventricular fibrillation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular tachycardia 
11 
11 
0.34% 
(0.17%, 0.61%) 
Vomiting 
3 
3 
0.09% 
(0.02%, 0.27%) 
Weaning failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Weight decreased 
1 
1 
0.03% 
(0.00%, 0.17%) 
Wound dehiscence 
1 
1 
0.03% 
(0.00%, 0.17%) 
Adverse Events in Literature 
The potential AEs associated with the implantation of CRT-P or CRT-D  systems have been documented 
in various articles in medical scientific literature.  A summary of those events and their published 
incidence are included below. 
1. Ahsan SY, Saberwal B, Lambiase PD, Chaubey S, Segal OR, Gopalamurugan AB, McCready J, 
Rogers DP, Lowe MD, and Chow AWC.  An 8-year single-centre experience of cardiac 

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resynchronization therapy: procedural success, early and late complications, and left ventricular 
lead performance.  Europace 2013;15:711-717. 
Retrospective data were analyzed for all acute and chronic complications occurring over 490 consecutive 
CRT device procedures in 402 patients, from 2000 through 2008.  Associated complications were 
reported by timeframe. 
Table 25: Complications reported in Ahsan et al. 
 
 
2. Dickstein K, Bogale N, Priori S, Auricchio A, Cleland JG, Gitt A, Limbourg T, Linde C, van 
Veldhuisen DJ, Brugada J; Scientific Committee; National Coordinators.  The European Cardiac 
Resynchronization Therapy Survey.  European Heart Journal 2009; 30:2450–2460. 
The primary aim of this survey was to describe current European practice associated with CRT 
implantations.  A total of 140 centers from 13 European countries contributed data from consecutive 
patients successfully implanted with a CRT device with or without an ICD between November 2008 and 
June 2009.  The total number of patients enrolled was 2438. 
Table 26: Complications reported in Dickstein et al. 
Event 
Incidence (%) 
Peri-procedural complications 
10 
Bleeding 
1 
Pocket haematoma 
3 
Pneumothorax 
1 
Pericardial tamponade 
0.3 
Coronary sinus dissection 
1 
Phrenic nerve pacing 
2 
Lead dislocation 
3 

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Post–implantation device related complications 
4 
Lead displacement 
2 
Lead malfunction 
0 
Phrenic nerve stimulation 
2 
 
3. Kirkfeldt R.E., Johansen J.B., Nohr E.A., Jorgensen O.D., Nielsen J.C. Complications after cardiac 
implantable electronic device implantations: An analysis of a complete, nationwide cohort in 
Denmark.  European Heart Journal 2014 35:18 1186-1194. 
This was a population-based cohort study in all Danish patients who underwent a Cardiac Implantable 
Electronic Device (CIED) procedure from May 2010 to April 2011.  The study population consisted of 5918 
consecutive patients.  Total of 562 patients (9.5%) experienced at least one complication. 
Table 27: Complications reported by Kirkfeldt et al. shows cumulative incidence of complications at 6 
monthsa. 
Table 27: Complications reported by Kirkfeldt et al. 
Complication type 
All (n=5918) 
New Implant 
(n=4335) 
Generator 
replacement 
(n=1136) 
Upgrade/Lead 
revision (n=427) 
Any complication 
562 (9.5; 8.7–
10.2) 
432 (9.9; 9.0–
10.8) 
67 (5.9; 4.5–7.3) 
63 (14.8; 11.4–
18.1) 
Any major complicationb 
329 (5.6; 5.0–
6.1) 
253 (5.8; 5.1–
6.5) 
40 (3.5; 2.4–4.6) 
36 (8.4; 5.8–11.1) 
Any minor complicationc 
250 (4.2; 3.7–
4.7) 
189 (4.3; 3.7–
4.9) 
30 (2.6; 1.7–3.6) 
31 (7.3; 4.8–9.7) 
Major complications 
 
Lead related re-intervention 
143 (2.4; 2.0–
2.8) 
120 (2.8; 2.3–
3.2) 
10 (0.9; 0.3–1.4) 
13 (3.0; 1.4–4.7) 
Infection 
49 (0.8; 0.6–1.1) 
24 (0.6; 0.3–0.8) 
17 (1.5; 0.8–2.2) 
8 (1.9; 0.6–3.2) 
Local infection 
22 (0.4; 0.2–0.5) 
10 (0.2; 0.1–0.4) 
8 (0.7; 0.2–1.1) 
4 (1.0; 0.0–1.9) 
Systemic 
infection/endocarditis 
27 (0.5; 0.3–0.6) 
14 (0.3; 0.2–0.5) 
9 (0.8; 0.3–1.3) 
4 (0.9; 0.0–1.9) 
Pneumothorax requiring 
drainage 
51 (0.9; 0.6–1.1) 
45 (1.0; 0.7–1.3) 
0 
6 (1.4; 0.3–2.5) 
Cardiac perforation 
38 (0.6; 0.4–0.8) 
35 (0.8; 0.5–1.1) 
0 
3 (0.7; 0.0–1.5) 

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Cardiac perforation (No 
intervention) 
21 (0.4; 0.2–0.5) 
18 (0.4; 0.2–0.6) 
0 
3 (0.7; 0.0–1.5) 
Cardiac perforation 
(Intervention) 
17 (0.3; 0.2–0.4) 
17 (0.4; 0.2–0.6) 
0 
0 
Pocket revision because of pain 
25 (0.4; 0.3–0.6) 
10 (0.2; 0.1–0.4) 
9 (0.8; 0.3–1.3) 
6 (1.4; 0.3–2.5) 
Generator-lead interface 
problem with re-intervention 
7 (0.1; 0.0–0.2) 
3 (0.1; 0.0–0.1) 
4 (0.4; 0.0–0.7) 
0 
Haematoma requiring re-
intervention 
10 (0.2; 0.1–0.3) 
9 (0.2; 0.1–0.3) 
1 (0.1; 0.0–0.3) 
0 
Otherd 
16 (0.3; 0.1–0.4) 
16 (0.4; 0.2–0.5) 
0 
0 
Minor complications 
 
Haematomae 
138 (2.3; 1.9–
2.7) 
104 (2.4; 1.9–
2.8) 
20 (1.8; 1.0–2.5) 
14 (3.3; 1.6–5.0) 
Wound infection treated with 
antibiotics 
69 (1.2; 0.9–1.4) 
47 (1.1; 0.8–1.4) 
12 (1.0; 0.5–1.7) 
10 (2.3; 0.9–3.8) 
Pneumothorax conservatively 
treated 
39 (0.7; 0.5–0.9) 
32 (0.7; 0.5–1.0) 
0 
7 (1.6; 0.4–2.8) 
Lead dislodgement without re-
intervention 
10 (0.2; 0.1–0.3) 
9 (0.2; 0.1–0.3) 
0 
1 (0.2; 0.0–0.7) 
aReported as absolute frequencies and percentages with 95% CIs in parenthesis. 
bAll re-interventions were categorized as major complications due to their inherently higher risk of infections e.g. local CIED 
infections requiring re-intervention, systemic infections, pocket revisions etc. 
cMinor complications included haematomas resulting in a prolonged hospital stay, hospital re-admissions, or additional out-patient 
visits, wound infections treated with antibiotics, pneumothorax conservatively treated, and lead dislodgements without re-
intervention. 
dDeep venous thrombosis (n=8), Twiddler’s syndrome (n=3), wound revision (n=3), stroke (n=1), myocardial infarction (n=1) 
eResulting in prolonged hospital stay, hospital re-admission, or additional out-patient visit. 
 
 

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23. References 
                                               
 
1 Model 8040 InSync MIRACLE Study (IDE # G980219). 
 
2 Model 7272 InSync ICD Study (IDE # G990176). 
 
3 Thackray S, Coletta A, Jones P, Dunn A, Clark AL, Cleland, JGF.  Clinical trials update:  highlights of the 
scientific sessions of heart failure 2001, a meeting of the working group of heart failure of the European 
Society of Cardiology.  European Journal of Heart Failure 3 (2001): 491-494. 
 
4 Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood 
G, Santini M, Bailleul C, Daubert J.  Effects of multisite biventricular pacing in patients with heart failure 
and intraventricular conduction delay.  New England Journal of Medicine 344 (2001):873-880. 
 
5 Stellbrink C, Breithardt, O, Franke A, Sack S, Bakker P, Auticchio A, et al.  Impact of cardiac 
resynchronization therapy using hemodynamically optimized pacing on left ventricular remodeling in 
patients with congestive heart failure and ventricular conduction disturbances.  Journal of American 
College of Cardioliolgy 38 (2001): 1957-1965. 
 
6 Salukhe TV, Francis, DP, Sutton R.  Comparison of medical therapy, pacing and defibrillation in heart 
failure (COMPANION) trial terminated early; combines biventricular pacemaker defibrillators reduce all-
cause mortality and hospitalization.  International Journal of Cardiology 87 (2003): 119-120. 
 
7 MOSS AJ, Jackson Hall W, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NAM, Foster E, 
Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Silber D, ZarebaW, for the MADIT-CRT Trial 
Investigators.  Cardiac resynchronization therapy for the prevention of heart failure events.  New England 
Journal of Medicine (2009); 
 
8 Cleland JFG, Daubert J-C, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L, for the Cardiac 
Resynchronization-Heart Failure (CARE-HF) Study Investigators.  The effect of cardiac resynchronization 
on morbidity and mortality in heart failure.  New England Journal of Medicine 352 (2005): 1539-1549. 
 
9 Mozzafarian D, Benjamin EJ, Go AS, et al.  On behalf of the American Heart Association Statistics 
Committee and Stroke Statistics Subcommittee.  Heart disease and stroke statistics-2016 update: a report 
from the American Heart Association.  Circulation 133 ( 2016): e38-e360. 
 
10 Abraham, William T., et al.  “Cardiac resynchronization in chronic heart failure.” New England Journal 
of Medicine 346.24 (2002): 1845-1853. 
 
11 Higgins, Steven L., et al.  “Cardiac resynchronization therapy for the treatment of heart failure in 
patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias.” Journal of 
American College of Cardiology 42.8 (2003): 1454-1559. 
 
12 Tang, Anthony SL, et al.  “Cardiac-resynchronization therapy for mild-to-moderate heart failure.” New 
England Journal of Medicine 363.25 (2010): 2385-2395. 
 
 

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13 Moss, Arthur J., et al.  “Cardiac-resynchronization therapy for the prevention of heart-failure events.” 
New England Journal of Medicine 361.14 (2009): 1329-1338. 
 
14 Bristow, Michael R., et al.  “Cardiac-resynchronization therapy with or without an implantable 
defibrillator in advanced chronic heart failure.” New England Journal of Medicine 350.21 (2004): 2140-
2150. 
 
15 Sutton, Martin G. St John, et al.  “Effect of cardiac resynchronization therapy on left ventricular size 
and function in chronic heart failure.” Circulation 107.15 (2003): 1985-1990. 
 
16 Saxon, Leslie A., et al.  “Effects of long-term biventricular stimulation for resynchronization on 
echocardiographic measures of remodeling.” Circulation 105.11 (2002): 1304-1310. 
 
17 Auricchio, Angelo, et al.  “Long-term clinical effect of hemodynamically optimized cardiac 
resynchronization therapy in patients with heart failure and ventricular conduction delay.” Journal of 
American College of Cardiology 39.12 (2002): 2026-2033. 
 
18 Linde, Cecilia, et al.  “Randomized trial of cardiac resynchronization in mildly symptomatic heart failure 
patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure 
symptoms.” Journal of American College of Cardiology 52.23 (2008): 1834-1843. 
 
19 Cleland John GF, et al.  The effect of cardiac resynchronization on morbidity and mortality in heart 
failure.” New England Journal of Medicine 352.15 (2005): 1539-1549. 
 
20 Crossley, George H., et al.  “Performance of a novel left ventricular lead with short bipolar spacing for 
cardiac resynchronization therapy: primary results of the Attain Performa Quadripolar Left Ventricular 
Lead Study.” Heart Rhythm 12.4 (2015): 751-758. 
 
21 Yee, Raymond, et al. “Novel active fixation mechanism permits precise placement of a left ventricular 
lead: early results from a multicenter clinical study.” Heart Rhythm 11.7 (2014): 1150-1155. 
 
22 Tomassoni G, Baker J et.al.  Postoperative Performance of the Quartet Left Ventricular Heart Lead, J 
Cardiovasc Electrophysiology, Vol 24, pp. 449-456, April 2013 
 
23 Mittal S, Nair D, et.al,, Performance of Anatomically Designed Quadripolar Left Ventricular Leads: 
Results from the NAVIGATE X4 Clinical Trial, J Cardiovasc Electrophysiology, DOI: 10.1111/jce.13044 
 
24 J. G. Ibrahim and M.-H. Chen, "Power prior distributions for regression models," Statistical Science, vol. 
15, no. 1, pp. 46-60, 2000. 
 
25 T. Haddad, A. Himes, L. Thompson, T. Irony, R. Nair, "Incorporation of stochastic engineering models 
as prior information in Bayesian medical device trials", Draft manuscript 
 
26 A. Gelman, J. Carlin, H. Stern and D. Rubin, Bayesian Data Analysis, Boca Raton: Chapman & Hall / 
CRC, 2004. 
 
27 S.M. Berry, B.P. Carlin, J.J. Lee, P. Muller, Bayesian adaptive methods for clinical trials. CRC press, 
2010. 

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056-F275, Clinical Investigation Plan Template, Version 2.0 
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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Attain StabilityTM Quad Clinical Study 
Study Product Name Attain StabilityTM Quad MRI SureScan Left 
Ventricular Lead (Model 4798) 
Sponsor/Local Sponsor Sponsor: 
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 U.S.A.  
1-800-328-2518 
Local Sponsors: 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
+1-905-460-3800 
 
Europe, Middle East, Africa (EMEA)Medtronic, 
Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
 
Hong Kong 
Medtronic Hong Kong Medical Ltd. 1104-11, 11/F, 
Tower 1,  
The Gateway,  
Harbour City, Kowloon,  
Hong Kong SAR, China 
+852-2919-1300 
 
Malaysia 
Medtronic International Ltd (Malaysia) 
B-23-1 Level 23, The Ascent, Paradigm  
No 1 Jalan SS7/26A Kelena Jaya 46301 
PetalingJaya 
Selangor 
Malaysia 
+603 7883 8000 
Document Version Version 2.0; 13/JAN/2017 

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Lead Principal Investigators Dr. George H. Crossley III, MD (Co-Chair) 
Associate Professor of Medicine; Electrophysiologist 
Fellowship Program Director 
Vanderbilt University Medical Center 
1211 Medical Center Drive 
Nashville, TN 37232 
(615) 322-5000 
 
Dr. Kevin Jackson, MD (Co-Chair) 
Assistant  Professor of Medicine; Electrophysiologist 
Director, Duke Cardiac Resynchronization Therapy 
Center 
Medical Director, Electrophysiology Services 
Duke University Medical Center Rm 7451-D 
Durham, North Carolina 27710 
(919) 681-5441 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic.  
Any distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited.  Persons to whom the information is disclosed must know that it is confidential and that it 
may not be further disclosed by them. 
 
 

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1. Sponsor Contact 
Medtronic, Inc. is sponsoring the Attain Stability Quad Clinical Study.  Regional contact information is 
provided below.  This information may be subject to change during the course of the Attain Stability 
Quad Clinical Study.  Periodic updates to study contact information will be sent to sites as needed.  
Table 1: Study Sponsor Contact Information 
Study Contacts 
Worldwide Clinical Study Leader  
 
Melissa Thalin, Principal Clinical Research 
Specialist 
Direct Phone: (+1-763) 526-1808 
melissa.a.thalin@medtronic.com 
United States 
 
Ann Vacca, Prin. Customer Specialist  
Direct Phone: +(1-301) 785-7294 
ann.vacca@medtronic.com 
Canada 
 
Mary McCann, Sr. Clinical Research Specialist 
Direct Phone: (+1-905) 460-3639 
mary.mccann@medtronic.com  
Europe, the Middle East and Africa (EMEA) 
 
Rinie Peters, Associate Clinical Research 
Specialist 
Direct Phone: (+31)-43-356-6632  
rinie.peters@medtronic.com 
Hong Kong 
 
Grace Wong, Clinical Research Supervisor 
Direct Phone: (+852) 2919-1305 
grace.wong@medtronic.com 
Malaysia 
 
Sheikh Abdul Aziz, Sr. Clinical Research 
Specialist 
Direct Phone: (+60-3) 7946-9079 
sheikh.hafiz@medtronic.com 
Study Monitors and Contacts 
Worldwide Monitoring Leader 
 
Taryn Randall, Clinical Monitoring Manager 
Direct Phone: (+1-763) 250-0785  
Direct Fax: (+1-651) 367-0759 
taryn.randall@medtronic.com  
Monitoring Leader EMEA, Hong Kong, Malaysia 
 
Anja Hesse, CRHF Portfolio Specialist CRHF 
Direct Phone: +49215981490 
Direct Fax: +4921027069069 
anja.hesse@medtronic.com 
Sponsor’s Medical Expert 
David Steinhaus, M.D., VP & GM Heart Failure and Medical Director CRHF 
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure 
8200 Coral Sea Street N.E., MVC42 
Mounds View, MN 55112 
United States 
Phone: (+1-763) 526-1250 
Fax: (+1-651) 367-0671 
david.m.steinhaus@medtronic.com 
 

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2. CROs/Core Laboratories 
This information may be subject to change during the course of the Attain Stability Quad Clinical Study.  
Periodic updates to study contact information will be sent to sites as needed. 
Table 2: CRO and Core Laboratory Information 
Contact Information 
Role 
Cognizant Technology Solutions 
500 Frank W. Burr Blvd. 
Teaneck, NJ 07666 
United States 
Direct Phone: (201) 801-0233 
Direct Fax: (201) 801-0243 
Review of electronic case report forms and 
management of discrepancies 
 
 

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3. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
o 
Initial Release 
Melissa Thalin, Principal Clinical 
Research Specialist 
 
Rinie Peters, Associate Clinical 
Research Specialist 
 
Ann Vacca, Principal Customer 
Specialist 
 
Shelby Li, Senior Principal 
Statistician 
 
Joao Monteiro, Senior Statistician 
2.0 
o 
Added slitting information for Implant 
analyzer PCT at synopsis and table 8 
o 
Remote visits:  
 
Changed wording to clarify 
required actions 
 
Removed manual PCT test  
 
Deleted rationale for final 
vector progammed  
o 
Recurring 6 mth FU: 
 
Removed PNS test 
 
Removed Patient Global 
Assessment 
o 
System Modification 
 
Reduced electrical testing 
requirements 
o 
Patient Global Assessment 
 
Added to Glossary 
 
Removed from Baseline and 
3 month visits 
o 
Vectors 
 
Added additional 4 CRT-P 
vectors (LV to Can) 
throughout  
o 
Investigator Lead Handling 
Assessment 
 
Added to Implant visit 
o 
Adjusted # of participating centers 
o 
Updated exclusion criteria #2 
o 
Updates to grammer, version ,and 
footers 
Melissa Thalin, Principal Clinical 
Research Specialist 
 
Rinie Peters, Associate Clinical 
Research Specialist 

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4. Investigator Statement 
Investigators will be provided with a separate investigator agreement to document their obligation and 
commitment with respect to study conduct.  
 
 

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5. Index 
 
1. 
Sponsor Contact .......................................................................................................... 3 
2. 
CROs/Core Laboratories ............................................................................................ 4 
3. 
Version History ........................................................................................................... 5 
4. 
Investigator Statement................................................................................................. 6 
5. 
Index ........................................................................................................................... 7 
6. 
List of Tables ............................................................................................................ 10 
7. 
List of Figures ........................................................................................................... 11 
8. 
Glossary ..................................................................................................................... 11 
9. 
Synopsis .................................................................................................................... 15 
10. 
Introduction .............................................................................................................. 27 
10.1. 
Background ................................................................................................................. 27 
10.2. 
Purpose ........................................................................................................................ 28 
11. 
Objectives and Endpoints ......................................................................................... 28 
11.1. 
Objectives ................................................................................................................... 28 
11.1.1. 
Primary Objective(s) ....................................................................................................... 28 
11.1.2. 
Secondary Objective(s) .................................................................................................. 29 
11.2. 
Endpoints .................................................................................................................... 29 
12. 
Study Design ............................................................................................................. 30 
12.1. 
Duration ....................................................................................................................... 31 
12.2. 
Rationale ..................................................................................................................... 31 
12.3. 
Study Oversight ......................................................................................................... 32 
13. 
Product Description .................................................................................................. 33 
13.1. 
General......................................................................................................................... 33 
13.2. 
Manufacturer .............................................................................................................. 41 
13.3. 
Packaging .................................................................................................................... 41 
13.4. 
Intended Population ................................................................................................. 41 
13.5. 
Equipment ................................................................................................................... 41 
13.6. 
Product Use ................................................................................................................. 42 
13.7. 
Product Receipt, Tracking, and Accountability ................................................... 42 
13.8. 
Product Storage ......................................................................................................... 42 
13.9. 
Product Return ........................................................................................................... 43 
14. 
Selection of Subjects .................................................................................................. 43 
14.1. 
Study Population ....................................................................................................... 43 
14.2. 
Subject Enrollment .................................................................................................... 43 
14.3. 
Inclusion Criteria ....................................................................................................... 44 
14.4. 
Exclusion Criteria ....................................................................................................... 44 
14.5. 
Minimization of Bias.................................................................................................. 44 

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15. 
Study Procedures ....................................................................................................... 45 
15.1. 
Study Personnel Requirements .............................................................................. 45 
15.2. 
Site Activation ............................................................................................................ 46 
15.3. 
Equipment Requirements ........................................................................................ 47 
15.4. 
Schedule of Events .................................................................................................... 47 
15.5. 
Subject Consent ......................................................................................................... 49 
15.6. 
Enrollment ................................................................................................................... 51 
15.7. 
Baseline ....................................................................................................................... 51 
15.8. 
Implant/PHD .............................................................................................................. 51 
15.8.1. 
Final System Configuration ............................................................................................ 52 
15.8.2. 
Implant Procedure ........................................................................................................... 52 
15.8.2.1. 
Venogram ..................................................................................................................... 52 
15.8.2.2. 
Implanting the LV lead ............................................................................................... 52 
15.8.2.3. 
CRT System Testing and Programming During Implant ........................................ 54 
15.8.2.4. 
Final Lead Placement Data Collection ....................................................................... 54 
15.8.2.5. 
Pre-Hospital Discharge CRT System Testing and Programming........................... 55 
15.9. 
3 Months Post-Implant (remote or in office visit) ............................................. 55 
15.10. 
6 Months Post-Implant (in office visit) ............................................................. 56 
15.11. 
12 Months Post-Implant (in office visit) ........................................................... 57 
15.12. 
Recurring 6 Month Follow-ups (remote or inoffice visit) .............................. 58 
15.13. 
Device Interrogation/Save-to-Media ................................................................ 58 
15.14. 
System Modifications ............................................................................................ 58 
15.15. 
Study Exit ................................................................................................................. 60 
15.15.1. 
Study Completed ......................................................................................................... 61 
15.15.2. 
Lost to Follow-up ......................................................................................................... 61 
15.15.3. 
Study Exit Upon Sponsor Request ............................................................................ 61 
15.16. 
Subject Withdrawal or Discontinuation ............................................................ 61 
15.16.1. 
Subject Chooses to Exit (i.e. revokes consent) ....................................................... 61 
15.16.2. 
Investigator Withdraws Subject ................................................................................ 61 
15.17. 
Assessment of Efficacy .......................................................................................... 63 
15.18. 
Assessment of Safety ............................................................................................ 63 
15.19. 
Recording Data ....................................................................................................... 63 
15.20. 
Deviation Handling ................................................................................................ 63 
16. 
Risks and Benefits ..................................................................................................... 64 
16.1. 
Potential Risks ........................................................................................................... 64 
16.2. 
Risk Minimization ...................................................................................................... 66 
16.3. 
Potential Benefits ...................................................................................................... 67 
16.4. 
Risk-Benefit Rationale.............................................................................................. 67 
17. 
Adverse Event Assessments....................................................................................... 67 
17.1. 
Adverse Event and Device Deficiency Assessment ............................................ 67 
17.1.1. 
Adverse Events ................................................................................................................ 67 
17.1.2. 
Device Deficiencies.......................................................................................................... 68 
17.1.3. 
Event Updates and Resolution ...................................................................................... 68 
17.2. 
Definitions/Classifications ...................................................................................... 69 
17.3. 
Reporting of Adverse Events ................................................................................... 75 
17.3.1. 
Adverse Events and Device Deficiency Classification ................................................. 75 

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17.3.2. 
Adverse Events and Device Deficiency Reporting Requirements ............................. 76 
17.4. 
Subject Death ............................................................................................................. 79 
17.4.1. 
Death Data Collection ..................................................................................................... 79 
17.4.2. 
Death Classification and Reporting ............................................................................... 80 
17.5. 
Product Complaint Reporting ................................................................................. 80 
18. 
Data Review Committees .......................................................................................... 81 
18.1. 
Clinical Events Committee ....................................................................................... 81 
18.2. 
Data Monitoring Committee .................................................................................... 82 
19. 
Statistical Design and Methods ................................................................................. 82 
19.1. 
Primary Objectives .................................................................................................... 82 
19.1.1. 
Primary Safety Objective ................................................................................................ 82 
19.1.2. 
Primary Efficacy Objective #1 ....................................................................................... 84 
19.1.3. 
Primary Efficacy Objective # 2 ...................................................................................... 86 
19.2. 
Secondary Objectives ............................................................................................... 87 
19.2.1. 
Secondary Objective # 1 ................................................................................................ 87 
19.2.2. 
Secondary Objective # 2 ................................................................................................ 87 
19.2.3. 
Secondary Objective # 3 ................................................................................................ 91 
19.3. 
Additional Analysis .................................................................................................... 92 
19.3.1. 
Poolability Analysis .......................................................................................................... 92 
19.3.2. 
Sensitivity Analysis .......................................................................................................... 92 
19.3.3. 
Additional Data Collection .............................................................................................. 92 
19.3.3. 
Overall Study Sample Size Requirements .................................................................... 92 
20. 
Ethics ........................................................................................................................ 93 
20.1. 
Statement(s) of Compliance ................................................................................... 93 
21. 
Study Administration ................................................................................................. 94 
21.1. 
Monitoring ................................................................................................................... 94 
21.2. 
Data Management ..................................................................................................... 95 
21.3. 
Direct Access to Source Data/Documents ........................................................... 96 
21.4. 
Confidentiality ............................................................................................................ 96 
21.5. 
CIP Amendments ....................................................................................................... 96 
21.6. 
Warranty/Insurance Information ......................................................................... 96 
21.6.1. 
Warranty ........................................................................................................................... 96 
21.6.2. 
Insurance (EMEA) ........................................................................................................... 96 
21.6.3. 
Insurance (Canada) ........................................................................................................ 97 
21.6.4. 
Insurance (Malaysia) ...................................................................................................... 97 
21.6.5. 
Insurance (Hong Kong) .................................................................................................. 97 
21.7. 
Record Retention ....................................................................................................... 97 
21.7.1. 
Investigator Records ....................................................................................................... 97 
21.7.2. 
Investigator Reports ....................................................................................................... 98 
21.7.3. 
Sponsor Records .............................................................................................................. 99 
21.7.4. 
Sponsor Reports .............................................................................................................. 99 
21.8. 
Publication and Use of Information .................................................................... 101 
21.8.1. 
Publication Committee .................................................................................................. 102 
21.8.2. 
Management of Primary, Secondary, and Ancillary Publications ........................... 102 
21.8.3. 
Criteria for Determining Authorship............................................................................ 102 

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21.8.4. 
Transparency ................................................................................................................. 103 
21.9. 
Suspension or Early Termination ......................................................................... 103 
21.9.1. 
Planned Study Closure .................................................................................................. 103 
21.9.2. 
Early Termination or Suspension ................................................................................ 103 
21.9.3. 
Procedures for Termination or Suspension ............................................................... 104 
22. 
Appendices .............................................................................................................. 106 
23. 
References ............................................................................................................... 122 
 
6. List of Tables 
Table 1: Study Sponsor Contact Information ................................................................................................ 3 
Table 2: CRO and Core Laboratory Information ........................................................................................... 4 
Table 3: Glossary of Terms .................................................................................................................... 11 
Table 4: Steering Committee Members ...................................................................................................... 32 
Table 5: Comparison of Medtronic Quadripolar LV Leads............................................................................. 35 
Table 6: Comparison of Medtronic Attain Stability Bipolar and Quadripolar LV Leads ......................................... 37 
Table 7: Study Component Information .................................................................................................... 40 
Table 8: Data Collection and Study Procedure Requirements at Subject Visits .................................................... 48 
Table 9: Visit Windows ......................................................................................................................... 49 
Table 10: Additional adverse events related to the lead and programmed parameters ............................................ 65 
Table 11: Implant Techniques that may damage the lead ............................................................................... 66 
Table 12: Adverse Event and Device Deficiency Definitions .......................................................................... 69 
Table 13: Adverse Event Classification Responsibilities ................................................................................. 76 
Table 14: Reporting Requirements ........................................................................................................... 76 
Table 15: Subject Death Classification Responsibilities .................................................................................. 80 
Table 16: Safety Performance of Market Released Quadripolar Lead ................................................................ 83 
Table 17: Prior weight from Attain Stability (Model 20066) and prior weight from Attain Performa as a function of the 
posterior Bayesian p-value (𝒑𝒑) ................................................................................................................. 89 
Table 18: Required Sample Size by Study Objective...................................................................................... 92 
Table 19: Investigator Reports Applicable for All Geographies per Medtronic Requirements ................................. 98 
Table 20: Sponsor Reports for Canada .................................................................................................... 100 
Table 21: Sponsor Reports for EMEA, Malaysia, Hong Kong ...................................................................... 100 
Table 22: Sponsor Reports for the United States ....................................................................................... 101 
Table 23: Listing of Potential Adverse Events Associated with System Implant ................................................ 107 
Table 24: System or procedure-related adverse events from previous clinical studies .......................................... 108 
Table 25: Complications reported in Ahsan et al. ....................................................................................... 119 

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Table 26: Complications reported in Dickstein et al. ................................................................................... 119 
Table 27: Complications reported by Kirkfeldt et al. ................................................................................... 120 
 
7. List of Figures 
Figure 1: Study Visits ............................................................................................................................ 31 
Figure 2: Attain Stability Quad MRI SureScan LV Lead (Model 4798) Specifications Drawing ................................ 34 
Figure 3: Comparison of Attain Performa Leads and the Attain Stability Lead Model 4798 .................................... 37 
Figure 4: Attain Stability Bipolar (Model 20066/4796) & Attain Stability Quad MRI SureScan (Model 4798) Active 
Fixation Leads .................................................................................................................................... 39 
Figure 5: Primary Safety Objective Sample Size Consideration by Difference Performance Assumption ................... 84 
Figure 6: Simulated PCT Distribution ....................................................................................................... 85 
Figure 7: Loss Function 𝒂𝒂𝒂𝒂= 𝟏𝟏−𝒆𝒆−𝒑𝒑∗𝟓𝟓𝟓𝟓41T .......................................................................................... 89 
Figure 8: Credible Intervals for Scenarios of Agreement Between Historical and Current Data ............................... 90 
 
8. Glossary 
Table 3: Glossary of Terms 
Term 
Definition 
2090 
Medtronic CareLink Programmer with the 
application software installed.   
2290 
Medtronic Analyzer 
Medtronic Attain Stability Quad MRI SureScan 
(Model 4798) LV Lead 
The quadripolar LV lead being studied 
(investigational in the United States/Canada, 
commercially available in EMEA, Hong Kong, and 
Malaysia).   
Active Fixation Helix 
A non-electrically active side helix, positioned 
between the LV 3 and LV 4 electrodes that will 
allow fixation of the Attain Stability Quad MRI 
SureScan (Model 4798) LV Lead in the cardiac vein.  
ADE 
Adverse Device Effect 
AE 
Adverse Event 
Ag 
Silver 
CABG 
Coronary Artery Bypass Graft 

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Term 
Definition 
CAD 
Coronary Artery Disease 
CDF 
Cumulative Distribution Function 
CEC 
Clinical Events Committee 
CIP 
Clinical Investigation Protocol 
CRF 
Case Report Form 
CRT 
Cardiac Resynchronization Therapy: Established 
pacing therapy for patients with heart failure 
CRT-D 
Cardiac Resynchronization Therapy - Defibrillator 
CRT-P 
Cardiac Resynchronization Therapy - Pacemaker 
CS 
Coronary Sinus 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
DEKRA 
Deutscher Kraftfahrzeug-Überwachungs-Verein 
(German Motor Vehicle Inspections Association) 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
EMEA 
Europe, the Middle East, and Africa 
eCRF 
Electronic Case Report Form 
MEC/IRB/HREB/Ethics Board 
Ethics Committee 
FAL 
Foreseeable Adverse Event List 
FDA 
Food and Drug Administration 
Fr 
French 
GCP 
Good Clinical Practice 

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Term 
Definition 
HF 
Heart Failure 
HTN 
Hypertension 
IC 
Informed Consent 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigation Device Exemption 
Ir 
Iridium 
IRB 
Institutional Review Board 
LAR 
Legally Authorized Representative 
LBBB 
Left Bundle Branch Block 
LV 
Left Ventricular 
LVEF 
Left Ventricular Ejection Fraction 
MCRD 
Monolithic Controlled Release Device which is 
located on the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) electrodes which elutes 
steroid to reduce inflammatory response within the 
cardiac vein. 
Mechanical Stop 
A component on the Attain Stability Quad MRI 
SureScan (Model 4798) LV Lead located at the 
base of the helix to prevent wedging of endothelial 
tissue in the helix and to prevent tissue ingrowth. 
MedDRA 
Medical Dictionary for Regulatory Activities 
OC 
Oracle Clinical (database management system) 
OTW 
Over-the-wire 
PCT 
Pacing Capture Threshold 
Patient Global Assessment 
Self-reported assessment to provide information on 
patient condition compared to previous heart 
failure status 

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Term 
Definition 
PHD 
Pre-Hospital Discharge means the point at which a 
subject has been released from the hospital post 
implant procedure. 
PMA 
Premarket Approval 
PNS 
Phrenic Nerve Stimulation 
POR 
Power On Reset 
Pt 
Platinum 
PTCA 
Percutaneous Transluminal Coronary Angioplasty 
QOL 
Quality of Life 
RA 
Right Atrial 
RRT 
Recommended Replacement Time 
RV 
Right Ventricular 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SC 
Steering Committee 
SDN 
Software Distribution Network 
TÜV 
Technischer Überwachungsverein (German safety 
validation organization) 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
USADE 
Unanticipated Serious Adverse Device Effect 
VF 
Ventricular Fibrillation 
VT 
Ventricular Tachycardia 
 
 

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9. Synopsis 
Title 
Attain StabilityTM Quad Clinical Study 
Product Name 
Attain StabilityTM Quad MRI SureScan Left Ventricular Lead 
(Model 4798) 
Sponsor  
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 U.S.A. 
1-800-328-2518 
Local Sponsor 
Canada 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
+1-905-460-3800 
 
EMEA 
Medtronic, Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
 
Hong Kong 
Medtronic Hong Kong Medical Ltd. 
1104-11, 11/F, Tower 1,  
The Gateway,  
Harbour City, Kowloon,  
Hong Kong SAR, China 
+852-2919-1300 
 
Malaysia 
Medtronic International Ltd (Malaysia) 
B-23-1 Level 23, The Ascent, Paradigm, No 1 Jalan 
SS7/26A Kelena Jaya 46301 Petaling Jaya 
Selangor 
Malaysia 
+603 7883 8000 
Indication under investigation  
All subjects included in the study will be implanted with a 
Medtronic market released de novo CRT-P or CRT-D 
device, compatible market released Medtroinc RA and 
Medtronic RV leads and an Attain Stability QuadSureScan 
LV lead (Model 4798). For subjects enrolled who are 
receiving an upgrade to a CRT system, existing non-
Medtronic RV and/or existing non-Medtronic RA leads that 
are not recalled, market withdrawn, and/or have a medical 
alert may be used.   

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Given the vast similarities between the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) and the Attain 
Performa family of leads, the proposed indications for use 
are the same.  The indications are as follows: 
The Attain Stability Quad MRI SureScan 4798 steroid-
eluting, quadripolar electrode, IS4 transvenous lead is 
indicated for chronic pacing in the left ventricle via the 
cardiac vein, when used with a compatible Medtronic 
Cardiac Resynchronization Therapy (CRT) system.  
Extended bipolar pacing is available using this lead in 
combination with a compatible market approved  CRT-D 
system and RV defibrillation lead. 
Investigation Purpose 
The Attain Stability Quad Clinical Study is a prospective, 
non-randomized, multi-site, global, Investigational Device 
Exemption (IDE) interventional clinical study.  The 
purpose of this clinical study is to evaluate the safety and 
efficacy of the Attain Stability Quad MRI SureScan LV lead 
(Model 4798).  This study will not be considered 
investigational in geographies with CE Mark of the Attain 
Stability Quadripolar LV lead (4798).  However, data 
collected from all study subjects will be represented in the 
final report and the PMA Supplement (PMA-S) to the 
Model 4196 Original PMA. 
Product Status 
The Attain Stability Quad Clinical Study will be conducted 
using a research system composed of an approved CRT-D 
or CRT-P System.  The Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) is an active fixation quadripolar LV 
lead based on the Attain Performa lead family models 
(4298, 4398, and 4598).  The lead incorporates an active 
fixation helix similar to the Attain Stability bipolar LV lead 
(Model 20066/4796) which is designed to allow an 
implanter more options in lead location.   
The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) will be considered investigational in geographies 
where the product is not available commercially and will 
be labeled for clinical use only.  These geographies include 
but are not limited to the US and Canada.  Investigational  
Attain Stability Quad Leads will be distributed to a site 
only when Medtronic has received all required 
documentation (including but not limited to Ethic 
Committee approval, a signed Clinical Trial Agreement and 
documentation of training) and has notified the site of site 
readiness.  Distribution of the investigational product to 
study sites will be managed by Medtronic and can only be 

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ordered by Medtronic personnel.  Site with these clinically 
labeled Attain Stability Quad MRI SureScan LV Leads 
(Model 4798) will track disposition upon receipt or return 
of the lead but also upon implant or explant of the lead. 
Disposition logs will be available within the electronic data 
management system and shall be maintained at each site 
in all geographies to track investigational product 
information.  
For geographies where the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is not considered 
investigational, commercially approved devices will be 
used.  Sites that use commercially available Attain Stability 
Quad MRI SureScan LV Leads (Model 4798) will track 
device disposition upon implant or explant on the lead 
CRFs. 
The Medtronic approved CRT-P or CRT-D devices will be 
programmed and interrogated using a Medtronic CareLink 
(2090) programmer.  Medtronic may incorporate 
additional programmers as they receive regulatory 
approval. 
The CareLink Monitor Model 2490C is an external monitor 
that is indicated for use in the transfer of patient and 
device data from implanted Medtronic devices.  The 
CareLink Monitor Model 2490C interrogates implanted 
devices and temporarily stores these data, collaborates 
with the appropriate Medtronic server to confirm the 
establishment of an Internet connection with server, 
performs any required file translation functions necessary 
for data transfer, executes data file transfer, and 
collaborates with the appropriate Medtronic server to 
confirm data file transfer through the Internet connection 
with the server.  The CareLink Monitor 2490C is not a 
programmer and cannot be used to program implanted 
device parameters.  CareLink monitors are not a substitute 
for appropriate medical attention in the event of an 
emergency and should only be used as directed by a 
physician. 
Approved Medtronic CRT-P and CRT-D devices used in this 
study qualify for use with the Medtronic CareLink Monitor 
and Medtronic CareLink Network.  
Medtronic may incorporate additional home monitors as 
they receive regulatory approval. 
Medtronic’s commercially available Model 2290 Analyzer 
must be available at each center during the implant 

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procedure to determine acceptable electrical parameters.  
Medtronic may incorporate additional analyzers as they 
receive regulatory approval. 
Primary Objective(s) 
Primary Safety Objective: Lead complication-free 
rate at 6 months 
The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) will be considered safe if the probability of subjects 
free of Model 4798 lead-related complications at 6 months 
post-implant is greater than 87% (i.e., the lower bound of 
a one-sided 97.5% confidence interval must be greater 
than 87%). 
The study primary safety endpoint is Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) related complications 
through 6 months post implant.  All reported system and 
procedure-related AEs will be reviewed by an event review 
committee for LV lead relatedness and severity 
(complication vs observation, refer to 17.1.2 for 
defintions).  
Primary Efficacy Objectives: Lead pacing capture 
thresholds at 6 months 
To demonstrate the effectiveness of the Attain Stability 
Quad MRI SureScan LV lead (Model 4798) the study will 
evaluate the likelihood that there are at least two 
programmable vectors  for each patient post implant.  The 
effectiveness of this lead will be evaluated based on two 
primary efficacy objectives.  More specifically, both 
primary efficacy objectives must be met simultaneously.   
Primary Efficacy Objective #1 
The Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) will meet the objective if the 
proportion of subjects with at least one LV lead 
pacing vector having a pacing capture threshold 
less than or equal to 2.5 V at 0.5ms pulse width at 
6 months post-implant is greater than 80% (i.e., 
the lower bound of a one-sided 97.5% confidence 
interval must be greater than 80%). 
The endpoint for the primary efficacy objective is 
whether or not there is at least one Model 4798 
LV lead pacing vector with pacing capture voltage 
thresholds less than or equal to 2.5V.  This 
endpoint will be measured at the 6-month post 
implant follow-up visit. 

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Primary Efficacy Objective #2 
The Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) will meet the objective if the 
proportion of subjects with at least one additional 
LV lead pacing vector having a pacing capture 
threshold less than or equal to 4.0 V at 0.5ms 
pulse width at 6 months post-implant is greater 
than 80% (i.e., the lower bound of a one-sided 
97.5% confidence interval must be greater than 
80%).  
The co-primary efficacy endpoint is whether or not 
a second Model 4798 lead configuration has a 
pacing capture threshold less than or equal to 4V, 
excluding the pacing vector that is already 
counted to the primary efficacy endpoint #1. This 
endpoint will be measured at 6-month post 
implant follow-up visit. 
Secondary  
Objective(s) 
The secondary objectives are descriptive in nature and are 
intended to provide additional information about the Attain 
Stability Quad Model 4798 LV lead. There will be no 
established performance requirements for these secondary 
objectives. 
o 
Implant procedure related information: success 
rate, implant related times 
o 
Endpoints will include implant success rate 
and procedure durations.  
o 
6-month reliability: post implant lead failure 
modes (i.e. complication rate) 
o 
Endpoint is Model 4798 lead related 
complications. 
o 
Electrical measurements (PCT and Impedance) at 
follow-ups 
o 
Endpoints are the electrical measurements 
(pacing capture thresholds and impedance 
values) for the four extended bipolar 
(CRT-D) or unipolar (CRT-P) vectors, i.e. 
LV1 to RVCoil/Can, LV2 to RV Coil/Can, 
LV3 to RV Coil/Can and LV4 to RV 
Coil/Can (refer to 15.8.2.3 for the testing 
procedure requirements) 

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Study Design 
The Attain Stability Quad Clinical Study is a prospective, 
non-randomized, multi-site, global, Investigational Device 
Exemption (IDE) interventional clinical study.  The 
purpose of this clinical study is to evaluate the safety and 
efficacy of the Attain Stability Quad MRI SureScan LV lead 
(Model 4798) in patients indicated for a de novo LV lead 
implant.  This will be assessed through primary safety and 
primary efficacy endpoints. 
All subjects included in the study will be implanted with a 
Medtronic market released de novo CRT-P or CRT-D 
device and an Attain Stability Quad MRI SureScan LV Lead 
(Model 4798).  Compatible market released Medtronic RA 
and Medtronic RV leads will be required.  For subjects 
enrolled who are receiving an upgrade to a CRT system, 
existing non-Medtronic RV and/or existing non-Medtronic 
RA leads that are not recalled, market withdrawn, and/or 
have a medical alert may be used.   
Up to 471 subjects will be enrolled into the study and up 
to 471 Attain Stability Quad MRI SureScan LV Leads 
(Model 4798) implanted, to ensure a minimum effective 
sample size of 400 Model 4798 leads implanted with 6 
months post implant follow up visits (assuming 15% 
attrition).  For the secondary endpoint of individual lead 
failure modes, Bayesian methods utilizing data from up to 
37 historical patients will be used.  All other objectives will 
be analyzed using only patients enrolled in this study.   
After a successful implant, threshold testing will occur per 
protocol requirement.  Subjects will then be followed at 
implant, three months, six months and every six months 
thereafter until FDA approval is obtained or until study 
closure, whichever comes first. 
The study duration is expected to be approximately 19 
months.  This represents 13 months for subject enrollment 
and 6 months for subject follow-up for the last subject 
enrolled.  Subjects are anticipated to be in the study for 
on average 12 months.  The first enrollment is projected 
to occur in May 2017.   
Sample Size 
Up to 471 subjects will be enrolled into the study, to 
ensure a minimum effective sample size of 400 Model 
4798 leads implanted with 6 months post implant follow 
up visits (assuming 15% attrition) at up to 56 sites 
worldwide. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
• 
Patient meets CRT implant criteria as determined 

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by local regulatory and/or hospital policy  
• 
Patient (or legally authorized representative) has 
signed and dated the study-specific 
Consent Form 
• 
Patient is 18 years of age or older, or is of legal 
age to give informed consent per local and 
national law 
• 
Patient is expected to remain available for follow-
up visits 
Exclusion Criteria: 
• 
Patient has had a previous unsuccessful LV lead 
implant attempt 
• 
Patient has a previous CRT system or LV lead 
implanted (for example, transvenous or epicardial) 
• 
Patient is currently implanted with a recalled (i.e. 
market-withdrawn, recalled or safety alert) RA 
and/or RV lead  
• 
Patient has known coronary venous vasculature 
that is inadequate for lead placement 
• 
Patient has unstable angina pectoris or has had an 
acute myocardial infarction (MI) within the past 30 
days 
• 
Patient has had a coronary artery bypass graft 
(CABG) or percutaneous transluminal coronary 
angioplasty (PTCA) within the past 90 days 
• 
Patient has contraindications for standard 
transvenous cardiac pacing (e.g., mechanical right 
heart valve) 
• 
Patient has had a heart transplant (patients 
waiting for heart transplants are allowed in the 
study) 
• 
Patient has known renal insufficiency that would 
prevent them from receiving an occlusive 
venogram during the implant procedure 
• 
Patient is contraindicated for <1mg 
dexamethasone acetate 
• 
Patient is enrolled in any concurrent drug and/or 
device study that may confound the results of this 
study 
• 
Patient has a terminal illness and is not expected 
to survive more than six months 
• 
Patient meets exclusion criteria required by local 
law (e.g. age, pregnancy, breast feeding, etc.) 
• 
Patient is unable to tolerate an urgent 
thoracotomy 
Study Procedures and Assessments 
Clinical data will be collected at the study milestones: at 
enrollment, baseline, implant/PHD, 3M, 6M, thereafter 

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every occurring 6M and study exit visits: 
Enrollment/Baseline:  
o 
Subject Informed Consent  
o 
Inclusion/Exclusion criteria verified 
o 
Subject demographics  
o 
Cardiovascular medications 
o 
Cardiovascular medical history 
o 
NYHA classification 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
Implant:  
o 
Occlusive venogram with pre-determined 
target vessel location identified 
o 
Analyzer PCT data collection post lead 
fixation and prior to connecting the leads 
to the CRT-P/D device: 
1. Pre-slitting the cannulation 
catheter and following 
guidewire/stylet has been pulled 
back proximal to the helix and 
electrodes 
2. Post slitting the cannulation 
catheter 
o 
Investigator Lead Handling Assessment 
o 
System and procedure information 
PHD CRT System Testing and Programming using the 
implanted CRT-P or CRT-D device and the device 
programmer: 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors  
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors  
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 

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o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
3 Month (remote or in office visit):  
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the 
final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the 
final programmed vector 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media 
(or CareLink transmission) 
o 
AE Assessment 

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o 
Study deviations 
o 
Device deficiencies 
6 Month:  
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors 
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors  LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors  
o 
NOTE: A one time manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 

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o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
12 Month:  
Lead Impedance 
o 
Collect LV Lead Impedances using Vector 
Express on all vectors 
o 
Perform a manual LV Lead Impedance 
Test for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using 
Vector Express on all 16 vectors 
o 
NOTE: A one time manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse 
width for missing Vector Express values 
on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to 
RVcoil/Can and the final programmed 
vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms 
on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, 
measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing 
will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead 
pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 

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Recurring 6 Month follow-ups (remote or inoffice 
visit):  
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the 
final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the 
final programmed vector 
o 
NOTE: A onetime manual reprogramming 
the pulse width to 0.5ms will be required 
(Out of the box pulse width is set at 
0.4ms) 
o 
Retain printouts at the site 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media 
(or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
Study Exit:  
o 
Report the reason for exit 
o 
Final Interrogation file (or Carelink 
transmissions) for exits occuring prior to 
the 6 month visit) 
o 
Study Deviations 
o 
AEs  
o 
Device Deficiencies 
Safety Assessments 
Adverse Event and Device Deficiency handling in the Attain 
Stability Quad Clinical Study is ISO 14155:2011 compliant for 
all participating geographies with the exception that only 
those AEs which are related to the subject’s system, 
procedure, accessory, or are cardiovascular-related, heart 
failure-related, MRI-related, and all Serious AEs, will be 
collected (refer to Section 17 for AE assessment).  This 
ensures any AEs which could potentially be relevant will be 
collected.  Reporting of these events to Medtronic will occur 
on an Adverse Event (AE) Form, including date of AE, 
treatment, resolution, assessment of both the seriousness of 
the AE and the relatedness to the investigational device or 
procedure.  Each AE must be recorded on a separate AE 
eCRF.  Documented pre-existing conditions are not 
considered AEs unless the nature or severity of the condition 
has worsened. 

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 Statistics 
The primary objective will be analyzed using the time-to-
first event Kaplan-Meier survival analysis method.  A 
minimum number of subjects who have completed their 6 
months post-implant visits will be required.  Time 0 will be 
the day a subject undergoes the implant procedure of a 
Attain Stability Quad MRI SureScan LV Lead (Model 4798), 
which will be independent of success status of this implant 
procedure.  Event date is the onset date of a subject’s first 
complication that is related to the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) according to CEC 
adjudication.  Subjects who undergo an Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) implant 
attempt and do not experience any LV lead related 
complications, will be censored at the time of their last 
known exposure to the Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) for the survival analysis.  For any 
lost-to-follow up subject, the last contact date will be used 
as the censor date.  The 1-sided 97.5% confidence limit 
lower bound for the survival probability at 6 months (183 
days) will be calculated using the log-log survival function 
approach (Kalbfleisch and Prentice 2002). 
 
10. Introduction  
10.1. Background 
Several clinical trials (including MIRCLE1, MIRACLE-ICD2, CONTAK-CD3, MUSTIC4, PATH-CHF5, 
COMPANION6, MADIT CRT7, and CARE-HF8) have demonstrated the benefit of cardiac resynchronization 
therapy (CRT) among patients with moderate to severe heart failure (HF) with a prolonged QRS duration 
and depressed Left Ventricular (LV) function.   
Approximately 5.7 million people in the United States (US) are living with HF9.  Heart Failure may be a 
chronic condition which causes the heart to not pump oxygenated blood efficiently through the body due 
to stiffening of the heart muscle.  Heart Failure may affect one or both sides of the heart.  It is most 
often caused by coronary artery disease (CAD) or uncontrolled hypertension (HTN).  Patients who suffer 
from HF experience a variety of different symptoms including most often fatigue, cough, shortness of 
breath, swollen feet (edema) and weight gain. 
Heart Failure is treated with medications and sometimes cardiac devices (i.e. pacemaker or defibrillator 
with CRT).  Medications work to relieve symptoms and reverse the effects of HF.  Cardiac 
Resynchronization Therapy devices treat HF by synchronizing the left and right ventricles of the heart 
which improves the heart’s ability to pump oxygenated blood to the body.10 11 12 13 14 15 16 17 18 19 20 21 
Cardiac Resynchronization Therapy devices are primarily made up of 4 main components; the can or 
battery, a Right Atrial (RA) lead, a Right Ventricular (RV) lead, and a Left Ventricular (LV) lead. 

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The LV lead specifically is important at maintaining ventricular synchrony.  In 2014, Medtronic released 
the Attain® PerformaTM family of LV leads (models 4298, 4398 and 4598).  The three different shapes of 
these leads (double canted, straight, and S-shaped) were designed to enable the lead to be passively 
fixed within different anatomies of coronary vessels.  In addition, the 4 strategically placed electrodes on 
the lead were designed to offer 16 different electrical vector programming configurations.  
Medtronic also released the Attain Stability bipolar LV lead (Model 20066/4796) (CE Mark approved in 
September 30, 2013) in Europe.  This lead has a side helix which enables it to be actively fixated to the 
vessel wall.  The active fixation is an advantageous component in vessels that are wide or have short 
take-offs.  The next generation of LV lead is known as the Attain StabilityTM Quad MRI SureScan LV lead 
(Model 4798).  This is a quadripolar lead similar to its Attain Performa predecessor leads and has a side 
helix for active fixation like the Attain Stability bipolar lead.   
10.2. Purpose 
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, 
Investigational Device Exemption (IDE), interventional clinical study.  The purpose of this clinical study is 
to evaluate the safety and efficacy of the Attain Stability™ Quad MRI SureScan LV Lead (Model 4798).  
This study will not be considered investigational in geographies with CE Mark of the Attain Stability™ 
Quad MRI SureScan LV lead (Model 4798).  However, data collected from all study subjects will be 
represented in the final clinical report and the PMA Supplement (PMA-S) to the Attain Ability Model 4196 
Original PMA (P080006, approved April 7, 2009).  Subjects successfully implanted with the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) will be followed at implant, three months, six months and 
every six months thereafter until FDA approval is obtained or until study closure, whichever comes first. 
11. Objectives and Endpoints 
11.1. Objectives 
11.1.1. 
Primary Objective(s) 
Primary Safety Objective: Lead complication-free rate at 6 months 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered safe if the probability of 
subjects free of Model 4798 lead-related complications at 6 months post-implant is greater than 87% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 87%). 
Primary Efficacy Objectives: Lead pacing capture thresholds at 6 months 
To demonstrate the effectiveness of the Attain Stability Quad MRI SureScan LV Lead (Model 4798), the 
study will evaluate the likelihood that there are at least two programmable vectors for each patient post 
implant.  The effectiveness of this lead will be evaluated based on two primary efficacy objectives.  More 
specifically, both primary efficacy objectives must be met simultaneously.   
Primary Efficacy Objective #1 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet this objective if the 
proportion of subjects with at least one LV lead pacing vector having a pacing capture threshold 
less than or equal to 2.5 V at 0.5 ms pulse width at 6 months post-implant is greater than 80% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 80%). 

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Primary Efficacy Objective #2 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet this objective if the 
proportion of subjects with at least one additional (or second) LV lead pacing vector having a 
pacing capture threshold less than or equal to 4.0 V at 0.5 ms pulse width at 6 months post-
implant is greater than 80% (i.e., the lower bound of a one-sided 97.5% confidence interval 
must be greater than 80%).  
11.1.2. 
Secondary Objective(s)  
The secondary objectives are descriptive in nature and are intended to provide additional information 
about the Attain Stability Quad MRI SureScan LV Lead (Model 4798).  There will be no established 
performance requirements for these secondary objectives. 
o 
To summarize implant procedure related information: success rate, implant related times 
o 
To estimate 6-month reliability: post implant lead failure modes (i.e. complication rate)  
o 
To estimate electrical measurement values (Pacing Capture Thresholds (PCTs) and Lead 
Impedance) at 6 months post-implant 
11.2. Endpoints 
11.2.1 Primary Endpoints 
Primary Safety Endpoint 
The study primary safety endpoint is Attain Stability Quad MRI SureScan LV Lead (Model 4798) related 
complications through 6 months post implant.  All reported system and procedure-related AEs will be 
reviewed by an event review committee for LV lead relatedness and severity (complication vs 
observation, refer to 17.1.2 for defintions).  
Primary Efficacy Endpoint #1 
The Model 4798 LV lead has sixteen (16) programmable pacing vectors.  The endpoint for the primary 
efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing 
capture voltage thresholds less than or equal to 2.5V.  This endpoint will be measured at the 6-month 
post implant follow-up visit. 
Primary Efficacy Endpoint #2 
The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing 
capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the 
primary efficacy endpoint #1.  This endpoint will be measured at 6-month post implant follow-up visit. 
11.2.2 Secondary Endpoints 
To summarize implant procedure related information 
Implant procedure related endpoints will include implant success rate and procedure durations.  
To estimate 6-month reliability 
The Model 4798 LV lead 6-month reliability endpoint is Model 4798 lead related complications.  
To estimate electrical measurement values (Pacing Capture Thresholds (PCTs) and Lead 
Impedance) at 6 months post-implant 

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The electrical measurements are pacing capture thresholds and impedance values for the four extended 
bipolar (CRT-D) vectors (i.e. LV1 to RVCoil, LV2 to RV Coil, LV3 to RV Coil, LV4 to RV Coil) or the unipolar 
(CRT-P) vectors (i.e. LV1 to Can, LV2 to Can, LV3 to Can, LV4 to Can) (refer to 15.8.2.3 for the testing 
procedure requirements). 
12. Study Design  
The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site, global, 
Investigational Device Exemption (IDE), interventional clinical study.  The purpose of this clinical study is 
to evaluate the safety and efficacy of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) in 
patients indicated for a de novo LV lead implant.  This will be assessed through a primary safety and 
primary efficacy endpoints. 
All subjects included in the study will be implanted with a Medtronic market released de novo CRT-P or 
CRT-D device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798).  Compatible market 
released Medtronic RA and Medtronic RV leads will be required.  For subjects enrolled who are receiving 
an upgrade to a CRT system, existing non-Medtronic RV and/or existing non-Medtronic RA leads that are 
not recalled, market withdrawn, and/or have a medical alert may be used.   
Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400 Model 4798 leads 
implanted with 6 months post implant follow up visits (assuming 15% attrition).  For the secondary 
endpoint of individual lead failure modes, Bayesian methods utilizing data from up to 37 historical 
patients will be used.  All other objectives will be analyzed using only patients enrolled in this study.  
After a successful implant, threshold testing will occur to show one LV vector with pacing capture 
threshold (PCT) ≤ 2.5 V @ 0.5ms and with sufficient safety margin was programmed.  Subjects will then 
be followed at implant, three months, six months and every six months thereafter until FDA approval is 
obtained or until study closure, whichever comes first. 
See Figure 1 and Section 15 for further detail on study procedures and data collection as well as time-
points for data collection.  

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Figure 1: Study Visits 
Enrollment/Baseline Visit
De novo LV Lead (Attain Stability 
Quad MRI SureScan LV lead) 
Implant
(Implant/PHD visit)
Follow-up @ 3 months
(in office or remote visit)
Follow-up @ 6 months
(in office visit)
Follow-up 12 months
(in office visit)
Exit if unsuccessful Attain Stability 
Quad MRI SureScan LV lead 
implant
Follow-up every 6 months 
thereafter
(in office or remote visit)
 
The study is expected to be conducted at up to 56 sites worldwide.  Participating geographies are 
expected to include, but are not limited to: the United States, Canada, EMEA, Malaysia, and Hong Kong.  
To ensure a widespread distribution of data and to minimize site bias in the study results, the maximum 
number of subjects allowed at a single site is 50 subjects.  
12.1. Duration 
The study duration is expected to be approximately 19 months.  This represents 13 months for subject 
enrollment and 6 months for subject follow-up for the last subject enrolled.  Subjects are anticipated to 
be in the study for on average 12 months.  The first enrollment is projected to occur in May 2017.  
Subjects will complete visits at enrollment/baseline, implant, 3 months, 6 months, and then every 6 
months thereafter.  Subjects will not be replaced with newly enrolled subjects upon early exit.  As 
described in Section 19, the sample size accounts for attrition.  
12.2. Rationale 
Upon market release, this Attain Stability Quad MRI SureScan LV Lead (Model 4798) will provide 
physicians an alternative option to actively fixate the lead utilizing a side helix feature to achieve stability.  
The Attain Stability Quad Clinical Study is designed to demonstrate that the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is safe and effective.  See Section 19 for further background information 
and evaluation of clinical data.  See Section 10 for further background on the study design. 

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12.3. Study Oversight 
The study will utilize a Steering Committee (SC).  The SC is responsible for the scientific content of the 
study and for providing input for the execution of the study.  Members of the SC may be study site 
investigators.  The purpose of the SC is to provide unbiased opinions and expertise to the Attain Stability 
Quad Clinical Study design and process.  The SC will support the execution of the Attain Stability Quad 
Clinical Study and provide guidance, feedback and direction to the clinical study.  The SC is comprised of 
the members as indicated in Table 4 below.   
Table 4: Steering Committee Members 
Committee Member  
Contact information 
George H. Crossley III, MD  
Steering Committee Co-Chair 
Electrophysiology 
Fellowship Program Director 
Vanderbilt University Medical Center 
1211 Medical Center Drive 
Nashville, TN 37232 
United States 
(615) 322-5000 
george.crossley@vanderbilt.edu 
Kevin P. Jackson, MD  
Steering Committee Co-Chair 
Electrophysiologist 
Duke Cardiology of Raleigh 
Medical Office Building 6 
3320 Wake Forest Road 
2nd Floor, Suite 200 
Raleigh, NC 27609 
United States 
(919) 862-5100 
k.j@duke.edu 
Dr. Maria Grazia Bongiorni 
Electrophysiologist 
University Hospital of Pisa 
Lungarno Antonio Pacinotti 
43, 56126  
Pisa PI Italia 
+39 050 221 2111 
m.g.bongiorni@med.unipi.it 
Prof. Svein Faerestrand 
Electrophysiologist 
University of Bergen 
Jonas Liesvei 65  
Bergen, Norway 5021 
+47 55 97 67 04 
svein.faerestrand@helse-bergen.no 
Dr. Axel Kloppe 
Electrophysiologist 
Berufsgenossenschaftliches Universitätsklinikum  
Bergmannsheil GmbH,  
Bürkle-de-la-Camp-Platz 1,  
44789 Bochum, Germany  
+49 234 3026050 
axel.kloppe@bergmannsheil.de 

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Melissa Kong, MD 
Electrophysiologist 
Silicon Valley Cardiology 
1300 Stockbridge Ave   
Redwood City, CA 94061 
United States 
(650) 363-5262 
mhkong1@gmail.com 
Raymond Yee, MD 
Electrophysiologist 
London Health Sciences Centre  
339 Windemere Road  
London, ON N6A 5A5 
Canada 
(519) 663-3671 
ryee@uwo.ca 
Francois Philippon, MD 
Electrophysiologist 
Institut Universitaire de Cardiologie et de Pneumologie de Quebec  
2725 Chemin Ste-Foy 
Quebec G1V 4G5 
Canada 
(418) 656-8711 
francois.philippon@fmed.ulaval.ca 
 
The study will also utilize a Clinical Events Committee (CEC) who will be responsible for adjudicating 
adverse events and deaths, including procedure and/or system-related complications.  Further details for 
the CEC are provided in Section 18.1. 
13. Product Description 
13.1. General 
The Medtronic Attain Stability Quad MRI SureScan (Model 4798) is a steroid-eluting, quadripolar 
electrode, transvenous, over-the-wire (OTW), IS4-LLLL compatible, active fixation, cardiac vein pacing LV 
lead.  This lead is similar to the Attain Performa family of quadripolar leads (Models 4298, 4398, and 
4598) but also has a side helix for active fixation which is similar to the Attain Stability bipolar lead 
(Model 20066/4796) (available outside of the United States).  Figure 2 is a drawing of the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) illustrating the specifications and location of the four 
electrodes in comparison to the side helix. 

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Figure 2: Attain Stability Quad MRI SureScan LV Lead (Model 4798) Specifications Drawing 
 
 
Table 5 provides compares of the Attain Performa family of leads design features to the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798). 
 

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Table 5: Comparison of Medtronic Quadripolar LV Leads 
 
Attain Performa 
Attain Stability 
Quad 
Design Feature 
Model 4298 
Model 4398 
Model 4598 
Model 4798 
Shape 
Double Canted 
Straight 
S-Shaped 
Single Canted 
Implant Method 
Guide wire, 
stylet, or hybrid 
guide wire via 
Medtronic 
Delivery System 
Same as 4298 
Same as 4298 
Guide wire, 
stylet, or hybrid 
guide wire via 
Medtronic 
Delivery System 
and active 
fixation 
Delivery System 
Inner Diameter 
≥ 5.7 Fr ID 
Same as 4298 
Same as 4298 
Same as 4298 
Lead Body 
Diameter 
5.3 Fr 
proximal/3.9 Fr 
distal 
Same as 4298 
Same as 4298 
4.4 Fr 
proximal/3.9 Fr 
distal 
Lead Body 
Conductor 
Single Quadfilar 
Coil 
(Multiconductor) 
Same as 4298 
Same as 4298 
Same as 4298 
Conductor 
Material 
Ag core-low 
Titanium 
MP35Ncoil 
Same as 4298 
Same as 4298 
Same as 4298 
Insulation 
(Outer/Inner) 
Polyurethane 
55D SI-PI 
Same as 4298 
Same as 4298 
Same as 4298 
Polarity 
Selectable Quad-
electrode 
Same as 4298 
Same as 4298 
Same as 4298 
Electrode 
Material 
PT/Ir* alloy with 
TiN coating 
Same as 4298 
Same as 4298 
Same as 4298 
Fixation Helix 
Material 
N/A 
N/A 
N/A 
Pt/Ir** alloy 
Electrode 
Spacing 
21mm/ 1.3mm/ 
21mm 
Same as 4298 
Same as 4298 
Same as 4298 
Surface Area per 
5.8 
Same as 4298 
Same as 4298 
Same as 4298 

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Electrode (mm2) 
Steroid and Dose 
/  MCRD 
Dexamethasone 
acetate 
Each (4) Ring 
72µg 
Same as 4298 
Same as 4298 
Same as 4298 
Total Target 
Dose 
288 µg/lead 
Same as 4298 
Same as 4298 
Same as 4298 
*90/10 Platinum Iridium 
**80/20 Platinum Iridium 
Similar to the Attain Performa family of leads, the Attain Stability Quad MRI SureScan LV Lead (Model 
4798) contains 4 electrodes with surface area of 5.8 mm2 per electrode and is designed to function as 
cathodes or anodes, depending on how the device LV pacing vector is programmed:  
• 
electrode LV1, the distal electrode, positioned near the distal tip of the lead  
• 
electrode LV2, positioned 21 mm proximal to electrode LV1 
• 
electrode LV3, positioned 1.3 mm proximal to electrode LV2 
• 
electrode LV4, the proximal electrode, positioned 21 mm proximal to electrode LV3 
The electrode spacing on the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is identical to the 
approved Attain Performa family of leads.  This includes a non-uniform electrode spacing consisting of a 
reduced electrode spacing configuration (LV2-LV3) that alters the size of the electric field that is 
generated when stimulating the heart tissue.  This close electrode spacing is designed to reduce the 
likelihood of stimulating the phrenic nerve while still allowing for optimal lead placement and acceptable 
pacing capture thresholds.  
Similar to Attain Performa, each electrode contains a Monolithic Controlled Release Device (MCRD) for 
elution of steroid to reduce inflammatory response within the cardiac vein.  The MCRDs contain a 
combined-total target dosage of 288 μg of dexamethasone acetate steroid.  The target dose of the 
steroid is 72 μg at each MCRD.  Upon exposure to body fluids, the steroid elutes from the MCRDs.  The 
steroid suppresses the inflammatory response that is believed to cause threshold rise typically associated 
with implanted pacing electrodes.  
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) has the same lead body conductor (Single 
Quadfilar Coil (Multiconductor), conductor material (Ag core-low Titanium MP35N coil), insulation 
(outer/inner) (Polyurethane 55D SI-PI), and requires a similar delivery system inner diameter as the 
Attain Performa family of leads (≥ 5.7 Fr ID). 
Unlike the Attain Performa family of leads, the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
has a slightly smaller lead body diameter.  The lead body diameter of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) is 4.4 Fr proximal (compared to 5.3 Fr on the Attain Performa family of 
leads) and 3.9 French distal (same as Attain Performa family of leads).  This slightly smaller lead body 
tubing diameter is designed to enhance torquability and steerability to facilitate adherence of the side helix 
in the target location. 
Figure 3 is a visual comparison between the Attain Perform leads and the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) illustrating the similar electrode location but different lead body diameter. 
 

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Figure 3: Comparison of Attain Performa Leads and the Attain Stability Lead Model 4798 
 
A detailed comparison of the Attain Stability bipolar lead (Model 4796) and Attain Stability Quad lead 
(Model 4798) is presented in Table 6. 
Table 6: Comparison of Medtronic Attain Stability Bipolar and Quadripolar LV Leads 
 
Attain Stability 
Attain Stability Quad 
Design Feature 
Model 4796/20066 
Model 4798 
Shape 
Single Canted 
Same as 4796/20066 
Implant Method 
Guide wire, Stylet, or 
hybrid guide wire via 
Medtronic Delivery 
System and active 
fixation 
Same as 4796/20066 
Delivery System 
Inner Diameter 
> 5.7 Fr ID 
Same as 4796/20066 
Lead body 
diameter 
3.9 Fr proximal / 3.4 Fr 
distal 
4.4 Fr proximal /3.9 Fr 
distal 
Lead Body 
Conductor 
Single 2 Filar Coil 
(Multiconductor) 
Single Quadfilar Coil 
(Multiconductor) 
Conductor Material 
Ag core-low Titanium 
MP35N coil 
Same as 4796/20066 

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Attain Stability 
Attain Stability Quad 
Design Feature 
Model 4796/20066 
Model 4798 
Shape 
Single Canted 
Same as 4796/20066 
Insulation 
(Outer/Inner) 
Polyurethane 55D 
SI-PI 
Same as 4796/20066 
Polarity 
bipolar 
Selectable Quad-
electrode 
Electrode Material 
Pt/Ir* alloy with TiN 
coating 
Same as 4796/20066 
Fixation Helix 
Material 
Pt/Ir** alloy 
 
Same as 4796/20066 
Electrode Spacing 
21 mm 
21mm / 1.3mm / 21mm 
Surface Area per 
electrode  (mm2) 
5.8 
Same as 4796/20066 
Steroid and Dose /  
MCRD 
Dexamethasone acetate 
Tip 160µg , Ring 72µg 
Dexamethasone acetate 
Each (4) Ring 72µg 
Total Target Dose 
232µg/lead 
288 µg/lead 
Molded Tip Seal 
Silicone (with steroid), 
pierced hole 
Silicone (without 
steroid), cross-cut hole 
Fixation Method 
Helix 
Same as 4796/20066 
Connector 
IS-1 B1 
IS4-LLLL 
Length (cm) 
88 cm only 
78 and 88 cm 
*90/10 Platinum Iridium 
**80/20 Platinum Iridium 
The non-electrically active side fixation helix component is similar to the Attain Stability Bipolar LV lead 
(Model 20066/4796) and is designed to enable active fixation in the cardiac vein.  The Attain Stability 
Quad MRI SureScan LV Lead (Model 4798) side helix is positioned between the LV3 and LV4 electrode; 
specifically 10 mm proximal from the LV3 electrode (see Figure 2).   
A mechanical stop component is located at the base of the helix to prevent wedging of the endothelial 
tissue in the helix and to prevent tissue ingrowth.  The helix component is platinum (Pt) iridium (Ir) alloy 
(Pt/Ir 80/20).  This same Pt/Ir material is also used in the market released right ventricular active 
fixation lead Models 5076, 3830, and 4076.  Both the helix and mechanical stop components are identical 
to those used on the CE Mark approved Medtronic Attain Stability model 20066/4796 active fixation lead 
and are shown in Figure 4.  

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The Model 4798 lead has one distal curve/cant.  This distal curve geometry (angle) is identical to the 
Attain Performa model 4298, as well as Attain Ability models 4196 and 4296 most distal cant.  The 
single distal cant is also identical to the CE Mark approved model 20066/4796 active fixation lead 
(Figure 4). The purpose of the distal cant is to provide physicians the ability to “steer” the distal tip of 
the lead when navigating difficult vein anatomy or acute vasculature angulation by rotating the lead 
(counterclockwise) and aligning the distal tip towards the desired direction.  The distal cant for the 
Model 4798 lead is not intended, or necessary, to provide any fixation of the implanted lead as any 
retention force from the cant would be negligible compared to the stability provided by the properly 
implanted and verified fixated helix.  
Figure 4: Attain Stability Bipolar (Model 20066/4796) & Attain Stability Quad MRI SureScan 
(Model 4798) Active Fixation Leads 
 
 
The Attain Stability Quad Clinical Study will be conducted to evaluate the safety and efficacy of the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) in combination with CRT system components 
mentioned in Table 7. 

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Table 7: Study Component Information 
Component  
US/Canada 
EMEA/Hong Kong/Malaysia 
Attain Stability Quad MRI 
SureScan LV Lead (Model 
4798) 
Investigational 
Market-released 
Medtronic CRT-P or 
Medtronic CRT-D (with 
VectorExpress capabilities) 
Market-released 
Market-released 
Medtronic RV lead (non-
Medtronic and non-
recalled/non-market 
withdrawaled/non-safety 
alerted lead acceptable for 
upgrades) 
Market-released 
Market-released 
Medtronic RA lead (optional) 
(non-Medtronic and non-
recalled/non-market 
withdrawn/non-safety 
alerted lead acceptable for 
upgraded systems) 
Market-released 
Market-released 
 
Given the similarities between the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the 
Attain Performa family of leads, the proposed indications for use are the same.  The indications are as 
follows: 
Proposed Indication Statement for Use for the Attain Stability Quad Lead: 
The Attain Stability Quad MRI SureScan 4798 steroid-eluting, quadripolar electrode, IS4 transvenous lead 
is indicated for chronic pacing in the left ventricle via the cardiac vein, when used with a compatible 
Medtronic Cardiac Resynchronization Therapy (CRT) System.  Extended bipolar pacing is available using 
this lead in combination with a compatible market approved CRT-D system and RV lead. 
Market-Released Right Atrial Lead 
Commercially available Medtronic RA lead models with an IS-1 connector are required when an RA lead is 
implanted with de novo CRT systems.  An RA lead is not required to be implanted in circumstances 
determined appropriate per physician’s medical assessment.  Medtronic commercially available RA leads 
with an IS-1 connector are recommended but compatible non-Medtronic leads are permissible in enrolled 
patients receving a CRT system upgrades.   
Medtronic Market-Released Right Ventricular Lead 
Commercially available Medtronic RV defibrillation leads with a DF4 connector are required for de novo 
CRT systems.  Medtronic RV defibrillation leads with DF1 connectors may be incorporated in the study as 
DF1-compatible CRT-P and CRT-D devices are made available for the study.  A non-Medtronic RV lead is 
permissible in enrolled patients receving a CRT system upgrades. 

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13.2. Manufacturer 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is manufactured by Medtronic, Inc.  
13.3. Packaging 
Packaging and labeling for all market approved system components can be found with each package 
insert.  Manuals can be found on http://manuals.medtronic.com.  For CE Marked devices the labeling is in 
the appropriate local language. 
For investigational products (e.g. in the US and Canada), the language of labeling and clinical manuals 
will be in English and/or local language where it is required.  Investigational products will be clearly 
labeled e.g. “exclusively for clinical investigation.”   
In Canada, each investigational device will be labelled with the statements “Investigational Device”; “To 
be Used by Qualified Investigators Only”; “Instrument de recherche” and “Réservé uniquement à l’usage 
de chercheurs compétents”. 
13.4. Intended Population 
In the Attain Stability Quad Clinical Study, the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
is to be used in subjects where a de novo LV lead is indicated.  The Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) is intended to be used in conjunction with a market released Medtronic CRT-P or 
CRT-D device, a Medtronic (for de novo CRT implants) RV lead, and a Medtronic (for de novo CRT 
implants) RA lead (optional).    
A complete SureScan system is required for use in the MRI environment.  Before performing an MRI 
scan, refer to the SureScan MRI technical manual for MRI-specific warnings and precautions. 
13.5. Equipment 
All commercially available equipment will be used according to their approved intended use. 
Medtronic CareLink (2090) Programmer 
The Medtronic approved CRT-P or CRT-D devices will be programmed and interrogated using a Medtronic 
CareLink (2090) programmer.  Medtronic may incorporate additional programmers as they receive 
regulatory approval. 
Medtronic CareLink Home Monitor 2490C and Network 
The CareLink Monitor Model 2490C is an external monitor that is indicated for use in the transfer of 
patient and device data from implanted Medtronic devices.  The CareLink Monitor Model 2490C 
interrogates implanted devices and temporarily stores these data, collaborates with the appropriate 
Medtronic server to confirm the establishment of an Internet connection with server, performs any 
required file translation functions necessary for data transfer, executes data file transfer, and collaborates 
with the appropriate Medtronic server to confirm data file transfer through the Internet connection with 
the server.  The CareLink Monitor 2490C is not a programmer and cannot be used to program implanted 
device parameters.  CareLink monitors are not a substitute for appropriate medical attention in the event 
of an emergency and should only be used as directed by a physician.  Approved Medtronic CRT-P and 
CRT-D devices used in this study qualify for use with the Medtronic CareLink Monitor and Medtronic 

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CareLink Network.  Medtronic may incorporate additional home monitors as they receive regulatory 
approval. 
Pacing System Analyzer 
Medtronic’s commercially available Model 2290 Analyzer must be available at each center during the 
implant procedure to determine acceptable electrical parameters.  Medtronic may incorporate additional 
analyzers as they receive regulatory approval. 
13.6. Product Use 
See Section 13 Product Description. 
13.7. Product Receipt, Tracking, and Accountability 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered investigational in 
geographies where the product is not available commercially and will be labeled for clinical use only.  
These geographies include but are not limited to the US and Canada.  Investigational Attain Stability 
Quad Leads will be distributed to a site only when Medtronic has received all required documentation 
(including but not limited to Ethic Committee approval, a signed Clinical Trial Agreement and 
documentation of training) and has notified the site of site readiness.   
Distribution of the investigational product to study sites will be managed by Medtronic and investigational 
products can only be ordered by Medtronic personnel.  Sites with these clinically labeled Attain Stability 
Quad MRI SureScan LV Leads (Model 4798) will track disposition upon receipt or return of the lead but 
also upon implant or explant of the lead.  Disposition logs will be available within the electronic data 
management system and shall be maintained at each site in all geographies to track investigational 
product information.  The logs should be updated when an investigational product is received, opened, 
implanted explanted, disposed of or returned to Medtronic.  The logs will track the following 
investigational lead data (but are not limited to) model and serial numbers of devices delivered to the 
site, subject IDs of the subjects, implanted, received dates of devices, implant/used dates, explant dates, 
returned-to-sponsor dates and reasons, initials of all persons who received, used or disposed each 
device, and method of disposal.  Medtronic will perform periodic reconciliation of investigational product 
to ensure traceability. 
For geographies where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is not considered 
investigational, commercially approved devices will be used.  Sites that use commercially available Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) will track device disposition upon implant or explant 
of the lead on the CRFs. 
13.8. Product Storage 
All investigational products must be stored in a secure location at the site.  It is the responsibility of the 
investigator to correctly handle, store and track the investigational products.  Further details may be 
found in the Clinical Manual or User Manual (dependent on each geography’s commercial release of the 
product). 

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13.9. Product Return 
All explanted, open but unused, and defective products (devices or leads, etc.) should be returned to 
Medtronic for analysis whenever possible and when permissible by local laws and regulations.  If the 
products are explanted but not returned, a justification is required to be reported on the appropriate case 
report form(s) or disposition log(s) (note that this is not considered a study deviation).  In geographies 
where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is considered investigational, the 
Disposition Log must be updated in the event of an explant.  To receive a Returned Product Mailer Kit, 
please contact your local Medtronic field personnel or representative.  All unused investigational products 
must be returned to Medtronic upon study closure at the site. 
14. Selection of Subjects 
14.1. Study Population 
Patients of both genders that are 18 years of age and older (or of legal age to give informed consent per 
local and national law) that are indicated for a de novo LV lead implantation and who meet all inclusion 
and no exclusion criteria are eligible for an Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implant attempt.  There will be no control group for this study. 
14.2. Subject Enrollment 
Patients who meet all of the inclusion and none of the exclusion criteria (see sections 14.3 and 14.4) are 
eligible to be enrolled in this study.  Upon signing and dating the Informed Consent Form (ICF), the 
patient is considered a subject enrolled in the study. 

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14.3. Inclusion Criteria 
• 
Patient meets CRT implant criteria as determined by local regulatory and/or hospital policy  
• 
Patient (or legally authorized representative) has signed and dated the study-specific Informed 
Consent Form 
• 
Patient is 18 years of age or older, or is of legal age to give informed consent per local and 
national law 
• 
Patient is expected to remain available for follow-up visits 
14.4. Exclusion Criteria 
• 
Patient has had a previous unsuccessful LV lead implant attempt 
• 
Patient has a previous CRT system or LV lead implanted (for example, transvenous or epicardial) 
• 
Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or safety alert) RA 
and/or RV lead  
• 
Patient has known coronary venous vasculature that is inadequate for lead placement 
• 
Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the 
past 30 days 
• 
Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary 
angioplasty (PTCA) within the past 90 days 
• 
Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right 
heart valve) 
• 
Patient has had a heart transplant (patients waiting for heart transplants are allowed in the 
study) 
• 
Patient has known renal insufficiency that would prevent them from receiving an occlusive 
venogram during the implant procedure 
• 
Patient is contraindicated for <1mg dexamethasone acetate 
• 
Patient is enrolled in any concurrent drug and/or device study that may confound the results of 
this study 
• 
Patient has a terminal illness and is not expected to survive more than six months 
• 
Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.) 
• 
Patient is unable to tolerate an urgent thoracotomy 
14.5. Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias.  
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
• 
Subjects will be evaluated at baseline to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria  
• 
Subject demographics and medical history will be collected at baseline and differences that may 
affect primary endpoints will be identified 
• 
To ensure widespread distribution of data between sites, the maximum number of subjects 
allowed per site is 50 
• 
All implanters in the study will be experienced in the implant of CRT-P and/or CRT-D systems 
• 
Data collection requirements and study procedures will be standardized across all sites and 
geographies 

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• 
All study site personnel and Medtronic personnel will be trained on their respective aspects of the 
study using standardized training materials, and required to follow the CIP 
• 
Per the specifications in the Monitoring Plan, monitoring visits will be conducted for adherence to 
the CIP and to verify the CRF data against source data 
• 
Pre-defined statistical methods specified in the CIP and the Statistical Analysis Plan (SAP) will be 
followed 
• 
The SC members will not have influence on the treatment decisions by study site investigators 
during the trial 
• 
An independent and blinded CEC will regularly review and adjudicate reported adverse events 
and deaths (per Section 18.1) 
• 
Registration of the trial on ClinicalTrials.gov and the publication plan will ensure that study results 
will be reported 
• 
All study investigators are required to meet 21 CFR Part 54, Financial Disclosure by Clinical 
Investigators, to identify potential bias due to financial interest in the outcome of the study  
In summary, potential sources of bias that may be encountered in this Attain Stability Quad Clinical Study 
have been considered and minimized by careful study design. 
15. Study Procedures  
Prior to performing study related procedures, all sites must have Ethics Committee (EC) and associated 
regulatory authority approval if applicable (e.g., Competent Authority approval) as well as documentation 
from Medtronic of site readiness. 
Medtronic representatives may perform the following activities at the study sites during the study, if 
appropriately trained and under supervision of the Principal Investigator: 
• 
Study training relevant and pertinent to the involvement of personnel conducting study activities 
and investigator responsibilities 
• 
Technical support at all visits (e.g. programming of the CRT-P or CRT-D device according to 
study requirements, performing device interrogations/save-to-media, etc.), but no CRF data entry 
shall be performed by Medtronic personnel  
• 
Monitoring activities 
15.1. Study Personnel Requirements 
Site personnel training and delegation will be completed prior to participation in the Attain Stability Quad 
Clinical Study.  The site personnel training consists of required training topics (CIP, Informed Consent 
Form, CRFs, regulations).  Members of the study site team will receive training on the applicable clinical 
study requirements relevant to their role before contributing to the clinical study. 
All Principal Investigators shall: 

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• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
• 
Be qualified practitioners and experienced in the diagnosis, management, and treatment of HF 
subjects with CRT devices 
• 
Be experienced in the field of application and trained in the use of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) 
• 
Disclose potential conflicts of interest, including financial that interfere with the conduct of the 
clinical investigation or interpretation of results 
• 
Be knowledgeable with the method of obtaining an informed consent 
In addition, the Principal Investigator shall be able to demonstrate that the proposed investigational site: 
• 
Has an experienced CRT implanter who is experienced and trained in the handling/implanting of 
CRT-P and/or CRT-D devices 
• 
Has the required number of eligible subjects needed within the agreed recruitment period 
• 
Has one or more qualified investigators, a qualified investigation site team and adequate facilities 
for the foreseen duration of the clinical investigation  
15.2. Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train site personnel on the CIP, 
the implant procedure, relevant standards and regulations, informed consent process, and on data 
collection and reporting tools.  If new members join the study site team, they will receive training on the 
applicable clinical study requirements relevant to their role before contributing to the clinical study.  For 
new members, local Ethics Committee notification requirements must be met, as well as Medtronic 
requirements noted on the training and delegation form.  
A Clinical Trial Agreement (CTA) shall be entered into effect by Medtronic, the participating investigation 
site and/or the principal clinical investigator at each investigational site as per local legal requirements, 
and returned, fully executed, to Medtronic prior to the commencement of any study activities.  Financial 
aspects of conducting and reporting a study will be specified in the agreement.  By signing and dating the 
agreement the investigator indicates approval of the CIP. 
Prior to performing study related activities, all sites must have Ethics Committee approval, as applicable 
for that geography. 
All local and regional regulatory requirements will be fulfilled prior to site activation and enrollment of 
subjects into the study.  Each study site must have written documentation from Medtronic of site and 
investigator readiness before beginning any study-related activities.  Requirements for activation vary by 
geography, and may include, but are not limited to the following:  
• 
Written documentation of Ethics Committee approval of the current version of the CIP and 
ICF, subject materials (e.g. Global Assessment and KCCQ), and voting list (as required by 
local law)   
• 
Regulatory authority approval or notification (as required per local law)  
• 
Fully executed CTA on file with the sponsor  
• 
Financial Disclosure (for Principal Investigators and Co-Investigators)   
• 
Current Curriculum Vitae (CV) (signed and dated as required by local law) of investigators 
and key members (as required by local law) of the investigation site team on file with the 
sponsor  
• 
Documentation of delegated tasks 

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• 
Documentation of study site personnel training  
Additional requirements imposed by the Ethics Committee and regulatory authority shall be followed, if 
applicable.  
Medtronic will provide each study site with documentation of study site readiness; this letter must be sent 
prior to subject enrollment. 
15.3. Equipment Requirements 
The following equipment must be available at each site to support study activities: 
• 
Medtronic 2290 Analyzer (or latest market released Medtronic analyzer) 
• 
Medtronic 2090 programmer (or latest market released Medtronic programmer) 
• 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) (either clinically labeled product or 
commercial released product located at the site or carried to the implant by the Medtronic 
representative) 
• 
Computer with high speed internet access using a web browser compatible with the electronic 
data management system for electronic database entry  
The equipment necessary for the assessment for the study includes the Medtronic 2290 Analyzer and 
Medtronic 2090 programmer.  The maintenance and calibration of the equipment used for this study will 
be assessed outside of this clinical study.  Sites are responsible for maintaining and calibrating non-
analyzer/programmer equipment used in the course of this study in accordance with established site 
practice or local regulation.  Records should be kept and able to be provided upon request by the 
Sponsor or regulatory agency.   
15.4. Schedule of Events 
Clinical data will be collected at the study milestones detailed in Table 8.  Data will be collected via 
electronic case report forms (eCRFs), still cine images, analyzer/programmer print-outs, and interrogation 
files.  Post-implant follow-ups apply only to those subjects in whom an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) was successfully implanted or an implant was attempted.  Subject visits 
will occur at enrollment, baseline, implant/pre-hospital discharge (PHD), 3 months post-implant, 6 
months post-implant, and every 6 months thereafter until PMA approval of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) implanted or study termination, whichever comes first.  Medtronic 
personnel may assist study personnel during implant and study visits.

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Table 8: Data Collection and Study Procedure Requirements at Subject Visits 
STUDY PROCEDURE 
Enrollment
/Baseline 
Implant/
PHD 
3 months 
post-implant 
(remote or 
inoffice visit) 
6 months 
post-
implant 
(inoffice 
visit) 
12 
months 
post-
implant 
(inoffice 
visit) 
Recurring 6 
month 
follow-ups 
(remote or 
inoffice 
visit) 
Exit 
Subject Informed Consent 
 
 
 
 
 
 
 
Inclusion / Exclusion criteria 
verified 
 
 
 
 
 
 
 
Subject demographics 
 
 
 
 
 
 
 
Cardiovascular medications 
 
 
 
 
 
 
 
Cardiovascular medical history 
 
 
 
 
 
 
 
NYHA classification 
 
 
 
 
 
 
 
Patient Global Assessment 
 
 
 
 
 
 
 
Kansas City Cardiomyopathy 
Questionnaire (KCCQ) 
 
 
 
 
 
 
 
Occlusive venogram with pre-
determined pacing location 
identified 
 
 
 
 
 
 
 
Analyzer PCT data collection (pre 
and post slitting the cannulation 
catheter) 
 
 
(Implant) 
 
 
 
 
 
Investigator Lead Handling 
Assessment 
 
 
(Implant) 
 
 
 
 
 
System and procedure 
information 
 
 
 
 
 
 
 
Lead Impedance (all 16 vectors) 
 
 
 (final 
programmed  
vector only) 
 
 
 (final 
programmed  
vector only) 
 
Pacing Capture Thresholds (all 
16 vectors) 
 
 
 (final 
programmed  
vector only) 
 
 
 (final 
programmed  
vector only) 
 
Phrenic Nerve Stimulation (final 
programmed vector) 
 
 
 (inoffice visit 
only) 
 
 
 
 
 
Phrenic Nerve Stimulation 
(vectors LV1 to RVcoil/Can, LV2 
to RVcoil/Can, LV3 to 
RVcoil/Can, LV4 to RVcoil/Can) 
 
 
 
 
 
 
 
Rationale for selecting specific 
LV lead pacing vector for final 
programming 
 
 
 
 
 
 
 
Final device interrogation/save-
to-media 
 
 
 (CareLink 
transmission is 
acceptable for 
remote visits) 
 
 
 (CareLink 
transmission 
is acceptable 
for remote 
visits) 
 (required 
only if subject 
exits prior to 6 
months post-
implant visit; 
CareLink 
transmission is 
acceptable) 
AE Assessment 
 
 
 
 
 
 
 
Exit Subject 
 
 
 
 
 
 
 
Adverse Events (incl. AE with 
outcome of death) 
As they occur 
Device Deficiencies 
System Modifications 
Study Deviations 

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Table 9 below specifies permitted time windows for the required subject visits.  Subject visit target dates 
and windows for each follow-up will be made available to the study site.  Should a subject miss a visit or 
the visit falls outside the pre-specified window, a study deviation must be reported and the original 
follow-up schedule maintained for subsequent visits.  Data analyses will include follow-up visits, 
regardless of whether the visit occurs within the window.  Therefore, a late visit is preferred over a 
missed visit but must be accompanied by a deviation.  
Table 9: Visit Windows 
Visit 
Window 
Implant 
0-30 days since Baseline 
Assessment 
  
(days since implant) 
Pre-hospital discharge 
0-7 
3-month 
76 - 106 
6-month 
183 - 213 
12-month 
350 - 380 
18-month 
518 - 578 
24-month 
701 - 761 
 
15.5. Subject Consent 
Informed consent (IC) is defined as a legally effective documented confirmation of a subject’s voluntary 
agreement to participate in a particular clinical study after information has been given to the subject on 
all aspects of the clinical study that are relevant to the subject’s decision to participate (ISO 14155:2011).  
This process includes obtaining IC and an Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language (data protection authorization; i.e. HIPAA in 
the US) as required by law.  Informed Consent Forms are required to be approved by the study site’s 
Institutional Review Board (IRB) or Ethics Committee (EC) and Medtronic, and signed and dated by the 
subject and the Principal Investigator.  A subject may only consent after information has been given to 
the subject on all aspects of the clinical study that are relevant to the subject’s decision to participate.  
Prior to enrolling subjects, each site must have documented IRB/EC approval of the IC Form (ICF) and 
the data protection authorization as required by law.  Any changes to a previously approved ICF 
throughout the course of the study must be reviewed and approved by Medtronic and the IRB/EC 
reviewing the application before being used to consent or re-consent a study subject.  The document(s) 
must be controlled (i.e. versioned and dated) to ensure it is clear which version(s) was approved by 
Medtronic and the IRB/EC.  All important new information should be provided in written form to new and 
existing subjects throughout the study.  If relevant, all affected subjects must be asked to confirm their 
continuing IC in writing.   

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Prior to initiation of any study-specific procedures, IC must be obtained from the subject (or legally 
authorized representative).  Likewise, privacy or health information protection regulation may require 
subjects to sign additional forms to authorize sites to submit subject information to the study sponsor.  
The IC process must be conducted by the principal investigator or an authorized designee, and the ICF 
and data protection authorization, as required by law, must be given to the subject in a language he/she 
is able to read and understand.  
The process of obtaining informed consent shall: 
• 
Ensure that the principal investigator or an authorized designee conducts the IC process. 
• 
Include all aspects of the Attain Stability Quad Clinical Study that are relevant to the subject's 
decision to participate throughout the clinical study. 
• 
Avoid any coercion or undue improper influence on, or inducement of the subject to participate. 
• 
Not waive or appear to waive the subject’s legal rights. 
• 
Ensure the ICF and data protection authorization, as required by law, are given to the subject in 
a non-technical language the subject is able to read and understand. 
• 
Provide ample time and opportunity for the subject to read and understand the ICF to inquire 
about details of the study, and to consider participation.  All questions about the study should be 
answered to the satisfaction of the subject. 
• 
Include a personally dated signature of the subject acknowledging that their participation in the 
study is voluntary. 
• 
Include a personally dated signature by the principal investigator or authorized designee 
responsible for conducting the IC process, as required by local law. 
• 
Include any other locally required signatories, such as witnesses, as indicated by country-specific 
legislations. 
• 
Provide the subject with a copy of the ICF, the data protection authorization, as required by law, 
and any other written information, signed and dated if required by local law. 
• 
Ensure subjects are notified of any significant new findings about the study that become 
available during the course of the study which are pertinent to the safety and well-being of the 
subject, as this could impact a subject’s willingness to participate in the study. 
If IC is obtained the same day the subject begins participating in study-related procedures, it must be 
documented that consent was obtained prior to participation in any study-related procedures.  It is best 
practice for the IC process to be documented in the subject’s case history, regardless of circumstance. 
In the event the subject cannot read and/or write, witnessed (impartial third party) IC will be allowed, 
provided detailed documentation of the process is recorded in the subject’s case history and the witness 
signs and dates the ICF.  Informed consent shall be obtained through a supervised oral process.  An 
independent witness must be present throughout the process.  The ICF and any other information must 
be read aloud and explained to the prospective subject, if allowed by local law.  The witness signs and 
personally dates the ICF, attesting that the information was accurately explained and that informed 
consent was freely given.  The subject should “make his mark” (sign or otherwise physically mark the 
document so as to indicate consent) on the ICF as well.  The ICF should document the method used for 
communication with the prospective subject and the specific means by which the prospective subject 
communicated agreement to participate in the study.  
The original of the signed ICF must be filed in the hospital/clinical chart and/or with the subject’s study 
documents.  A second signed original or a copy should be given to the subject for their records (if 
applicable). 

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The ICF and data protection authorization, as required by law, must be available for monitoring, auditing 
and regulatory inspections.  
Geography specific ICF Templates will be provided under separate cover.  
15.6. Enrollment 
The point of enrollment is defined as the time at which a patient has signed and dated the ICF.  The date 
the subject signed (or legally authorized representative) the ICF and data protection authorization, as 
required by law, must be documented in the subject’s medical records.  At that point, the patient is 
considered a subject in the study, a study subject ID number will be assigned, and the subject must be 
followed for the duration of the study unless the subject exits the study prior to study closure.  Each 
investigational center will be responsible for maintaining subject identification records (e.g. subject 
identification log) according to ISO 14155.  
Enrollment will occur on the same day as the baseline visit.  Once IC is obtained, report AEs/deaths, 
study deviations and subject exits as they occur.  To accurately track subject enrollment, Medtronic 
should be notified of the enrollment as soon as possible after a patient has signed the ICF. 
15.7. Baseline 
The baseline visit can be a stand-alone visit or can occur on the same day as, but not later than, the 
implant visit.  The following procedures will be completed/data will be collected at the baseline visit: 
o 
Subject Informed Consent  
o 
Inclusion/Exclusion criteria verified 
o 
Subject demographics  
o 
Cardiovascular medications 
o 
Cardiovascular medical history 
o 
NYHA classification 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ)  
Cardiovascular medications include ACE inhibitors, ARBs, antiarrhythmic, anti-coagulants, antithrombotics, 
and antiplatelet, antihypertensive, antilipidemics (statins), beta blockers, calcium channel blockers, 
diuretics, digitalis, inotropes, nitrates, digoxin, and vasodilators. 
If implant does not occur within 30 days of enrollment, verification of all inclusion and all exclusion 
criteria must be repeated before an implant attempt. 
15.8. Implant/PHD 
Information collected at Implant/PHD will include data from the day of the implant procedure until 
released from the hospital.  The implant CRF will be used to collect data at implant.  Implantation of the 
CRT device and right heart leads should be performed according to the Instruction for Use (IFU) in 
geographies where the devices are commercially available. 
Any Medtronic commercially released right atrial (RA) and any Medtronic commercially released right 
ventricular (RV) lead may be implanted.  Existing non-Medtronic RV and/or RA leads that are not recalled, 
market withdrawn, and/or have a medical alert may be used in enrolled who are receiving an upgrade to 

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a CRT system.  The right-heart leads should be implanted according to the labeling provided with the 
applicable lead. 
The implanted system device must include a Medtronic commercially released CRT device which can be 
programmed to utilize all electrodes, allowing upgrades from implantable pulse generators (IPGs) and 
implantable cardioverter defibrillators (ICDs).  Device and lead requirements are as follows: 
• 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
• 
For de novo CRT implants, any Medtronic commercially released transvenous (active or passive 
fixation) RA pacing lead (unless medical justification to exclude this lead) and any Medtronic 
commercially released transvenous (active or passive fixation) RV lead 
• 
For upgrades to a CRT system, existing non-Medtronic RV and/or non-Medtronic RA leads that 
are not recalled, market withdrawn, and/or have a medical alert may be used in enrolled who are 
receiving an upgrade to a CRT system  
• 
Medtronic commercially released CRT devices that measure discrete LV electrical values from all 
four electrodes (i.e. Vector Express) 
15.8.1. 
Final System Configuration 
For information on the requirements for the implanted system refer to Section 13.  The system is 
successfully implanted when the Medtronic CRT device is successfully connected to the RA, RV and the 
LV lead (except if a medical condition such as chronic atrial fibrillation excludes the need for an RA lead).  
The configuration of the successfully implanted system components will be collected.  This will include 
the serial number of each implanted component (CRT-D or CRT-P device, and leads), and the location of 
lead placement. 
15.8.2. 
Implant Procedure 
Implantation of the CRT device and cardiac leads must be performed by a trained clinical study 
investigator and according to the manufacturer’s instructions for use.  It is recommended to use 
Medtronic catheters that are compatible with the Attain Stability Quad MRI SureScan LV Lead (Model 
4798) (e.g., > 7 Fr) during the implant for gaining access to the coronary sinus (CS).   
For complete information regarding the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and 
the implant procedure, reference the Clinical Manual in the US and Canada or the Instructions for 
Intended Use (Technical Manual in EMEA, Hong Kong, and Malaysia).  These documents are located 
under a separate cover. 
15.8.2.1. Venogram 
An occlusive venogram is required for venous visualization of the subject’s coronary vasculature and will 
be used to pre-determine a desired target pacing location prior to placing the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798).  Once the pre-determined target pacing location is determined, a 
venous image will be collected.  A copy of the venous image will be submitted to Medtronic and kept on 
file at the center.  
15.8.2.2. Implanting the LV lead 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be implanted according to the implant 
instructions found within the lead packaging.  The Attain Stability Quad MRI SureScan LV Lead (Model 
4798) can be positioned with the aid of a guide wire (0.36 mm to 0.46 mm or 0.014 inches to 0.018 

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inches in diameter), stylet, an inner catheter, or an inner catheter plus hybrid guide wire.  If a stylet is 
used for lead positioning, only use the stylets packaged with the lead or in a stylet kit (downsized knob).   
Always use a stylet that is 3 cm shorter than the lead length listed on the IS4 connector label.  Other 
stylets may extend beyond the lead tip causing injury or perforation of the cardiac vein or heart.  If using 
a Medtronic integrated valve system (e.g. SureValve), rotate the helix counterclockwise to allow safe 
passage of the helix when inserting the lead into the delivery system to prevent the side helix from 
inadvertently attaching to the valve.  Rust stylets are not recommended with this lead due to the risk of 
conductor coil/insulation perforation. 
Follow the Attain Stability Quad MRI SureScan LV Lead (Model 4798) package insert carefully for fixating 
the side helix to the vein.  Consider using a J-shaped stylet if fixation is unsuccessful.  An overview of the 
key implanting tips includes: 
• 
Rotate the lead counterclockwise when inserting the lead through the SureValve to prevent the 
helix from attaching to the valve 
• 
Refrain from wedging the lead into the vessel so that the lead can easily rotate during fixation 
allowing torque to transfer from the proximal end to the distal end of the lead 
• 
To fixate the side helix in the desired location, rotate the lead clockwise with the guidewire 
inserted in the lead which will provide extra stiffness to the lead 
• 
Ensure the guidewire is removed to allow for lead pliability to visualize and confirm lead fixation 
during the Push Test and the Pull Test  
• 
To reposition the lead, insert the guidewire and rotate the lead counterclockwise without applying 
tension to the lead to unfixate 
Information on surgical data, such as tool use, and implant times, etc. will be collected during the implant 
procedure. 
In an event that one Attain Stability Quad MRI SureScan LV Lead (Model 4798) is determined to be not 
suitable for a patient after the initial lead insertion; the implanting physician must assess the onset of any 
potential AEs.  A second Attain Stability Quad MRI SureScan LV Lead (Model 4798) may only be 
introduced upon confirmation that no system-related AEs resulted from the first Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) implant attempt.  Any LV lead related AE observed during the initial LV 
lead attempt prohibits an attempt of a second Attain Stability Quad MRI SureScan LV Lead (Model 4798). 
If the subject does not have a successful Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
implant at the conclusion of the initial implant procedure, the subject should be followed until procedure 
or system related AEs are resolved or are unresolved with no further actions planned, whichever occurs 
later. 
If an attempt to implant the Attain Stability Quad MRI SureScan LV Lead (Model 4798) does not occur, or 
if the Model 4798 LV lead cannot be implanted, the reasons why the lead was not attempted or 
attempted but not implanted must be documented on the Implant and Study Exit CRF.  See additional 
definitions below. 
No Attain Stability Quad MRI SureScan LV Lead (Model 4798) Attempted (lead not inserted 
into the body) 
An Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt is defined as any time a Model 
4798 lead is introduced into the body.  Subjects that do not have an Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) implant attempted will be exited from the study following their implant procedure 

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unless another Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt is scheduled.  Adverse 
events, device deficiencies and deviations must be documented before the subject is exited. 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) Attempted but Not Implanted 
An Attain Stability Quad MRI SureScan LV Lead (Model 4798) that is inserted into the body that is not 
successfully placed will be considered an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 
4798) attempt.  Note: An unsuccessful implant itself is not considered an AE.  Adverse Events occurring 
during an unsuccessful implant (e.g. dissection, perforation) will be recorded and classified.  Subjects 
with an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempt will be followed 
until procedure or system related AEs have been resolved or are deemed unresolvable with no further 
action planned. 
15.8.2.3. CRT System Testing and Programming During Implant 
Prior to connecting the leads to the CRT can, initial electrical measurements will be taken using the 
Analyzer (Model 2290 or market released equivalent) to confirm adequate pacing thresholds (PCTs) prior 
to closing the pocket per the site’s standard testing method.  These PCTs will be collected on the same 
vector, at two timepoints once the lead is fixated and prior to connecting the leads to the can using the 
Analyzer.  The timepoints are as follows; 
1.) Prior to slitting the cannulation catheter – Collect the first PCT using the Analyzer after the 
lead is fixated and the guidewire/stylet has been pulled back proximal to the helix and electrodes.  
2.) Post slitting the cannulation catheter – Collect the second PCT using the Anlyzer after the lead 
is fixated and following slitting of the cannulation catheter.   
These PCT measurements will be collected on the CRF.  This data will only be collected if an Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) is successfully placed. 
Pacing voltage thresholds are measured to determine whether the underlying myocardium will respond 
effectively to pacing and to evaluate lead stability in the cardiac vein.  It is required to perform LV pacing 
threshold measurements during implant using the pacing threshold test at a 0.5ms pulse width.  It is 
recommended to begin at 2.5 Volts and decrease amplitude after at least 3 pulses until capture is lost.  If 
there is no capture at 2.5 V; stop the test and repeat at a higher voltage using the 0.5ms pulse width.  
The lowest amplitude where capture consistently occurs is the pacing threshold value.  Collect data using 
the Analyzer (Model 2290 or market released equivalent). 
It is recommended that physicians locate a final LV pacing site that can be captured using less than or 
equal to 2.5 V at 0.5ms, R-wave sensing of at least 4.0 mV, and does not cause diaphragmatic 
stimulation at 10V at 0.5ms.  For additional details regarding the left ventricular leads and implant tools, 
refer to the respective technical manuals provided with each product.  
Individual patient venous anatomies as well as pathologies present in the left ventricular myocardium are 
factors that will influence LV lead placement.  Therefore, the best cardiac vein lead electrode location to 
stimulate the LV may vary for each patient.  
15.8.2.4. Final Lead Placement Data Collection 
Following fixation and once the final position of the lead is determined, collect a venous image of the final 
placement of the lead.  A copy of the venous image will be submitted to Medtronic and kept on file at the 
center.  

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15.8.2.5. Pre-Hospital Discharge CRT System Testing and Programming  
The following electrical testing will be performed using the implanted CRT-P or CRT-D device and the 
device programmer once the leads are connected to the CRT-P or CRT-D and pre-hospital discharge: 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors 
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors  LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
Other data collected prior to hospital discharge following the implant includes; 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies  
15.9. 3 Months Post-Implant (remote or in office visit) 
The 3 month scheduled follow-ups may be done remotely or inoffice.  For remote visits, CareLink 
transmissions may substitute device interrogations.  The following procedures will be completed and data 
will be collected at the 3 month Follow-up visit; 
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the final programmed vector 
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) (in office visit only) 

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o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media (or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.10. 
6 Months Post-Implant (in office visit) 
The following procedures will be completed and data will be collected during the 6 months in office 
Follow-up visit. 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on vectors LV1 to RVcoil/Can, LV2 to 
RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If at any tested vector PNS is present at 8.0V at 0.5ms, measure the PNS 
threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
 
 

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Other Data Collection 
o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.11. 
12 Months Post-Implant (in office visit) 
The following procedures will be completed and data will be collected during the 12 month in office 
Follow-up visit. 
Lead Impedance 
o 
Collect LV Lead Impedances using Vector Express on all vectors  
o 
Perform a manual LV Lead Impedance Test for missing Vector Express values on vectors 
LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and the final 
programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Perform PCTs at 0.5ms pulse width using Vector Express on all 16 vectors  
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Perform a manual PCT test at 0.5ms pulse width for missing Vector Express values on 
vectors LV1 to RVcoil/Can, LV2 to RVcoil/Can, LV3 to RVcoil/Can, LV4 to RVcoil/Can and 
the final programmed vector  
o 
Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 

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o 
NYHA classification  
o 
Patient Global Assessment 
o 
Kansas City Cardiomyopathy Questionnaire (KCCQ) 
o 
Rationale for selecting specific LV lead pacing vector for final programming 
o 
Final device interrogation/save-to-media 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.12. 
Recurring 6 Month Follow-ups (remote or inoffice visit) 
After the 12 Month Follow-Up visit, subjects will be seen every 6 months. These scheduled follow-ups are 
considered “Recurring 6 month follow-up visits”.  These scheduled follow-ups may be done remotely or 
inoffice.  For remote visits, CareLink transmissions may substitute device interrogations.  The following 
procedures will be completed during these visits: 
Lead Impedance 
o 
Obtain LV Lead Impedance Test for the final programmed vector  
o 
Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain PCTs at 0.5ms pulse width on the final programmed vector  
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
Retain printouts at the site 
Other Data Collection 
o 
NYHA classification  
o 
Final device interrogation/save-to-media (or CareLink transmission) 
o 
AE Assessment 
o 
Study deviations 
o 
Device deficiencies 
15.13. 
Device Interrogation/Save-to-Media 
For the implant and follow-up visits, a final “Interrogate All” device interrogation file (.pdd) must be 
obtained and saved in a digital format (Save-to-Media).  Store one copy of the save-to-media at the site 
and send a copy to Medtronic.  Do not clear device data.  
A device interrogation (final “Interrogate All”) and Save-to-Media should also be completed at the time of 
study exit (prior to 6 month visit), a system modification (initial and final “Interrogate All”), and in the 
case of a death (where possible).   
15.14. 
System Modifications 
A system modification will be reported in the event the device and/or leads require invasive modification 
(e.g. generator or lead explant, generator or lead replacement, lead repositioning, etc.).  In the event of 
a system modification, regardless of outcome of the modification, subjects should remain in the study 

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when possible and the follow-up visit schedule for the subject will remain unchanged.  For a system 
modification the following information/activities are required to be collected: 
o 
Modification or replace/explant date 
o 
Reason for modification  
o 
Information on device or lead modified   
o 
Information on any replacement device(s) 
o 
Final device interrogation/save-to-media  
o 
Study deviations 
o 
AEs and device deficiencies (as applicable) 
It is recommended that all explanted Medtronic products (device, leads, etc.) are returned to Medtronic 
for analysis per local process and when permissible by local laws and regulations. 
In the event that subject has a re-attempt after a previous unsuccessful system modification, the 
subsequent attempt(s) must be reported via CRF as separate system modifications.    
Attain Stability Quad MRI SureScan LV Lead (Model 4798) repositioned or replaced with 
another Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is repositioned or replaced, the following 
LV lead electrical tests and data collection must be completed:  
Lead Impedance 
o 
Obtain  LV Lead Impedance Test for the final programmed vector 
o 
Perform a manual test for a missing value 
o 
NOTE: Retain printouts at the site 
Pacing Capture Thresholds (PCT) 
o 
Obtain a PCT at 0.5ms pulse width using Vector Express on the final programmed vector 
o 
Perform a manual test for a missing value  
o 
NOTE: A one time manual reprogramming the pulse width to 0.5ms will be required (Out 
of the box pulse width is set at 0.4ms) 
o 
NOTE: Retain printouts at the site 
Phrenic Nerve Stimulation (PNS) 
o 
Test for presence of PNS at 8.0V at 0.5ms on final programmed vector 
o 
NOTE: If PNS is present at 8.0V at 0.5ms, measure the PNS threshold at 0.5ms 
o 
NOTE: PNS observed during this testing will not be considered an AE 
Other Data Collection 
o 
Record the reason why the final configuration was selected for final programming 
o 
Record any programming changes to the LV lead apart from the LV lead pacing vector 
since the last visit and provide rationale for the change(s) 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) capped or explanted without 
replacement with another Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is capped or explanted without 
replacement while the subject is in the study, subjects will continue to be followed per their original 
follow-up schedule for safety monitoring until study closure.  LV lead electrical testing and interrogation 
files will not be required at follow-ups for subjects without the full protocol required system implanted. 

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Explant of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the Medtronic 
CRT-P or CRT-D device without replacement with another Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) and Medtronic CRT-P or CRT-D device 
Subjects who have their Attain Stability Quad MRI SureScan LV Lead (Model 4798) and Medtronic CRT-P 
or CRT-D device explanted without replacement during a system modification procedure should be exited 
from the study as soon as all system related and/or system modification procedure related AEs are 
resolved.  If no system or procedure related AEs are present at the conclusion of such a system 
modification procedure, the subject should be exited immediately. 
Medtronic CRT-P or CRT-D device explanted without replacement, Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) remains implanted 
If the Medtronic CRT-P or CRT-D device is explanted and a replacement device will be implanted, all 
attempts should be made to replace with another Medtronic CRT-P or CRT-D device.  In the event that an 
explanted Medtronic CRT-P or CRT-D device cannot be replaced with a new Medtronic CRT-P or CRT-D 
device, subjects who still have an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted 
will continued to be followed for safety monitoring in person per their original follow-up schedule until 
study closure.  Events related to the Attain Stability Quad MRI SureScan LV Lead (Model 4798) should be 
reported.  Left ventricular lead electrical testing will not be required at follow-ups for subjects without the 
full protocol required system implanted.  In an event that a second Attain Stability Quad MRI SureScan 
LV Lead (Model 4798) was implanted as a result of an Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) related complication, the subject will be followed for safety, however the second implanted 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) will not be included for the analyses of study 
objectives except reportable system related adverse events. 
15.15. 
Study Exit  
Study Exit is defined as the moment when a subject officially stops participating in the study.  Date and 
reason for subject exit must be reported to Medtronic at the earliest opportunity. 
Subjects will be exited from the study for any of the following situations: 
• Study completed 
• Subject lost to follow-up 
• Subject did not meet eligibility criteria and was not yet implanted with an Attain Stability Quad 
MRI SureScan LV Lead (Model 4798)    
• Subject did not have a successful implant and no attempt at re-implant is made 
• Subject did not provide consent or data protection authorization, as required by law 
• Subject chooses to exit (i.e. revokes consent) 
• Investigator withdraws subject  
Prior to exiting a subject from the study, it is recommended to follow the subject until all ongoing system- 
and procedure-related AEs are resolved, unresolved with no further actions planned, or 30 days post the 
6 month visit, whichever occurs first.  Following exit, subjects will continue to receive standard medical 
care.  There will be no further required study-related follow-up visits for these subjects.  All data through 
the time of the subject’s exit will be available for data analyses. 
If possible, the following procedures should be performed / data collected at the exit visit: 

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o 
Report the reason for exit 
o 
Final interrogation file (or CareLink transmission) for exits occurring prior to the 6 month visit 
o 
Study deviations 
o 
AEs and device deficiencies (as applicable) 
After subjects are exited from the study they should receive standard medical care and should be 
managed and followed per physician discretion.  
15.15.1. Study Completed 
All subjects will be followed until FDA Pre-Market Approval (PMA) of the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798).  Medtronic will notify sites when the study is complete.  Upon exiting 
subjects, if the current follow-up visit and exit visit are combined, then both the follow-up CRF and a 
Study Exit CRF need to be completed but only one device interrogation/save-to-media needs to be 
completed and collected.  If AEs are unresolved at time of exit, it should be noted on the AE CRF that the 
AE is unresolved at time of study exit.   
15.15.2. Lost to Follow-up 
In the case that the subject is determined to be lost to follow-up, details of a minimum of two attempts 
and the method of attempt (e.g., one letter and one phone record or two letters) to contact the subject 
must be recorded.  In addition, follow the regulations set forth by the governing IRB or EC. 
15.15.3. Study Exit Upon Sponsor Request 
A subject must be exited from the study if the sponsor suspends study enrollment and a subject has 
signed the ICF but no implant attempt of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
has occurred (see Section 15.8.2.2). 
15.16. 
Subject Withdrawal or Discontinuation  
15.16.1. Subject Chooses to Exit (i.e. revokes consent) 
A subject can withdraw from the study at any time.  If the subject wishes to exit from the study (i.e. the 
subject revokes consent), the site is required to document the reason for exit on the Exit CRF.  In 
addition, study sites shall follow the regulations set forth by the governing Ethics Committee.  For 
countries following ISO 14155, permission may be requested to follow up with the patient outside of the 
study due to withdrawal based on problems related to the investigational feature safety or performance.  
If possible, the following data should be collected prior to subject withdrawal: 
• 
Report the reason for subject withdrawal 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
15.16.2. Investigator Withdraws Subject 
No subjects should be withdrawn by investigators unless compelling medical justification is present.  It is 
recommended investigators discuss any withdrawals with the study sponsor prior to exiting subjects.  If 

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an Investigator withdrawal is necessary, the following data should be collected prior to subject 
withdrawal if possible: 
• 
Report the reason for subject withdrawal 
• 
Final device interrogation/save-to-media  
• 
Study deviations 
• 
AEs and device deficiencies (as applicable) 
 The following are reasons for investigator-initiated subject withdrawal; 
Medical Necessity 
A subject may be exited from the study if an investigator feels it is necessary to withdraw the subject 
from the study due to a medical condition or other reason.  In such cases, the subject will be notified and 
provided an explanation regarding the reasons for the study exit. 
Explant of Medtronic CRT-P or CRT-D Device and Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) 
Subjects in which the Attain Stability Quad MRI SureScan LV Lead (Model 4798) and the Medtronic CRT-P 
or CRT-D device are explanted without replacement (i.e., subject no longer has a Medtronic CRT-P or 
CRT-D device and an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted) shall be 
exited from the study (refer to Section 15.8.2.2).  Subjects exposed to an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) through a lead attempt must be followed through at least one month or 
until all implant related AEs (system-, and/or procedure-related) have resolved or are unresolved with no 
further actions planned.  Subjects who have either an Attain Stability Quad MRI SureScan LV Lead (Model 
4798) (active or not active) or a Medtronic CRT-P or CRT-D device implanted will continued to be 
followed for safety until study completion. 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) Not Implanted 
Subjects that are not anticipated to have an implant attempt (e.g. do not meet inclusion/exclusion 
criteria) must be exited from the study.  Subjects that have a CRT system implant attempt, but who do 
not have an Attain Stability Quad MRI SureScan LV Lead (Model 4798) attempted (See Section 15.8.2.2 
for definition) will be exited from the study following their procedure unless an Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) attempt is scheduled.  If this attempt is more than 30 days from the 
baseline assessment, verification of the baseline data must be completed prior to a subsequent implant 
attempt. 
Subjects with an unsuccessful Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant attempt 
will be followed at pre hospital discharge and one month unless there are ongoing implant related AEs 
(system- and/or procedure related), in which case they will be followed beyond one month until the 
implant related (i.e., system-, and/or procedure related) AEs have been resolved or are considered 
unresolved with no further actions planned.  The subjects may be followed via a clinic visit or by phone 
contact.  In geographies where the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is market-
released, subjects will be exited from the study after the assessment of implant procedure or CRT system 
related AEs if the initial attempt of one Attain Stability Quad MRI SureScan LV Lead (Model 4798) model 
was unsuccessful.  The subject may undergo implant attempts with any market released LV lead that 
provides the best benefit to the patient, but data collection on these subsequent attempts will not be 
required as these subjects will be considered exited from the study. 

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15.17. 
Assessment of Efficacy 
The primary efficacy objective is based on the pacing capture threshold data collected as discussed in 
Section 19.1.  
15.18. 
Assessment of Safety  
The primary safety objective is based on the Adverse Event data collected.  Further information on the 
collection of Adverse Events is discussed in Section 17.1.1.  
15.19. 
Recording Data 
The study will collect data using Oracle Clinical, an electronic data management system for clinical 
studies.  Sites will enter data onto CRFs within the Oracle Clinical database.  
Data reported on the CRFs shall be derived from source documents, which may include worksheets, 
patient medical records, programmer printouts and device interrogation/save-to-media files.  These 
source documents must be created and maintained by the investigational site team.  Further detail on 
data management is provided in Section 21.2. 
15.20. 
Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the Clinical 
Investigation Plan or the Clinical Trial Agreement.  
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, or 
makes a conscious decision to deviate.  In all geographies, prior approval is not required when a 
deviation is necessary to protect the safety, rights or well-being of a subject in an emergency or in 
unforeseen situations beyond the investigator’s control (e.g. subject failure to attend scheduled follow-up 
visits, inadvertent loss of data due to computer malfunction, inability to perform required procedures due 
to subject illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward.   
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis).  However, 
prior approval from Medtronic is required for such situations.  
All study deviations must be reported to Medtronic regardless of whether they are medically justifiable, 
pre-approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
The deviation must be recorded in Oracle Clinical with an explanation for the deviations.  In the 
occurrence of a corrupted device interrogation/save-to-media file, Medtronic will request a deviation to 
document that a readable device interrogation/save-to-media file is unavailable.  
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the IRB/EC as well as 
Medtronic as soon as possible but no later than five (5) working days, or according to local requirements.  
Reporting of all other study deviations should comply with IRB/EC policies and/or local laws and 
deviations must be reported to Medtronic as soon as possible upon the site becoming aware of the 
deviation.    

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Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, and 
terminate the study).  Repetitive or serious investigator compliance issues may result in initiation of a 
corrective action plan with the investigator and site, and in some cases, necessitate suspending 
enrollment until the problem is resolved or ultimately terminating the investigator's participation in the 
study.  Medtronic may provide site-specific reports to investigators summarizing information on deviations 
that occurred at the investigational site on a periodic basis. 
16. Risks and Benefits 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of the product, 
from the research and development phase through the study phase and market release.  The risk 
analysis process for the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is being performed in 
accordance with ISO 14971, and will ensure that the level of risk has been reduced as low as possible 
and is acceptable prior to starting the Attain Stability Quad Clinical Study.   
Potential Risks 
Standard risks associated with the medical device used in this study, an analysis of Adverse Device 
Effects and a history of modification or recall of device under investigation or equivalent devices are listed 
in the Instruction for Use Manual or Clinical Manual. 
The potential adverse events (listed in alphabetical order) related to the use of transvenous leads inlcude, 
but are not limited to, the following conditions: 

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• 
Air embolism 
• 
Avulsion or other damage to the endocardium, valve, or vein (particularly in fragile hearts) 
• 
Cardiac dissection or perforation 
• 
Cardiac tamponade 
• 
Coronary sinus dissection  
• 
Death 
• 
Endocarditis or pericarditis 
• 
Erosion through the skin 
• 
Extracardiac muscle or nerve stimulation 
• 
Fibrillation or other arrhythmias 
• 
Heart Block 
• 
Heart wall or vein wall rupture 
• 
Hematoma/seroma 
• 
Infection 
• 
Lead conductor fracture or insulation failure 
• 
Lead dislodgement 
• 
Myocardial irritability 
• 
Myopotential sensing 
• 
Pericardial effusion or rub 
• 
Pneumothorax 
• 
Rejection phenomena (local tissue reaction, fibrotic tissue formation) 
• 
Threshold elevation or exit block 
• 
Thrombosis 
• 
Thrombotic embolism 
Additional potential adverse events related to the lead and the programmed paramenters include, but are 
not limited to, the following: 
Table 10: Additional adverse events related to the lead and programmed parameters 
Potential adverse event 
Indicator of potential 
adverse event 
Corrective actions to 
consider 
Lead dislodgementi 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Reprogram the LV pacing 
polarity. Reposition the lead. 
Lead dislodgementi 
Intermittent or continuous 
oversensing 
Reprogram the LV pacing 
polarity. Reposition the lead. 
Lead conductor fracture 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Replace the lead. Reprogram the 
LV pacing polarity. 
Lead conductor insulation failure 
Intermittent or continuous loss of 
capture or LV EGM signal 
integrity (including sensing)i 
Replace the lead. Reprogram the 
LV pacing polarity. 
Threshold elevation or exit block 
Loss of capturei 
Adjust the implantable device 
output. Reprogram the LV pacing 
polarity. Replace or reposition 
the lead. 
I Transient loss of capture or LV EGM signal integrity (including sensing) may occur following surgery until 
lead stabilization takes place. If stabilization does not occur, lead dislodgement may be suspected. 

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Implant techniques that may damage the lead include, but are not limited to, the following techniques: 
Table 11: Implant Techniques that may damage the lead 
Implant techniques that may 
damage the lead 
Possible effects on the lead 
Corrective action to consider 
Forcing the lead through the 
introducer/delivery system 
Electrode, conductor coil, or 
insulation damage 
Replace the lead. 
Use of too medial of an approach 
with venous introducer resulting 
in clavicle and first rib binding 
Conductor coil fracture, insulation 
damage 
Replace the lead. 
Using too stiff a stylet 
Conductor coil/insulation 
perforation 
Replace the lead. 
Puncturing the periosteum or 
tendon when using subclavian 
introducer approach resulting in 
binding 
Conductor coil fracture, insulation 
damage 
Replace the lead. 
Advancing the lead through the 
non-coronary central access 
veins without the stylet or guide 
wire fully inserted 
Tip distortion or insulation 
perforation 
Replace the lead. 
Inserting the proximal end of the 
guide wire through the lead tip 
seal without using the guide wire 
insertion tool 
Lead tip seal damage or 
conductor coil/insulation damage 
Replace the lead. 
 
Subjects who are pregnant may be at increased risk (e.g., radiation exposure, and other unforeseen risk 
to the fetus), and are excluded from participation in the study.  If a subject becomes pregnant during the 
study, she must notify the physician immediately.  The subject will remain in the study for intention to 
treat analysis, but the investigator will avoid any procedures that may be determined harmful. 
There may be other discomforts and risks related to the CRT-P or CRT-D device, the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798), and/or this study that are not foreseen at this time.  Interactions 
with concomitant medical treatment are not expected. 
The adverse event collection requirements in this study will ensure that risks associated with the study 
device and the Attain Stability Quad MRI SureScan LV Lead (Model 4798) are adequately monitored.  
16.2. Risk Minimization 
Medtronic has minimized the risks to the subject by the following: 
• 
Performing required laboratory and pre-clinical testing prior to the Attain Stability Quad Clinical 
Study; this information is available under  separate cover in the RPI with the FDA IDE submission 
and the CER with the CE-Mark 
• 
Implementing quality control measures into development and production processes 
• 
Providing guidelines for subject selection and evaluation, and subject inclusion and exclusion 
criteria 
• 
Providing adequate instructions via the Attain Stability Quad MRI SureScan LV Lead (Model 4798) 
User Manual, training, and labeling 

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• 
Selecting implanters that have demonstrated previous experience with implanting CRT-P or CRT-
D devices and specifically LV leads 
• 
Selecting investigators that have demonstrated previous experience with the programming, 
interrogating, and monitoring of CRT-P or CRT-D devices 
• 
After enrollment in the Attain Stability Quad Clinical Study, at each protocol required follow-up, 
the investigator must interrogate the study device to verify appropriate study device function and 
to evaluate the subject’s health and assess for any AEs 
16.3. Potential Benefits 
The potential benefits of having the Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted 
are similar to other LV leads currently available to the public.  The Attain Stability Quad MRI SureScan LV 
Lead (Model 4798) is expected to increase lead stability and reduce the need for patients to undergo an 
additional procedure to replace a dislodged/displaced lead.  Due to the active fixation helix, it may be 
possible to place the lead in veins of various sizes.  There is a possibility that the Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) may offer no additional benefit over similar LV leads.  The 
information gained from this study could result in the improved management of other CRT patients. 
16.4. Risk-Benefit Rationale 
The risk-benefit analysis has shown that there are no major additional risks associated with the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798), other than those associated with the implant, while 
benefits to the patient are possible.  Any residual risk associated with this study is considered low and 
acceptable. 
17. Adverse Event Assessments 
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are crucial 
for the protection of subjects.  Reporting and analysis of safety data are mandated by regulatory 
authorities worldwide.  Medtronic has established procedures in conformity with worldwide regulatory 
requirements to ensure appropriate reporting of safety information.  This study is conducted in 
accordance with these procedures and regulations. 
Data collected in this study may be used in support of global regulatory approvals.  Since the safety 
reporting requirements and classification systems vary for each regulatory agency, requirements from all 
geographies are taken into account for the collection and reporting of safety information.  Adverse Events 
and Device Deficiencies will be reported in all geographies. 
17.1. Adverse Event and Device Deficiency Assessment 
17.1.1. 
Adverse Events 
Adverse Event definitions are provided in Table 12.   The following AEs will be collected throughout the 
study duration, starting at the time the informed consent form is signed:  

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• 
All procedure related AEs  
• 
All system related AEs 
• 
All accessory related AEs 
• 
All cardiovascular related AEs  
• 
All Serious Adverse Events (SAEs), regardless of relatedness  
Reporting of these events to Medtronic will occur on an AE Form, including date of AE, treatment, 
resolution, assessment of both the seriousness of the AE and the relatedness to the investigational device 
or procedure.  Each AE must be recorded on a separate AE eCRF.  Documented pre-existing conditions 
are not considered AEs unless the nature or severity of the condition has worsened.  In addition, AEs 
impacting users or other persons, Non-subject Adverse Events, (reportable per ISO 14155) will be 
collected.  
In all geographies, Unavoidable AEs, listed in Table 12, need not be reported unless the AE worsens or is 
present outside the stated timeframe post-implant.  
For AEs that require immediate reporting (see Table 14), initial reporting may be done by contacting the 
study sponsor per the sponsor contact information.  The original completed AE CRF must be submitted to 
Medtronic as soon as possible.   
Any medication, whether cardiovascular or not, associated with the treatment of an AE must be reported.  
Medication changes that are not related to adverse events will not be collected.  
Subject deaths are also required to be reported.  Refer to Section 17.4 for Subject Death collection and 
reporting requirements.  
17.1.2. 
Device Deficiencies 
Device deficiency (DD) information will be collected throughout the study and reported to Medtronic. 
Note that DDs that result in an Adverse Device Effect (ADE) to the subject should be captured as an AE 
only.  Device Deficiencies that did not lead to an AE but could have led to a Serious Adverse Device Effect 
(SADE) (i.e., if suitable action had not been taken, if intervention had not been made, or if the 
circumstances had been less fortunate) require immediate reporting (see Table 14).  For DDs that require 
immediate reporting, initial reporting may be done by contacting the study sponsor per the sponsor 
contact information. 
17.1.3. 
Event Updates and Resolution 
For any changes in status of a previously reported AE (i.e. change in actions taken, change in outcome, 
change in relatedness), information needs to be updated on, or added to the original AE form.  All AEs 
must be followed until the AE has been resolved, is unresolved with no further actions planned, the 
subject dies or exits the study, or until study closure, whichever occurs first.  
In the event that a subject is exited from the study prior to their 6 month visit, all efforts should be made 
to continue following the subject until all unresolved system or procedure related adverse events, as 
classified by the investigator, are resolved or unresolved with no further actions planned.  
At the time of study exit, all collected AEs with an outcome of ”Unresolved” must be reviewed and an 
update to the original AE must be reported.  At a minimum, if there are no changes to the description, 
relatedness, test and procedures or actions taken, the outcome must be updated to reflect “Unresolved 
at time of study exit”. 

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17.2. Definitions/Classifications 
Where the definition indicates “device”, it refers to any device used in the study.  This might be the 
device under investigation, or any market released component of the system, and includes but is not 
restricted to: the CRT-P or CRT-D  device, the RA, RV or LV leads, the programmer, and implant tools.   
Table 12: Adverse Event and Device Deficiency Definitions 
General 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
 
NOTE 1: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the 
procedures involved. 
NOTE 3: For users or other persons, this definition is 
restricted to events related to investigational medical 
devices. 
(ISO 14155:2011, 3.2) 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational 
medical device 
 
NOTE 1: This definition includes adverse events resulting 
from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from 
an error use or from intentional misuse of the 
investigational medical device. (ISO 14155:2011, 3.1) 
Device Deficiency (DD) 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance.  
 
NOTE: Device deficiencies include malfunctions, use errors 
and inadequate labeling (ISO 14155:2011, 3.15) 
Relatedness 
Procedure Related 
An Adverse Event that is directly related to the implantation 
or surgical modification of the system.  
 
NOTE: In general, this excludes events that are inherent to 
any surgical procedure (e.g. anesthesia complications) as 
well as indirect subsequent consequences of the procedure 
(e.g. reaction to pain medication). 

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System Related 
 
 
(includes all implantable 
components and features, 
associated introduction tools, 
operational and installed software 
and programmers as defined in the 
Clinical Investigation Plan) 
An adverse event that results from the presence or 
performance of any component of the system. 
 
Device-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the 
device.  
RA lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the RA 
lead.  
RV lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the RV 
lead.  
LV lead-related: An adverse event that results from the 
presence or performance (intended or otherwise) of the LV 
lead.  
a) LV Lead Fixation-related: An adverse event that 
results from the presence or performance of the 
side-helix. 
 
Accessory Related 
Programmer Related:  An adverse event that results from 
the presence or performance (intended or otherwise) of the 
programmer 
 
Implant tool-related: An adverse event that results from 
the presence or performance (intended or otherwise) of the 
implant tool.  
Cardiovascular Related 
An Adverse Event relating to the heart and the blood 
vessels or the circulation (e.g. Atrial Fibrillation, Myocardial 
Infarction, stroke, perivascular disease) 
Heart Failure Related 
An adverse event related to worsening heart failure signs 
and symptoms such as hypervolemic and hypovolemic 
status requiring the administration, alteration, adjustment 
or augmentation of HF therapy (diuretics, inotropes and/or 
vasodilators etc.) or the utilization of ultrafiltration devices. 
MRI Related 
An adverse event which is caused by the interaction 
between the pacing system and the MRI system that occurs 
during the MRI procedure and up through the one-month 
post-MRI/waiting period follow-up visit. 

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Not Related 
Relationship to the device or procedures can be excluded 
when: 
 
The event is not a known side effect of the product 
category the device belongs to or of similar devices 
and procedures; 
 
The event has no temporal relationship with the 
use of the device or the procedures; 
 
The serious event does not follow a known 
response pattern to the medical device (if the 
response pattern is previously known) and is 
biologically implausible; 
 
The discontinuation of medical device application or 
the reduction of the level of activation/exposure – 
when clinically feasible – and reintroduction of its 
use (or increase of the level of activation/exposure) 
do not impact the serious event; 
 
The event involves a body-site or an organ not 
expected to be affected by the device or 
procedure; 
 
The serious event can be attributed to another 
cause (e.g., an underlying or concurrent 
illness/clinical condition, an effect of another 
device, drug, treatment, or other risk factors); 
 
The event does not depend on a false result given 
by the device used for diagnosis (when applicable); 
 
Harms to the subject are not clearly due to use 
error; 
 
In order to establish the non-relatedness, not all 
the criteria listed above might be met at the same 
time, depending on the type of device/procedures 
and the event. 
Unlikely 
The relationship with the use of the device seems not 
relevant and/or the event can be reasonably explained by 
another cause, but additional information may be obtained. 
Possible 
The relationship with the use of the investigational device is 
weak but cannot be ruled out completely. Alternative 
causes are also possible (e.g. an underlying or concurrent 
illness/ clinical condition or/and an effect of another device, 
drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also 
be classified as possible. 

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Probable 
The relationship with the use of the investigational device 
seems relevant and/or the event cannot reasonably 
explained by another cause, but additional information may 
be obtained.  
Causal Relationship 
The event is associated with the device or study procedures 
beyond reasonable doubt when: 
 
The event is a known side effect of the product 
category the device belongs to or of similar devices 
and procedures; 
 
The event has a temporal relationship with device 
use/application or procedures; 
 
The event involves a body-site or organ that the 
device or procedures are applied to or the device or 
procedures have an effect on; 
 
The serious event follows a known response 
pattern to the medical device (if the response 
pattern is previously known); 
 
The discontinuation of medical device application 
(or reduction of the level of activation/exposure) 
and reintroduction of its use (or increase of the 
level of activation/exposure) impact on the serious 
event (when clinically feasible); 
 
Other possible causes (e.g., an underlying or 
concurrent illness/clinical condition or/and an effect 
of another device, drug, or treatment) have been 
adequately ruled out; 
 
Harm to the subject is due to error in use; 
 
The event depends on a false result given by the 
device used for diagnosis (when applicable); 
 
In order to establish the relatedness, not all the 
criteria listed above might be met at the same 
time, depending on the type of device/procedures 
and the serious event. 
 
 
 
 
 
 
 
 

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Seriousness 
Serious Adverse Event (SAE) 
 
Adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the 
subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or 
a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-
threatening illness or injury or permanent 
impairment to a body structure or a body function, 
c) led to fetal distress, fetal death or a congenital 
abnormality or birth defect 
 
NOTE 1: Planned hospitalization for a pre-existing 
condition, or a procedure required by the CIP, without 
serious deterioration in health, is not considered a serious 
adverse event. 
(ISO 14155:2011, 3.37)  
Serious Adverse Device Effect 
(SADE)  
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
(ISO 14155:2011, 3.36)  
Unanticipated Adverse Device Effect 
(UADE) 
 
Any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated 
with, a device, if that effect, problem, or death, was not 
previously identified in a nature, severity, or degree of 
incidence in the investigational plan or application 
(including a supplementary plan or application), or any 
other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of 
subjects. (21 CFR 812.3(s)) 
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in 
the current version of the risk analysis report 
 
NOTE 1: Anticipated serious adverse device effect (ASADE) 
is an effect which by its nature, incidence, severity or 
outcome has been identified in the risk analysis report. 
(ISO 14155:2011, 3.42)  

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Complication 
An adverse event that includes the following is considered a 
complication:  
• 
Results in death,  
• 
Involves any termination of significant device 
function, or  
• 
Requires an invasive intervention  
 
Non-invasive (21 CFR 812.3 (k)): when applied to a 
diagnostic device or procedure, means one that does not 
by design or intention:  Penetrate or pierce the skin or 
mucous membranes of the body, the ocular cavity, or the 
urethra, or enter the ear beyond the external auditory 
canal, the nose beyond the nares, the mouth beyond the 
pharynx, the anal canal beyond the rectum, or the vagina 
beyond the cervical os 
 
Note (FDA): Blood sampling that involves simple 
venipuncture is considered noninvasive, and the use of 
surplus samples of body fluids or tissues that are left over 
from samples taken for non-investigational purposes is also 
considered noninvasive. 
 
*** Only system or procedure related AEs will be classified 
as complication or observation 
Observation 
Any Adverse Event that is not a complication. 
 
*** Only system or procedure related AEs will be classified 
as complication or observation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Other 
Unavoidable Adverse Event 
An Adverse Event inherent to a surgical procedure that is 
expected to occur in all subjects for a projected duration 
according to the Investigator’s opinion, including, but not 
limited to:  
 
Event Description 
Timeframe 
(hours) 
from the 
Surgical 
Procedure 
Anesthesia related nausea / vomiting  
24 
Low-grade fever (<100°F or 37.8°C) 
48 
Pocket site / Incisional pain 
72 
Mild to moderate bruising / ecchymosis 
168 
Sleep problems (insomnia) 
72 
Back pain related to laying on table 
72 
Shoulder pain/discomfort/stiffness 
related to shoulder immobilization 
during procedure 
72 
17.3. Reporting of Adverse Events 
17.3.1. 
Adverse Events and Device Deficiency Classification 
All reported AEs and DDs will be reviewed by a Medtronic representative.  Adverse Events will be 
classified according to the definitions provided. 
Upon receipt of AEs at Medtronic, a Medtronic representative will review the AE/DD for completeness and 
accuracy and when necessary will request clarification and/or additional information from the 
Investigator.  Medtronic will utilize the Medical Dictionary for Regulatory Activities (MedDRA), to assign a 
MedDRA term for each AE based on the information provided by the investigator.  
Regulatory reporting of AEs and DDs that could have led to an SADE will be completed according to local 
regulatory requirements.  Refer to Table 14 for a list of required investigator and Medtronic reporting 
requirements and timeframes.  It is the responsibility of the investigator to abide by any additional AE 
reporting requirements stipulated by the IRB/EC responsible for oversight of the study. 
APPENDIX 1 contains the Foreseeable Adverse Event List (FAL), which is a list of adverse events related 
to the system or procedure that have been observed in previous studies and may be experienced by 
subjects.  This list may help to assess if an AE is unanticipated in nature.   
For emergency contact regarding a UADE, SAE and/or SADE, contact a Attain Stability Quad Clinical Study 
representative immediately (refer to the study contact list provided in the site’s study documents 
binder/investigator site file or refer to the Sponsor Contact Information section provided in the CIP). 
Adverse Events and Deaths will be classified according to the standard definitions as outlined below:  

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Table 13: Adverse Event Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Relatedness 
Investigator 
Device, RA Lead, RV Lead, LV Lead, Implant Tool(s), 
Programmer, Procedure, Cardiovascular, Heart Failure, 
MRI 
Sponsor 
Device, RA Lead, RV Lead, LV Lead, Implant Tool(s), 
Programmer, Procedure 
Seriousness 
Investigator 
SAE  
Sponsor 
SAE, UADE/USADE, Device Deficiency with SADE potential 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided by 
Investigator 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-Cardiac, 
Unknown 
An independent Clinical Events Committee (CEC) will review and adjudicate, at a minimum, all events 
classified by the investigator or Medtronic as procedure or system related to determine relatedness and 
complication or observation classifications.    In addition, the CEC will also review and adjudicate all 
Adverse Events resulting in death. 
17.3.2. 
Adverse Events and Device Deficiency Reporting Requirements 
Regulatory reporting of AEs and device deficiencies will be recorded and reported according to local 
regulatory requirements.  It is the responsibility of the Investigator to abide by the adverse event 
reporting requirements stipulated by local law and the site’s IRB/EC.  
Table 14: Reporting Requirements 
Serious Adverse Events (SAEs) 
Investigator submit to: 
Medtronic 
Canada: Investigators are required to report SAEs to the sponsor immediately except for 
those SAEs that the protocol or other document (e.g. Investigator’s Brochure (IB)) identifies 
as not needing immediate reporting.   The immediate reports should be followed promptly by 
detailed, written reports.  
Medical Devices Regulations, sections 59-61.  A guidance for “immediately” is within 72 hours 
of the investigator becoming aware of the event;  Report to sponsor, without unjustified 
delay ISO 14155:2011, sec 9.8.b). 
EMEA: Immediately after the investigator first learns of the event or new information in 
relation with an already reported event.  
All geographies: Report to the sponsor, without unjustified delay, all serious adverse 
events. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies:  Submit to Ethics Committee per local reporting requirement. 

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Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Adverse Device Effects (ADEs),  
Investigator submit to: 
Medtronic 
EMEA: Immediately after the investigator first learns of the event or new information in 
relation with an already reported event. 
All geographies: Submit in a timely manner after the investigator first learns of the effect. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Serious Adverse Device Effects (SADEs), Unanticipated Adverse Device Effects (UADEs), 
Unanticipated Serious Adverse Device Effects (USADEs),  
Investigator submit to: 
Medtronic 
US: Submit as soon as possible, but no later than within 10 working days after the 
investigator first learns of the event.  (21 CFR 812.150(a)(1)) 
Canada: SADEs on the patient, the user or any other person must be reported to the 
Sponsor within 72 hours after it comes to the attention of the qualified investigator. 
It is recommended for the investigator to report safety events as soon as possible but no 
longer than 15 calendar days.”  
All geographies:  Immediately after the investigator learns of the event or of new 
information in relation to an already reported event. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement 
Ethics 
Committee 
All geographies: Submit to Ethics Committees per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies:  Submit to Ethics Committee per local reporting requirement. 
Investigators All geographies: Submit per local reporting requirement. 

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All other reportable Adverse Events  
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the event. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Device Deficiencies with SADE potential 
Investigator submit to: 
Medtronic 
Canada: DDs that have resulted in any of the consequences characteristic of an SAE on the 
patient, the user or any other person or could do so were it to reoccur must be reported to 
the Sponsor within 72 hours after it comes to the attention of the qualified investigator 
EMEA: Immediately after the investigator first learns of the deficiency or of new information 
in relation with an already reported deficiency. 
All other geographies: Submit or report as required per local reporting requirements. 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
Sponsor submit to: 
Regulatory 
authorities 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 
All other Device Deficiencies 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first learns of the 
deficiency. 
Regulatory 
authorities 
Canada: any DD that: 
a. 
has resulted in any of the consequences characteristic of an SAE on the patient, 
the user or any other person; These must be reported by Medtronic to the 
Regulator within 10 days from the date Medtronic becomes aware. 
or 
b. 
could do so were it to reoccur.  These must be reported by Medtronic to the 
Regulator within 30 days from the date Medtronic becomes aware. 
 
All geographies: Submit to regulatory authority per local reporting requirement. 
Ethics 
Committee 
All geographies: Submit to Ethics Committee per local reporting requirement. 

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17.4. Subject Death 
17.4.1. 
Death Data Collection 
All subject deaths must be reported by the investigator to Medtronic on an AE form (AE with outcome of 
death) as soon as possible after the investigator first learns of the death.  In case of death, there should 
be one SAE with the outcome of death reported.  
In the event of a subject’s death, it is recommended that the implanted system be explanted and 
returned to Medtronic for analysis whenever possible per local process.  Local laws and procedures must 
be followed where applicable. 
System Interrogation Data Recommendations: 
• 
After the subject has died but prior to explant, it is strongly recommended that the system be 
interrogated and a full summary interrogation (Interrogate All) performed when possible, and 
saved in a digital format (Save-to-Media).  Store one copy of the save-to-media at the site and 
send a copy to Medtronic.   
• 
Make the device interrogation/save-to-media file before any programming to prevent overwriting 
information in the device’s memory and/or distinguishing between events detected during versus 
before the explant procedure. 
• 
Recommend obtaining the exact date and time of death as lower temperatures after death can 
cause ERI and other “event flags” to be stored in the device memory. 
If the system is not interrogated, an explanation must be entered on the AE form.  For ICD systems, the 
ventricular tachycardia (VT) and ventricular fibrillation (VF) detection capabilities must be disabled to 
avoid inadvertent shocks.  If any system component is returned to Medtronic, internal return product 
reporting systems may be used to gather additional information about the returned device/component. 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic Attain Stability Quad Clinical Study team.  When a death occurs in a hospital, a copy of the 
death summary report and all relevant hospital records should be sent to the Medtronic Attain Stability 
Quad Clinical Study team, if available.  If an autopsy is conducted, the autopsy report should also be sent 
to the Medtronic Attain Stability Quad Clinical Study team if available and allowed by state/local law.  
When the death occurs at a remote site, it is the investigative site’s responsibility to attempt retrieval of 
information about the death.  Additionally, device disposition information should be updated.  In 
summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death  
• 
Relatedness to system and/or procedure 
• 
Device interrogation and Save-to-Media (if available) 
• 
Device disposition information 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and allowed by state/local law) 

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17.4.2. 
Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. The Investigator 
shall classify each subject death per the following definitions: 
Cardiac Death: A death directly related to the electrical or mechanical dysfunction of the heart. 
Sudden Cardiac Death (SCD): Natural death due to cardiac causes, indicated by abrupt loss of 
consciousness within one hour of the onset of acute symptoms; preexisting heart disease may have been 
known to be present, but the time and mode of death are unexpected. If time of onset cannot be 
determined, SCD will alternatively be defined as any unexpected cardiac death occurring out of the 
hospital or in the emergency room as dead on arrival. 
Non-sudden Cardiac Death: All cardiac deaths that are not classified as sudden deaths, including all 
cardiac deaths of hospitalized subjects on inotropic support. 
Non-cardiac Death: A death not classified as a cardiac death. 
Unknown Classification: Unknown death classification is intended for use only when there is insufficient or 
inadequate information to classify the death. 
Table 15: Subject Death Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-cardiac, 
Unknown 
The Clinical Events Committee will review all deaths and provide a final adjudication of the death 
classification.  
Regulatory reporting of Subject Deaths will be completed according to local regulatory requirements.  
17.5. Product Complaint Reporting 
Product complaint reporting and vigilance reporting are applicable and AEs related to any market-
released device during the study must be reported.  The reporting of product complaints is not part of 
the Attain Stability Quad Clinical Study and should be done in addition to the AE reporting requirements.  
Refer to local regulations for reporting requirements.  
Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that has 
been placed on the market. 
• 
Abuse: Abnormal use (definition acc. #4.1 of Meddev 2.12-1 rev8) 
• 
Misuse: Use error (definition acc. #4.20 of Meddev 2.12-1 rev8) 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse of 
the product.  Reporting must be done immediately and via the regular channels for market-released 
products.  The reporting of product complaints by the clinical team must be done according to the local 
Standard Operating Procedures.  Medtronic will notify the regulatory authorities (e.g. Competent 
Authority) as applicable for the following incidents immediately upon learning of them: 

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• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as 
any inadequacy in the labeling or instructions for use which led or might have led to the death or 
serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
• 
Any serious deterioration in the state of health, including: 
o 
Life-threatening illness or injury 
o 
Permanent impairment of a body function or permanent damage to a body structure 
o 
A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure 
18. Data Review Committees  
18.1. Clinical Events Committee 
The study will utilize a Clinical Events Committee (CEC). At regular intervals, an independent CEC will 
review events and adjudicate at a minimum all system, and procedure-related events.  Additionally, the 
CEC will provide an adjudication of the death classification for all reported deaths. 
The CEC will consist of a minimum of three (3) non-Medtronic-employed physicians that are not 
participating investigators for the study, including a CEC chairperson.  
Medtronic personnel may facilitate and participate in CEC meetings but will be non-voting members. 
For AEs and deaths reviewed by the CEC, Medtronic will provide the CEC with the Investigator’s 
description and classification and supportive documentation (when available).  The CEC is responsible for 
reviewing the Investigator’s assessment and supportive documentation (when available), reviewing 
applicable definitions, and determining final classifications for all adjudication parameters. For AEs, 
classification includes system/procedure relatedness and complication or observation.  Additionally, the 
CEC will provide an adjudication for all reported deaths, including system/procedure relatedness and 
cardiac relatedness. 
If the CEC disagrees with the investigator’s classification of the event, the difference will be provided to 
the investigator.  If the investigator agrees with the CEC’s adjudication, the CRF documenting the AE will 
be updated accordingly. 
If the investigator does not agree with the CEC’s adjudication classification, both determinations will be 
provided within the final report; however the CEC’s adjudication will be used for data analysis.  The 
disagreement will also be included in reporting to ethics committees and regulatory authorities, if 
required. 
 
 

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18.2. Data Monitoring Committee 
A Data Monitoring Committee (DMC) will not be utilized for this study considering: 
 
• 
An independent CEC will be formed to adjudicate at minimum all system and procedure related 
events and all deaths. 
• 
This study does not meet FDA’s recommended criteria (Guidance for Clinical Trial Sponsors: 
Establishment and Operation of Clinical Trial Data Monitoring Committees) for when a study 
should use a DMC, primarily because the study is not evaluating the effectiveness of a treatment 
intended to prolong life or reduce the risk of a major adverse health outcome. 
• 
As a result of risk analysis and mitigation efforts as outlined in Section 16, any residual risk 
associated with this study is considered low and acceptable. 
• 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is a modification of the currently 
market approved Attain Performa lead Models 4298, 4398, and 4598 is a modification of the 
currently market approved Model 4396 LV lead.  The Attain Stability Quad lead Model 4798 has a 
similar electrode spacing as the Attain Performa lead Models 4298, 4398, and 4598.  
• 
Study will be conducted under FDA oversight via an investigational device exemption (IDE). 
19. Statistical Design and Methods 
This section presents statistical considerations for the study design and provides a high-level description 
of planned analysis and reporting.  More details will be given in a separate Statistical Analysis Plan (SAP) 
that will be completed before data freeze for the primary objective analysis.  Any deviation to the pre-
specified statistical analyses will be noted in the study report.  The analysis of the study objectives will be 
completed when the sample size requirements (see Table 18) for all the study primary and secondary 
objectives are met.  An interim analysis will be conducted when 360 subjects are enrolled in the study.  
This interim analysis is specifically designed for one of the secondary objectives (details in Section 
19.2.2). 
19.1. Primary Objectives 
19.1.1. 
Primary Safety Objective 
Objective 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be considered safe if the probability of 
subjects free of Model 4798 lead-related complications at 6 months post-implant is greater than 87% 
(i.e., the lower bound of a one-sided 97.5% confidence interval must be greater than 87%). 
Hypothesis: 
H0: S(6-month) ≤ 87% 
H1: S(6-month) > 87% 
where S6-month is the probability that a subject remains free from Model 4798 lead related complications 
through 6 months since implant. 
Endpoint Justification 
The study primary safety endpoint is Attain Stability Quad MRI SureScan LV Lead (Model 4798) related 
complications.  All reported system and procedure-related AEs will be reviewed by an event review 
committee  for LV lead relatedness and severity (see Section 18.1).  

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Utilizing lead related complication free survival probability to evaluate lead safety performance is widely 
accepted across cardiac device manufacturers and in the medical literature.  Current already market-
released Quadripolar LV lead 6-month safety performance is summarized in Table 16.  The population 
performance of the Attain Stability Quad MRI SureScan LV Lead (Model 4798) is expected to be similar to 
the Medtronic Attain Performa Model 4298 lead. 
Table 16: Safety Performance of Market Released Quadripolar Lead 
 
Medtronic  
Attain Performa 
St. Jude Medical 
Quartet22  
Boston Scientific 
ACUITY X423 
6-month LV 
Lead 
Complication 
Free 
Survival 
Probability 
Estimate 
Model 4298 (Canted): 96.0% 
Model 4398 (Straight): 98.8% 
Model 4598 (S-shape): 96.2% 
96% at 3 months 
Straight: 96.5%  
Spiral: 98.5%  
Statistical Analysis Methods  
The primary objective will be analyzed using the time-to-first event Kaplan-Meier survival analysis 
method.  Time 0 will be the day a subject undergoes the implant procedure of a Attain Stability Quad 
MRI SureScan LV Lead (Model 4798), which will be independent of success status of this implant 
procedure. Event date is the onset date of a subject’s first complication that is related to the Attain 
Stability Quad MRI SureScan LV Lead (Model 4798) according to CEC adjudication.  Subjects who 
undergo an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant attempt and do not 
experience any LV lead related complications will be censored at the time of their last known exposure to 
the Attain Stability Quad MRI SureScan LV Lead (Model 4798) for the survival analysis.  For any lost-to-
follow up subject, the last contact date will be used as the censor date.  The 1-sided 97.5% confidence 
limit lower bound for the survival probability at 6 months (183 days) will be calculated using the log-log 
survival function approach (Kalbfleisch and Prentice 2002).  
Sample Size Consideration 
The primary safety objective performance criterion is set to be identical to Medtronic’s Attain Performa 
Clinical Study (IDE Number: G120213).  Therefore, the sample size calculation assumptions are derived 
based on the Model 4298 lead study results.  The Attain Performa Model 4298 lead reported a 6-month 
complication free survival probably of 96.0%, with 97.5% Confidence Lower Limit of 94.3% (PMA-s 
clinical report).  
The binomial calculation (Z-test) is used for initial sample size estimation.  In order to preserve the 
overall study power, a type II error less than 10% was used for the sample size calculation.  A sample 
size of 170 subjects completing their 6-month visit achieves greater than 90% power to detect a 
difference of 7% using the one-sided binomial test.  The target significance level is 0.025.  These results 
assume that the population proportion under the null hypothesis is 87% with an expected value of 94% 
(Figure 5). To account for 15% attrition, the enrollment size for this objective is 200. 

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Figure 5: Primary Safety Objective Sample Size Consideration by Difference Performance 
Assumption 
 
Determination of Patients / Data for Analysis 
All consented subjects who undergo an Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant 
attempt will be included in the analysis cohort.  If a patient experiences multiple Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) implant procedures during the study, the analysis cohort will only 
consider the first procedure.  In the event multiple complications occur, the survival analysis endpoint is 
reached when the first Attain Stability Quad MRI SureScan LV Lead (Model 4798) related complication 
occurs. 
19.1.2. 
Primary Efficacy Objective #1 
Objective 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) will meet the first primary efficacy 
objective if the proportion of subjects with at least one Attain Stability Quad MRI SureScan LV Lead 
(Model 4798) pacing vector having a pacing capture threshold (PCT) less than or equal to 2.5 V at 0.5ms 
pulse width at 6 months post-implant is greater than 80% (i.e., the lower bound of the one-sided 97.5% 
confidence interval must be greater than 80%). 
Hypothesis 
H0: P16-month ≤ 80% 
HA: P16-month > 80%, 
where P16-month is the proportion of subjects with pacing voltage thresholds ≤ 2.5V at 0.5ms  at 6 months 
follow-up visit post-implant for at least one LV lead pacing vector. 
Endpoint Justification 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is equipped with the identical four 
electrodes to the Attain Performa LV leads.  At the same time, the unique fixation mechanism may cause 
the distal end of the lead (tip) to be implanted away from the apical region of the heart, and therefore 
90.3% 
90.8% 
60.0%
65.0%
70.0%
75.0%
80.0%
85.0%
90.0%
95.0%
100.0%
170
180
190
200
210
220
Power 
Sample Size at 6 months 
0.93
0.94
0.95
0.96

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the PCT may be slightly higher than the values observed in other Quadripolar LV leads.  Therefore, we 
simulated the lead pacing threshold values based on the Attain Performa IDE study data, but excluding 
the PCT values collected at the most distal electrode.  The simulation estimated that 89% of the subjects 
will achieve this endpoint (Figure 6). 
Figure 6: Simulated PCT Distribution 
 
 
Statistical Analysis Methods 
All subjects with valid pacing thresholds measured at the 6 month follow-up visit will be included in this 
analysis.  The proportion of subjects having at least one LV lead pacing vector with voltage thresholds 
less than or equal to 2.5V will be calculated.  The lower bound of the 1-sided 97.5% Confidence Interval 
will be calculated using the Exact binomial method.  Any subject in which no valid pacing threshold value 
is measured  or who has an unable-to-capture result via all LV lead pacing vectors will be reviewed and 
adjudicated for a possible lead related AE but will not be included for this evaluation if the occurrence is 
deemed to be a system related event (e.g. lead dislodgement). However, this event may be counted 
against the safety primary endpoint based on the CEC’s final classification. 
Sample Size 
The primary efficacy endpoint will be analyzed using the Exact binomial method.  In order to preserve the 
overall study power, a type II error less than 10% was used for the sample size calculation.  A sample 
size of 145 subjects achieves 91% power to detect a difference of 0.1 using a one-sided binomial test at 
a target significance level of 0.025.  These results assume that the population proportion under the null 
hypothesis is 80%, with an expected proportion of 90%.  
 
 

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Determination of Patients / Data for Analysis 
All subjects enrolled into this study satisfying the following conditions will be included in this analysis: 
• 
Successfully implanted with a Medtronic Quad CRT-P or CRT-D  device and Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) 
• 
Completed 6-month follow-up visit  
• 
Initially implanted Attain Stability Quad MRI SureScan LV Lead (Model 4798) is active at the 6–
month follow-up visit 
• 
At least one available and valid pacing threshold at the 6-month follow-up visit 
19.1.3. 
Primary Efficacy Objective # 2 
Objective 
The Attain Stability Quad lead will meet the second primary efficacy objective if the proportion of subjects 
with at least one additional (or second) LV lead pacing vector having a pacing capture threshold less than 
or equal to 4.0 V at 0.5ms pulse width at 6 months post-implant is greater than 80% (i.e., the one-sided 
97.5% lower confidence bound must be greater than 80%).  
Hypothesis 
H0: P26-month ≤ 80% 
HA: P26-month > 80%, 
where P26-month is the proportion of subjects with at least one additional LV lead pacing vector with pacing 
voltage thresholds ≤ 4.0V at 0.5ms at 6 months post-implant follow-up visit. 
Endpoint Justification 
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) has 16 LV programmable pacing vectors .  
Subjects may have the pacing configuration programmed or reprogrammed at each clinic visit.  A pacing 
threshold of 4.0 V will allow an adequate safety margin for programming LV pacing output.  The 
maximum pacing amplitude of the CRT-P or CRT-D devices capable of programming pacing output to any 
LV lead pacing vector is 8.0V.  In actual clinical practice, a less than 3V safety margin is used for the 
programmed LV lead pacing output in 99% of the patients.  
Statistical Analysis Methods  
The efficacy endpoint #2 will be analyzed using the Exact binomial method.  The proportion of subjects 
with at least 2 LV lead pacing vectors  having voltage thresholds less than or equal to 4.0V at 0.5ms will 
be calculated.  The lower bound of the 1-sided 97.5% Confidence Interval will be calculated using the 
Exact binomial method.  Any subject in which no valid pacing threshold values are measured  or with an  
Unable-to-capture result via all LV lead  pacing vectors  will be reviewed and adjudicated for possible lead 
related complications, and therefore may be counted against the study safety endpoint.  However, it will 
be counted as a failure if there is not any additional LV lead pacing vectors  (excluding the vector that is 
already include for the efficacy endpoint #1) are unable to capture with no lead related events reported. 
Sample Size 
The Attain Performa Model 4298 LV lead observed 97.7% subjects who were able to obtain a non-
programmed pacing vector with PCT less than or equal to 4 volts.  A sample size of 50 subjects 
completing the 6 month visit achieves 98% power to detect a difference of 0.18 using a one-sided 
binomial test at a target significance level of 0.025.  These results assume that the population proportion 
under the null hypothesis is 80%, with the expected proportion of 97%.  

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Determination of Patients / Data for Analysis 
All subjects enrolled into this study satisfying the following conditions will be included in this analysis: 
• 
Successfully implanted with a Medtronic Quad CRT-P or CRT-D  device and Attain Stability Quad 
MRI SureScan LV Lead (Model 4798) 
• 
Completed 6-month follow-up visit  
• 
Initially implanted Attain Stability Quad MRI SureScan LV Lead (Model 4798) lead is active at the 
6–month follow-up visit 
• 
At least one available and valid pacing threshold at the 6-month follow-up visit. In the event a 
subject failed to provide more than one valid pacing threshold value, that subject will be 
considered as not having at least one additional LV lead pacing with PCT ≤ 4.0V at 0.5ms at 6 
months post-implant follow-up visit 
19.2. Secondary Objectives  
19.2.1. 
Secondary Objective # 1 
Objective - Implant procedure related information: success rate, implant related times 
The Attain Stability Quad LV lead implant success rate will be estimated as the number of subjects with 
Attain Stability Quad MRI SureScan LV Lead (Model 4798) successfully implanted divided by the total 
number of subjects who had a Attain Stability Quad MRI SureScan LV Lead (Model 4798) implant 
attempt.  A 2-sided 95% Confidence Interval will be calculated using the Exact Binomial method. 
The distribution of implant related times will be summarized through statistical summaries such as mean, 
standard deviation, minimum, median and maximum.  Only subjects with the Attain Stability Quad MRI 
SureScan LV Lead (Model 4798) successfully implanted will be included in this calculation.  The total 
implant time is defined as time from initial incision to final skin closure.  Fluoroscopy time is defined as 
the total time the fluoroscope is imaging.  Cannulation time is defined as the time from insertion of the 
first CS cannulation catheter to the first successful CS cannulation.  Successful lead placement time is 
defined as the time from lead insertion of the successfully placed lead to the time when the lead is placed 
in its first acceptable pacing location.   
19.2.2. 
Secondary Objective # 2 
Objective - 6-month reliability: post implant lead failure modes  
The Attain Stability Quad MRI SureScan LV Lead (Model 4798) is a composite of two existing market 
released Medtronic products.  The helix fixation is identical to the Attain Stability LV Lead Model 
20066/4796 (market released outside of the US).  The remainder of the lead is similar to the Attain 
Performa LV Lead Model 4298, released worldwide.   
Historical datasets will be used as informative priors for lead related complications.  More specifically, 
analysis of all complications related to fixation (helix performance) will use data from the Attain Stability 
(Model 20066/4796) research study, conducted outside of the US.  Analysis of all other lead related 
complications will use data from the Attain Performa clinical study, conducted globally.  Credible intervals 
will be constructed for each individual failure mode within the two groups. 
 
 

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Historical Data (for secondary endpoints only) 
o 
Fixation-related LV lead complications - Data from the 37 patients who completed 6-
month follow up with a successfully implanted 20066 lead in the Attain Stability study will 
be used as an informative prior.  
o 
All other LV lead-related complications - Data from the 401 patients who completed 6-
month follow up in the Attain Performa 4298 study will be used as an informative prior. 
These historical datasets will be downweighted such that their effective sample size will not exceed the 
9% of the total sample size (i.e at most 37 subjects at 6 months). 
Statistical Analysis Methods 
The weighted historical data will be incorporated using the power prior method24.  The weight of the 
historical data will be adjusted using a loss function25, which scales from 0 to 1 according to the similarity 
of the historical and observed data.  This loss function adjusts the amount of weight the prior receives.  
The comparison between historical and observed data will be performed twice, once for each group of 
complications (fixation-related and all other).  The objective of using a loss function with the power prior 
method is to reduce the influence of an informative prior in the parameter estimation, when the historical 
data does not agree with the current study data.  
If analysis of failure rate shows a high level of agreement between historical and current study data or 
there is better performance for Attain Stability Quad MRI SureScan LV Lead (Model 4798) compared to 
historical data, the historical data will be weighted at or near a maximum level (9% of total effective 
sample size).  If the Attain Stability Quad MRI SureScan LV Lead (Model 4798) performs worse than 
historical data, the historical data will receive very little or zero weight.  Note that there will be two loss 
function weights, one for fixation-related complications and one for all other complications.  Credible 
interval calculations will be done separately for individual failure modes within the two groups of 
complications (fixation and all other).  
Denote by 𝜃𝜃𝑐𝑐 and 𝜃𝜃ℎ the probabilities of lead complication for the current and historical studies 
respectively.  The posterior distributions of 𝜃𝜃𝑐𝑐 and 𝜃𝜃ℎ respectively, both with minimally informative priors 
are: 
𝜃𝜃𝑐𝑐= 𝑏𝑏𝑏𝑏𝑏𝑏𝑎𝑎(𝑦𝑦𝑐𝑐+ 1, 𝑛𝑛𝑐𝑐−𝑦𝑦𝑐𝑐+ 1) 
𝜃𝜃ℎ= 𝑏𝑏𝑒𝑒𝑡𝑡𝑡𝑡(𝑦𝑦ℎ+ 1, 𝑛𝑛ℎ−𝑦𝑦ℎ+ 1) 
These posterior distributions are then stochastically compared using a posterior Bayesian p-value26 as: 
𝑝𝑝= 𝑃𝑃(𝜃𝜃𝑐𝑐≤𝜃𝜃ℎ) 
The desired characteristics for the loss function are: 
1. For 𝑝𝑝≥~0.5, there is a high level of agreement between current and historical data, therefore 
the loss function should allow a0 to be close to 1, allowing for full weight of historical data.  
2. Conversely, for 𝑝𝑝< ~0.5, there begins to be evidence of disagreement between current and 
historical data, and a0 should start to down-weight the prior, i.e. a0 approaches zero as 𝑝𝑝 
approaches zero. 
The Weibull cumulative distribution function (CDF) meets these criteria: 
𝑎𝑎0 = 1 −𝑒𝑒−(𝑝𝑝∗5)2 

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Note that for the case where the number of samples in the prior is different than the effective number, a 
scaling factor will be applied, where 𝑛𝑛ℎ is the desired effective number of prior samples and 𝑁𝑁ℎ is the 
actual number of prior samples: 
𝑎𝑎0 = 𝑛𝑛ℎ
𝑁𝑁ℎ
ൣ1 −𝑒𝑒−(𝑝𝑝∗5)2൧ 
Sample values are listed in Table 17 below and illustrated in Figure 7.  The comparison between current 
and historical data will be performed for all LV lead fixation related complications using Attain Stability 
(Model 20066) historical data and for all other LV lead related complications using Attain Performa 
historical data. 
Table 17: Prior weight from Attain Stability (Model 20066) and prior weight from Attain 
Performa as a function of the posterior Bayesian p-value (𝒑𝒑) 
 
Prior weight from Attain 
Stability (Model 20066) 
Prior weight from Attain 
Performa 
𝒑𝒑 
𝑎𝑎0 = 1 −𝑒𝑒−(𝑝𝑝∗5)2 
𝑎𝑎0 = 37
401 ൣ1 −𝑒𝑒−(𝑝𝑝∗5)2൧ 
0.01 
0.002 
0.000 
0.05 
0.061 
0.006 
0.1 
0.221 
0.020 
0.2 
0.632 
0.058 
0.5 
0.998 
0.092 
 
Figure 7: Loss Function 𝒂𝒂𝟎𝟎= 𝟏𝟏−𝒆𝒆−(𝒑𝒑∗𝟓𝟓)𝟐𝟐 
 
 
 

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Note that the loss function proposed here does not reduce the strength of the prior when the current 
study outperforms the historical data.  This implementation of the loss function is only concerned with 
negative impacts to patients, i.e. it penalizes an optimistic prior while not penalizing a pessimistic prior. 
Also, note that this function is selected for the shape of the CDF rather than due to conventional 
statistical properties of the Weibull distribution.  
Figure 8 illustrates the effect of the power prior coupled with the loss function.  The figure shows credible 
intervals in scenarios where the prior is optimistic (better performance than current study), in agreement 
(similar performance to the current study), and pessimistic (worse performance than the clinical study).  
Note that the prior data source in Figure 8 is the Attain Performa study, with 401 patients.  As will be 
discussed later, these data are scaled to represent a maximum of 37 patients (i.e. 9% weight).   
Figure 8: Credible Intervals for Scenarios of Agreement Between Historical and Current Data 
 
The prior data set in Figure 8 has 401 samples.  However, the maximum effective historical data sample 
size is 𝑛𝑛ℎ= 37, for a maximum weight of 9%.  Therefore, the prior will be scaled by a factor of (37/401).  
As an example, illustrated in the middle panel above, if the effective sample size is 34 out of 37, the prior 
has received 89% of the maximum weight, or 8.5%. 
The panels in Figure 8 can be interpreted as follows:  

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• 
Top panel: The current data shows lower performance than the prior.  The loss function 
produces a substantial penalty resulting in almost no weight to the prior (1%).  The posterior 
(final estimate) is essentially the same as the current study.   
• 
Middle panel: The current data is very similar to the prior.  The loss function penalty is small, 
resulting in a prior weight of 8.5% (recall that the maximum weight is 9.2%).  Because the 
agreement is good, the posterior(final estimate) is similar to both the prior and current study.   
• 
Bottom panel: The current data is very similar, with slightly better performance than the prior.  
The loss function produces a weight very close to the maximum of 9.2%.  The posterior (final 
estimate) is a balance between the prior and current study.  
Sample Size 
A Bayesian adaptive design is set up to enroll patients until a sufficient sample size is achieved to have 
high probability of meeting the required effective sample size of 𝑛𝑛𝑒𝑒= 400.  The number of enrolled 
patients in the study may vary from 363 to 400 subjects due to the adaptations to the trial.  This study 
follows methods from Berry, et.al.27  
The interim analysis will take place after 360 subjects have been enrolled into the study.   
The Adaptive Bayesian sample size algorithm will stop or continue enrollment accordingly to the 
following: 
1.) If the predictive probability of 𝑛𝑛𝑒𝑒≥400 is larger than 80% then enrollment will stop. 
2.) If the predictive probability of 𝑛𝑛𝑒𝑒≥400 is less than 80%, enroll sufficient additional patients to 
make the probability of 𝑛𝑛𝑒𝑒≥400 at least 80%.   
At the time of the interim analysis, some patients will not have completed the full evaluation period.  A 
longitudinal model will be employed to enable final observations to be imputed for those subjects with 
incomplete information.  
There are 3 types of subjects at a given interim analysis: 
1.) Subjects that have complete data 
2.) Subjects that have partial data (censored value at a particular time) 
3.) Subjects that have no information (subjects that have not been enrolled) 
Predictive probabilities for types 2 and 3 will have to be computed.  The predictive probability model that 
will be used is a piecewise exponential.  This will allow the final outcomes for the subjects who have not 
had an event and have not completed 6 month follow up to be simulated. 
Note this Bayesian approach to borrow information from historical datasets will only be used for the 
secondary objective #2. 
19.2.3. 
Secondary Objective # 3  
Objective – Electrical measurements (PCT and Impedance) at follow-ups 
Pacing Capture Threshold (PCT) and impedance data will be collected using VectorExpressTM.  Pacing 
vector changes will be monitored for all implanted patients at follow-up visits. 
Summary statistics for PCT and impedance at each time point (i.e. Implant, 6 months, etc.).  The 
distribution of the electrical measurements at the final programmed pacing vector will be presented as n, 
mean, standard deviation, minimum, median and maximum.  In the event of a replacement of a 
Medtronic Quad CRT-P or CRT-D  device and/or the implanted LV lead, only measurements from the 

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Attain Stability Quad MRI SureScan LV Lead (Model 4798) implanted at the initial implant procedure will 
be included in the analysis cohort for this objective. 
19.3. Additional Analysis  
19.3.1. 
Poolability Analysis 
Additional analysis will be conducted to summarize study primary objectives by patient characteristics, 
such as gender, age group,  race and study site geography.  The purpose of the poolability analysis is to 
identify if there is any clinical meaningful difference in a subgroup of patients.  These analyses will not be 
statistically powered, and there is no pre-specified statistical significance level for these analyses. 
19.3.2. 
Sensitivity Analysis 
All subjects enrolled into this study and successfully implanted with a Medtronic Quad CRT-P or CRT-D  
device and Attain Stability Quad MRI SureScan LV Lead (Model 4798) will be included in the primary 
efficacy analysis datasets (efficacy objectives #1 and #2).  Sensitivity analysis such as the Tipping Point 
method or similar will be conducted to investigate the influence of subjects who were successfully 
implanted with the required system however missed a 6 month post implant follow-up test(s) (due to 
reasons such as missing in-office visit, subject exit, death and/or the initial implanted lead was 
deactivated).  For this purpose, all subjects with successful implant who do not meet analysis cohort 
requirements, will be considered as the worst case scenario (i.e. failure to meet the efficacy 
endpoints).The results will be submitted as part of the clinical reports.   
19.3.3. 
Additional Data Collection 
Heart failure clinical outcomes will be assessed. The measurements, including NYHA classification, death, 
heart failure related hospitalization, heart failure related study exits and subject self-reported global 
assessment for each subject will be obtained at 6 months post-implant.  Summary statistics will be 
provided.  
19.3.3. 
Overall Study Sample Size Requirements 
The sample size requirement  at 6-months for each of the study objectives is displayed in Table 18. The 
first row does not account for attrition, while the second row is inflated by 15% attrition. The sample size 
for Secondary Objective #2 assumes the conservative case that the interim look results in, no borrowing 
of historical data. Therefore, the overall sample size for the study is 471.  
Table 18: Required Sample Size by Study Objective  
 
Primary 
Safety 
Objective 
Primary 
Efficacy 
Objective 
#1 
Primary 
Efficacy 
Objective 
#2 
Secondary 
Objective 
#1  
Secondary 
Objective 
#2 (post-
implant 
failure 
modes) 
Secondary 
Objective 
#3 
Overall 
Number 
needed at 
6-months 
170 
145 
50 
NA 
400 
NA 
400 
Number of 
enrollments 
200 
171 
59 
NA 
471 
NA 
471  
 

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20. Ethics 
20.1. Statement(s) of Compliance  
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as good clinical practice (GCP).  Good Clinical Practice includes review and approval by an 
independent IRB/EC before initiating a study, continuing review of an ongoing study by an IRB/EC, and 
obtaining and documenting the freely given IC of a subject before initiating the study. 
The clinical investigation shall not begin until all required approvals and documents from the IRB/EC and 
a regulatory authority, if needed, have been received.  Any additional requirements imposed by the 
IRB/EC or regulatory authority shall be followed, if appropriate. 
The Attain Stability Quad Clinical Study was designed to reflect the GCP principles outlined in ISO 
14155:2011 and other international clinical requirements outlined below. These include the protection of 
the rights, safety and well-being of human subjects, controls to ensure the scientific conduct and 
credibility of the clinical investigation and the definition of responsibilities of the sponsor and 
investigators.  In accordance with ISO 14155:2011, the sponsor shall avoid improper influence on, or 
inducement of, the subject, monitor, any investigator(s) or other parties participating in, or contributing 
to, the clinical investigation.  All investigators shall avoid improper influence on or inducement of the 
subject, sponsor, monitor, other investigator(s) or other parties participating in or contributing to the 
clinical investigation.  Adverse Event and Device Deficiency handling in the Attain Stability Quad Clinical 
Study is ISO 14155:2011 compliant for all participating geographies with the exception  that only those 
AEs which are related to the subject’s system, procedure, accessory, or are cardiovascular-related, and all 
Serious AEs, will be collected. This ensures any AEs which could potentially be relevant will be collected. 
The scope and duration of the Attain Stability Quad Clinical Study would make collection of all AEs to be 
a significant burden for investigators and investigative sites. Therefore, only a subset of AEs will be 
collected in this study, including any that could be potentially relevant. 
The principles of the Declaration of Helsinki have been implemented through the IC process, IRB/EC 
approval, study training, clinical trial registration, pre-clinical testing, risk-benefit assessment and 
publication policy.  
Ultimately, all sites in all geographies will follow and comply with: 
• 
Principles of Declaration of Helsinki 
• 
21 CFR Part 11 (Electronic Records, Electronic Signatures) (per local law) 
• 
21 CFR Part 54 (Financial Disclosure by Clinical Investigators) 
• 
The Clinical Trial Agreement 
• 
The procedures described within this CIP 
• 
Local Ethics Board Requirements 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to:  

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• 
In the United States, the study will be conducted under an FDA IDE in compliance with 21 CFR 
Parts: 
o 
50: Protection of Human Subjects 
o 
56: Institutional Review Boards 
o 
812: Investigational Device Exemptions 
• 
In Canada, SOR/98-282, Section 59-88 will be followed and Mandatory Problem Reporting 59(1), 
59(2), 60 (1)). 
• 
In EMEA the study will be conducted in compliance with the Active Implantable Medical Device 
Directive (AIMDD) and Declaration of Helsinki version 2013.  
• 
In Hong Kong and Malaysia, the study will be conducted in compliance with the Declaration of 
Helsinki version 2013.   
• 
In EMEA, an IB is not required for this study as it is a post market study 
The study will be publicly registered prior to first enrollment in accordance with the 2007 Food and Drug 
Administration Amendments Act FDAAA and Declaration of Helsinki on http://clinicaltrials.gov (PL 110-85, 
section 810(a)).  In addition, the study may be registered in local regulatory databases where required by 
local law.  
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law/regulations) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical ethics committee or institutional review board. 
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above 
mentioned groups prior to implementation of the revised CIP at the site.  
21. Study Administration 
21.1. Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this Attain Stability Quad Clinical 
Study.  Trained Medtronic personnel or delegates appointed by Medtronic may perform study monitoring 
at the study site in order to ensure that the study is conducted in accordance with the CIP, the CTA, and 
applicable regulatory and local requirements.  Medtronic, or delegates, must therefore be allowed access 
to the subjects’ case histories (clinic and hospital records, and other source data/documentation) upon 
request as per the Subject IC, Data Protection Authorization (where applicable) and CTA.  The principal 
investigator should also be available during monitoring visits.  
Monitoring for the study, including site initiation visits, interim monitoring visits, and closeout visits, will 
be done in accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess site study progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to IRB/EC approval and review of 
the study, maintenance of records and reports, and review of source documents against subject CRFs.  
Monitors review site regulatory and study compliance by identifying findings of non-compliance and 
communicating those findings along with recommendations for preventative/corrective actions to site 
personnel.  Monitors may work with study personnel to determine appropriate corrective action 

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recommendations and to identify trends within the study or at a particular site.  Regulatory documents 
may be reviewed at each study site.   
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, findings from previous monitoring visits 
and any suspected inconsistency in data that requires investigation. 
21.2. Data Management 
Data will be collected using Oracle Clinical, an electronic data management system for clinical studies.  
CRF data will be stored in a secure, password-protected database which will be backed up nightly.  Data 
will be reviewed using programmed and manual data checks.  Data queries will be made available to sites 
for resolution.  Study management reports may be generated to monitor data quality and study progress.  
At the end of the study, the data will be frozen and will be retained indefinitely by Medtronic. 
Only authorized persons can complete CRFs.  CRFs shall be signed by the Principle Investigator.  The 
Principle Investigator can delegate the CRF sign off task to Sub-Investigators only.  Delegation of 
authority will be specified on the appropriate documentation. 
All records and other information about subjects participating in this study will be treated as confidential.  
Data will be transferred and processed by Medtronic or a third party designated by Medtronic in a key 
coded form, unless it’s impossible to make it anonymous, for instance, where the subject’s name cannot 
be removed from the data carrier.     
Procedures in the CIP require source documentation.  Source documentation will be maintained at the 
site.  Source documents, which may include worksheets, patient medical records, programmer printouts 
and device interrogation files, must be created and maintained by the investigational site team.  For 
source documentation, the investigational site study team must sign and date any copies or printouts of 
original source documents with a statement that this is a complete and true reproduction of the original 
source document. 
The data reported on the CRFs shall be derived from source documents and be consistent with these 
source documents, and any discrepancies shall be explained in writing.  The CRF may be considered 
source for the following data collection elements recorded directly on the CRFs: 
• 
Enrollment Notification 
o 
Site assigned patient reference 
• 
Baseline 
o 
Administrative information 
• 
Adverse Event eCRF 
o 
Date study site became aware of event 
o 
Relatedness of adverse event 
• 
Device Deficiency eCRF 
o 
Date study site became aware of event 
• 
Subject Death 
o 
Date study site became aware of death 
o 
Relatedness of death 
• 
System Modification 
o 
Justification for explanted product not being returned to Medtronic 
• 
Deviations 

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o 
Reason for deviation 
• 
Investigational product Disposition Log 
o 
Date the Investigational Attain Stability Quad lead was implanted/explanted  
Even when the CRF may be considered as source, an alternate method of source documentation is 
always strongly encouraged. 
Save-to-media data collected at office visits will be sent to Medtronic.  Upon receipt, device data will be 
maintained within a Medtronic device database and retrieved for analysis and reporting. 
21.3. Direct Access to Source Data/Documents  
The sponsor or a regulatory authority may audit or inspect the study site to evaluate the conduct of the 
study.  The clinical investigator(s)/institution(s) shall allow study related monitoring, audits, IRB/EC 
review and regulatory inspection.  
21.4. Confidentiality 
All records and other information about subjects participating in this study will be treated as confidential.  
21.5. CIP Amendments 
Approval of subsequent revisions to the CIP is required at each study site from the following groups prior 
to implementation of the revised CIP at the site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent medical ethics committee or institutional review board. 
If a CIP amendment occurs, site personnel will need to be re-trained as necessary, and will need to 
submit any changes to their IRB/EC as required by the committee.  Protocol amendments will also be 
reported to and approved by the FDA, or regulatory authority. 
21.6. Warranty/Insurance Information 
21.6.1. 
Warranty 
Warranty information is provided in the product packaging for the commercially released CRT-P or CRT-D 
devices and leads, and additional copies are available upon request. 
21.6.2. 
Insurance (EMEA) 
Medtronic Bakken Research Center B.V. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical study liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the EC 
and/or Competent Authority (CA). 

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21.6.3. 
Insurance (Canada) 
Medtronic of Canada  is a wholly owned subsidiary of Medtronic, which as the parent company of such 
entity maintains appropriate general liability insurance coverage as required under applicable laws and 
regulations and will comply with applicable local law and custom concerning specific insurance coverage.  
If required, a General Liability insurance statement/certificate will be provided to the Ethics Committee. 
21.6.4. 
Insurance (Malaysia) 
Medtronic International Ltd. is a wholly owned subsidiary of Medtronic, which as the parent company of 
such entity maintains appropriate clinical trial liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the Ethics 
Committee. 
21.6.5. 
Insurance (Hong Kong) 
Medtronic Hong Kong Medical Ltd.   Ltd. is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entity maintains appropriate clinical trial liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage.  If required, a Clinical Trial insurance statement/certificate will be provided to the 
Ethics Committee. 
21.7. Record Retention 
21.7.1. 
Investigator Records 
The investigator is responsible for the preparation and retention of the records including, but not limited 
to, those cited below.  All of the below records, with the exception of case history records and case 
report forms, should be kept in the Investigator Site File (e.g., the study binder provided to the 
investigator) or Subject Study Binder.  Case Report Forms must be maintained and signed electronically 
by an investigator within the electronic data capture system during the study.  The following records are 
subject to inspection and must be retained for a period of two years (or longer as local law/regulation or 
hospital administration requires) after product approval.  Measures shall be taken to avoid loss or 
premature destruction. 
• 
All correspondence between the IRB/EC, sponsor, monitor, regulatory authority and/or the 
investigator that pertains to the investigation, including required reports.  
• 
Subject’s case history records, including:  
o 
Signed and dated informed consent form, in accordance with local requirements  
o 
Observations of adverse events/adverse device effects/device deficiencies 
o 
Medical history 
o 
Baseline, Implant and follow-up data (if applicable) 
o 
Documentation of the dates and rationale for any deviation from the protocol 
• 
Electronically signed and dated eCRFs and a blank set of CRFs where required by local law 
• 
All approved versions of the CIP, IC  
• 
Fully executed Clinical Trial Agreement 
• 
Ethics Committee approval documentation.  Written information that the investigator or other 
study staff, when member of the Ethics Committee, did not participate in the approval process. 

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Approval documentation must include the Ethics Board composition, where required per local 
law.   
• 
Regulatory authority notification, correspondence and approval, where required per local law. 
• 
List of investigation sites: This list is not yet final at the time of CIP development. The list will be 
provided under separate cover and will be maintained by the sponsor. 
• 
Financial disclosure (investigators) 
• 
Enrollment Log (for sites following ISO 14155) 
• 
For sites where the Attain Stability Quad lead is considered investigational, device disposition logs 
containing Model and serial numbers of devices implanted, subject IDs of the subjects implanted, 
implant/used dates, explant dates, returned-to-sponsor dates and reasons and method of 
disposal/destruction 
• 
Current curriculum vitae (signed and dated in EMEA only) of principal investigators and key 
members of investigation site team (as required by local law) 
• 
Documentation of delegated tasks 
• 
Study training records for investigation site team 
• 
Assurance certificates (EMEA, Hong Kong, and Malaysia) 
• 
Any other records that FDA and local regulatory agencies require to be maintained (e.g. Ethics 
Committee Roster, study equipment calibration information) 
• 
Final Study Report including the statistical analysis 
21.7.2. 
Investigator Reports 
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all CRFs, AEs and ADEs (reported per the country-specific collection requirements), DDs, deaths, 
crossovers and any deviations from the CIP.  If any action is taken by an IRB/EC with respect to this 
Attain Stability Quad Clinical Study, copies of all pertinent documentation must be forwarded to Medtronic 
in a timely manner.  Reports are subject to inspection and to the retention requirements as described 
above for investigator records.  
Investigator reporting requirements for safety data are listed in Section 17.3).  
Table 19: Investigator Reports Applicable for All Geographies per Medtronic Requirements 
Report  
Submit to 
Description/Constraints 
Withdrawal of Ethics 
Committee approval 
Sponsor and 
Relevant 
Authorities 
The investigator must report a withdrawal of approval by 
the reviewing Ethics Committee of the investigator’s part of 
the investigation within 5 working days. 
Study Deviations  
Sponsor and 
Ethics Committee 
Any deviation from the clinical investigation plan shall be 
recorded together with the explanation of the deviation. 
Notice of deviations from the CIP to protect the life or 
physical well-being of a subject in an emergency shall be 
given as soon as possible, but no later than 5 working days 
after the emergency occurred.  Except in such emergency, 
prior approval is required for changes in the plan or 
deviations.  
Failure to obtain 
informed consent 
Sponsor and 
Ethics Committee 
Informed consent shall be obtained in writing and 
documented before a subject is enrolled into the Attain 
Stability Quad Clinical Study 
Final Report 
Ethics Committee 
and  
Relevant 
Authorities 
This report must be submitted within 3 months of study 
completion or termination. 

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21.7.3. 
Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records that includes, but is not 
limited to: 
• 
All correspondence which pertains to the Attain Stability Quad Clinical Study 
• 
Executed Clinical Trial Agreement 
• 
Financial disclosures (investigators) 
• 
Current curriculum vitae (signed and dated in EMEA only) of principal investigators and key 
members of investigation site team (as required by local law) 
• 
Device Disposition Logs containing Model and serial numbers of devices implanted, subject IDs of 
the subjects implanted, implant/used dates, explant dates, returned-to-sponsor dates and 
reasons and method of disposal/destruction 
• 
Electronically signed and dated eCRFs 
• 
All approved informed consent templates, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all Ethics Committee approval letters and relevant Ethics Committee correspondence 
and Ethics Committee voting list/roster/letter of assurance 
• 
List of names, addresses, and professional position of the clinical investigators and coordinating 
clinical, if appointed.  
• 
Names and addresses of the institutions in which the Attain Stability Quad Clinical Study will be 
conducted: This list is not yet final at the time of CIP development. The list will be provided 
under separate cover and will be maintained by the sponsor. 
• 
Regulatory authorities correspondence, notification and approval as required by national 
legislation 
• 
Insurance certificates (EMEA, Hong Kong, and Malaysia)  
• 
Names/contact addresses of monitors 
• 
Monitoring reports (interim monitoring visit reports, follow-up letters and close-out visit reports) 
• 
Site qualification visit reports 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the Attain Stability Quad Clinical Study 
• 
The approved Clinical Investigation Plan and study related reports, and revisions 
• 
Documentation of delegated tasks 
• 
Study training records for site personnel and Medtronic personnel involved in the study 
• 
Sample of CRFs 
• 
Any other records that local regulatory agencies require to be maintained 
21.7.4. 
Sponsor Reports 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in the 
tables below (by geography).  In addition to the reports listed below, Medtronic shall, upon request of 
reviewing Ethics Committee, regulatory agency or FDA, provide accurate, complete and current 
information about any aspect of the Attain Stability Quad Clinical Study.  Safety data Medtronic reporting 
requirements are listed in Section 17.3). 
 
 
 

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Table 20: Sponsor Reports for Canada 
Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities, and  
Head of the 
Institution 
Provide prompt notification of termination or suspension 
and reason(s).  
Recall and device 
disposition 
Investigators, 
Ethics Committee 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, 
or otherwise dispose of any devices.   
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  
Site specific study deviations will be submitted to 
investigators periodically.   
Table 21: Sponsor Reports for EMEA, Malaysia, Hong Kong 
Report  
Submit to 
Description/Constraints 
Premature 
termination or 
suspension of the 
clinical investigation 
Investigators, 
Ethics 
Committee, 
Relevant 
authorities and 
Head of the 
Institution 
Provide prompt notification of termination or suspension 
and reason(s) per local law.  (ISO 14155:2011) 
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics Committee 
and relevant 
authorities 
Investigators and other Ethics Committees will be notified 
only if required by local laws or by the Ethics Committee. 
Withdrawal of CA 
approval 
Investigators, 
Ethics 
Committee, and 
relevant 
authorities 
Investigators, Ethics Committees and relevant authorities 
will be notified only if required by local laws or by the Ethics 
Committee. 
Progress Reports 
Ethics Committee 
and 
regulatory 
authorities 
This will be submitted to the Ethics Committee and 
regulatory authorities only if required by local law. 
Final report 
Investigators, 
Ethics 
Committee, and 
Regulatory 
authorities upon 
request 
• 
The investigator shall have the opportunity to review 
and comment on the final report.   
• 
If a clinical investigator does not agree with the final 
report, his/her comments shall be communicated to the 
other investigator(s).   
• 
The signature of the principal Investigator in each 
site should be obtained. 
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  (ISO 
14155:2011) 
Site specific study deviations will be submitted to 
investigators periodically.   

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Table 22: Sponsor Reports for the United States 
Report  
Submit to 
Description/Constraints 
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics 
Committee, 
FDA, and 
relevant 
authorities 
Notification within five working days.  (21 CFR 
812.150(b)(2))   
Withdrawal of FDA 
approval 
Investigators, 
Ethics 
Committee, and 
relevant 
authorities 
Notification within five working days.  (21 CFR 
812.150(b)(3)) 
Investigator List 
FDA 
Submit at 6-month intervals, a current list of the names and 
addresses of all investigators participating in the 
investigation.  (21 CFR 812.150(b)(4)) 
Progress Reports 
Ethics Committee 
and  
FDA 
Progress reports will be submitted at least annually.  (21 
CFR 812.150(b)(5), 812.36(f)   
Recall and device 
disposition 
Investigators, 
Head of 
Institution, 
Ethics 
Committee, 
relevant 
authorities, and  
FDA 
Notification within 30 working days and will include the 
reasons for any request that an investigator return, repair, 
or otherwise dispose of any devices.  (21 CFR 
812.150(b)(6)) 
Failure to obtain 
informed consent  
FDA 
Investigator’s report will be submitted to FDA within five 
working days of notification.  (21 CFR 812.150(b)(8)) 
Final report 
Investigators, 
Ethics 
Committee,  
Regulatory 
authorities upon 
request, and FDA 
Medtronic will notify FDA within 30 working days of the 
completion or termination of the investigation.   A final 
report will be submitted to the FDA, investigators, and 
IRBs/MECs within six months after completion or 
termination of this study.  (21 CFR 812.150(b)(7)) 
Study deviation  
Investigators 
Ensure that all deviations from the Clinical Investigation 
Plan are reviewed with the appropriate clinical 
investigator(s), are reported on the case report forms and 
the final report of the clinical investigation.  
Site specific study deviations will be submitted to 
investigators periodically.   
Other 
IRB, FDA 
Accurate, complete, and current information about any 
aspect of the investigation.  (21 CFR 812.150(b)(10)) 
 
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in secured file cabinets at Medtronic 
during the course of this study.  After closure of the study Medtronic will archive records and reports as 
required by applicable regulations. 
21.8. Publication and Use of Information 
Publications from the Attain Stability Quad Clinical Study will be handled according to Medtronic Policies 
and Standard Operating Procedures and as indicated in the CTA. 

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21.8.1. 
Publication Committee 
The Attain Stability Quad Clinical Study will utilize a Publication Committee which will include the Steering 
Committee members as well as Medtronic personnel.  This committee will manage study publications with 
the goal of publishing findings from the data.  The Publication Committee will develop the final 
Publication Plan as a separate document. 
The Publication Committee’s role is to:  
• 
Manage elements addressed in the publication plan as outlined in this section 
• 
Develop the final Publication Plan under separate cover 
• 
Execute the Publication Plan 
• 
Oversee the publication of primary, secondary and ancillary study results 
• 
Review and prioritize publication proposals 
• 
Provide input on publication content, and  
• 
Determine authorship 
In addition, the committee will apply and reinforce the authorship guidelines set forth in the Publication 
Plan.  Membership in the Publication Committee does not guarantee authorship.  The committee will 
meet as needed. 
21.8.2. 
Management of Primary, Secondary, and Ancillary Publications 
The Publication Committee reviews, prioritizes and manages all publications including primary, secondary 
and ancillary publications.  Primary and secondary publications are those that address analyses of any or 
all primary objectives or secondary/ancillary objectives, respectively, as specified in the Clinical 
Investigation Plan.  An ancillary publication is any publication that does not address the study objectives 
identified in the Clinical Investigation Plan.  They include publications proposed and developed by other 
Medtronic departments or entities, clinicians participating in this Attain Stability Quad Clinical Study and 
clinicians not participating in this Attain Stability Quad Clinical Study.  The committee will work with 
Medtronic to ensure that requests do not present conflicts with other proposals, are not duplicative and 
to determine which ancillary publication proposals, if any, will be supported. 
The committee may decide that no publications, including abstracts, will be published prior to the end of 
the study or with individual site data.  Requests for publications on study objectives utilizing subset data 
(e.g., regional) will be evaluated for scientific validity and the ability of Medtronic to provide resources.  
21.8.3. 
Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical Journal 
Editors (ICMJE), Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org).  Individual authorship criteria defined by the target journal or conference will be 
followed when it differs from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data 
• 
Drafting the article or revising it critically for important intellectual content 
• 
Final approval of the version to be published 
Decisions regarding authorship and contributor-ship will be made by the publication committee.  The 
selected authors will be responsible for drafting the publication.  All selected authors must fulfill the 

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authorship conditions stated above to be listed as authors, and all contributors who fulfill the conditions 
must be listed as authors. 
All investigators not listed as co-authors will be acknowledged as the “Medtronic Attain Stability Quad 
Clinical Study Investigators” and will be individually listed according to the guidelines of the applicable 
scientific journal when possible.  Any other contributors will be acknowledged by name with their specific 
contribution indicated. 
21.8.4. 
Transparency 
Transparency of study results will be maintained by the following means: 
• 
A final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, IRB/ECs and Competent Authorities of participating countries when required by 
local law 
• 
Registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated  
• 
Submitting for publication the primary study results after the study ends  
• 
Disclosing conflicts of interest (e.g. financial) of the co-authors of publications according to the 
policies set forth by the corresponding journals and conferences  
• 
Making an individual sites study data accessible to the corresponding investigator after the 
completion of the study, if requested  
21.9. Suspension or Early Termination 
21.9.1. 
Planned Study Closure 
Study Closure is a process initiated by distribution of a study closure letter.  Study closure is defined as 
closure of a clinical study that occurs when Medtronic and/or regulatory requirements have been satisfied 
per the CIP and/or by a decision by Medtronic or regulatory authority, whichever occurs first.  The study 
closure process is complete upon distribution of the Final Report or after final payments, whichever 
occurs last.  Ongoing IRB/EC oversight is required until the overall study closure process is complete.  
Upon study closure, subjects should be managed and followed per physician discretion. 
21.9.2. 
Early Termination or Suspension 
Early Termination of the Study is the closure of a clinical study that occurs prior to meeting defined 
endpoints.  This is possible for the whole study or a single site.  Study Suspension is a temporary 
postponement of study activities related to enrollment and distribution of the product.  This is possible for 
the whole study or a single site.  In the event the whole study or a single site is terminated, subjects will 
be exited.  
Study-Wide Termination or Suspension 
Possible reasons for considering study suspension or termination of the study include but are not limited 
to: 
• 
Adverse events associated with the system or product under investigation which might endanger 
the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or regulatory body (where the study is operating under regulatory body 
authority)  

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• 
Technical issues during the manufacturing process 
Investigator/Site Termination or Suspension 
Possible reasons for clinical investigator or site termination or suspension include but are not limited to: 
• 
Failure to obtain initial IRB/EC approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups)  
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring findings in a timely manner, etc.)  
• 
Institutional Review Board/Ethics Committee suspension of the site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)  
• 
Investigator request (e.g. no longer able to support the study)  
21.9.3. 
Procedures for Termination or Suspension 
Medtronic-Initiated and Regulatory Authority-Initiated 
• 
Medtronic will promptly inform the clinical investigators of the (early) termination or suspension 
and the reasons and inform the regulatory authority(s) where required 
• 
In the case of study termination or suspension for reasons other than a temporary IRB/EC 
approval lapse, the investigator will promptly inform the IRB/EC  
• 
In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare 
Investigator-Initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension 
• 
The investigator will promptly inform the institution (where required per regulatory requirements)  
• 
The investigator will promptly inform the IRB/EC 
• 
The investigator will promptly inform the regulatory authorities (for regions following ISO only) 
• 
The investigator will promptly inform the subjects and/or the personal physician of the subjects 
to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare 
Institutional Review Board Ethics Committee-Initiated 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days 
• 
Subject enrollment must stop until the suspension is lifted 
• 
Subjects already enrolled should continue to be followed in accordance with IRB/EC policy or its 
determination that an overriding safety concern or ethical issue is involved 
• 
The investigator will inform his/her institution (where required per local requirements)  

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• 
The investigator will promptly inform the subjects, and/or the personal physician of the subjects, 
with the rationale for the study termination or suspension 
• 
The investigator will promptly inform the regulatory authorities (for regions following ISO 14155 
only) 
 
 

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22. Appendices 
APPENDIX 1: Foreseeable Adverse Event List 
The information provided in this section pertains to foreseeable AEs that may be observed in study 
subjects and may collectively assist in identifying those events that are unexpected in nature.  The 
foreseeable adverse events information consists of three parts: (1) listing of potential adverse events 
associated with implantation of CRT system and transvenous leads, (2) rates of AEs reported from 
previous Medtronic studies evaluating CRT systems and transvenous leads, and (3) AEs rates reported in 
published literature for procedures similar to the CRT system implant procedure.  This information will be 
used in combination with device labeling, current event reporting information, and other published data 
to assess for an unexpected occurrence.  
The implantation of the study device, CRT-P or CRT-D, involves surgery, therefore, standard AEs 
associated with a surgical procedure may be experienced (e.g. anesthesia complications, injury, 
infections, bleeding, exacerbation of pre-existing conditions, healing complications, etc.).  The focus of 
this section is to specifically address in more detail, those events that are foreseeable due to the use, 
performance, and/or presence of the system under investigation.  
Additional potential risks associated with the implantation of the CRT system and the Attain Stability 
Quad MRI SureScan LV Lead (Model 4798), as well as risk minimization are discussed within Section 16. 
Treatment required for procedure and/or system related adverse events that are experienced may 
include medication, device reprogramming, device modification (e.g. repositioning, surgical 
abandonment, surgical removal), or other surgical and medical remedies.  The AEs associated with the 
use of transvenous leads, pacing and defibrillation systems include, but are not limited to, the following: 

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Table 23: Listing of Potential Adverse Events Associated with System Implant 
• 
acceleration of tachyarrhythmias (caused by device) 
• 
air embolism 
• 
bleeding 
• 
body rejection phenomena, including local tissue reaction 
• 
cardiac dissection 
• 
cardiac perforation 
• 
cardiac tamponade 
• 
chronic nerve damage 
• 
constrictive pericarditis 
• 
death 
• 
device migration 
• 
endocarditis 
• 
erosion 
• 
excessive fibrotic tissue growth 
• 
extrusion 
• 
fibrillation or other arrhythmias 
• 
fluid accumulation 
• 
formation of hematomas/seromas or cysts 
• 
heart block 
• 
heart wall or vein wall rupture 
• 
hemothorax 
• 
infection 
• 
keloid formation 
• 
lead abrasion and discontinuity 
• 
lead migration/dislodgment 
• 
complications and mortality due to inability to deliver appropriate and intended therapy 
• 
muscle and/or nerve stimulation 
• 
myocardial damage 
• 
myocardial irritability 
• 
myopotential sensing 
• 
pericardial effusion 
• 
pericardial rub 
• 
pneumothorax 
• 
poor connection of the lead to the device, which may lead to oversensing, undersensing, or a 
loss of therapy 
• 
stroke 
• 
threshold elevation 
• 
thrombotic embolism 
• 
thrombosis 
• 
tissue necrosis 
• 
valve damage (particularly in fragile hearts) 
• 
venous occlusion 
• 
venous perforation 

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An additional potential AE associated with the use of transvenous left ventricular pacing leads is coronary 
sinus dissection. 
Additional potential AEs associated with the use of ICD systems include, but are not limited to, the 
following events: 
• 
inappropriate shocks 
• 
potential mortality due to inability to defibrillate 
• 
shunting current or insulating myocardium during defibrillation 
Patients susceptible to frequent shocks despite medical management could develop psychological 
intolerance to an ICD system that might include the following conditions: 
• 
dependency 
• 
depression 
• 
fear of premature battery depletion 
• 
fear of shocking while conscious 
• 
fear that shocking capability may be lost 
• 
imagined shocking (phantom shock) 
Adverse Events Reported in Previous Medtronic Studies 
The listing below provides an example of reported system and procedure related AEs in recent Medtronic 
studies.  This table includes a summary of combined system or procedure related AEs as reported in the 
Concerto-AT, Insync III US, 4194, 4195, 4196, 4396, Adaptive CRT, and Attain Performa studies along 
with their incidence.  The observed rate is based on the study populations that included a total of 3,246 
subjects.  In total, there were 1749 system or procedure related events.  This includes both serious and 
non-serious events.  The rate is calculated as number of subjects that experience the event, not 
accounting for duration of follow-up. 
Table 24: System or procedure-related adverse events from previous clinical studies 
MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Abdominal pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Acidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Acute respiratory failure 
4 
4 
0.12% 
(0.03%, 0.32%) 
Adverse drug reaction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Air embolism 
1 
1 
0.03% 
(0.00%, 0.17%) 
Alcohol withdrawal syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Alpha haemolytic streptococcal 
infection 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Anaemia 
7 
7 
0.22% 
(0.09%, 0.44%) 
Anaemia postoperative 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anaphylactic shock 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anticoagulation drug level below 
therapeutic 
1 
1 
0.03% 
(0.00%, 0.17%) 
Anxiety 
3 
3 
0.09% 
(0.02%, 0.27%) 
Application site rash 
2 
2 
0.06% 
(0.01%, 0.22%) 
Arterial haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arteriovenous fistula 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arteriovenous fistula operation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arthralgia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Arthritis bacterial 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ascites 
1 
1 
0.03% 
(0.00%, 0.17%) 
Atelectasis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Atrial fibrillation 
19 
19 
0.59% 
(0.35%, 0.91%) 
Atrial flutter 
4 
4 
0.12% 
(0.03%, 0.32%) 
Atrial tachycardia 
5 
4 
0.12% 
(0.03%, 0.32%) 
Atrioventricular block 
16 
16 
0.49% 
(0.28%, 0.80%) 
Back pain 
3 
3 
0.09% 
(0.02%, 0.27%) 
Bacteraemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac arrest 
8 
8 
0.25% 
(0.11%, 0.49%) 
Cardiac failure 
46 
43 
1.32% 
(0.96%, 1.78%) 
Cardiac failure chronic 
5 
5 
0.15% 
(0.05%, 0.36%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Cardiac pacemaker battery 
replacement 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac perforation 
8 
8 
0.25% 
(0.11%, 0.49%) 
Cardiac sarcoidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiac tamponade 
3 
3 
0.09% 
(0.02%, 0.27%) 
Cardiac vein dissection 
38 
37 
1.14% 
(0.80%, 1.57%) 
Cardiac vein perforation 
5 
5 
0.15% 
(0.05%, 0.36%) 
Cardiogenic shock 
3 
3 
0.09% 
(0.02%, 0.27%) 
Cardiomyopathy 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cardiovascular disorder 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cellulitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Cerebral infarction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cerebrovascular accident 
3 
3 
0.09% 
(0.02%, 0.27%) 
Chest discomfort 
4 
4 
0.12% 
(0.03%, 0.32%) 
Chest pain 
8 
8 
0.25% 
(0.11%, 0.49%) 
Chronic obstructive pulmonary 
disease 
3 
3 
0.09% 
(0.02%, 0.27%) 
Circulatory collapse 
1 
1 
0.03% 
(0.00%, 0.17%) 
Colitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Complication of device insertion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Complication of device removal 
4 
4 
0.12% 
(0.03%, 0.32%) 
Constipation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Contusion 
2 
2 
0.06% 
(0.01%, 0.22%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Cough 
1 
1 
0.03% 
(0.00%, 0.17%) 
Cystitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Decubitus ulcer 
1 
1 
0.03% 
(0.00%, 0.17%) 
Deep vein thrombosis 
14 
14 
0.43% 
(0.24%, 0.72%) 
Dehydration 
1 
1 
0.03% 
(0.00%, 0.17%) 
Delirium 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device alarm issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device battery issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device capturing issue 
30 
29 
0.89% 
(0.60%, 1.28%) 
Device computer issue 
19 
19 
0.59% 
(0.35%, 0.91%) 
Device connection issue 
19 
19 
0.59% 
(0.35%, 0.91%) 
Device damage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device dislocation 
125 
107 
3.30% 
(2.71%, 3.97%) 
Device electrical impedance issue 
12 
12 
0.37% 
(0.19%, 0.64%) 
Device extrusion 
2 
1 
0.03% 
(0.00%, 0.17%) 
Device failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device lead damage 
13 
13 
0.40% 
(0.21%, 0.68%) 
Device lead issue 
1 
1 
0.03% 
(0.00%, 0.17%) 
Device misuse 
9 
9 
0.28% 
(0.13%, 0.53%) 
Device pacing issue 
69 
67 
2.06% 
(1.60%, 2.61%) 
Device psychogenic complication 
7 
7 
0.22% 
(0.09%, 0.44%) 
Device related infection 
3 
3 
0.09% 
(0.02%, 0.27%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Device signal detection issue 
2 
2 
0.06% 
(0.01%, 0.22%) 
Device stimulation issue 
443 
349 
10.75% 
(9.71%, 11.87%) 
Diabetes 
1 
1 
0.03% 
(0.00%, 0.17%) 
Diarrhea 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dizziness 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dressler's syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Drug hypersensitivity 
3 
3 
0.09% 
(0.02%, 0.27%) 
Dysarthria 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dyspnoea 
2 
2 
0.06% 
(0.01%, 0.22%) 
Dyspnoea exertional 
1 
1 
0.03% 
(0.00%, 0.17%) 
Dyspnoea paroxysmal nocturnal 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ecchymosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Electromagnetic interference 
1 
1 
0.03% 
(0.00%, 0.17%) 
Endocarditis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Endocarditis staphylococcal 
1 
1 
0.03% 
(0.00%, 0.17%) 
Erythema multiforme 
1 
1 
0.03% 
(0.00%, 0.17%) 
Fatigue 
5 
5 
0.15% 
(0.05%, 0.36%) 
Fluid overload 
1 
1 
0.03% 
(0.00%, 0.17%) 
Gastroenteritis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Gastrointestinal haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Haematoma 
2 
2 
0.06% 
(0.01%, 0.22%) 
Haematuria 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Haemoptysis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Haemothorax 
4 
4 
0.12% 
(0.03%, 0.32%) 
Hot flush 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hydrothorax 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyperglycaemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyperkalaemia 
4 
4 
0.12% 
(0.03%, 0.32%) 
Hypersensitivity 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hypertension 
1 
1 
0.03% 
(0.00%, 0.17%) 
Hyponatraemia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Hypotension 
20 
20 
0.62% 
(0.38%, 0.95%) 
Hypovolaemia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ileus 
1 
1 
0.03% 
(0.00%, 0.17%) 
Impaired healing 
2 
2 
0.06% 
(0.01%, 0.22%) 
Implant site bruising 
2 
2 
0.06% 
(0.01%, 0.22%) 
Implant site cellulitis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site effusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site erosion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site erythema 
6 
6 
0.18% 
(0.07%, 0.40%) 
Implant site haematoma 
98 
96 
2.96% 
(2.40%, 3.60%) 
Implant site haemorrhage 
6 
6 
0.18% 
(0.07%, 0.40%) 
Implant site hypoaesthesia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Implant site infection 
44 
44 
1.36% 
(0.99%, 1.82%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Implant site inflammation 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site irritation 
5 
5 
0.15% 
(0.05%, 0.36%) 
Implant site oedema 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site pain 
72 
64 
1.97% 
(1.52%, 2.51%) 
Implant site rash 
3 
3 
0.09% 
(0.02%, 0.27%) 
Implant site swelling 
4 
4 
0.12% 
(0.03%, 0.32%) 
Implant site warmth 
1 
1 
0.03% 
(0.00%, 0.17%) 
Incision site complication 
1 
1 
0.03% 
(0.00%, 0.17%) 
Incision site haemorrhage 
5 
5 
0.15% 
(0.05%, 0.36%) 
Incision site pain 
4 
4 
0.12% 
(0.03%, 0.32%) 
Incisional drainage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Infection 
2 
2 
0.06% 
(0.01%, 0.22%) 
Infusion site extravasation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Intracardiac thrombus 
6 
6 
0.18% 
(0.07%, 0.40%) 
Lead dislodgement 
33 
30 
0.92% 
(0.62%, 1.32%) 
Leukocytosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Localized oedema 
1 
1 
0.03% 
(0.00%, 0.17%) 
Mediastinal effusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Medical device discomfort 
3 
3 
0.09% 
(0.02%, 0.27%) 
Medical device site reaction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Monoparesis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Muscle spasms 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Muscle twitching 
1 
1 
0.03% 
(0.00%, 0.17%) 
Musculoskeletal chest pain 
2 
2 
0.06% 
(0.01%, 0.22%) 
Musculoskeletal pain 
42 
40 
1.23% 
(0.88%, 1.67%) 
Musculoskeletal stiffness 
1 
1 
0.03% 
(0.00%, 0.17%) 
Myocardial infarction 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nausea 
1 
1 
0.03% 
(0.00%, 0.17%) 
Neck pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nephrosclerosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Neuropathy peripheral 
1 
1 
0.03% 
(0.00%, 0.17%) 
Nodal rhythm 
2 
2 
0.06% 
(0.01%, 0.22%) 
Non-cardiac chest pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Oedema peripheral 
12 
12 
0.37% 
(0.19%, 0.64%) 
Oliguria 
1 
1 
0.03% 
(0.00%, 0.17%) 
Operative haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Orthostatic hypotension 
2 
2 
0.06% 
(0.01%, 0.22%) 
Oversensing 
34 
33 
1.02% 
(0.70%, 1.42%) 
Oxygen saturation decreased 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pacemaker generated arrhythmia 
6 
6 
0.18% 
(0.07%, 0.40%) 
Pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pain in extremity 
1 
1 
0.03% 
(0.00%, 0.17%) 
Palpitations 
9 
9 
0.28% 
(0.13%, 0.53%) 
Paraesthesia 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Pericardial effusion 
16 
15 
0.46% 
(0.26%, 0.76%) 
Pericarditis 
4 
4 
0.12% 
(0.03%, 0.32%) 
Phantom shocks 
4 
3 
0.09% 
(0.02%, 0.27%) 
Phlebitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Pleural effusion 
21 
21 
0.65% 
(0.40%, 0.99%) 
Pneumonia 
9 
9 
0.28% 
(0.13%, 0.53%) 
Pneumothorax 
43 
43 
1.32% 
(0.96%, 1.78%) 
Pocket erosion 
4 
4 
0.12% 
(0.03%, 0.32%) 
Post procedural haemorrhage 
2 
2 
0.06% 
(0.01%, 0.22%) 
Presyncope 
3 
3 
0.09% 
(0.02%, 0.27%) 
Procedural haemorrhage 
1 
1 
0.03% 
(0.00%, 0.17%) 
Procedural headache 
2 
2 
0.06% 
(0.01%, 0.22%) 
Procedural pain 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pruritus 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pruritus generalized 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulmonary embolism 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulmonary oedema 
3 
3 
0.09% 
(0.02%, 0.27%) 
Pulmonary sepsis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Pulseless electrical activity 
2 
2 
0.06% 
(0.01%, 0.22%) 
Pyrexia 
5 
5 
0.15% 
(0.05%, 0.36%) 
Rash 
8 
8 
0.25% 
(0.11%, 0.49%) 
Rash generalized 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Renal failure 
8 
8 
0.25% 
(0.11%, 0.49%) 
Renal failure acute 
2 
2 
0.06% 
(0.01%, 0.22%) 
Renal impairment 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory acidosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory distress 
1 
1 
0.03% 
(0.00%, 0.17%) 
Respiratory failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sepsis 
3 
3 
0.09% 
(0.02%, 0.27%) 
Sepsis syndrome 
1 
1 
0.03% 
(0.00%, 0.17%) 
Septic shock 
4 
4 
0.12% 
(0.03%, 0.32%) 
Sinus arrest 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sinus bradycardia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sinus tachycardia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Staphylococcal infection 
2 
2 
0.06% 
(0.01%, 0.22%) 
Stitch abscess 
1 
1 
0.03% 
(0.00%, 0.17%) 
Subclavian vein thrombosis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Subcutaneous emphysema 
1 
1 
0.03% 
(0.00%, 0.17%) 
Subcutaneous haematoma 
1 
1 
0.03% 
(0.00%, 0.17%) 
Sudden cardiac death 
10 
10 
0.31% 
(0.15%, 0.57%) 
Superior vena cava stenosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Supraventricular extrasystoles 
1 
1 
0.03% 
(0.00%, 0.17%) 
Supraventricular tachycardia 
2 
2 
0.06% 
(0.01%, 0.22%) 
Syncope 
1 
1 
0.03% 
(0.00%, 0.17%) 

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MedDRA Preferred Term 
Number of 
Occurrences 
Number of 
Subjects 
Event Rate 
95% 
Confidence 
Interval 
Tachycardia 
1 
1 
0.03% 
(0.00%, 0.17%) 
Thrombophlebitis 
2 
2 
0.06% 
(0.01%, 0.22%) 
Thrombosis 
8 
8 
0.25% 
(0.11%, 0.49%) 
Thrombotic stroke 
1 
1 
0.03% 
(0.00%, 0.17%) 
Toxicity to various agents 
1 
1 
0.03% 
(0.00%, 0.17%) 
Twiddler's syndrome 
5 
5 
0.15% 
(0.05%, 0.36%) 
Undersensing 
7 
7 
0.22% 
(0.09%, 0.44%) 
Urinary retention 
2 
2 
0.06% 
(0.01%, 0.22%) 
Vena cava thrombosis 
1 
1 
0.03% 
(0.00%, 0.17%) 
Venous occlusion 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular dyssynchrony 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular extrasystoles 
2 
2 
0.06% 
(0.01%, 0.22%) 
Ventricular fibrillation 
1 
1 
0.03% 
(0.00%, 0.17%) 
Ventricular tachycardia 
11 
11 
0.34% 
(0.17%, 0.61%) 
Vomiting 
3 
3 
0.09% 
(0.02%, 0.27%) 
Weaning failure 
1 
1 
0.03% 
(0.00%, 0.17%) 
Weight decreased 
1 
1 
0.03% 
(0.00%, 0.17%) 
Wound dehiscence 
1 
1 
0.03% 
(0.00%, 0.17%) 
Adverse Events in Literature 
The potential AEs associated with the implantation of CRT-P or CRT-D  systems have been documented 
in various articles in medical scientific literature.  A summary of those events and their published 
incidence are included below. 
1. Ahsan SY, Saberwal B, Lambiase PD, Chaubey S, Segal OR, Gopalamurugan AB, McCready J, 
Rogers DP, Lowe MD, and Chow AWC.  An 8-year single-centre experience of cardiac 

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resynchronization therapy: procedural success, early and late complications, and left ventricular 
lead performance.  Europace 2013;15:711-717. 
Retrospective data were analyzed for all acute and chronic complications occurring over 490 consecutive 
CRT device procedures in 402 patients, from 2000 through 2008.  Associated complications were 
reported by timeframe. 
Table 25: Complications reported in Ahsan et al. 
 
 
2. Dickstein K, Bogale N, Priori S, Auricchio A, Cleland JG, Gitt A, Limbourg T, Linde C, van 
Veldhuisen DJ, Brugada J; Scientific Committee; National Coordinators.  The European Cardiac 
Resynchronization Therapy Survey.  European Heart Journal 2009; 30:2450–2460. 
The primary aim of this survey was to describe current European practice associated with CRT 
implantations.  A total of 140 centers from 13 European countries contributed data from consecutive 
patients successfully implanted with a CRT device with or without an ICD between November 2008 and 
June 2009.  The total number of patients enrolled was 2438. 
Table 26: Complications reported in Dickstein et al. 
Event 
Incidence (%) 
Peri-procedural complications 
10 
Bleeding 
1 
Pocket haematoma 
3 
Pneumothorax 
1 
Pericardial tamponade 
0.3 
Coronary sinus dissection 
1 
Phrenic nerve pacing 
2 
Lead dislocation 
3 

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Post–implantation device related complications 
4 
Lead displacement 
2 
Lead malfunction 
0 
Phrenic nerve stimulation 
2 
 
3. Kirkfeldt R.E., Johansen J.B., Nohr E.A., Jorgensen O.D., Nielsen J.C. Complications after cardiac 
implantable electronic device implantations: An analysis of a complete, nationwide cohort in 
Denmark.  European Heart Journal 2014 35:18 1186-1194. 
This was a population-based cohort study in all Danish patients who underwent a Cardiac Implantable 
Electronic Device (CIED) procedure from May 2010 to April 2011.  The study population consisted of 5918 
consecutive patients.  Total of 562 patients (9.5%) experienced at least one complication. 
Table 27: Complications reported by Kirkfeldt et al. shows cumulative incidence of complications at 6 
monthsa. 
Table 27: Complications reported by Kirkfeldt et al. 
Complication type 
All (n=5918) 
New Implant 
(n=4335) 
Generator 
replacement 
(n=1136) 
Upgrade/Lead 
revision (n=427) 
Any complication 
562 (9.5; 8.7–
10.2) 
432 (9.9; 9.0–
10.8) 
67 (5.9; 4.5–7.3) 
63 (14.8; 11.4–
18.1) 
Any major complicationb 
329 (5.6; 5.0–
6.1) 
253 (5.8; 5.1–
6.5) 
40 (3.5; 2.4–4.6) 
36 (8.4; 5.8–11.1) 
Any minor complicationc 
250 (4.2; 3.7–
4.7) 
189 (4.3; 3.7–
4.9) 
30 (2.6; 1.7–3.6) 
31 (7.3; 4.8–9.7) 
Major complications 
 
Lead related re-intervention 
143 (2.4; 2.0–
2.8) 
120 (2.8; 2.3–
3.2) 
10 (0.9; 0.3–1.4) 
13 (3.0; 1.4–4.7) 
Infection 
49 (0.8; 0.6–1.1) 
24 (0.6; 0.3–0.8) 
17 (1.5; 0.8–2.2) 
8 (1.9; 0.6–3.2) 
Local infection 
22 (0.4; 0.2–0.5) 
10 (0.2; 0.1–0.4) 
8 (0.7; 0.2–1.1) 
4 (1.0; 0.0–1.9) 
Systemic 
infection/endocarditis 
27 (0.5; 0.3–0.6) 
14 (0.3; 0.2–0.5) 
9 (0.8; 0.3–1.3) 
4 (0.9; 0.0–1.9) 
Pneumothorax requiring 
drainage 
51 (0.9; 0.6–1.1) 
45 (1.0; 0.7–1.3) 
0 
6 (1.4; 0.3–2.5) 
Cardiac perforation 
38 (0.6; 0.4–0.8) 
35 (0.8; 0.5–1.1) 
0 
3 (0.7; 0.0–1.5) 

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Cardiac perforation (No 
intervention) 
21 (0.4; 0.2–0.5) 
18 (0.4; 0.2–0.6) 
0 
3 (0.7; 0.0–1.5) 
Cardiac perforation 
(Intervention) 
17 (0.3; 0.2–0.4) 
17 (0.4; 0.2–0.6) 
0 
0 
Pocket revision because of pain 
25 (0.4; 0.3–0.6) 
10 (0.2; 0.1–0.4) 
9 (0.8; 0.3–1.3) 
6 (1.4; 0.3–2.5) 
Generator-lead interface 
problem with re-intervention 
7 (0.1; 0.0–0.2) 
3 (0.1; 0.0–0.1) 
4 (0.4; 0.0–0.7) 
0 
Haematoma requiring re-
intervention 
10 (0.2; 0.1–0.3) 
9 (0.2; 0.1–0.3) 
1 (0.1; 0.0–0.3) 
0 
Otherd 
16 (0.3; 0.1–0.4) 
16 (0.4; 0.2–0.5) 
0 
0 
Minor complications 
 
Haematomae 
138 (2.3; 1.9–
2.7) 
104 (2.4; 1.9–
2.8) 
20 (1.8; 1.0–2.5) 
14 (3.3; 1.6–5.0) 
Wound infection treated with 
antibiotics 
69 (1.2; 0.9–1.4) 
47 (1.1; 0.8–1.4) 
12 (1.0; 0.5–1.7) 
10 (2.3; 0.9–3.8) 
Pneumothorax conservatively 
treated 
39 (0.7; 0.5–0.9) 
32 (0.7; 0.5–1.0) 
0 
7 (1.6; 0.4–2.8) 
Lead dislodgement without re-
intervention 
10 (0.2; 0.1–0.3) 
9 (0.2; 0.1–0.3) 
0 
1 (0.2; 0.0–0.7) 
aReported as absolute frequencies and percentages with 95% CIs in parenthesis. 
bAll re-interventions were categorized as major complications due to their inherently higher risk of infections e.g. local CIED 
infections requiring re-intervention, systemic infections, pocket revisions etc. 
cMinor complications included haematomas resulting in a prolonged hospital stay, hospital re-admissions, or additional out-patient 
visits, wound infections treated with antibiotics, pneumothorax conservatively treated, and lead dislodgements without re-
intervention. 
dDeep venous thrombosis (n=8), Twiddler’s syndrome (n=3), wound revision (n=3), stroke (n=1), myocardial infarction (n=1) 
eResulting in prolonged hospital stay, hospital re-admission, or additional out-patient visit. 
 
 

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23. References 
                                               
 
1 Model 8040 InSync MIRACLE Study (IDE # G980219). 
 
2 Model 7272 InSync ICD Study (IDE # G990176). 
 
3 Thackray S, Coletta A, Jones P, Dunn A, Clark AL, Cleland, JGF.  Clinical trials update:  highlights of the 
scientific sessions of heart failure 2001, a meeting of the working group of heart failure of the European 
Society of Cardiology.  European Journal of Heart Failure 3 (2001): 491-494. 
 
4 Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood 
G, Santini M, Bailleul C, Daubert J.  Effects of multisite biventricular pacing in patients with heart failure 
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