Imagining Study of Lead Implant for His Bundle Pacing
Conditions: Cardiac Pacemaker, Artificial
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Signed By
Meaning of Signature
Date/Time (UTC)
APPROVALS
CONFIDENTIAL
  
DOCUMENT/RECORD 
 
 
This document/record is electronically controlled; printed copies are considered uncontrolled. 
System of Record: Regulatory Affairs Domain 
 
Document Name
Version
Title
Document Approver
Document Approver
Document Author
Cicic, Aida
03/22/2018 19:21:14
4.0
Document Approver
03/22/2018 17:03:48
Fischer, Trent
V4 19Mar2018
Document Approver
Hughes, Lisa
03/22/2018 17:38:24
03/26/2018 13:26:06
Yang, Ping
03/22/2018 15:28:12
Randall, Taryn
Stein, Jeff
Document Approver
Document Approver
03/22/2018 15:58:44
Bergemann, Tracy
03/22/2018 17:12:16
Kolbow, Melissa
Chesness, Dana
03/22/2018 15:36:44
03/22/2018 15:51:17
Document Author
03/23/2018 14:20:25
Brooke, David
Document Approver
CIP IMAGE-HBP.pdf
Document Approver

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 1 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  
Imaging Study of Lead Implant for His Bundle 
Pacing (IMAGE-HBP) 
Clinical Investigation Plan Identifier 
MDT17005 
Sponsor/Local Sponsor 
Medtronic, PLC. 
Cardiac Rhythm and Heart Failure Clinical 
Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 USA 
1-800-328-2518 
Document Version 
V4 19 Mar 2018 
Lead Principal Investigator  
Pugazhendhi Vijayaraman, MD 
Director, Cardiac Electrophysiology 
Geisinger Wyoming Valley Medical Center 
1000 E Mountain Blvd 
Wilkes Barre, PA 18711 
(570) 808-5995 
Pvijayaraman1@geisinger.edu 
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. 
 
 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 2 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
1. Investigator Statement 
The Investigator Statement will be provided as a separate document. 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 3 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Table of Contents  
 
 
 
1. 
Investigator Statement ...................................................................................................... 2 
Table of Contents ...................................................................................................................... 3 
List of Tables ............................................................................................................................. 6 
List of Figures ............................................................................................................................ 6 
Sponsor Contact Information .................................................................................................... 7 
CROs and Core Labs .................................................................................................................. 7 
2. 
Glossary .............................................................................................................................. 8 
3. 
Synopsis ........................................................................................................................... 10 
4. 
Introduction ..................................................................................................................... 13 
4.1. Background ........................................................................................................................... 13 
4.2. Purpose ................................................................................................................................. 16 
5. 
Objectives and Endpoints ................................................................................................. 16 
5.1. Objectives ............................................................................................................................. 16 
5.1.1. 
Primary Objective .................................................................................................................. 16 
5.1.2. 
Secondary Objectives ............................................................................................................ 16 
5.1.3. 
Ancillary Objectives ............................................................................................................... 17 
6. 
Study Design .................................................................................................................... 17 
6.1. Duration ................................................................................................................................ 19 
6.2. Rationale ............................................................................................................................... 19 
7. 
Product Description.......................................................................................................... 19 
7.1. General ................................................................................................................................. 19 
7.2. Manufacturer ......................................................................................................................... 19 
7.3. Packaging .............................................................................................................................. 19 
7.4. Intended Population ............................................................................................................... 20 
7.5. Equipment ............................................................................................................................. 20 
8. 
Selection of Subjects ........................................................................................................ 22 
8.1. Study Population .................................................................................................................... 22 
8.2. Subject Enrollment ................................................................................................................. 22 
8.3. Inclusion Criteria .................................................................................................................... 22 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 4 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
8.4. Exclusion Criteria ................................................................................................................... 23 
8.5. Minimization of Bias ............................................................................................................... 23 
9. 
Study Procedures ............................................................................................................. 24 
9.1. Schedule of Events ................................................................................................................. 24 
9.2. Subject Screening .................................................................................................................. 25 
9.3. Subject Consent ..................................................................................................................... 25 
9.4. Enrollment ............................................................................................................................. 27 
9.5. Enrollment Data Collection ...................................................................................................... 27 
9.6. Implant ................................................................................................................................. 27 
9.7. Implant Data Collection .......................................................................................................... 27 
9.8. Scheduled Follow-up Visits ..................................................................................................... 28 
9.8.1. 
Pre-Hospital Discharge ...................................................................................................... 29 
9.8.2. 
Cardiac CT Scan ............................................................................................................... 30 
9.8.3. 
1 week, 6 month and 12 month visit ................................................................................. 30 
9.8.4. 
3 month visit .................................................................................................................... 30 
9.9. Device Interrogation / Save-to-Media ...................................................................................... 31 
9.10. 
System Modification ......................................................................................................... 31 
9.11. 
Subject Withdrawal or Discontinuation ............................................................................... 32 
9.11.1. 
Lost to Follow-up .......................................................................................................... 33 
9.11.2. 
Subject chooses to exit (i.e. revokes informed consent) .................................................. 33 
9.11.3. 
Investigator Withdraws Subject ..................................................................................... 33 
9.12. 
Assessment of Safety ....................................................................................................... 33 
9.13. 
Recording Data ................................................................................................................ 34 
9.14. 
Deviation Handling ........................................................................................................... 34 
10. Risks and Benefits ............................................................................................................ 34 
10.1. 
Potential Risks .................................................................................................................. 34 
10.2. 
Potential Benefits ............................................................................................................. 35 
10.3. 
Risk-Benefit Rationale ....................................................................................................... 35 
11. Adverse Events and Device Deficiencies .......................................................................... 36 
11.1. 
Adverse Events ................................................................................................................ 36 
11.2. 
Device Deficiencies ........................................................................................................... 36 
11.3. 
Processing Updates and Resolution ................................................................................... 37 
11.4. 
Definitions/Classifications .................................................................................................. 37 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 5 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
11.5. 
Reporting of Adverse Events ............................................................................................. 41 
11.5.1. 
Adverse Event and Device Deficiency Classification ......................................................... 41 
11.5.2. 
Adverse Event and Device Deficiency Reporting Requirements ......................................... 42 
11.6. 
Subject Death .................................................................................................................. 43 
11.6.1. 
Death Data Collection .................................................................................................... 43 
11.6.2. 
Death Classification and Reporting ................................................................................. 44 
12. Data Review Committees ................................................................................................. 45 
13. Statistical Design and Methods ........................................................................................ 45 
13.1. 
Primary Objective ............................................................................................................. 45 
13.1.1. 
Objective ............................................................................................................................ 45 
13.1.2. 
Endpoint Definition ........................................................................................................... 45 
13.1.3. 
Sample Size Determination ............................................................................................... 45 
13.1.4. 
Analysis Methods ............................................................................................................... 46 
13.2. 
Secondary Objectives ....................................................................................................... 46 
13.2.1. 
Secondary Objective #1 ..................................................................................................... 46 
13.2.2. 
Secondary Objective #2 ..................................................................................................... 46 
13.2.3. 
Secondary Objective #3 ..................................................................................................... 47 
13.2.4. 
Secondary Objective #4 ..................................................................................................... 47 
13.2.5. 
Secondary Objective #5 ..................................................................................................... 48 
13.3. 
Ancillary Objectives .......................................................................................................... 48 
13.3.1. 
Ancillary Objective #1 ........................................................................................................ 48 
13.3.2. 
Ancillary Objective #2 ........................................................................................................ 48 
13.3.3. 
Ancillary Objective #3 ........................................................................................................ 49 
14. Ethics ................................................................................................................................ 49 
14.1. 
Statement(s) of Compliance .............................................................................................. 49 
15. Study Administration ....................................................................................................... 50 
15.1. 
Monitoring ....................................................................................................................... 50 
15.2. 
Data Management ............................................................................................................ 51 
15.3. 
Direct Access to Source Data/Documents ........................................................................... 51 
15.4. 
Confidentiality .................................................................................................................. 51 
15.5. 
Liability ............................................................................................................................ 52 
15.6. 
CIP Amendments ............................................................................................................. 52 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 6 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
15.7. 
Record Retention ............................................................................................................. 52 
15.8. 
Publication and Use of Information .................................................................................... 52 
15.9. 
Suspension or Early Termination ....................................................................................... 53 
16. References ....................................................................................................................... 53 
17. Appendices ....................................................................................................................... 54 
18. Version History ................................................................................................................. 55 
 
List of Tables 
Table 1: Definitions for His Bundle Pacing .................................................................................................. 14 
Table 2: Data collection and study procedure requirements ..................................................................... 24 
Table 3: Follow-up Visit Windows ............................................................................................................... 29 
Table 4: Adverse Event and Device Deficiency Definitions ......................................................................... 37 
Table 5: Adverse Event Classification Responsibilities ............................................................................... 41 
Table 6: Reporting Requirements ............................................................................................................... 42 
Table 7: Subject Death Classification Responsibilities ................................................................................ 44 
Table 8: Estimation Precision for Implant Success Proportion ................................................................... 45 
 
List of Figures 
Figure 1: His Bundle Anatomy ..................................................................................................................... 15 
Figure 2: Study Visits ................................................................................................................................... 18 
Figure 3: DR220 Holter ................................................................................................................................ 22 
 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 7 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Sponsor Contact Information  
Medtronic contact information is provided below.  This information is subject to change during the course 
of the clinical study.  Periodic updates to study contact information will be sent to the sites as needed. 
Study sponsors and contacts 
US clinical study leader 
Lisa Hughes, Prin Field Clinical Engineer 
Direct Phone: 515-344-7599 
Direct Fax: 651-367-8923 
Lisa.c.hughes@medtronic.com  
Monitoring contacts 
US monitoring leader 
Taryn Randall, Clinical Monitoring Manager 
Direct Phone: 763-250-0785 
Taryn.randall@medtronic.com  
 
CROs and Core Labs 
No core labs will be used in this study.  At the time of finalization of this clinical investigation plan, there 
is only one CRO currently planned: 
Contact Information 
Duties Performed 
Cognizant Technology Solutions 
500 Frank W Burr Blvd 
Teaneck, NJ 07666 
Direct Phone: 201-801-0233 
Direct Fax: 201-801-0243 
• 
Development of study electronic case 
report forms, edit checks, and study 
management reports 
• 
Review of electronic case report 
forms, and management of 
discrepancies 
 
 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 8 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
2. Glossary 
Below is a list of terms and definitions and/or acronyms used within this document.  
Term 
Definition 
AE 
Adverse Event 
AVN 
Atrioventricular Node 
BBB 
Bundle Branch Block 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
CV 
Curriculum Vitae 
DD 
Device Deficiency 
e.g. 
For example 
eCRF 
Electronic Case Report Form 
EGM 
Electrogram 
EKG 
Electrocardiogram 
EP 
Electrophysiology 
GCP 
Good Clinical Practice 
HB 
Bundle of His / His Bundle 
HBP 
His bundle pacing 
HIPAA 
Health Insurance Portability and Accountability 
Act 
HV 
His-Ventricular 
IC 
Informed Consent 
ICF 
Informed Consent Form 
IPG 
Implantable Pulse Generator 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 9 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Term 
Definition 
IRB 
Institutional Review Board 
LAO 
Left Anterior Oblique (fluoroscopy view angle) 
LV 
Left Ventricle 
MA 
Medical Advisor 
MedDRA 
Medical Dictionary for Regulatory Activities 
PCT 
Pacing Capture Threshold 
RA 
Right Atrial 
RAO 
Right Anterior Oblique (fluoroscopy view angle) 
RV 
Right Ventricle 
S-QRS 
Stimulus to QRS 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
US 
United States 
V 
Ventricle or Ventricular 
 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 10 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
3. Synopsis 
Title 
Imaging Study of Lead Implant for His Bundle Pacing (IMAGE-HBP) 
Product Name 
Medtronic SelectSecureTM MRI SureScanTM Model 3830 pacing lead 
Sponsor  
Medtronic, PLC 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN 55112 USA 
1-800-328-2518 
Investigation Purpose 
The purpose of this research study is to assess the implant success 
proportion of the Medtronic SelectSecureTM MRI SureScanTM Model 
3830 pacing lead at the bundle of His for His bundle pacing, evaluate 
implant lead electrical measurements and changes over time, 
estimate the correlation between lead location and selective vs. non-
selective HBP, and estimate the correlation between long-term lead 
performance and implant characteristics. Data from the study may be 
used to standardize the implant workflow to help improve the ease 
and predictability of His bundle pacing implants.  
Product Status 
The IMAGE-HBP Study will be conducted using market released 
products.  The implanted system will comprise of any market 
approved Medtronic implantable pacemaker, market approved 
Medtronic pacing lead for the right atrium (if applicable) and the 
Medtronic SelectSecureTM MRI SureScanTM Model 3830 pacing lead 
for His bundle pacing.  The Medtronic SelectSecureTM MRI SureScanTM 
Model 3830 pacing lead is market approved for pacing and sensing in 
the atrium or ventricle.  
Primary Objective(s) 
Assess the implant success proportion of the Medtronic 
SelectSecureTM MRI SureScanTM Model 3830 pacing lead at the bundle 
of His for His bundle pacing. 
• 
Implant success will be defined as the presence of a H 
wave on the implanted lead electrogram and a His bundle 
pacing capture threshold equal to or less than 2.5V at 
1.0ms. 
Secondary Objective(s) 
The secondary objectives are descriptive in nature and are intended 
to provide additional information about His bundle pacing with the 
Medtronic SelectSecureTM MRI SureScanTM Model 3830 lead.  There 
will be no established performance requirements for these secondary 
objectives. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 11 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
Estimate the correlation between lead position and 
selective vs. non-selective His bundle pacing occurrence 
at implant 
• 
Assess changes in lead electrical measurements over time 
• 
Assess changes in QRS duration over time 
• 
Estimate the correlation between implant characteristics 
and long-term lead electrical performance at 12 months 
• 
Characterize the occurrence of complications related to 
the procedure or lead for His bundle pacing up to 12 
months 
 
Study Design 
This is a prospective, non-randomized, multi-site, clinical research 
study.   
All subjects included in the study will be implanted with a Medtronic 
market released de novo Implantable Pacemaker, Medtronic 
SelectSecureTM MRI SureScanTM Model 3830 lead at the bundle of His 
for His bundle pacing, and compatible market released Medtronic 
Right Atrial lead (if applicable).  The subjects with an implant of the 
Medtronic SelectSecureTM MRI SureScanTM Model 3830 lead for His 
bundle pacing will undergo a Cardiac CT Scan and be followed up to 
twelve months post implant for electrical testing.  Subjects that do 
not receive an implanted SelectSecureTM MRI SureScanTM Model 3830 
pacing lead for His bundle pacing will be exited from the study at the 
time of the unsuccessful implant or after any reportable Adverse 
Events are resolved. 
Sample Size 
Up to 70 patients will be enrolled to ensure  approximately 62 
patients undergo an implant procedure. 
• 
A sample size of 62 patients (who undergo an implant 
procedure) will produce a two-sided 95% confidence 
interval with a width equal to 0.15 for the implant success 
proportion when the observed implant success 
proportion is 0.9. 
Inclusion/Exclusion Criteria 
The following is a list of inclusion/exclusion criteria: 
Inclusion criteria 
• 
Subject has a Class I or II indication for implantation of an 
implantable pacemaker  
• 
Subject (or legally authorized representative) has signed 
and dated the study-specific Consent Form 
• 
Subject is 18 years of age or older, or is of legal age to 
give informed consent per local and national law 
• 
Subject is expected to remain available for follow-up visits 
Exclusion criteria 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 12 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
Subject is contraindicated for Cardiac CT 
• 
Subject has an existing or prior pacemaker, ICD or CRT 
device implant 
• 
Subject is intended to receive an implant of a Left 
Ventricle lead or CRT device  
• 
Subject life expectancy is less than 1 year 
• 
Pregnant women or breastfeeding women, or women of 
child bearing potential and who are not on a reliable form 
of birth regulation method or abstinence 
• 
Subjects with exclusion criteria required by local law (e.g. 
age or other) 
• 
Subject with a medical condition that precludes the 
patient from participation in the opinion of the 
investigator 
• 
Subject is enrolled in a concurrent study that may 
confound the results of this study. Co-enrollment in any 
concurrent clinical study (including registries) requires 
approval of the study manager or designee. 
 
Study Procedures and 
Assessments 
Enrollment/Baseline 
• 
Eligibility Verification 
• 
Informed Consent 
• 
Demographics 
• 
Primary Indication for implant 
• 
Medical History 
Implant 
• 
Implant tools used 
• 
His mapping testing 
• 
Implant procedure times 
• 
Final lead electrical testing 
• 
Final system configuration 
• 
EKG measurements 
• 
Fluoroscopy Cine images  
• 
Physician Questionnaire 
Pre-hospital discharge 
• 
Electrical lead testing 
• 
EKG rhythm strips and measurements 
Cardiac CT Scan 
• 
Cardiac CT Scan images 
1 week, 3 month, 6 month, 12 month Follow-up 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 13 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
Electrical lead testing 
• 
Electrical lead testing with strength duration (3 month 
only) 
• 
DR220 Holter monitor (1 week and 3 or 6 month) 
• 
EKG rhythm strips and measurements 
Adverse Events/Device Deficiency 
• 
Description 
• 
Diagnostic tests and procedures 
• 
Actions taken 
• 
Relatedness and Classifications 
• 
Outcome 
System Modification 
• 
Reason for modification 
• 
Final device information 
• 
Final lead electrical testing 
• 
EKG printouts and measurements 
Protocol Deviation 
• 
Description 
• 
Reason 
Study Exit 
• 
Reason for exit 
• 
Lost to follow-up 
Safety Assessments 
Device Deficiencies and Adverse Events related to the procedure or 
Medtronic SelectSecureTM MRI SureScanTM Model 3830 pacing lead 
for His bundle pacing will be collected.  In addition, all SAEs that result 
in death will be collected. 
Statistics 
The estimated implant success proportion will be calculated as the 
proportion of all subjects who undergo an implant attempt that is 
successful.  
A 95% confidence interval for the proportion of successful implants 
will be constructed using the Wilson method. 
4. Introduction  
4.1. 
Background  
The human cardiac conduction system is admirably suited to deliver coordinated electrical impulses that 
result in synchronous and mechanically efﬁcient ventricular myocardial contraction. Pacing stimulation 
at the bundle of His (HB), which conducts through the Purkinje system is fundamentally different than a 
myocardial stimulation elsewhere in the right ventricle (RV) which results in abnormal physiology.  
Indeed, chronic right ventricular apical pacing may be associated with increased risk of death1,2, heart 
failure, hospitalization3, and the development of persistent atrial ﬁbrillation4,5.  

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 14 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
The bundle of His, or common atrioventricular (AV) bundle, consists of specialized myocardial cells 
located distal to the atrioventricular node (AVN). The HB acts as a conduit between the atrium and the 
ventricles, transmitting depolarization from the AVN through the ﬁbrous skeleton to the right and left 
bundle branches and ultimately the Purkinje system6.  
Permanent pacing of the HB to restore the native intrinsic AV conduction system continues to gain 
popularity with implanters.7 Over the last two decades several investigators reported experience with 
permanent His bundle pacing (HBP) resulting in paced QRS morphology similar to an intrinsically 
conducted beat.8-13  These clinical data showed HBP was feasible and associated with improvement in 
left ventricular dimensions, functional status, cardiothoracic ratio, and ejection fraction. Reaching the 
targeted implant area for HBP remains technically challenging because of the lack of anatomical and 
electrical markers used to facilitate traditional lead implant. Paced QRS morphology is not sufficient to 
confirm successful HBP location and the fluoroscopic image may mislead the implanter to an 
undesirable pacing site.  AV nodal, HB, AV septal and proximal bundle branch pacing may result in the 
same QRS morphology but completely different electrical performance (Figure 1).14  
Definitions for Selective HBP and Non-Selective HBP are separated based on the patient’s intrinsic QRS 
morphology and determined by electrocardiogram (EKG) identifiers and pacing capture thresholds 
(PCT).  Table 115 provides the definitions for Selective and Non-Selective HBP for patients with initial 
normal QRS and patients with a bundle branch block (BBB). 
 
Table 1: Definitions for His Bundle Pacing 
 
Normal QRS 
Bundle Branch Block# 
With correction* 
Without correction 
Selective HBP 
• S-QRS = HV with 
isoelectric interval 
• Discrete local V 
electrogram in HBP 
lead with S-V=H-V 
• Paced QRS = native QRS 
• Single capture 
thresholds (His bundle) 
 
• S-QRS < H-QRS with 
isoelectric interval 
• Discrete local V 
electrogram in HBP lead  
• Paced QRS < native QRS 
• 2 distinct capture 
thresholds (HBP with 
BBB correction, HBP 
without BBB correction) 
• S-QRS < or > H-QRS 
with isoelectric interval 
• Discrete local V 
electrogram in HBP  
• Paced QRS = native QRS 
• Single capture 
threshold (HBP with 
BBB) 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 15 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Non-Selective 
HBP 
• S-QRS < H-QRS (usually 
0, S-QRSend = H-QRSend) 
with or without 
isoelectric interval 
(Pseudodelta wave +/-) 
• Direct capture of local 
V electrogram in HBP 
lead by stimulus 
artifact (local 
myocardial capture) 
• Paced QRS > native QRS 
with normalization of 
precordial and limb 
lead axes with respect 
to rapid dV/dt 
components of the QRS 
• 2 distinct capture 
thresholds (HBP 
capture, RV capture) 
 
• S-QRS < H-QRS (usually 
0, S-QRSend < H-QRSend) 
with or without 
isoelectric interval 
(Pseudodelta wave +/-) 
• Direct capture of local V 
electrogram in HBP lead 
by stimulus artifact 
• Paced QRS < native QRS 
• 3 distinct capture 
thresholds (HBP with 
BBB correction, HBP 
without BBB correction, 
RV capture) 
 
• S-QRS < H-QRS (usually 
0) with or without 
isoelectric interval 
(Pseudodelta wave +/-) 
• Direct capture of local 
V electrogram in HBP 
lead by stimulus 
artifact 
• Paced QRS > native QRS 
• 2 distinct capture 
thresholds (HBP with 
BBB, RV capture) 
# including infra-nodal AV block; * Narrowing of QRS 
S-QRS stimulus to QRS; V ventricular; BBB bundle branch block; RV right ventricle; HBP His bundle pacing 
 
 
Figure 1: His Bundle Anatomy 
Compact AV node (1) converges into a 
transitional zone (2) before continuing 
as the His bundle (3) at the apex of 
triangle of Koch. The His bundle 
penetrates the membranous septum 
and continues as bundle branches (4) 
on the summit of muscular septum. 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 16 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
To address the clinical challenges, the IMAGE-HBP study will seek to evaluate and understand the 
correlation between implant electrical performance, lead implant location and chronic HBP lead 
electrical performance. 
Additionally, the IMAGE-HBP study will look to identify a correlation between anatomical landmarks and 
the electrical signature of HBP, which may allow investigators to refine an implant flowchart and lead to 
a better understanding of use conditions of both implant tools and leads during an implant for HBP. 
Therefore, the IMAGE-HBP study will collect data to help improve the ease and predictability of the 
implant and improve electrical performance of HBP. 
4.2. 
Purpose 
The IMAGE-HBP Study is a prospective, non-randomized, multi-site, clinical research study.   
The purpose of this research study is to assess the implant success proportion of the Medtronic 
SelectSecureTM MRI SureScanTM Model 3830 pacing lead at the bundle of His for His bundle pacing, 
evaluate implant lead electrical measurements and changes over time, evaluate changes in QRS 
duration over time, estimate the correlation between lead location and selective vs. non-selective HBP, 
and estimate the correlation between long-term lead performance and implant characteristics. Data 
from the study may be used to standardize the implant workflow to help improve the ease and 
predictability of His bundle pacing implants.  
5. Objectives and Endpoints 
5.1. 
Objectives 
5.1.1. 
Primary Objective 
The primary objective is to assess the implant success proportion of the Medtronic SelectSecureTM MRI 
SureScanTM Model 3830 pacing lead at the bundle of His for His bundle pacing.  Implant success will be 
defined as the presence of a H wave on the implanted lead EGM and a HB pacing capture threshold 
equal to or less than 2.5V at 1.0ms.  
5.1.2. 
Secondary Objectives  
The secondary objectives are descriptive in nature and are intended to provide additional information 
about HBP with the SelectSecureTM MRI SureScanTM Model 3830 pacing lead.  There will be no 
established performance requirements for these secondary objectives. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 17 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
Estimate the correlation between the lead position and selective vs. non-selective HBP 
occurrence at implant 
• 
Assess changes in lead electrical measurements over time 
• 
Assess changes in QRS duration over time 
• 
Estimate the correlation between implant characteristics and long-term lead electrical 
performance at 12 months 
• 
Characterize the occurrence of complications related to the procedure or lead for His bundle 
pacing up to 12 months 
5.1.3. 
Ancillary Objectives 
Additional analyses may be done on data and images collected during the study as outlined below.   
These analyses are descriptive in nature and are intended to provide additional information about His 
bundle pacing with the Medtronic SelectSecureTM MRI SureScanTM Model 3830 lead. 
• 
To characterize performance of existing delivery tools and Medtronic SelectSecureTM MRI 
SureScanTM Model 3830 lead for HBP 
• 
To summarize implant procedure information 
• 
To characterize the survival for subjects up to 12 months post-implant. 
 
6. Study Design  
The Imaging Study of Lead Implant for His Bundle Pacing (IMAGE-HBP) is a prospective, non-randomized, 
multi-site, clinical research study.  The purpose of this research study is to assess the implant success 
proportion of the Medtronic SelectSecureTM MRI SureScanTM Model 3830 pacing lead at the bundle of 
His for His bundle pacing, evaluate implant lead electrical measurements and changes over time, 
evaluate changes in QRS duration over time, estimate the correlation between lead location and 
selective vs. non-selective HBP, and estimate the correlation between long-term lead performance and 
implant characteristics. Data from the study may be used to standardize the implant workflow to help 
improve the ease and predictability of His bundle pacing implants.  
All subjects included in the study will be implanted with a Medtronic market released de novo 
implantable pacemaker, Medtronic SelectSecureTM MRI SureScanTM Model 3830 lead for HBP, and 
compatible market released Medtronic Right Atrial lead (if applicable).  The subjects with an implant of 
the Medtronic SelectSecureTM MRI SureScanTM Model 3830 lead for HBP will undergo a Cardiac CT Scan 
and be followed up to twelve months post implant for electrical testing.  Subjects that do not receive an 
implanted SelectSecureTM MRI SureScanTM Model 3830 pacing lead for HBP will be exited from the study 
at the time of the unsuccessful implant or after any reportable AEs are resolved. 
An unsuccessful implant is not considered an adverse event; however any adverse events occurring 
during an unsuccessful implant attempt (e.g. perforation) must be evaluated for reporting. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 18 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
The SelectSecureTM MRI SureScanTM Model 3830 pacing lead implant for HBP procedure data collection 
will occur during the standard implant procedure and is expected to add approximately 20 minutes to 
the procedure.  This time includes: 
• 
Collection of electrical measurements during lead placement and fixation 
• 
Two fluoroscopy cine image views of final lead system implant 
 
The study will enroll up to 70 subjects in order to achieveapproximately 62 subjects who will undergo an 
intended Medtronic SelectSecureTM MRI SureScanTM Model 3830 lead implant procedure attempt for 
HBP.  The study is expected to be conducted at up to 5 sites in the United States (US). 
 
See Figure 2 and Section 9 for further detail on study procedures and data collection as well as time 
points for data collection. 
 
Figure 2: Study Visits 
 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 19 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
6.1. 
Duration 
The study duration is expected to be approximately 28 months from first center activation until closure.  
This represents 10 months for subject enrollments, 12 months for subject follow-up and 6 months for 
study closure.  Subjects are anticipated to be in the study for 12 months.  Subjects will complete visits at 
enrollment/baseline, implant, pre-hospital discharge, 1 week, 3 months, 6 months and 12 months. 
6.2. 
Rationale  
Over the last two decades several investigators reported experience with permanent HBP resulting in 
paced QRS morphology similar to an intrinsically conducted beat.8-13  These clinical data showed HBP 
was feasible and associated with improvement in left ventricular dimensions, functional status, 
cardiothoracic ratio, and ejection fraction. Reaching the targeted implant area for HBP remains 
technically challenging14.  To address the clinical challenges, the IMAGE-HBP study will seek to evaluate 
and understand the correlation between lead location implant electrical performance using electro-
anatomical images and chronic HBP lead electrical performance.  The study will collect data to help 
improve the ease and predictability of the implant and better electrical performance of HBP. 
See section 4 for further background on the study design.  See section 13 for further background 
information and evaluation of clinical data.  
7. Product Description 
7.1. 
General 
The study will be conducted using the components described in section 7.5.  All components are market 
released and will be used according to approved indications.  Instructions for use of the devices used in 
this study are provided in their respective manuals.  
7.2. 
Manufacturer 
The SelectSecureTM MRI SureScanTM Model 3830 pacing lead is manufactured by Medtronic, PLC.  In 
addition, all other study equipment is manufactured by Medtronic, unless otherwise noted. 
7.3. 
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  

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 20 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
7.4. 
Intended Population 
All subjects in this study will receive a Medtronic single or dual chamber pacemaker for approved 
indications. 
7.5. 
Equipment 
All of the components are being used according to approved labeling. 
Medtronic SelectSecureTM MRI SureScanTM Model 3830 Lead or Medtronic SelectSecure Model 3830 
Lead 
The Medtronic SelectSecureTM MRI SureScanTM Model 3830 steroid eluting, bipolar, implantable, 
nonretractable screw-in, atrial/ventricular, catheter delivered, transvenous lead is designed for pacing 
and sensing in the atrium or ventricle.  The Medtronic SelectSecureTM MRI SureScanTM Model 3830 may 
also be labeled and referred to as the Medtronic SelectSecure Model 3830. 
Medtronic Leads and Pacemaker device 
The Medtronic lead is a commercially available bipolar pace/sense lead labeled for implantation in the 
right atrium or right ventricle.  The leads are connected to a commercially available Medtronic 
implantable pacemaker. 
 Medtronic Delivery Catheter 
The Medtronic delivery catheters are commercially available and indicated for the introduction of 
various types of pacing or defibrillator leads and catheters within the chambers. 
Medtronic CareLink (2090) Programmer 
The Medtronic approved IPG devices will be programmed and interrogated using a Medtronic CareLink 
(2090) programmer or Medtronic CareLink Encore programmer.  Medtronic may incorporate additional 
programmers as they receive regulatory approval. 
Medtronic Pacing System Analyzer 
Medtronic’s commercially available Model 2090 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. 
Medtronic Model 5833SL Cable 
The Medtronic Model 5833SL surgical cables will provide connectivity from the lead connector pins to 
the Temporary Extension Cable. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 21 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Temporary Extension Cables 
The temporary extension cables connect the Medtronic Model 5833SL Cable to the EP Data recording 
system.  The cable features a patented 2 mm protected pin quick connection allowing for a safe and fast 
connection between an electrode/lead from a patient or another cable to a diagnostic machine or an 
external pacemaker. (e.g. Cardiotronic Osypka Medical XI.MDT) 
Disposable Pacing Cable 
Disposable Pacing Cable used for transvenous and temporary pacing.  The cable is designed to provide a 
safe connection between 2 mm shrouded pin pacing catheters and Medtronic temporary pacemaker or 
Medtronic Pacing System Analyzer. (e.g. Remington Medical Adap-2000-12) 
EP Data recording system 
The EP recording system used in this procedure must be able to record and export data in a digital 
format and provide standard 2 mm female touch protected sockets for connectivity.  The EP recording 
system will record signals originating from the electrodes in the Medtronic SelectSecureTM MRI 
SureScanTM Model 3830 lead or market released EP catheter and save them in an electronic format for 
subsequent analysis. 
DR220 Holter Monitor 
The DR220 Digital Recorder (NorthEast Monitoring, Inc, MA, USA) is a Holter monitor that is designed to 
facilitate the ambulatory cardiac monitoring of those subjects who may benefit from such monitoring on 
order of a physician, including but not limited to those with complaints of palpitations, syncope, chest 
pains, shortness of breath, or those who need to be monitored to judge their current cardiac function, 
such as subjects who have recently received pacemakers.  The DR220 Digital Recorder is intended for 
use with Medtronic System-B compatible implantable pulse generators, implantable cardiac 
defibrillators, and cardiac resynchronization therapy devices and implantable cardiac monitors.  A Holter 
monitor is an external box used to record electrical heart signals from electrode patches attached to the 
skin (ECG) as well as from the cardiac device (EGM).  There are no contraindications for the use of a 
DR220 Holter monitor.  The Holter monitor will be used in accordance with its labeling.  Only trained 
study personnel should apply the monitors. 
The data obtained by monitoring is not analyzed at the time of the recording.  After the recording is 
complete, the data must later be returned and analyzed at Medtronic.  No personal information will be 
entered and collected by DR220 recorder. 
The DR220 Holter Recorder used in this study is a portable ECG device able to collect telemetry signals 
and marker channel information from a Medtronic device for up to 48 hours.  For the purposes of this 
study, the holter will be used during the in-office visit and will be removed at the conclusion of the visit.  
Each patient will have 2 DR220 Holter monitors collected during the study.  The first during the 1 week 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 22 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
visit and second at the 3 month visit (the second can be collected at the 6 month visit if missed at the 3 
month visit).  The Holter Recorder has application for any subject with a Medtronic IPG.  For the 
purposes of this study, the intended use of the Holter Recorder is to acutely uplink continuous EGM 
signals that will be collected by the IPG in Holter mode. 
Figure 3: DR220 Holter 
  
8. Selection of Subjects 
8.1. 
Study Population 
Subjects 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 pacemaker implant and lead for His bundle 
pacing who meet all inclusion and no exclusion criteria are eligible for the study.  There will be no 
control group for this study. 
8.2. 
Subject Enrollment 
Subjects who meet all the inclusion and none of exclusion criteria (see sections 8.3 and 8.4) are eligible 
to be enrolled in the study.  Upon signing and dating the Informed Consent Form (ICF), the patient is 
considered enrolled in the study.  
8.3. 
Inclusion Criteria 
• 
Subject has a Class I or II indication for implantation of an implantable pacemaker  
• 
Subject (or legally authorized representative) has signed and dated the study-specific 
Consent Form 
• 
Subject is 18 years of age or older, or is of legal age to give informed consent per local and 
national law 
• 
Subject is expected to remain available for follow-up visits 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 23 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
8.4. 
Exclusion Criteria 
• 
Subject is contraindicated for Cardiac CT 
• 
Subject has an existing or prior pacemaker, ICD or CRT device implant 
• 
Subject is intended to receive an implant of a LV lead or CRT device  
• 
Subject life expectancy is less than 1 year 
• 
Pregnant women or breastfeeding women, or women of child bearing potential and who are 
not on a reliable form of birth regulation method or abstinence 
• 
Subjects with exclusion criteria required by local law (e.g. age or other) 
• 
Subject with a medical condition that precludes the patient from participation in the opinion 
of the investigator 
• 
Subject is enrolled in a concurrent study that may confound the results of this study. Co-
enrollment in any concurrent clinical study (including registries) requires approval of the 
study manager or designee. 
 
8.5. 
Minimization of Bias 
Potential sources of bias in this study may result from selection of subjects, treatment of subjects, and 
evaluation of study data.  Methods incorporated in the study design to minimize potential bias include 
but are not limited to: 
• 
To ensure widespread distribution of data between sites, the maximum number of subjects 
allowed per site is half of the final study implant attempt enrollments. 
• 
Patients will be screened to confirm eligibility for enrollment with defined 
inclusion/exclusion criteria prior to enrollment (Section 8.3 and 8.4) 
• 
Subject demographics will be collected at baseline to investigate possible differences that 
may affect study endpoints 
• 
Data collection requirements and study procedures will be standardized across all centers 
• 
All study center personnel and Medtronic personnel will be trained on their respective roles 
in the study using standardized training materials.  All study clinicians will be trained on and 
required to follow the CIP. 
• 
All implanters in the study will have at least 1 year of experience in the implantation of the 
Medtronic SelectSecureTM MRI SureScanTM Model 3830 pacing lead for His bundle pacing 
and has performed at least 20 procedures 
 
In summary, potential sources of bias that may be encountered in this clinical investigation have been 
considered and minimized by careful study design. 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 24 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
9. Study Procedures  
9.1. 
Schedule of Events 
Table 2: Data collection and study procedure requirements 
Study Procedure 
Enrollment 
/Baseline 
Implant 
Cardiac 
CT Scan 
Pre-Hospital 
Discharge, 1 
week, 6 
month, 12 
month 
3 month  
Study 
exit 
Patient informed 
consent 
X 
 
 
 
 
 
Inclusion/Exclusion 
Assessment 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Implant procedure times 
 
X 
 
 
 
 
Physician questionnaire 
 
X 
 
 
 
 
Pacing Capture 
Thresholds at 0.5ms and 
1.0ms 
 
X 
 
X 
X 
 
Pacing Capture 
Thresholds for strength 
duration curve 
 
X 
 
 
X 
 
12 Lead EKG rhythm 
strips and 
measurements 
 
X 
 
X 
X 
 
Device interrogation / 
Save-to-media 
 
X 
 
X 
X 
X 
Cine images RAO 30 / 
LAO 60 
 
X 
 
 
 
 
EP recordings 
 
X 
 
 
 
 
Cardiac CT Scan 
 
 
X 
 
 
 
Holter (DR220) 
 
 
 
X* (1 week 
visit) 
 
X* 
 
Exit subject 
 
 
 
 
 
X 
Study deviations 
 
 
As they occur 
 
 
System modifications 
 
Adverse Events / Deaths 
 
Device Deficiencies 
 
*2 Holters will be collected per patient.  First at 1 week and the second at the 3 month visit (the second can be collected at 
the 6 month visit if missed at the 3 month visit). 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 25 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
9.2. 
Subject Screening  
Screening will be performed as patients are scheduled for initial pacemaker implants with intended lead 
placement for His bundle pacing. 
9.3. 
Subject Consent 
The patient is considered enrolled in the study upon signing and dating the informed consent form.  
Informed Consent is defined as a legally effective documented confirmation of a subject’s (or their 
legally authorized representative) 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.  This process includes obtaining an Informed Consent Form (ICF) and an 
Authorization to Use and Disclose Personal Health Information/Research Authorization/and other 
privacy language as required by law that has been approved by the study site’s Ethics 
Committee/Institutional Review Board (IRB) and signed and dated by the subject (or their legally 
authorized representative).  A subject may only consent after information has been given to the subject 
on all aspects of the clinical investigation that are relevant to the subject’s decision to participate.  
Informed consent may be given by the legally authorized representative only if a subject is unable to 
make the decision to participate in a clinical investigation and the site/IRB agrees to allow this.  In such 
cases, the subject shall also be informed about the clinical investigation within his/her ability to 
understand. 
Investigators shall consider all subjects who meet eligibility requirements for study participation to avoid 
any bias in the subject population.  Prior to enrolling subjects, each site’s Ethics Committee/IRB will be 
required to approve the CIP, ICF, the Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language, and any other written study information to 
be provided to the subjects.  The document(s) must be controlled (i.e. versioned and/or dated) to 
ensure it is clear which version(s) were approved by the Ethics Committee/IRB.  Any adaptation of the 
sample ICF must be reviewed and approved by Medtronic and the Ethics Committee/IRB reviewing the 
application prior to enrolling subjects. 
Refer to Appendix B for the sample Informed Consent Form. 
The investigator must notify the subject (or their legally authorized representative) 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 relevant, approval may be requested from subjects to confirm their continued 
participation. 
Prior to initiation of any study-specific procedures, patient informed consent must be obtained from the 
subject (or their legally authorized representative).  Likewise, privacy or health information protection 
regulation may require subjects to sign additional forms to authorize sites to submit subject information 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 26 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
to the study sponsor.  The informed consent process must be conducted by the principal investigator or 
an authorized designee, and the ICF and Authorization to Use and Disclose Personal Health Information/ 
Research Authorization/other privacy language as required by law must be given to the subject (or their 
legally authorized representative) in a language he/she is able to read and understand.  The process of 
patient informed consent must be conducted without using coercion, undue improper influence on or 
inducement of the subject to participate by the investigator or other site personnel.  The informed 
consent process shall not waive or appear to waive the subject’s legal rights.  The language used shall be 
as non-technical as possible and must be understandable to the subject and the impartial witness, 
where applicable. 
The subject must have ample time and opportunity to read and understand the ICF, to inquire about 
details of the study, and to decide whether to participate in the clinical study.  All questions about the 
study should be answered to the satisfaction of the subject.  
When the subject decides to participate in the clinical study, the ICF and the Authorization to Use and 
Disclose Personal Health Information/research Authorization/other privacy language must be signed and 
personally dated by the subject and investigator or authorized designee, as required by local law.  If 
applicable, a witness shall also sign and personally date the ICF to attest that the information in the ICF 
was accurately explained and clearly understood by the subject, and that informed consent was freely 
given. 
A copy of the ICF and the Authorization to Use and Disclose Personal Health Information/research 
Authorization/other privacy language, signed and dated as required by law, must be provided to the 
subject. 
If the ICF is obtained the same day the subject begins participating in study-related procedures, it must 
be documented in the subject’s case history that consent was obtained prior to participation in any 
study-related procedures.  It is best practice for the informed consent process to be documented in the 
subject’s case history, regardless of circumstance. 
In the event the subject cannot read and/or write, a 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.  The subject should “make his/her 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 and the Authorization to Use and Disclose Personal Health 
Information/Research Authorization/other privacy language as required by law must be filed in the 
hospital/clinical chart or with the subject’s study documents.  The ICF and Authorization to Use and 
Disclose Personal Health Information/Research Authorization/other privacy language as required by law 
must be available for monitoring and auditing.  Any Medtronic personnel who support the study 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 27 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
procedure must be able to review the subject’s signed and dated ICF and verify its completeness prior to 
proceeding with the procedure.  In the event that Medtronic personnel identify patient informed 
consent as being incomplete, the study procedures will not be allowed to occur until the consent of the 
subject can be adequately and appropriately obtained. 
9.4. 
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 through their 12 month post-implant clinic visit unless the subject exits the study prior to study 
closure.  Once informed consent is obtained, report AEs/deaths, study deviations and subject exits as 
they occur. 
9.5. 
Enrollment Data Collection 
An Enrollment Form will be completed for all study subjects, which will collect at a minimum the 
following information: 
• 
Standard demographics 
• 
Medical History 
• 
Adherence to inclusion/exclusion criteria 
9.6. 
Implant  
For this study a successful implant of a lead for His bundle pacing is defined as His bundle pacing capture 
threshold of less than or equal to 2.5V at 1.0ms.   
9.7. 
Implant Data Collection 
The implant CRF will be used to collect data at implant.   
The implanted system must include a Medtronic commercially released IPG device, SelectSecureTM MRI 
SureScanTM 3830 lead for His bundle pacing and a second market approved lead (if applicable). 
Set-up and Implantation 
The following steps outline the suggested setup procedure for the study.  The specific order is a 
guideline, not a requirement: 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 28 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
Assemble the HBP recording system according to the IMAGE-HBP Study Procedure 
Workbook 
• 
Prep subject for standard IPG implant and HB mapping 
• 
Use SelectSecure delivery system of choice to place a SelectSecureTM MRI SureScanTM Model 
3830 lead to the desired HB location. 
• 
Implant SelectSecureTM MRI SureScanTM model 3830 lead for HBP  
• 
Perform lead sensing, impedance and pacing capture threshold tests.  Print threshold test 
strips at final implant location at 0.5ms and 1.0ms 
• 
Remove delivery system 
• 
Collect RAO 30/LAO 60 cine images of final lead location after delivery system removal 
• 
Implant second lead (if applicable) and permanent pacemaker as standard procedure 
 
Electrical Mapping and 12 lead EKG recording 
• 
Print an initial 12 lead through EP recording system of patient intrinsic rhythm 
• 
Pacing capture threshold for each lead location 
• 
Record HV interval, Stimulus-V interval, QRS duration, P wave amplitude and R wave 
amplitude for each testing location 
 
Pacing Capture Thresholds (PCT) / Sensing / Impedance at final lead location 
• 
Perform a manual HB and RV PCT through the analyzer and device at 0.5ms and 1.0ms and 
print threshold test strips 
• 
For Selective HB patients perform a manual HB PCT at 0.1 (or 0.12) ms; 0.2 (or 0.21) ms;  
0.76 (or 0.8) ms ; and 1.5 ms and print test results 
• 
Print a screen of pacing at HB PCT, RV PCT at 0.5ms and 1.0ms from EP recording system 
• 
Document R wave and impedance results 
 
Physician Questionnaire 
Other Data Collection  
• 
Final device interrogation/Save to Media 
• 
Adverse Events  
• 
Study deviations 
• 
Device Deficiencies 
9.8. 
Scheduled Follow-up Visits 
After the index implant of a Medtronic SelectSecureTM MRI SureScanTM Model 3830 pacing lead for His 
bundle pacing is reported in the study database, the database will calculate the target dates and 
windows for each follow-up visit to the site.  Should a subject miss a visit or the visit fall outside the pre-

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 29 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
specified window, a study deviation must be reported and the original follow-up schedule maintained 
for subsequent visits. 
Data analyses 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.  Follow-
up visit windows are listed in Table 3 and are based on days post-index procedure.   
Subject compliance to the follow-up windows will be monitored through protocol deviation reporting. 
Table 3: Follow-up Visit Windows 
Occurrence/Visit 
Window 
(Calculated days post-procedure) 
Window Start (# of days) 
Window End (# of days) 
Pre-hospital discharge 
0 
5 
Cardiac CT Scan 
0 
17 
1 week office 
5 
17 
3 month office 
60 
106 
6 month office 
153 
213 
12 month office 
335 
395 
 
9.8.1. 
Pre-Hospital Discharge   
The following electrical testing will be performed using the implanted IPG and the device programmer: 
Pacing Capture Thresholds (PCT) / Sensing / Impedance measurements  
• 
Perform a manual HB and RV PCT at 0.5ms and 1.0ms and print threshold test strips 
• 
Document R wave and impedance results 
 
12 Lead EKG rhythm strip 
• 
Print 12 lead EKG rhythm strip capturing presenting rhythm, intrinsic rhythm, PCTs at 0.5ms, 
PCTs at 1.0ms and while pacing at final device programmed outputs and document QRS 
duration for each 
 
Other Data Collection  

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 30 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
Final device interrogate ALL and Save to Media 
• 
Adverse Events  
• 
Study deviations 
• 
Device Deficiencies 
9.8.2. 
Cardiac CT Scan 
The following data will be collected during the Cardiac CT Scan. 
• 
Cardiac CT Scan with contrast focusing on RA and RV chambers 
 
9.8.3. 
1 week, 6 month and 12 month visit 
The following electrical testing will be performed using the implanted IPG and the device programmer. 
In addition, a DR220 Holter monitor will be used at the 1 week visit.  The DR220 Holter monitor will also 
be used at the 6 month visit if missed at the 3 month visit. 
Pacing Capture Thresholds (PCT) / Sensing / Impedance measurements 
• 
Perform a manual HB and RV PCT at 0.5ms and 1.0ms and print threshold test strips 
• 
Document R wave and impedance results 
 
12 Lead EKG rhythm strip 
• 
Print 12 lead EKG rhythm strip capturing presenting rhythm, intrinsic rhythm, PCTs at 0.5ms, 
PCTs at 1.0ms and while pacing at final device programmed outputs and document QRS 
duration for each 
  
Other Data Collection  
• 
Final device interrogate ALL and Save to Media 
• 
Adverse Events  
• 
Study deviations 
• 
Device Deficiencies 
9.8.4. 
3 month visit 
The following electrical testing will be performed using the implanted IPG and the device programmer. 
In addition, a second DR220 Holter monitor will be used at the 3 month visit (if not able to collect at this 
visit, collect at the 6 month visit). 
Pacing Capture Thresholds (PCT) / Sensing / Impedance measurements 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 31 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Selective HBP patients 
• 
Perform a manual HB PCT at 0.1 (or 0.12) ms; 0.2 (or 0.21) ms; 0.5 (or 0.52) ms; 0.76 (or 0.8) 
ms ; 1.0 ms; and 1.5 ms and print test results 
• 
Perform a manual RV PCT at 0.5ms and 1.0ms and print threshold test strips 
• 
Document R wave and impedance results 
 
• Non-Selective HBP patients 
• 
Perform a manual HB and RV PCT at 0.5ms and 1.0ms and print threshold test strips 
• 
Document R wave and impedance results 
 
12 Lead EKG rhythm strip 
• 
Print 12 lead EKG rhythm strip capturing presenting rhythm, intrinsic rhythm, at all PCTs and 
while pacing at final device programmed outputs and document QRS duration for each 
  
Other Data Collection  
• 
Final device interrogate ALL and Save to Media 
• 
Adverse Events  
• 
Study deviations 
• 
Device Deficiencies 
9.9. 
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, system modification and in the case of a death (where possible). 
9.10. System Modification 
A system modification CRF will be completed in the event the device and/or lead(s) require invasive 
modification (e.g. generator or lead explant, generator or lead replacement, lead repositioning).  In the 
event of a system modification, regardless of outcome of the modification, the follow-up visit schedule 
for the subject will remain unchanged.  For a system modification, the following information/activities 
are required to be collected: 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 32 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
Modification or replace/explant date 
• 
Reason for modification 
• 
Information on device or lead modified 
• 
Information on any replacement device or lead(s) 
• 
SelectSecureTM MRI SureScanTM Model 3830 Pacing Capture Thresholds at 0.5ms and 1.0ms  
• 
Final System Configuration 
• 
Initial and Final device interrogate ALL and save-to-media 
• 
Adverse Events  
• 
Study deviations 
• 
Device Deficiencies 
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 a subject has a re-attempt after a previous unsuccessful system modification, the 
subsequent attempt(s) must be reported via CRF as separate system modifications. 
9.11. Subject Withdrawal or Discontinuation 
Study exit is defined as the moment when a subject officially stops participating in the study.  From that 
moment onward no data will be collected from the subject.  The date and the reason for exiting the 
subject 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 does not have an implant of a SelectSecureTM MRI SureScanTM 3830 lead for His 
bundle pacing 
• 
Subject death 
• 
Subject lost to follow-up 
• 
Subject did not meet eligibility criteria 
• 
Subject chooses to exit 
• 
Investigator withdraws subject 
 
If possible, the following procedures should be performed / data collected at the exit visit: 
• 
Report the reason for exit 
• 
Final interrogate ALL and save-to-media file for exits occurring prior to the 12 month visit 
• 
Adverse Events  
• 
Study deviations 
• 
Device Deficiencies 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 33 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
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. 
9.11.1. 
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. 
9.11.2. 
Subject chooses to exit (i.e. revokes informed 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 informed consent), the site is required to document the reason for exit on the Study Exit 
eCRF. In addition, study sites shall follow the regulations set forth by the governing IRB.  If possible, the 
following data should be collected prior to subject withdrawal: 
• 
Report the reason for the subject withdrawal 
• 
Final device interrogation/save-to-media 
• 
Adverse Events 
• 
Study deviations 
• 
Device deficiencies  
9.11.3. 
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 
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 
• 
Adverse Events 
• 
Study deviations 
• 
Device deficiencies  
9.12. Assessment of Safety 
Device Deficiencies and Adverse Events related to the procedure or Medtronic SelectSecureTM MRI 
SureScanTM Model 3830 pacing lead for His bundle pacing will be collected.  In addition, all SAEs that 
result in death will be collected.  Further information on the collection and assessment of Adverse 
Events is discussed in Section 11. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 34 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
9.13. Recording Data 
The study will collect data using Oracle Clinical, an electronic data management system for clinical 
studies.  Sites will enter data onto electronic case report forms (eCRFs) within the Oracle Clinical 
database. 
Data reported on the eCRFs shall be derived from source documents, which may include worksheets, 
patient medical records, EP Recording system printouts, 12 lead EKG, Device interrogation files, 
fluoroscopy image files, and programmer threshold test printouts. These source documents must be 
created and maintained by the clinical research study site team.  Further detail on data management is 
provided in Section 15.2.  
9.14. Deviation Handling 
A deviation is defined as an event in which the investigator or site personnel did not conduct the study 
according to the Clinical Investigational Plan (CIP) or applicable laws and regulations.  Every attempt 
must be made to avoid deviations. 
In the event the investigator deviates from the CIP to protect the life or physical well-being of a subject 
in an emergency, the investigator shall notify the sponsor and reviewing IRB within 5 working days after 
the emergency occurred. 
Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from 
the CIP.  Prior approval is not expected in situations where unforeseen circumstance is beyond the 
investigator’s control. 
Medtronic will be responsible for documenting and analyzing deviations, assessing their significance, 
and identifying any necessary corrective and/or preventive action.  All deviations will be recorded on the 
Protocol Deviation Case Report Form.  Medtronic will provide site-specific reports to investigators 
summarizing information on deviations that occurred at the investigational site on a periodic basis. 
10. Risks and Benefits 
10.1. Potential Risks 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a product, 
from the business analysis phase through development, market release, and post-market surveillance.   
All devices used in the IMAGE-HBP study will be commercially released and used in accordance with 
their approved labeling.  The safety and clinical performance of these devices have been demonstrated 
through previous-pre-clinical testing and previous clinical studies.  

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 35 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
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 analysis, but 
the investigator will avoid any procedures that may be determined harmful. 
Incremental risks for participating in this study may include the following risks associated with the 
additional procedures listed below: 
• 
Risk associated with Fluoroscopy exposure 
o During the implant procedure, additional cine recordings will be collected at the final lead 
fixation location.  The duration of the extra radiation exposure is expected to be less 
than 5 minutes of incremental time beyond what would be experienced during a 
standard implant procedure. 
• 
Risk associated with Cardiac CT Scans 
o Exposure to radiation from one test is similar to the amount of radiation you are naturally 
exposed to over one to five years. 
o The Cardiac CT Scan may detect an incidental finding, which is something that doesn’t 
cause symptoms now but may require more tests after being found. 
o Allergic reaction to contrast used during the Cardiac CT Scan 
 
10.2. Potential Benefits 
There may be no direct benefit to the subject from participating in this study.  The benefits of receiving a 
lead implant for His bundle pacing are the same if the patient participates in the study or not.   
The Cardiac CT Scan performed in this study is not for diagnostic purposes.  However, any potential 
abnormalities that are identified by the site investigator will be relayed to the subject with instruction 
for medical follow up. 
10.3. Risk-Benefit Rationale 
All identified risks as described in the previous sections have been successfully mitigated.  Any potential 
risks associated with this study are further minimized by selecting qualified investigators and training 
study personnel on the CIP.  While there may be no benefit of participation in the study there is the 
potential to aid in collecting information that may lead to new His bundle implant techniques for pacing. 
Overall residual risk of participating in the IMAGE-HBP study is considered acceptable. 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 36 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
11. Adverse Events and Device Deficiencies 
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are 
crucial for the protection of subjects.   Medtronic has established procedures to ensure appropriate 
reporting of safety information.   
11.1. Adverse Events 
Adverse Event (AE) definitions are provided in Table 4.  The following AEs will be collected throughout 
the study duration: 
• 
All AEs related to the Medtronic SelectSecureTM MRI SureScanTM model 3830 lead for His 
bundle pacing 
• 
Procedure related AEs related to the Medtronic SelectSecureTM MRI SureScanTM model 3830 
lead for His bundle pacing  
• 
SAEs resulting in subject death 
Events should be reported for the procedure or the lead for His bundle pacing that are considered to be 
possibly related, probably related or have a causal relationship. 
Reporting of these events to Medtronic will occur on an AE eCRF, including date of AE, treatment, 
resolution, assessment of both the seriousness of the AE and the relatedness to the product.  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.   
For AEs that require immediate reporting (see Table 6), initial reporting may be done by phone, email or 
on the eCRF completing as much information as possible.  The original completed AE eCRF 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 11.6 for Subject Death collection and 
reporting requirements. 
11.2. 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 on the AE 
eCRF 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 6).  For DDs that require 
immediate reporting, initial reporting may be done by contacting the study sponsor per the sponsor 
contact information. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 37 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
11.3. Processing 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 eCRF.  All AEs 
must be followed until the AE has been resolved, the subject dies or exits the study, or until study 
closure, whichever occurs first. 
At the time of the study exit, all collected AEs with an outcome of “not recovered/not resolved”, 
“recovering/resolving” or “unknown” must be reviewed and updates provided as applicable.   
11.4. Definitions/Classifications 
Where the definition indicates “device”, it refers to the SelectSecureTM MRI SureScanTM Model 3830 
pacing lead for His bundle pacing used in the study. 
Table 4: Adverse Event and Device Deficiency Definitions 
General 
Adverse Event (AE) 
(ISO 14155:2011, 3.2) 
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other person, 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. 
Adverse Device Effect (ADE) 
(ISO 14155:2011, 3.1) 
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. 
Device Deficiency (DD) 
(ISO 14155:2011, 3.15) 
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. 
Relatedness 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 38 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Lead for His bundle pacing Related 
An adverse event that results from the presence or 
performance (intended or otherwise) of the lead for HBP 
Procedure Related 
An Adverse Event that is directly related to the implantation or 
surgical modification of the lead for His bundle pacing.  
 
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). 
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 
investigational 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 on 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 
investigational 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 serious event. 
*The study will not be collecting AEs that are not related to the 
lead for His bundle pacing 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 39 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
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. 
*The study will not be collecting AEs that are unlikely related to 
the lead for His bundle pacing 
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. 
Probably 
The relationship with the use of the investigational device 
seems relevant and/or the event cannot reasonably be 
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);  

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 40 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
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) 
(ISO 14155:2011, 3.37) 
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 
* The study will be collecting only SAEs that led to a death 
Serious Adverse Device Effect 
(ISO 14155:2011, 3.36) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Complication 
An Adverse event that includes the following is considered a 
complication: 
a) Results in death, 
b) Involves any termination of significant device function, or 
c) Requires an invasive intervention 
 
Non-invasive (FDA, CFR 21; 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 
 
Observation 
Any adverse event that is not a complication 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 41 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
11.5.  Reporting of Adverse Events 
11.5.1. 
Adverse Event and Device Deficiency Classification 
All reported AEs and DDs will be reviewed by a Medtronic representative.  AEs will be classified 
according to the definitions provided. 
In this study, Device Deficiencies and Adverse Events classified as possibly related, probably related or 
has causal relationship with the procedure or Medtronic SelectSecureTM MRI SureScanTM Model 3830 
pacing lead for His bundle pacing will be collected.  In addition, all SAEs that result in death will be 
collected. 
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 MedDRA, The Medical Dictionary for Regulatory Activities (MedDRA), 
to assign a MedDRA term for each adverse event based on the information provided by the investigator. 
Regulatory reporting of AEs and DDs will be completed according to local regulatory requirements.  
Refer to Table 6 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 responsible for oversight of the study. 
For emergency contact regarding a SADE, contact an IMAGE-HBP 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 5: Adverse Event Classification Responsibilities 
What is classified? 
Who classifies? 
Classification Parameters 
Relatedness 
Investigator 
Lead for His bundle pacing, procedure  
Sponsor 
Lead for His bundle pacing, procedure 
Seriousness 
Investigator 
SAE 
Sponsor 
SAE 
Complication/Observation Sponsor 
Complication, Observation 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and 
other supporting data 
Sponsor 
MedDRA term assigned based on the data 
provided by Investigator 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 42 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
11.5.2. 
Adverse Event and Device Deficiency Reporting Requirements 
Regulatory reporting of AEs and DDs will be completed 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. 
Table 6: Reporting Requirements 
Adverse Device Effects (ADEs) 
Investigator submit to: 
Medtronic 
Submit in a timely manner after the investigator first learns of the effect. 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement. 
Institutional Review 
Board 
Submit to Institutional Review Board per local reporting requirement. 
Sponsor submit to 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement. 
Institutional Review 
Board 
Submit to Institutional Review Board per local reporting requirement. 
Serious Adverse Device Effects (SADEs) 
Investigator submit to 
Medtronic 
Submit to Medtronic as soon as possible 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement. 
Institutional Review 
Board 
Submit to Institutional Review Board per local reporting requirement. 
Sponsor submit to 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement 
Institutional Review 
Board 
Submit to Institutional Review Board per local reporting requirement. 
Investigators 
Submit per local reporting requirement. 
All other reportable Adverse Events 
Investigator submit to 
Medtronic 
Submit in a timely manner after the investigator first learns of the effect. 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement. 
Institutional Review 
Board 
Submit to Institutional Review Board per local reporting requirement. 
Device Deficiencies with SADE potential 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 43 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Investigator submit to 
Medtronic 
Submit as required per local reporting requirements. 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement. 
Institutional Review 
Board 
Submit to Institutional Review Board per local reporting requirement. 
Sponsor submit to 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement 
Institutional Review 
Board 
Submit to Institutional Review Board per local reporting requirement. 
All other Device Deficiencies 
Medtronic 
Submit in a timely manner after the investigator first learns of the 
deficiency. 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement. 
Institutional Review 
Board 
Submit to Institutional Review Board per local reporting requirement. 
 
11.6. Subject Death 
11.6.1. 
Death Data Collection 
All subject deaths must be reported by the investigator to Medtronic on an AE eCRF (AE with outcome 
of death) as soon as possible after the investigator first learns of the death.  
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.  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. 
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. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 44 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic IMAGE-HBP 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 IMAGE-HBP Study team, if 
available.  If an autopsy is conducted, the autopsy report should also be sent to the Medtronic IMAGE-
HBP Study team if available and allowed by state/local laws.  When the death occurs at a remote site, it 
is the investigative site’s responsibility to attempt retrieval of information about the death.  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) 
• 
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) 
11.6.2. 
Death Classification and Reporting 
Sufficient information will be required 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 7: Subject Death Classification Responsibilities 
What is classified? 
Who classifies? 
Classification Parameters 
Death Classification 
 Investigator 
Cardiac, Sudden Cardiac, Non-sudden Cardiac, Non-
cardiac, Unknown 
 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 45 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
12. Data Review Committees  
This study will not be using a Data Management Committee or Clinical Events Committee. 
13. Statistical Design and Methods 
13.1. Primary Objective 
13.1.1. 
Objective 
The primary objective is to assess the implant success proportion of the Medtronic SelectSecureTM MRI 
SureScanTM Model 3830 pacing lead at the bundle of His for His Bundle Pacing. 
13.1.2. 
Endpoint Definition 
Implant success will be defined as the presence of a H wave on the implanted lead EGM and a HB pacing 
capture threshold equal to or less than 2.5V at 1.0ms.  
Implant success proportion is defined as the proportion of all subjects who undergo an implant attempt 
that is successful.  
13.1.3. 
Sample Size Determination 
A sample size of 62 subjects with an implant attempt will produce a two-sided 95% confidence interval 
with a width equal to 0.15 (using the Wilson method) for the implant success proportion when the 
observed implant success proportion is 0.9. Table 8 below shows various scenarios for the precision of 
the implant success proportion estimate depending on the actual observed data. 
Table 8: Estimation Precision for Implant Success Proportion 
Observed implant success proportion 
(N=62 subjects attempting implant) 
Width of the two-sided  
95% confidence interval 
0.95 
0.116 
0.92 
0.14 
0.90 
0.15 
0.87 
0.168 
0.82 
0.188 
 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 46 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
13.1.4. 
Analysis Methods 
The observed implant success proportion will be calculated as follows: 
 
Implant Success Proportion =  # Subjects with implant success
 # Subjects with implant attempt 
A 95% confidence interval for the implant success proportion will be constructed using the Wilson 
method. 
13.2. Secondary Objectives 
The secondary objectives are descriptive in nature and are intended to provide additional information 
about His bundle pacing with the SelectSecureTM MRI SureScanTM Model 3830 pacing lead.  There will be 
no established performance requirements for these secondary objectives. 
13.2.1. 
Secondary Objective #1  
13.2.1.1. Objective 
This secondary objective is to estimate the correlation between the lead position and selective vs. non-
selective HBP occurrence at implant. 
13.2.1.2. Endpoint Definition 
The lead position is identified as anterior septum, mid septum or posterior septum. Location is 
determined by the implanting physician during implant and verified by Medtronic through evaluation of 
cardiac CT scan images.  The location determined from CT scan will be used in the analysis. 
The HBP at implant is classified as either selective or non-selective by the implanting physician based on 
the definitions specified in section 4.1, Table 1: Definitions for His Bundle Pacing.  
13.2.1.3. Analysis Methods 
The relationship between lead position (anterior septum, mid septum, posterior septum) and HBP 
selectivity (selective vs. non-selective) will be assessed using a logistic regression. Additionally, HV 
intervals will be compared between the three groups of lead positions using linear regression. 
13.2.2. 
Secondary Objective #2 
13.2.2.1. Objective 
This secondary objective is to assess changes in lead electrical measurements over time (HB PCT, R 
waves and impedance). 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 47 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
13.2.2.2. Endpoint Definition 
The lead electrical measurements that will be evaluated include HB pacing capture threshold (PCT) (in 
Volts) at 0.5ms, impedance (in Ohms), and R-wave amplitude (in mV) measured at the final lead location 
during the implant procedure, and then at the 3-month, 6-month, and 12-month follow-up visits. 
13.2.2.3. Analysis Methods 
The lead electrical measurements from each visit will be summarized using descriptive statistics (mean, 
median, standard deviation, minimum, maximum, etc.) and graphical displays. Longitudinal analysis will 
be conducted to estimate differences in electrical measurements from implant to subsequent follow-up 
visits. 
13.2.3. 
Secondary Objective #3 
13.2.3.1. Objective 
This secondary objective is to assess changes in QRS duration over time. 
13.2.3.2. Endpoint Definition 
Intrinsic QRS duration will be measured prior to the implant procedure, and then at the 3-month, 6-
month, and 12-month follow-up visits. 
13.2.3.3. Analysis Methods 
The QRS durations from each visit will be summarized using descriptive statistics (mean, median, 
standard deviation, minimum, maximum, etc.) and graphical displays. Longitudinal analysis will be 
conducted to estimate differences in QRS duration from implant to subsequent follow-up visits. 
13.2.4. 
Secondary Objective #4 
13.2.4.1. Objective 
This secondary objective is to estimate the correlation between implant characteristics and long-term 
lead electrical performance at 12 months post-implant. 
13.2.4.2. Endpoint Definition 
Long-term lead electrical performance is identified as the HB PCT at 12 months post-implant. Implant 
characteristics to be evaluated here include lead location, HB PCT at implant, and paced QRS duration at 
implant. 
13.2.4.3. Analysis Methods 
A multivariable regression analysis will be conducted to assess if there is any correlation between 
implant characteristics, including lead location, HB PCT, and QRS duration at implant, and the 12-month 
HB PCT.  

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 48 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
13.2.5. 
Secondary Objective #5 
13.2.5.1. Objective 
This secondary objective is to characterize the occurrence of any complications related to the procedure 
or the lead for His bundle pacing up to 12 months post-implant.  
13.2.5.2. Endpoint Definition 
Procedure and the lead for His bundle pacing related complications will be reported via the Adverse 
Event eCRF. Examples include but are not limited to: lead dislodgement, exit block, loss of capture, or 
high threshold causing action. 
13.2.5.3. Analysis Methods 
The types of complications related to the procedure or the lead for His bundle pacing will be 
summarized using frequencies and percentages. The probability of a subject being free of a complication 
related to the procedure or the lead for His bundle pacing through 12 months post-implant will be 
estimated using the Kaplan-Meier method. In addition, the relationship between implant characteristics, 
including lead position, HB PCT at implant, and QRS duration at implant, and the occurrence of 
complications related to the procedure or the lead for His bundle pacing will be assessed using a Cox 
proportional hazard regression model. 
 
13.3. Ancillary Objectives 
Additional analyses may be done on data and images collected during the study as outlined below. 
These analyses are descriptive in nature and are intended to provide additional information about His 
bundle pacing with the Medtronic SelectSecureTM MRI SureScanTM Model 3830 lead. 
13.3.1. 
Ancillary Objective #1 
13.3.1.1. Objective: 
This ancillary objective is to characterize the performance of existing delivery tools for the Medtronic 
SelectSecureTM MRI SureScanTM Model 3830 lead for HBP. 
13.3.1.2. Endpoint Definition: 
Physicians will report the performance of existing delivery tools for the 3830 lead for HBP via a Physician 
Questionnaire to be completed after each implant procedure.  
13.3.1.3. Analysis Methods: 
Responses to the Physician Questionnaire eCRF will be summarized using frequencies and percentages. 
13.3.2. 
Ancillary Objective #2 
13.3.2.1. Objective: 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 49 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
This ancillary objective is to summarize implant procedure information. 
13.3.2.2. Endpoint Definition: 
The implant procedure information to be characterized include: procedure times, number of fixation 
attempts, fluoroscopy time, delivery systems used. 
13.3.2.3. Analysis Methods: 
The implant procedure information will be summarized using descriptive statistics (mean, median, 
standard deviation, minimum, maximum for continuous variables, and frequencies and percentages for 
categorical variables). 
13.3.3. 
Ancillary Objective #3 
13.3.3.1. Objective: 
This ancillary objective is to characterize the survival for subjects up to 12 months post-implant.  
13.3.3.2. Endpoint Definition: 
Deaths will be reported via the Adverse Event eCRF. 
13.3.3.3. Analysis Methods: 
The causes of death will be summarized using frequencies and percentages. The probability of subject 
survival through 12 months post-implant will be estimated using the Kaplan-Meier method. 
 
14. Ethics 
14.1. Statement(s) of Compliance  
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as good clinical practice (GCP).  GCP includes review and approval by an independent IRB/Ethics 
Board before initiating a study, continuing review of an ongoing study by an IRB/Ethics Board and 
obtaining and documenting the freely given informed consent of a subject before initiating the study.   
The study will be conducted according to federal, national and local laws, regulations, standards, and 
requirements of the countries where the study is being conducted.  The study will also be conducted in 
accordance with the Declaration of Helsinki.  The principles of the Declaration of Helsinki have been 
implemented through the subject IC process, IRB/Ethics Board approval, study training, clinical trial 
registration, preclinical testing, risk benefit assessment, and publication policy.   
Ultimately, all sites will follow and comply with: 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 50 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• Principles of Declaration of Helsinki 
• 21 CFR Part 11 (Electronic Records, Electronic Signatures) 
• The Clinical Trial Agreement 
• The procedures described within this CIP 
• Local independent institutional review board 
 
The study will be conducted in compliance with 21 CRF Parts 50 (protection of human subjects) and 56 
(Institutional Review Boards).  Also, local laws and regulations will be applicable in the countries where 
the study is conducted. 
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)). 
Approval of the CIP is required from the following groups prior to any study procedures at a study 
center: 
• 
Medtronic 
• 
Investigator (Investigator Agreement) 
• 
An independent institutional review board 
The Investigator will forward to the sponsor any action taken by an IRB/Ethics Board with respect to the 
investigation. 
Subjects may be compensated for their time for this study if specified in the Agreement as agreed upon 
by the Investigator, site and Medtronic. 
15. Study Administration 
15.1. Monitoring  
It is the responsibility of Medtronic to ensure proper monitoring of clinical studies as needed to secure 
Investigator compliance.  Monitoring can occur on site or remotely.  If deemed necessary by Medtronic, 
appropriately trained Medtronic personnel or delegates appointed by Medtronic may perform study 
monitoring at the study site to ensure that the study is conducted in accordance with the CIP, the 
Clinical Trial Agreement, 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 Informed Consent, Research Authorization 
(where applicable) and Clinical Trial Agreement.  The principal investigator should also be available 
during monitoring visits.  
If monitoring occurs for this study, the frequency of monitoring visits will be based upon subject 
enrollment, duration of the study, study compliance number of deviations, findings from previous 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 51 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
monitoring visits and any suspected inconsistency in data that requires investigation.  Regulatory 
documents may be reviewed at each study site.  Any monitoring for the study will be done in 
accordance to the study-specific monitoring plan. 
Should Medtronic decide monitoring visits are necessary, the visits will be conducted periodically to 
assess site study progress, the investigator’s adherence to the CIP, regulatory compliance including but 
not limited to IRB/Ethics Committee approval and review of the study, maintenance of records and 
reports, and review of source documents against subject eCRFs.  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 recommendations and to identify trends 
within the study or at a particular site. 
15.2. Data Management 
The eCRF data will be stored in a secure, password-protected database which will be backed up nightly.  
eCRF data will be collected via remote data capture and entered into an Oracle Clinical database.  Data 
will be managed by Medtronic Core Clinical Solutions Data Management and External Partner Cognizant.  
At the end of the study, the data will be frozen and will be retained indefinitely by Medtronic.  
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.  The CT scanned images, EP 
recording system files and electrical testing printouts will be de-identified when possible. 
Procedures in the CIP require source documentation. Source documentation will be maintained at the 
site and copies of testing results and electrical data recordings will be sent to Medtronic.  The eCRF may 
serve as source documentation if not available within the medical record. 
15.3. 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/Ethics 
Board review and regulatory inspection by providing direct access to source data/documents. 
15.4. Confidentiality 
Subject confidential information may be accessed by Medtronic for this study.  All records and other 
information about subjects participating in this study will be treated as confidential.  Data will be 
transferred and processed by Medtronic in a key coded form, unless it’s impossible to make it 
anonymous, for instance, where the patient’s name cannot be removed from the data carrier, such as 
fluoroscopy images. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 52 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
15.5. Liability 
The study will be using market released products only.  All product will be used under current 
indications and standard procedures. 
15.6. CIP Amendments 
If CIP revision is required, CIP amendment will not be implemented at the site until approval of the 
revised CIP is obtained from the Investigator, the Sponsor and the IRB/Ethics Board. 
15.7. Record Retention 
The investigator is responsible for the preparation (review and signature) and/or retention of the 
records cited below.  The following records are subject to inspection and must be retained for a period 
of two years after study termination or closure: 
• 
All correspondence that pertains to the investigation. 
• 
Subject’s case history records, including: signed/dated subject informed consent form, 
procedure date, and documentation of the dates and rationale for any deviation from the 
protocol 
• 
IRB approval documents and documentation that the investigator did not participate in the 
approval process. 
• 
Any other records that local regulatory agencies require to be maintained. 
 
eCRFs must be maintained and signed electronically within the electronic data capture system during 
the study.  Medtronic will provide electronic copies of CRFs (i.e. Patient Data Report) from the database 
upon request following study closure. 
15.8. Publication and Use of Information 
A publication committee may be formed during the course of the study if deemed necessary.  Ideas for 
publications arising from findings of this study should be submitted in writing to the study sponsor.  
Unless otherwise provided in the Protocol, Investigator and Participating Institution shall submit any 
contemplated publication or presentation containing any information, data or results received or 
generated in the course of this study to Medtronic for review at least 60 days prior to submission, for a 
determination whether Confidential Information is disclosed.  If notified by Medtronic within such 60-
day period that such publication or presentation contains Confidential Information, Investigator and 
Participating Institution each agree to delete Confidential Information, other than Study results, prior to 
any publication or presentation. 
Authorship will be selected on the basis of the following: 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 53 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
• 
A significant contribution to the design of the clinical study 
• 
A significant contribution to subject enrollment in the clinical study 
• 
High procedure volume and quality of data as determined by the clinical study requirements 
15.9. Suspension or Early Termination 
Early Termination of the Study is the closure of a clinical study that occurs prior to meeting defined 
objectives.  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 case of a study suspension, subject enrollment and follow-up must stop until the suspension is 
lifted by Medtronic. 
Medtronic will promptly inform the clinical investigators of the termination or suspension and the 
reasons and inform the regulatory authority(ies) where required.  In the case of study termination or 
suspension for reasons other than a temporary IRB/Ethic Board approval lapse, the investigator will 
promptly inform the IRB/Ethic Board.  Subject follow-up will end in accordance with the plan specified at 
the time of the termination decision. 
16. References 
[1] 
Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, et al. Long-term 
follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. 
Lancet 1997; 350: 1210-1216. 
[2] 
Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, et al. Dual-chamber pacing or 
ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI 
Implantable Defibrillator (DAVID) Trial. JAMA 2002; 288: 3115-3123. 
[3] 
Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, et al. Adverse 
effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS 
duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation 2003; 107: 2932-
2937. 
[4] 
Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, et al. Effects of physiologic pacing 
versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of 
Physiologic Pacing Investigators. N Engl J Med 2000; 342: 1385-1391. 
[5] 
Kristensen L, Nielsen JC, Mortensen PT, Pedersen OL, Pedersen AK, Andersen HR. Incidence of 
atrial fibrillation and thromboembolism in a randomised trial of atrial versus dual chamber pacing in 177 
patients with sick sinus syndrome. Heart 2004; 90: 661-666. 
[6] 
Laske TG, Iaizzo PA. The cardiac conduction system. In: Iaizzo PA. Handbook of cardiac 
anatomy, physiology, and devices. Totowa, N.J.: Humana Press 2005: xiii, pp. 123–136 
[7] 
Williams DO, Scherlag BJ, Hope RR, El-Sherif N, Lazzara R, Samet P. Selective versus non-
selective His bundle pacing. Cardiovascular research 1976; 10: 91-100. 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 54 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
[8] 
Deshmukh P, Casavant DA, Romanyshyn M, Anderson K. Permanent, direct His-bundle pacing: a 
novel approach to cardiac pacing in patients with normal His-Purkinje activation. Circulation 2000; 101: 
869-877. 
[9] 
Barba-Pichardo R, Morina-Vazquez P, Venegas-Gamero J, Frutos-Lopez M, Moreno-Lozano V, 
Herrera-Carranza M. The potential and reality of permanent his bundle pacing. Revista espanola de 
cardiologia 2008; 61: 1096-1099. 
[10] 
Zanon F, Barold SS. Direct His bundle and paraHisian cardiac pacing. Annals of noninvasive 
electrocardiology : the official journal of the International Society for Holter and Noninvasive 
Electrocardiology, Inc 2012; 17: 70-78. 
[11] 
Sharma PS, Dandamudi G, Naperkowski A, Oren JW, Storm RH, Ellenbogen KA, et al. Permanent 
His-bundle pacing is feasible, safe, and superior to right ventricular pacing in routine clinical practice. 
Heart rhythm 2015; 12: 305-312. 
[12] 
Teng AE, Lustgarten DL, Vijayaraman P, Tung R, Shivkumar K, Wagner GS, et al. Usefulness of 
His Bundle Pacing to Achieve Electrical Resynchronization in Patients With Complete Left Bundle Branch 
Block and the Relation Between Native QRS Axis, Duration, and Normalization. The American journal of 
cardiology 2016; 118: 527-534. 
[13] 
Lustgarten DL, Crespo EM, Arkhipova-Jenkins I, Lobel R, Winget J, Koehler J, et al. His-bundle 
pacing versus biventricular pacing in cardiac resynchronization therapy patients: A crossover design 
comparison. Heart rhythm 2015; 12: 1548-1557. 
[14] 
Mulpuru SK, Cha YM, Asirvatham SJ. Synchronous ventricular pacing with direct capture of the 
atrioventricular conduction system: Functional anatomy, terminology, and challenges. Heart rhythm 
2016; 13: 2237-2246. 
 [15] 
Vijayaraman P, Dandamudi G, Zanon F, Sharma PS, Tung R, Huang W, Koneru J, Tada H, 
Ellenbogen KA, Lustgarten DL. Permanent His Bundle Pacing (HBP): Recommendations From a Multi-
Center HBP Collaborative Working Group For Standardization of Definitions, Implant Measurements And 
Follow-up. Heart Rhythm 2017; 10: 1016 
[16] 
Vijayaraman P, Naperkowski A, Ellenbogen KA, Dandamudi G. Electrophysiologic Insights Into 
Site of Atrioventricular Block: Lessons From Permanent His Bundle Pacing. JACC: Clinical 
Electrophysiology 2015; vol 1 no 6: 571-581 
[17] 
Upadhyay GA, Tung R. Selective versus non-selective his bundle pacing for cardiac 
resynchronization therapy. Journal of Electrocardiology 2017; 50 issue 2: 191-194 
[18] 
 Laske TG, Iaizzo PA. The cardiac conduction system. In: Iaizzo PA. The Handbook of Cardiac 
Anatomy, Physiology, and Devices, Totowa, NJ, Humana Press, 2005; pp. 123–136 
17. Appendices  
Appendix A: Draft data collection elements (Case Report Forms) 
Draft Case Report Forms for the IMAGE-HBP study will be provided under separate cover.  Final CRFs will 
be provided to sites via the electronic data management system after the site has fulfilled all 
requirements for database access. 
Appendix B: Informed consent template 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 55 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Informed consent template will be provided under separate cover. 
Appendix C: Participating investigators and institutions 
A complete list of participating investigators and institutions will be provided under separate cover upon 
request when available 
Appendix D: IRB list 
A complete list of participating IRBs and the Chairperson(s) will be distributed under a separate cover 
upon request when available. 
18. Version History 
 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
Not Applicable, New Document 
Lisa Hughes, Prin Field Clinical 
Engineer 
2.0 
Section 7.5: Adjusted Medtronic Delivery 
Catheter description to include commercially 
available delivery catheters 
 
Section 11.1: Removed ‘or delivery system’ 
from the second bullet to align with objectives 
and analysis plans 
Lisa Hughes, Prin Field Clinical 
Engineer 
3.0 
Table 1: Updated to match table referenced in 
publication 
 
Section 6: Update number of sites from 3 to up 
to 5.  
Changed enrollment number to up to 70 
enrollments to achieve approximately 62 
implant attempts. 
 
Section 7.5 Lead: Removed specification of RA 
lead to allow real world use of a second lead as 
RA or RV. 
 
Section 7.5 DR220 Holter: Added the holter to 
be collected at the 3 month visit (or 6 month 
visit if missed at 3 month). 
 
Lisa Hughes, Prin Field Clinical 
Engineer 
Tracy Bergemann, Sr Prin 
Statistician 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 56 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
Section 8.3: Removed reference to 
ACC/AHA/HRS 2008 guidelines to allow most 
recent guidelines to be used by physician. 
 
Section 8.5: Changed center enrollment cap to 
half of the final study implant attempt 
enrollments. 
 
Table 2: Added Holter to 3 month visit and 
notation to allow collect at the 6 month visit if 
missed at the 3 month visit. 
 
Section 9.7: Adjusted to allow second lead 
instead of specifying RA lead. 
Corrected reference to the Implant Procedure 
Workbook. 
Test strips vs test results to be printed. 
 
Section 9.8.1: Test strips vs test results to be 
printed. 
 
Section 9.8.3: Addition of holter collection at 6 
month visit if missed at 3 month visit.  
Test strips vs test results to be printed. 
 
Section 9.8.4: Addition of holter collection at 3 
month visit. 
Test strips vs test results to be printed. 
 
Section 13.1.3: Sample size determination 
adjusted per new enrollment size. 
 
Table 8: Updated the Estimation Precision for 
Implant Success Proportion based on new 
sample size. 
 
Reference 15: Adjusted reference to match the 
correct publication for 15. 
 
Appendix D: Updated IRB list for CIP version 3 
4.0 
Table 3: Cardiac CT Scan window end to 17 
days 
Lisa Hughes, Prin Field Clinical 
Engineer 

Imaging Study of Lead Implant for His Bundle 
Pacing Clinical Investigation Plan  
 
056-F275 
Version 4.0 
 
Page 57 of 57 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template