Expanding MRI (Magnetic Resonance Imaging) Access for Patients With New and Existing ICDs (Implantable Cardioverter Defibrillator) and CRT-Ds (Cardiac Resynchronization Therapy Defibrillator)
Phase: NA
Conditions: Magnetic Resonance Imaging
Sponsor: Boston Scientific Corporation

Boston Scientific  
ENABLE MRI Protocol 
91064823 Rev AE  
 
THESE DOCUMENTS ARE THE PROPERTY OF BOSTON SCIENTIFIC CORPORATION AND SHALL NOT BE 
REPRODUCED, DISTRIBUTED, DISCLOSED OR USED FOR MANUFACTURE OR SALE OF APPARATUS WITHOUT THE 
EXPRESS WRITTEN CONSENT OF BOSTON SCIENTIFIC CORPORATION. 
 
 
 
 
 
 
Page 1 of 128 
     
 
 
 
ENABLE MRI Clinical Study  
 
Expanding MRI Access for Patients with New and Existing 
 ICDs and CRT-Ds 
 
CLINICAL PROTOCOL 
11 August 2016 
Version AE 
 
IDE # G150181 
 
Sponsored By 
Boston Scientific, CRM 
4100 Hamline Avenue North 
St. Paul, MN 55112 USA 
 
Guidant Europe SA / NV, 
a Boston Scientific Company 
Clinical CRV Department  
Green Square 
Lambroekstraat 5D  
1831 Diegem,  
Belgium 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should 
be held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 

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Contact Information 
Role 
Contact  
Clinical Contact 
U.SContact: 
Julien Delumeau 
Clinical Trial Manager 
Boston Scientific, CRM 
Tel : +33(0)6 085600 11 
Julien.delumeau@bsci.com  
Europe, Israel and Asia Pacific Contact:  
Valérie Lens 
Clinical Trial Manager 
Boston Scientific, CRM 
Tel : +32(0)4 911539 90  
lensv@bsci.com  
US Technical Services 
1.800.322.3422 / 651.582.3422 
 
International Technical Services 
+32(0)2 416 72 22 
Coordinating 
Principal 
Investigator 
Europe:  
Prof. Aldo Rinaldi 
Cardiac Department 
6TH Floor East Wing  
St Thomas’ Hospital 
Westminster Bridge Rd 
SE1 7EH  London 
UK 
Asia Pacific: 
Prof. Hung Fat Tse 
Room 1928,19/F Block K,  
Queen Mary Hospital 
102 Pokfulam Road 
852 Hong Kong 
USA: 
Dr. Ulrika Birgersdotter-Green 
The Regents of the University of California (UCSD), San Diego School of 
Medicine 
9444 Medical Center Drive 
3rd floor, Room 3-089 D 
La Jolla, CA 92037 USA 
 
 
 

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Original Release: 18 June 2015 
Current Version: 11 August 2016 
Revision History 
Revision Number 
Release Date 
Section 
Change 
Reason for Change 
AA 
15 June 2015 
N/A 
Initial Release 
N/A 
AB 
12 August 
2015 
All sections 
 
Specification of MRI 
artifact as an Ancillary 
assessment. Included 
all Ancillary 
Assessments in Section 
2. 
Clarifications and 
corrections throughout 
Clarifications and 
corrections 
AC 
23 November 
2015 
 
Sections 2, 5, 
6, 7,  9, 11, 
12, 13, 17, 
20, 21 and 27 
 
Update the RA leads 
available for the US 
sites. Incorporated 
“For Cause” VF 
Induction and VF 
Induction Sub-Study. 
Adjusted sample size 
to accommodate an 
interim analysis. 
Administrative 
changes throughout 
document 
Clarify study design 
and incorporate VF 
Induction Sub-Study 
AD 
17 March 
2016 
Sections 2, 5, 
6, 10, 11, 12, 
13,  20 and 
21 
Addition of 
RELIANCE 4-FRONT 
Lead for the U.S. 
Updating protocol with 
new MEDDEV 
requirements. 
Administrative 
changes. 
Add an additional RV 
lead choice for the US 
and adapt to new 
MEDDEV guidance 
AE 
11 August 
2016 
Sections 2, 5, 
9, 10, 11, 12, 
13, 21 and 28 
Updated exclusion 
criteria 5 & 6 
Adding additional 
warnings for MRI 
protection mode 
Updated Phase I and 
Phase II definitions 
Updated MRI visit 
Heart Rhythm 
Monitoring 
Updated Medically 
Necessary MRI 
requirements 
Clarified that pre-scan 
time does not count 
Implement additional 
screening steps at 
inclusion and the MRI 
visit to better detect 
subjects at risk of 
complete AV Block 
Updated MEDDEV 
requirements for AE 
reporting 

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against the required RF 
and gradient intensive 
sequences 
 
 

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Protocol Authors 
Name 
Title 
Nathan Carter 
Biostatistician 
Brian Jingwa 
Clinical Data Manager 
Barbara Mercier 
Clinical Data Manager 
Laura Smith 
Clinical Research Associate 
Katerina Gibinska 
Clinical Research Associate 
Julien Delumeau 
Clinical Trial Manager 
Valérie Lens 
Clinical Trial Manager 
Troy Graczyk 
Regional Clinical Manager 
Christine Stuenkel 
Safety Trial Operations 
 
 
 

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2. Protocol Synopsis  
ENABLE MRI Study 
Objective(s) 
The objective of this study is to collect data to confirm the safety and 
effectiveness of the ImageReady™ MR Conditional Defibrillation System when 
used in the 1.5T MRI environment under the labeled Conditions of Use (Phase I). 
Additionally, the study will assess medically necessary MR scans according to the 
labeled Conditions of Use to provide real-world scanning data (Phase I and Phase 
II). 
The study also aims to demonstrate the continued ability of the ImageReady MR 
Conditional Defibrillation System to sense and detect ventricular fibrillation (VF) 
post MRI scan by collecting and analyzing data from spontaneous VF episodes, 
“for-cause” VF inductions, and from an optional VF induction Sub-study. 
Test system   
ImageReady MR Conditional Defibrillation System (ImageReady System) 
 
ImageReady 
MR 
Conditional 
Defibrillation 
System 
Components 
Table 2-1: ImageReady MR Conditional Defibrillation System 
Components  
Device Name 
Device Model Number 
Pulse Generators 
Phase I and II 
Phase II Only * 
CRT-D 
(IS1/DF4/IS4) 
VR ICD (DF4) 
DR ICD  (IS1/DF4) 
ORIGEN™ MINI ICD 
-- 
D000 
D002 
ORIGEN EL ICD 
-- 
D050 
D052 
ORIGEN X4 CRT-D 
G058 
-- 
-- 
INOGEN™ MINI ICD 
-- 
D010 
D012 
INOGEN EL ICD 
-- 
D140 
D142 
INOGEN X4 CRT-D 
G148 
-- 
-- 
DYNAGEN™ MINI ICD 
-- 
D020 
D022 
DYNAGEN EL ICD 
-- 
D150 
D152 
DYNAGEN X4 CRT-D 
G158 
-- 
-- 
AUTOGEN ™ MINI 
ICD* 
-- 
D044 
D046 
AUTOGEN EL ICD* 
-- 
D174 
D176 
AUTOGEN X4 CRT-D* 
G179 
-- 
-- 
Right Atrial Leads and Accessories 
FINELINE™ II Sterox 
4479, 4480 
FINELINE II Sterox EZ 
4469, 4470, 4471, 4472, 4473, 4474 
Suture Sleeves for FINELINE II Leads 
6220, 6221 
INGEVITY™ MRI* 
7735, 7736, 7740, 7741, and 7742 
Suture Sleeve for INGEVITY MRI* 
6402 
IS-1 Lead Port Plug 
7145 
Right Ventricular Leads and Accessories 

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ENABLE MRI Study 
RELIANCE 4-FRONT™ (DF4)**; ǂ 
0636, 0654, 0655, 0657, 0658, 0665, 0675, 
0676, 0682, 0683, 0685, 0686, 0692, 0693, 
0695, and 0696 
Suture Sleeve for RELIANCE 4-
FRONT leads**; ǂ 
6403 
ENDOTAK RELIANCE™ (DF4) 
0265, 0266, 0275, 0276, 0282, 0283, 0285, 
0286, 0292, 0293, 0295, and 0296 
Left Ventricular Leads and Accessories 
ACUITY™ X4 (IS4)  
4671, 4672, 4674, 4675, 4677, and 4678 
Suture Sleeve for ACUITY X4 leads 
4603 
Non-Implanted Components 
ZOOM™ LATITUDE™ PRM 
3120 
ZOOM LATITUDE PRM Software 
Application 
2868 v3.07 or later 
* May only be used internationally outside the US 
**The ACUITY X4 pacing lead and RELIANCE 4-FRONT lead may be investigational in the US during 
a portion or the entire duration of the study  
ǂ For the US, only existing RELIANCE 4-FRONT implants will be allowed 
Study Design 
A prospective, non-randomized, confirmatory, global study to be conducted as an 
IDE in the United States, and as a post market study in Europe, Israel and Asia 
Pacific 
Planned 
Number of 
Subjects 
500 subjects will be enrolled in the study.   
Planned 
Number of 
Centers / 
Countries 
Approximately 70 sites in the United States, Europe, Israel and Asia Pacific 
Primary Safety 
Endpoint-
Phase I 
MR scan-related Complication-free rate between the MR Scan and the MRI + 1 
Month Visit 
Primary 
Effectiveness 
Endpoints-
Phase I 
• 
Increase in RV pacing threshold from the pre-MR scan to the 1 Month post-
MR scan 
• 
Decrease in RV sensed amplitude from the pre-MR scan to the 1 Month post-
MR scan 
• 
Increase in LV pacing threshold from the pre-MR scan to the 1 Month post-
MR scan 

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ENABLE MRI Study 
• 
Decrease in LV sensed amplitude from the pre-MR scan to the 1 Month post-
MR scan 
Ancillary 
Assessments 
• 
Assessment of RV and LV impedances 
• 
Assessment of RA lead measurements 
• 
Assessment on MR scan effect on lead measurements 
• 
Assessment of VT/VF episodes post-MR-scan 
• 
Assessment of effect of medically necessary MR scans 
• 
Assessment of Beeper function 
• 
Assessment of programming the MRI Protection Mode 
• 
Assessment of Image Artifacts for non-medically necessary MR scans. 
• 
Collect real-world information from medically necessary MR scan(s)   
Follow-up 
Schedule  
Study procedures or clinic visits will occur at the following time periods: 
For patients with de novo implants,  
• 
Screening and Enrollment Visit (≤ 30 days prior to implant procedure )   
• 
Implant Procedure 
• 
Pre-Discharge Clinic Visit (3 – 72 hours post-implant) 
• 
MRI Visit (6-9 weeks post-implant) (Phase I only) 
• 
MRI  + 1 Month Visit (30 ± 7 days post-MRI Visit) (Phase I only) 
• 
Every Three-month follow-ups post MR scan (recommended) 
• 
Annual device follow-ups (for 3 years): Every 12 months ± 3 months 
For patients with existing implants,  
• 
Screening and Enrollment Visit 
• 
MRI Visit (within 6 weeks from enrollment) (Phase I only) 
• 
MRI + 1 Month Visit (30 ± 7 days post-MRI Visit) (Phase I only) 
• 
Every Three-month follow-ups post MR scan (recommended) 
• 
Annual device follow-ups (for 3 years): Every 12 months ± 3 months  
 
Study 
Duration 
The study is expected to start in 2015, and last approximately 5.5 years.  
 
 

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Key Inclusion 
Criteria 
1. Phase I: Subject is indicated per guidelines and will receive a CRT-D or ICD 
system consisting only of the following MR Conditional components* OR 
Subject is implanted with a functional and stable CRT-D or ICD system 
consisting only of the following MR Conditional components*    
Phase II: Subject is implanted with a functional and stable CRT-D or ICD 
system consisting only of the following MR Conditional components* 
* MR Conditional Components  
(refer to Table 2-1 for component model numbers): 
Lead/PG 
International 
(All Market Approved) 
US 
RA Lead 
INGEVITY MRI 
FINELINE II Sterox/Sterox EZ  
FINELINE II Sterox/Sterox EZ 
RV Lead 
RELIANCE 4-FRONT 
RELIANCE 4-FRONT1, ǂ 
ENDOTAK RELIANCE 
ENDOTAK RELIANCE 
LV Lead 
ACUITY X4 
ACUITY X4 1 
Phase I: PG 
• VR ICD  
 
• CRT-D2  
 
PG Header 
Device Name 
PG Header 
Device 
Name 
VR ICD (DF4),  
CRT-D2 
(IS1/DF4/IS4)  
ORIGEN  
INOGEN 
DYNAGEN 
AUTOGEN 
VR ICD 
(DF4),  
CRT-D2 
(IS1/DF4/IS4)  
ORIGEN  
INOGEN 
DYNAGEN 
Phase II: PG 
PG Header 
Device Name 
PG Header 
Device 
Name 
VR ICD (DF4),  
DR ICD2 
(IS1/DF4),  
CRT-D2 
(IS1/DF4/IS4) 
ORIGEN  
INOGEN 
DYNAGEN 
AUTOGEN 
VR ICD 
(DF4),  
CRT-D2 
(IS1/DF4/IS4) 
ORIGEN  
INOGEN 
DYNAGEN 
1 The ACUITY X4 pacing lead and RELIANCE 4-FRONT lead may be investigational in the US 
during a portion or the entire duration of the study  
ǂ For the US, only existing RELIANCE 4-FRONT implants will be allowed 
2 Port plug 7145 must be used in DR ICDs and CRT-Ds with no atrial lead   
2. Subject will receive or is implanted with an ICD or CRT-D pulse generator in 
the left or right pectoral region 
3. Subject is able and willing to undergo an MR scan without intravenous 
sedation (Phase I only) 
4. Subject is willing and capable of providing informed consent and participating 
in all testing/ visits associated with this clinical study at an approved clinical 
study center and at the intervals defined by this protocol 
5. Subject is age 18 or above, or of legal age to give informed consent specific to 
state and national law 
Key 
Exclusion 
Criteria 
1. Subject implanted with an ICD or CRT-D pulse generator with battery at 
Explant status 

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2. Subject has other active or abandoned implanted cardiac rhythm devices, 
components or accessories present such as pulse generators, leads, lead 
adaptors or extenders 
3. Presence of metallic objects that represent a contraindication to MR imaging at 
the discretion of the Radiologist and impacting the ability to conduct the study 
protocol 
4. Subject needs or will need a medically necessary MR scan, before completing 
the 1-month post-MR follow-up visit (Phase I only) 
5. Subject with: 
• 
A history of syncope related to brady-arrhythmia 
• 
A history of syncope of unknown etiology 
• 
Sinus pauses (Pause > 2 s) 
• 
Permanent or intermittent complete AV block 
• 
Documentation of progressive AV nodal block over time 
• 
Trifascicular block (alternating bundle branch block or PR > 200 ms 
with LBBB or other bifascicular block)  
Note: It is required to run a 12 lead ECG and a 10s rhythm strip to document 
this exclusion criterion. During ECG acquisition, subjects must be in either their 
own intrinsic rhythm or, in subjects with an existing device implant, the device 
must be programmed to VVI 40 ppm. 
6. Subject is not clinically capable of tolerating the absence of pacing or 
Resynchronization therapy support in a supine position for the duration that the 
pulse generator is in MRI Protection Mode, per Physician discretion 
7. Subject is not clinically capable of tolerating the absence of Tachycardia 
therapy support for the duration that the pulse generator is in MRI Protection 
Mode, per Physician discretion 
8. Subjects with a planned RA, RV or LV lead revision or extraction within 30 
days of enrollment (Phase I only) 
9. Subjects with an implanted lead that is planned to be extracted during the 
study implant procedure  
10. Subjects currently requiring dialysis 
11. Subject has a mechanical heart valve 
12. Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) 
13. Subject is currently on the active heart transplant list  
14. Subject has documented life expectancy of less than 12 months  
15. Subject is enrolled in a concurrent study, with the exception of local mandatory 
governmental registries and observational studies/registries, without the 
written approval from Boston Scientific 

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16. Women of childbearing potential who are or might be pregnant, and will 
receive an ICD or CRT-D pulse generator 
VF Induction 
Sub-study 
Exclusion 
Criteria 
In addition to meeting all of the inclusion criteria and none of the exclusion criteria 
of the ENABLE MRI study, subjects enrolled in the VF Induction Sub-study must 
also not meet any of the following VF Induction Sub-study exclusion criteria: 
1. Unstable heart failure requiring hospitalization in the last 30 calendar days  
2. Unable to tolerate sedation (e.g. IV sedation, general anesthesia)  
3. Planned cardiac revascularization procedure 
4. Right Ventricular Lead R wave is less than 5 mV  

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Statistical Methods  
Hypotheses testing in the ENABLE MRI Study will use standard statistical methodology. 
 
Endpoint 
Assessment 
Expected Value 
Performance Goal 
Test 
 
Alpha Level 
Power Level 
Number of Subjects  
Assumed Attrition 
Number of Subjects 
with Assumed  Attrition 
Safety 
Primary 
MR Scan-Related 
ImageReady 
System 
Complication-Free 
Rate  
97.5% 
90% 
Kaplan-Meier 
2.5% 
94.3% 
137 
30% 
195 
Effectiveness 
Primary 
RV 1 
Pacing Threshold - 
increase in pacing 
thresholds ≤ 0.5V 
(at 0.5 ms) 
97%  
87% 
One-sided 
Exact Test for 
a Single 
Binomial 
Proportion 
5% 
80% 
58 
40% 
97 
Primary 
RV 2 
Sensed Amplitude 
–remains ≥ 5.0 mV 
and above 50% of 
the value at the MR 
Follow-up Visit 
95%  
85% 
One-sided 
Exact Test for 
a Single 
Binomial 
Proportion 
5% 
80% 
68 
45% 
124 
Primary 
LV 1 
 
Pacing Threshold - 
increase in pacing 
thresholds ≤ 1V 
between MR 
Follow-up and Post-
MR Follow-up Visits 
97%  
87% 
One-sided 
Exact Test for 
a Single 
Binomial 
Proportion 
5% 
90% 
68 
40% 
114 
Primary 
LV 2 
Sensed Amplitude 
–remains ≥ 5.0 mV 
and above 50% of 
the value at the MR 
Follow-up Visit 
95%  
85% 
One-sided 
Exact Test for 
a Single 
Binomial 
Proportion 
5% 
90% 
85 
45% 
155 
Abbreviations: RV: Right Ventricle; LV: Left Ventricle 
 
   
 

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3. Table of Contents 
1. 
TITLE PAGE  .......................................................................................................................1 
2. 
PROTOCOL SYNOPSIS .........................................................................................................6 
3. 
TABLE OF CONTENTS .......................................................................................................13 
3.1 
Table of Figures .....................................................................................................20 
3.2 
Table of Tables ......................................................................................................20 
4. 
INTRODUCTION ................................................................................................................22 
5. 
DEVICE DESCRIPTION ......................................................................................................23 
5.1 
Boston Scientific’s ICD and CRT family of PGs ................................................24 
5.1.1 
MRI Protection Mode ...............................................................................24 
5.2 
Boston Scientific’s Right Atrial Leads and Accessories ....................................26 
5.3 
Boston Scientific’s Right Ventricular Leads and Accessories...........................27 
5.4 
Boston Scientific’s ACUITY X4 Quadripolar LV Lead and Accessories ........27 
5.5 
Programming System............................................................................................28 
6. 
CONDITIONS OF USE ........................................................................................................29 
6.1 
Cardiology ..............................................................................................................29 
6.2 
Radiology ...............................................................................................................31 
7. 
OBJECTIVES .....................................................................................................................31 
8. 
ENDPOINTS (PHASE I ONLY) ............................................................................................32 
8.1 
Primary Safety Endpoint ......................................................................................32 
8.2 
Primary Effectiveness Endpoints.........................................................................32 
9. 
DESIGN .............................................................................................................................32 
9.1 
Scale and Duration ................................................................................................32 
9.2 
Justification for the Study Design ........................................................................34 
10. SUBJECT SELECTION ........................................................................................................34 

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10.1 Study Population and Eligibility ..........................................................................34 
10.2 Inclusion Criteria ..................................................................................................35 
10.3 Exclusion Criteria .................................................................................................37 
10.3.1 
VF Induction Sub-study Exclusion Criteria .............................................39 
11. SUBJECT ACCOUNTABILITY .............................................................................................39 
11.1 Screening and Point of Enrollment .....................................................................39 
11.1.1 
Subjects enrolled under previous protocol versions .................................39 
11.1.2 
Subjects enrolled under protocol rev AE and future revisions .................40 
11.2 Withdrawal ............................................................................................................40 
11.3 Subject Status and Classification .........................................................................41 
11.3.1 
Intent .........................................................................................................41 
11.3.2 
Consent ineligible .....................................................................................42 
11.3.3 
Attempt .....................................................................................................42 
11.3.4 
Partial Implant ..........................................................................................42 
11.3.5 
Implant ......................................................................................................42 
11.3.6 
Existing Implant ........................................................................................43 
11.4 Enrollment Controls .............................................................................................43 
11.4.1 
Phase I .......................................................................................................43 
11.4.2 
Phase II .....................................................................................................43 
11.5 End-of-Study Action Plan ....................................................................................44 
12. STUDY METHODS .............................................................................................................44 
12.1 Data Collection ......................................................................................................44 
12.2 Study Candidate Screening ..................................................................................48 
12.3 Informed Consent .................................................................................................48 
12.4 Screening and Enrollment Visit ...........................................................................48 
12.4.1 
Screening and Enrollment Source Data Requirements .............................49 
12.5 Implant ...................................................................................................................49 
12.5.1 
Device Evaluation .....................................................................................50 
12.5.2 
Completing the Implant Visit ...................................................................54 
12.5.3 
Implant Source Data Requirements ..........................................................54 
12.6 Pre-Discharge ........................................................................................................54 
12.6.1 
Device Evaluation .....................................................................................54 

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12.6.2 
Completing the Pre-Discharge Visit .........................................................55 
12.6.3 
Pre-Discharge Source Data Requirements ................................................55 
12.7 MRI Visit (Phase I only) .......................................................................................55 
12.7.1 
Device Evaluation Prior to Commencement of MR Scan ........................56 
12.7.2 
Subject Evaluation Prior to Commencement of MR Scan .......................57 
12.7.3 
MR Scans ..................................................................................................58 
12.7.4 
Device Evaluation after the MR Scan ......................................................61 
12.7.5 
Completing the MRI Visit ........................................................................61 
12.7.6 
MRI Visit Source Data Requirements ......................................................62 
12.8 MRI + 1 Month Visit (Phase I only) ....................................................................64 
12.8.1 
Device Evaluation .....................................................................................64 
12.8.2 
VF Induction .............................................................................................64 
12.8.3 
Completing the MRI + 1 Month Visit ......................................................66 
12.8.4 
MRI + 1 Month Visit Source Data Requirements ....................................67 
12.9 Every Three-month Follow ups through Three Years (Recommended) .........67 
12.9.1 
Device Evaluation .....................................................................................68 
12.9.2 
Every Three-month Visit Source Data Requirements ..............................68 
12.10 Annual Follow ups through Three Years ...........................................................69 
12.10.1 Standard Device Evaluation .....................................................................69 
12.10.2 Completing the Annual Visit ....................................................................69 
12.10.3 Annual Visit Source Data Requirements ..................................................70 
12.11 Additional Visits ....................................................................................................70 
12.11.1 Required Data Collection .........................................................................71 
12.11.2 Recommended Data Collection ................................................................71 
12.11.3 Additional Follow-up Visit Source Data Requirements ...........................72 
12.12 Medically Necessary MRI Visits ..........................................................................72 
12.12.1 Medically Necessary MRI Visit Source Data Requirements ...................72 
12.13 Study Completion ..................................................................................................74 
13. STATISTICAL CONSIDERATIONS ......................................................................................74 
13.1 Endpoints (Phase I only) .......................................................................................74 
13.1.1 
Primary Safety Endpoint: MR Scan-Related ImageReady System 
Complication Free Rate ............................................................................74 
13.1.2 
Primary RV Effectiveness Endpoint 1: Pre-MR Scan vs. 1 Month Post-
MR Scan RV Pacing Threshold at 0.5 ms ................................................75 

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13.1.3 
Primary RV Effectiveness Endpoint 2: Pre-MR scan vs. 1 Month Post-
MR Scan RV Sensed Amplitude ..............................................................77 
13.1.4 
Primary LV Effectiveness Endpoint 1: Pre MR Scan- vs. 1 Month Post-
MR Scan LV Pacing Threshold at 0.5 ms ................................................78 
13.1.5 
Primary LV Effectiveness Endpoint 2: Pre-MR scan vs. 1 Month Post-
MR Scan LV Sensed Amplitude...............................................................80 
13.2 Ancillary Assessments ...........................................................................................81 
13.2.1 
Assessment of RV and LV Impedances ...................................................81 
13.2.2 
Assessment of RA lead measurements .....................................................81 
13.2.3 
Assessment on MR Scan Effect on Lead Measurements .........................81 
13.2.4 
Assessment of VT/VF...............................................................................82 
13.2.5 
Assessment of Effect of Medically Necessary MR Scans ........................82 
13.2.6 
Assessment of Beeper Function ................................................................82 
13.2.7 
Assessment of Programming the MRI Protection Mode ..........................82 
13.2.8 
Assessment of Image Artifacts for non-medically necessary MR scans ..83 
13.3 Sample Size Summary ..........................................................................................83 
13.4 General Statistical Methods .................................................................................83 
13.4.1 
Control of Systematic Error/Bias ..............................................................83 
13.4.2 
Control of Type I Error .............................................................................83 
13.4.3 
Number of Subjects per Investigative Site ...............................................83 
13.5 Data Analyses ........................................................................................................83 
13.5.1 
Interim Analyses .......................................................................................84 
13.5.2 
Pooling Analyses ......................................................................................84 
13.5.3 
Subgroup Analyses ...................................................................................85 
13.5.4 
Multivariate Analyses ...............................................................................85 
13.5.5 
Changes to Planned Analyses ...................................................................85 
14. DATA MANAGEMENT .......................................................................................................86 
14.1 Data Collection, Processing, and Review ............................................................86 
14.2 Data Retention .......................................................................................................86 
14.3 Image Artifact Core Laboratory .........................................................................86 
14.4 ECG Core Laboratory ..........................................................................................87 
15. AMENDMENTS ..................................................................................................................87 
16. DEVIATIONS .....................................................................................................................87 

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17. DEVICE ACCOUNTABILITY ..............................................................................................87 
17.1 Device Accountability for Existing Implants of Investigational Leads ............88 
17.2 Device Accountability for De-Novo Implants of Investigational Leads ...........88 
18. COMPLIANCE ....................................................................................................................89 
18.1 Statement of Compliance ......................................................................................89 
18.2 Investigator Responsibilities ................................................................................89 
18.2.1 
Delegation of Responsibility ....................................................................91 
18.3 Institutional Review Board/ Ethics Committee ..................................................91 
18.4 Sponsor Responsibilities .......................................................................................91 
18.4.1 
Role of Boston Scientific Representatives ...............................................92 
18.5 Insurance ................................................................................................................93 
19. MONITORING ....................................................................................................................93 
20. POTENTIAL RISKS AND BENEFITS ...................................................................................93 
20.1 Risks Associated with a CRT-D ...........................................................................93 
20.2 Risks Associated with an ICD ..............................................................................95 
20.3 Risks Associated with the Study Device(s) ..........................................................97 
20.4 Risks associated with Participation in the Clinical Study .................................97 
20.4.1 
Beeper .......................................................................................................98 
20.4.2 
Risks Related to VF Induction Testing .....................................................99 
20.5 Possible Interactions with Concomitant Medical Treatments ..........................99 
20.6 Risk Minimization Actions ...................................................................................99 
20.7 Anticipated Benefits ............................................................................................100 
20.8 Risk to Benefit Rationale ....................................................................................100 
21. SAFETY REPORTING .......................................................................................................100 
21.1 Events Reportable by Sites to Sponsor .............................................................100 
21.2 Event Definitions and Classification .................................................................101 
21.3 Unanticipated Adverse Device Effects ..............................................................103 
21.4 Adverse Event Classification for FDA Reporting ............................................104 
21.4.1 
Observation/Complication ......................................................................104 
21.4.2 
Adverse Event Type Classification ........................................................106 

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21.4.3 
Adverse Event Outcome Status ..............................................................106 
21.5 Subject Death Reporting ....................................................................................106 
21.6 Subject Death Classification ..............................................................................107 
21.7 Relationship to Study Device(s) or Procedure ..................................................111 
21.8 Investigator Reporting Requirements ...............................................................114 
21.9 Exceptions for Use of Investigational Feature at Non-Investigational Sites – 
US Only ................................................................................................................115 
21.10 Boston Scientific Device Deficiencies .................................................................116 
21.11 Reporting to Regulatory Authorities / IRBs / ECs / Investigators .................117 
22. INFORMED CONSENT......................................................................................................117 
23. COMMITTEES .................................................................................................................118 
23.1 Clinical Events Committee .................................................................................118 
24. SUSPENSION OR TERMINATION .....................................................................................119 
24.1 Premature Termination of the Study ................................................................119 
24.1.1 
Criteria for Premature Termination of the Study ....................................119 
24.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC Approval ...............................................................................................119 
24.3 Requirements for Documentation and Subject Follow-up ..............................119 
24.4 Criteria for Suspending/Terminating a Study Center .....................................120 
25. PUBLICATION POLICY ....................................................................................................120 
26. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS ...............................................121 
26.1 Subject Reimbursement......................................................................................121 
26.2 Compensation for Subject’s Health Injury ......................................................121 
27. ABBREVIATIONS AND DEFINITIONS ...............................................................................121 
27.1 Abbreviations ......................................................................................................121 
28. MR SCAN SEQUENCES PROTOCOL ................................................................................122 
28.1 Background ..........................................................................................................123 
28.2 MR Conditional Labeling ...................................................................................123 
28.3 Notes Regarding the MR Scan ...........................................................................123 

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29. MEDICARE STUDY CRITERIA .........................................................................................126 
30. BIBLIOGRAPHY ...............................................................................................................127 
 
 
 
 

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3.1 
Table of Figures 
Figure 5.4-1: ACUITY X4 Leads and Electrode Placement .................................................. 28 
Figure 9.1-1: ENABLE MRI Study Design ............................................................................ 34 
 
3.2 
Table of Tables 
Table 2-1: ImageReady MR Conditional Defibrillation System Components ......................... 6 
Table 5-1: ImageReady MR Conditional Defibrillation System Components ....................... 23 
Table 5-2: Programming System (Non-implanted Components) for ImageReady MR 
Conditional Defibrillation System ....................................................................... 29 
Table 10-1: Inclusion Criteria ................................................................................................. 36 
Table 10-2: Exclusion Criteria ................................................................................................ 38 
Table 10-3: VF Induction Sub-Study Exclusion Criteria ....................................................... 39 
Table 12-1: Data Collection Schedule .................................................................................... 46 
Table 12-2: Screening and Enrollment Source Documentation Requirements ...................... 49 
Table 12-3:  Test Parameters .................................................................................................. 51 
Table 12-4:  Implant Source Documentation Requirements ................................................... 54 
Table 12-5: Pre-Discharge Source Documentation Requirements ......................................... 55 
Table 12-6: MRI Visit Source Documentation Requirements ................................................ 62 
Table 12-7: MRI + 1 Month Source Documentation Requirements....................................... 67 
Table 12-8: Every Three Month Source Documentation Requirements ................................ 68 
Table 12-9: Annual Source Documentation Requirements .................................................... 70 
Table 12-10: Additional Follow-up Source Documentation Requirements ........................... 72 
Table 12-11: Medically Necessary MRI Visit Source Documentation Requirements ........... 73 
Table 20-1: Potential Adverse Events for Implantation of a Pulse Generator and/ or Lead 
System.................................................................................................................. 93 
Table 20-2 Potential Adverse Events of a Pulse Generator .................................................... 95 
Table 20-3: Potential Adverse Events for implantation of a Coronary Venous Lead ............ 95 
Table 20-4: Potential Adverse Events for implantation of a Pulse Generator and/ or Lead 
System.................................................................................................................. 95 
Table 20-5 Potential Intolerance to a Pulse Generator ........................................................... 96 

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Table 20-6: Situations that will no longer trigger audible Beeper tones once the device is 
programmed into MRI Protection Mode ............................................................. 99 
Table 21-1: Event Definitions ............................................................................................... 102 
Table 21-2: Definition of Observation and Complication .................................................... 104 
Table 21-3: Adverse Event Types I-V Utilized for BSC AE Classification ......................... 106 
Table 21-4: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event .................................................................................................................. 112 
Table 21-5: Investigator Reporting Requirements ................................................................ 115 
Table 27-1: Abbreviations .................................................................................................... 121 
Table 28-1: Scan Sequence Protocol .................................................................................... 124 
 

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4. Introduction 
Magnetic resonance imaging (MRI) is a diagnostic technique that images body parts by 
producing a static magnetic field followed by rapidly changing radiofrequency fields to 
excite hydrogen nuclei. MRI scanning is now the imaging modality of choice for many 
neurological and musculoskeletal conditions. In the past, implanted cardiac devices including 
pacemakers and implanted cardioverter-defibrillators have been contraindicated in MRI 
scanners 1,2. Recent studies, though, have suggested that select patients may be safely 
scanned 3,4. Medical societies in both Europe and the United States have acknowledged these 
findings with publication of expert opinion and guidelines on scanning patients with 
implanted cardiac devices5,6. 
A number of studies have reported on the relative safety of scanning patients with cardiac 
pacemakers or implantable cardioverter-defibrillators. Martin, et al. reported on 54 patients 
undergoing 62 scans. In their series, 9.4% of patients had significant pacing threshold 
changes, of which 1.9% required device reprogramming3. Nazarian, et al.7 evaluated 55 
patients undergoing 68 scans without any adverse events. In a series reported by Sommer, et 
al. 4, 82 patients underwent 115 scans. An increase in pacing thresholds was seen in 3.1% of 
leads. In a larger series, 103 patients underwent a total of 127 scans without any significant 
change in pacing thresholds immediately post-scan, though small changes in sensed 
amplitude and pacing impedances were seen8. In that series, no restriction was placed on 
landmark or on maximum SAR. When high-SAR scans (SAR greater than 2 W/kg) were 
evaluated separately, no significant change in pacing capture thresholds were seen, though 
immediately post-scan lead impedances and sensed amplitudes were lower. 
More recently, preliminary results from the first 829 cases (617 pacemakers, 212 ICDs, 1620 
leads) of a large, prospective, Investigational Device Exemption (IDE) study showed no 
deaths, device failures, generator/lead replacements, ventricular arrhythmias, or losses of 
capture during non-thoracic MRI at 1.5T for routine clinical care9. Nazarian et al 10, in a 
prospective non randomized trial involving 555 MRI scans from 488 patients, showed that 
MRI was performed safely. There was no immediate or long-term change in device variables 
that required system revision or reprogramming. Small changes in acute lead sensing, 
impedances, and capture thresholds after MRI were reported and attributed to heating at the 
lead–tissue interface10. 
Boston Scientific (BSC) intends to provide MR Conditional labeling to certain models of 
existing Implantable Cardiac Defibrillator (ICD) and Cardiac Resynchronization Therapy – 
Defibrillator (CRT-D) implantable pulse generators (PGs) and associated implantable leads.  
This combination of PGs and leads will be referred to as the ImageReady™ MR Conditional 
Defibrillation System (ImageReady System). The ImageReady System will have CE mark at 
the start of the ENABLE MRI study and commercially available in geographies that accept 
CE mark. The ENABLE MRI study will be used to support regulatory approval of the 
ImageReady System in additional geographies.   
 

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5. Device Description 
The ImageReady MR Conditional Defibrillation System included in the ENABLE MRI 
Clinical Study, here to forward referred to as the ImageReady System, consists of: 
• Certain models from the Next Generation (NG3) ICD  and CRT-D family of PGs 
(Section 5.1 and Table 5-1)  
• FINELINE II Sterox/Sterox EZ or INGEVITY MRI  pace/sense lead families for the 
Right Atrial (RA) lead (Section 5.2 and Table 5-1) 
• RELIANCE 4-FRONT™  or ENDOTAK RELIANCE  DF4 defibrillation lead 
families for the Right Ventricle (RV) lead (Section 5.3 and Table 5-1) 
• ACUITY X4 IS4 heart failure lead family for the Left Ventricle (LV) lead (Section 
5.4 and Table 5-1) 
The ImageReady MR Conditional Defibrillation System models will be labeled as “MR 
Conditional” as defined by the American Society for Testing and Materials (ASTM)1, when 
used as a system and in accordance with the labeled MRI Conditions of Use. 
Table 5-1: ImageReady MR Conditional Defibrillation System Components  
Device Name 
Device Model Number 
Pulse Generators 
Phase I and II 
Phase II Only * 
CRT-D (IS1/DF4/IS4) 
VR ICD (DF4) 
DR ICD  
(IS1/DF4) 
ORIGEN™ MINI ICD 
-- 
D000 
D002 
ORIGEN EL ICD 
-- 
D050 
D052 
ORIGEN X4 CRT-D 
G058 
-- 
-- 
INOGEN™ MINI ICD 
-- 
D010 
D012 
INOGEN EL ICD 
-- 
D140 
D142 
INOGEN X4 CRT-D 
G148 
-- 
-- 
DYNAGEN™ MINI ICD 
-- 
D020 
D022 
DYNAGEN EL ICD 
-- 
D150 
D152 
DYNAGEN X4 CRT-D 
G158 
-- 
-- 
AUTOGEN ™ MINI ICD* 
-- 
D044 
D046 
AUTOGEN EL ICD* 
-- 
D174 
D176 
AUTOGEN X4 CRT-D* 
G179 
-- 
-- 
Right Atrial Leads and Accessories 
FINELINE™ II Sterox 
4479, 4480 
FINELINE II Sterox EZ 
4469, 4470, 4471, 4472, 4473, 4474 
Suture Sleeves for FINELINE II Leads 
6220, 6221 
INGEVITY™ MRI* 
7735, 7736, 7740, 7741, and 7742 
Suture Sleeve for INGEVITY MRI* 
6402 
                                                 
1 ASTM Standard F2503-08, "Standard Practice for Marking Medical Devices and Other Items for Safety in the 
Magnetic Resonance Environment" ASTM International, West Conshohocken, PA, 2008, DOI: 10.1520/F2503-
08, www.astm.org. 

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Device Name 
Device Model Number 
IS-1 Lead Port Plug 
7145 
 
Right Ventricular Leads and Accessories 
RELIANCE 4-FRONT™ (DF4) **, ǂ 
0636, 0654, 0655, 0657, 0658, 0665, 0675, 
0676, 0682, 0683, 0685, 0686, 0692, 0693, 
0695, and 0696 
Suture Sleeve for RELIANCE 4-FRONT leads** , 
ǂ 
6403 
ENDOTAK RELIANCE™ (DF4) 
0265, 0266, 0275, 0276, 0282, 0283, 0285, 
0286, 0292, 0293, 0295, and 0296 
Left Ventricular Leads and Accessories 
ACUITY™ X4 (IS4) **   
4671, 4672, 4674, 4675, 4677, and 4678 
Suture Sleeve for ACUITY X4 leads** 
4603 
Non-Implanted Components 
ZOOM™ LATITUDE™ PRM 
3120 
ZOOM LATITUDE PRM Software Application 
2868 v3.07 or later 
 
* May only be used internationally outside the US 
**The ACUITY X4 pacing lead and RELIANCE 4-FRONT lead may be investigational in the US during a portion 
or the entire duration of the study  
ǂ For the US, only existing RELIANCE 4-FRONT implants will be allowed 
 
5.1 
Boston Scientific’s ICD and CRT family of PGs  
Boston Scientific’s MR Conditional defibrillators are comprised of select models of the 
AUTOGEN, DYNAGEN, INOGEN, and ORIGEN ICD and CRT-D devices. Only single 
chamber (VR) and dual chamber (DR) ICD devices with a DF4 right ventricular port and 
CRT-D devices with IS-1/DF4/IS4 port are MR Conditional. The BSC ICD and CRT-D 
models used in the study are approved for commercial use, with the exception of the 
AUTOGEN PGs which are not commercially approved in the US at the start of the study. In 
the US, the AUTOGEN PGs may become approved during the study; however the devices 
still cannot be used in the ENABLE MRI study in the US. 
The PG hardware was not changed. The PG firmware (FW) and Programmer Software 
Application (SW) was updated to provide MRI Protection Mode to these models. Refer to the 
ICD and CRT-D Reference Guide for additional information about the PGs.  
 
5.1.1 MRI Protection Mode 
MRI Protection Mode is accessible through the 3120 programmer/recorder/monitor (PRM) 
that has the 2868 software application (see Section 5.5). Prior to the patient undergoing an 
MRI scan, the PG must be programmed to the MRI Protection Mode using the PRM. 

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Adherence to the MRI Conditions of Use must be verified prior to each scan to assess the 
patient’s eligibility and readiness for an MR scan (see Section 6). 
 
At the start of the study, in international geographies, the ‘MRI Protection Mode’ will have 
CE mark and be available for commercial use.  
In the US, a programmer key (dongle) is required to interrogate the VR ICDs and 
CRT-Ds to access the investigational ‘MRI Protection Mode’.  
NOTE: MRI Protection Mode may become approved in the US during the study. If this 
occurs, then the dongle will no longer be needed to access MRI Protection Mode. 
In the MRI Protection Mode, the following features and functions are suspended: 
• Bradycardia sensing/pacing 
• Cardiac Resynchronization Therapy  
• Tachycardia detection and therapy 
• PaceSafe™** automatic threshold(s) 
• Daily diagnostics (Lead Impedance, Intrinsic Amplitude, Pace Threshold) 
• Motion and respiratory sensors 
• Magnet detection 
• RF telemetry 
• Battery voltage monitoring 
• Beeper is disabled 
** Only available internationally outside the US 
NOTE: In MRI Protection Mode there is no pacing and no antitachycardia therapy 
available.  
During MRI Protection Mode, the patient will not receive pacing until the PG is returned 
back to normal operation. Additionally, the system will not detect ventricular arrhythmias 
and the patient will not receive anti-tachycardia pacing (ATP) or shock defibrillation therapy 
until the pulse generator is programmed back to normal operation.  
Refer to the BSC ImageReady MR Conditional Defibrillation System MRI Technical Guide2, 
here to forward referred to as the BSC MRI Technical Guide, for additional information 
regarding MRI Protection Mode. 
5.1.1.1 
Beeper Feature 
The PGs contain a Beeper that can be utilized to alert the patient in certain situations or to 
provide audible feedback when transitioning into and out of certain modes of operation for 
health care provider (HCP) notification. The Beeper provides: (1) an audible patient warning 
                                                 
2 The BSC MRI Technical Guide is investigational in the US, at the start of the study. This may become 
approved in the US during the study. 

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when potential therapy failure is detected between scheduled PG checks with an HCP, and 
(2) audible feedback to HCP regarding the state of the PG such as, current tachycardia mode 
and when charging for shock therapy.  An inaudible Beeper results in an increase of the 
associated risk.   
The Beeper may no longer be audible following an MRI scan. Coming in contact with the 
strong magnetic field of an MRI scanner demagnetizes the magnet within the beeper and 
causes a permanent loss of the beeper volume. This phenomenon is dependent on the spatial 
orientation of the PG within the bore.  Boston Scientific testing has shown that the standard 
orientation of the PG within the patient pocket (planar within the chest) and the patient 
position condition of use (supine or prone within the bore) results in significant loss of 
beeper volume.   
Loss of Beeper volume cannot be recovered, even after leaving the MR scan environment 
and exiting MRI Protection Mode. LATITUDE NXT provides alerts for all patient safety 
events that would result in the PG beeping. 
It is strongly recommended that patients are followed on LATITUDE NXT after an 
MRI scan if they are not already. Otherwise, an in-clinic follow-up schedule of every 
three months is strongly recommended to monitor device performance.  
Refer to the BSC MRI Technical Guide for additional information on the Beeper.  
5.1.1.2 
MRI Protection Mode Time-out Function 
The MRI Protection Mode Time-out function allows the user to choose the length of time the 
PG remains in the MRI Protection Mode before returning to previous settings.  MRI 
Protection Mode is programmed using the PRM. The Time-out feature has programmable 
values of OFF, 3, 6, 9 and 12 hours. At the conclusion of the programmed duration the PG 
returns to the previously programmed therapy parameters and settings. MRI Protection Mode 
may also be exited manually at any time during the time-out period. If the MRI Protection 
Time-out value is programmed to OFF, the patient will not receive Bradycardia pacing, 
Cardiac Resynchronization Therapy, or Tachycardia therapy until the PG is programmed out 
of MRI Protection Mode and back to previous operation.  
Refer to the BSC MRI Technical Guide for additional information on the MRI Protection 
Mode Time-out Function. 
5.2 
Boston Scientific’s Right Atrial Leads and Accessories  
The FINELINE II Sterox/Sterox EZ (referred to as FINELINE II) and INGEVITY MRI leads 
are steroid-eluting, bipolar endocardial pacing leads designed for atrial or ventricular use for 
chronic pacing, and are compatible with PGs that accept IS-13 connectors. The FINELINE II 
and INGEVITY MRI lead families consist of passive fixation and active fixation leads. A 
radiopaque suture sleeve is pre-loaded on the INGEVITY MRI leads, and is also available in 
a slit form as an accessory (Table 5-1). Suture sleeves for FINELINE II leads are also 
                                                 
3 IS-1 refers to the international standard ISO 5841-3:2013 

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available as accessories (Table 5-1). In the ENABLE MRI study, the FINELINE II and 
INGEVITY MRI leads will be used in the right atrium. Refer to the Physician’s Lead 
Manuals for additional information about the leads. 
Boston Scientific’s Right Atrial lead and accessory models that are included in the 
ImageReady System and allowed for the study are listed in Table 5-1. 
The FINELINE II leads are approved for commercial use and may be used as part of the 
ImageReady System in the ENABLE MRI study at all study centers in Europe, Israel , Asia 
Pacific and the US.  
The INGEVITY MRI leads have CE mark and may be used in the ENABLE MRI study at 
centers in Europe, Israel and Asia Pacific. The INGEVITY MRI leads will not be used in the 
US. 
 
5.3 
Boston Scientific’s Right Ventricular Leads and Accessories  
The RELIANCE 4-FRONT (DF4) and ENDOTAK RELIANCE (DF4) leads are steroid-
eluting, ventricular endocardial cardioversion/defibrillation and pace/sense leads with an ISO 
standard DF44 terminal connector design. Passive and active fixation models are available in 
both lead families. Refer to the Physician Lead Manuals for additional information about the 
leads. 
Boston Scientific’s Right Ventricular lead and accessory models that are included in the 
ImageReady System and allowed for the study are listed in Table 5-1.  
Internationally, the RELIANCE 4-FRONT (DF4) and ENDOTAK RELIANCE (DF4) leads 
are approved for commercial use. In the US, the ENDOTAK RELIANCE (DF4) leads are 
approved for commercial use and may be used in the study. The RELIANCE 4-FRONT 
(DF4) lead will be investigational in the US during a portion or the entire duration of the 
ENABLE MRI study. Only patients with existing RELIANCE 4-FRONT (DF4) leads from 
another Boston Scientific-sponsored IDE study (NAVIGATE X4 Study, NCT02071173, 
G130222) will be allowed to participate in the US.  
5.4 
Boston Scientific’s ACUITY X4 Quadripolar LV Lead and Accessories 
The ACUITY X4 quadripolar coronary venous leads are intended for chronic left ventricular 
pacing and sensing. These steroid-eluting leads have an IS45 four-pole connector. A variety 
of pace/sense configurations are possible with the four distal electrodes that can function as 
cathodes (all four electrodes) or anodes (all except E1, the most distal electrode) when used 
with a compatible pulse generator. See Figure 5.4-1 below for a picture of the ACUITY X4 
leads as well as the layout of the electrodes on the lead. Refer to the Physician Lead Manuals 
for additional information about the leads. 
                                                 
4 DF4 refers to the international standard ISO 27186:2010 
5 IS4 refers to the international standard ISO 27186:2010. 

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Figure 5.4-1: ACUITY X4 Leads and Electrode Placement 
Note: Nomenclature of electrodes on the lead is E1, E2, E3, E4. The corresponding nomenclature on the BSC 
PRM is as follows: 
E1: LV Tip 1 
E2: LV Ring 2 
E3: LV Ring 3 
E4: LV Ring 4 
Boston Scientific’s ACUITY X4 quadripolar left ventricular lead and accessory models are 
included in the ImageReady System and are allowed for the study (see Table 5-1). 
Internationally, the ACUITY X4 leads are approved for commercial use. In the US, the 
ACUITY X4 leads may be investigational at the start of the study. If the ACUITY X4 lead 
becomes approved for commercial use in the US, the lead will no longer be tracked as an 
investigational lead. Any investigational ACUITY X4 leads used in the ENABLE MRI study 
will be reconciled in a report following approval. 
5.5 
Programming System 
The programming system consists of the commercially approved 3120 Zoom LATITUDE 
PRM and 2868 programmer software application (Table 5-2).  
The PRM is MR Unsafe and must remain outside the MRI site Zone III (and higher) as 
defined by the American College of Radiology Guidance Document for Safe MR Practices6. 
Under no circumstances should the PRM be brought into the MRI scanner room, the control 
room, or the MRI site Zone III or IV areas. 
In the US, a programmer key (dongle) is required to interrogate the VR ICDs and 
CRT-Ds to access the investigational ‘MRI Protection Mode’.  A programmer key is only 
available for use by a BSC representative. Therefore a BSC representative will need to be 
present any time the investigational ‘MRI Protection Mode’ is needed to be accessed (i.e., all 
MR scans). A programmer key is not required for device interrogation. It is anticipated that 
the ImageReady System will become approved for commercial use in the US during the 
course of the study. If this occurs, then a programmer key will no longer be needed to access 
the MRI Protection Mode. 
                                                 
6 Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007. 

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Table 5-2: Programming System (Non-implanted Components) for ImageReady MR 
Conditional Defibrillation System  
Device Name 
Device Model Number 
MR Status  
ZOOM LATITUDE PRM 
3120 
MR Unsafe 
ZOOM LATITUDE PRM 
Software Application 
2868 v3.07 or later 
N/A 
6. Conditions of Use  
The following MRI Conditions of Use must be satisfied as listed here and in the BSC MRI 
Technical Guide7.  Where differences exist between the BSC MRI Technical Guide and the 
ENABLE MRI Study protocol, they are noted, and the protocol extends the BSC MRI 
Technical Guide. 
The intended MRI Conditions of Use for the ImageReady System consist of the following 
items.  
6.1 
Cardiology  
1. Patient is implanted with an ImageReady MR Conditional Defibrillation System (see 
Section 5). 
2. No other active or abandoned implanted devices, components. or accessories present 
such as lead adaptors, extenders, leads, or pulse generators  
3. Pulse generator is in MRI Protection Mode during scan 
4. As soon as MRI Protection Mode is programmed, the patient must be continuously 
monitored by pulse oximetry and electrocardiography (ECG).  Ensure backup therapy 
is available (external rescue). 
5. Patient is judged to be clinically capable of tolerating no Tachycardia protection and 
no Bradycardia** support (including CRT) for the entire duration in which the pulse 
generator is in MRI Protection Mode 
**Note: For Phase I of the ENABLE MRI Study, pace-dependence will be defined as 
no underlying heart rhythm when paced at VVI 40. Label the ECG strip with the 
subject ID#, date, time, and Visit name.   
6. Patient does not have elevated body temperature or compromised thermoregulation at 
time of scan 
7. Pulse generator implant location restricted to left or right pectoral region 
                                                 
7 The BSC MRI Technical Guide is investigational in the US, at the start of the study. This may become 
approved in the US during the study. 

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8. At least six (6) weeks have elapsed since implantation and/or any lead revision or 
surgical modification of the MR Conditional Defibrillation System 
9. No evidence of a fractured lead or compromised pulse generator-lead system integrity 
 
 

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6.2 
Radiology 
1. MRI magnet strength 
 
RF field 
 
Maximum spatial gradient  
 
MRI equipment specification 
1.5 T only 
 
Approximately 64 MHz 
 
20T/m (2,000 G/cm) 
 
Horizontal, 1H proton, closed bore 
scanners only 
2. Specific Absorption Rate (SAR) 
limits for the entire active scan 
 Normal Operating Modea: 
• Whole body averaged,  < 2.0 
watts/kilogram (W/Kg) 
• Head, <  3.2 W/Kg 
3. Maximum specified gradient slew 
rate 
≤ 200 T/m/s per axis 
 
4. The use of receive-only coils is not restricted. Local transmit-only coils or 
local transmit/receive coils may be used, but should not be placed directly 
over the defibrillation system.   
5. Patient in supine or prone position only 
6. Patient must be continuously monitored by pulse oximetry and 
electrocardiography (ECG) for the entire duration in which the pulse 
generator is in MRI Protection Mode.  Ensure backup therapy is available 
(external rescue). 
 
a. As defined in IEC 60601-2-33, 201.3.224, 3rd Edition. 
7. Objectives  
The objective of the study is to collect data to confirm the safety and effectiveness of the 
ImageReady MR Conditional Defibrillation System when used in the 1.5T MRI environment 
under the labeled Conditions of Use. 
Additionally, the study will assess medically necessary MR scans according to the labeled 
Conditions of Use to provide real-world scanning data. 
The study also aims to demonstrate the continued ability of the ImageReady MR Conditional 
Defibrillation System to sense and detect VF post MRI scan by collecting and analyzing data 
from spontaneous VF episodes, “for-cause” VF inductions, and from an optional VF 
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8. Endpoints (Phase I only) 
For details around Phase I endpoints, see Section 13.1. 
8.1 
Primary Safety Endpoint 
• MR Scan-related ImageReady System Complication-Free Rate between the MR Scan 
and the MRI + 1 Month Visit   
8.2 
Primary Effectiveness Endpoints 
• Primary RV Effectiveness Endpoint 1:  Increase in RV pacing threshold (at 0.5 ms) 
from the pre-MR scan to the 1 Month post-MR scan 
• Primary RV Effectiveness Endpoint 2:  Decrease in RV Sensed Amplitude from the 
pre-MR scan to the 1 Month post-MR Scan 
• Primary LV Effectiveness Endpoint 1:  Increase in LV pacing threshold (at 0.5 ms) 
from the pre-MR scan to the 1 Month post-MR Scan 
• Primary LV Effectiveness Endpoint 2:  Decrease in LV Sensed Amplitude from the 
pre-MR scan to the 1 Month post-MR Scan 
 
9. Design   
The ENABLE MRI Study is a prospective, non-randomized, confirmatory, global study 
conducted as an IDE in the United States, and as a post market study in Europe, Israel and 
Asia Pacific.  
The study will be conducted in two phases as described in Section 9.1.  
A subset of subjects enrolled into Phase I of the ENABLE MRI study may be eligible to 
participate in the VF induction Sub-study as described in section 11.2.8.  
9.1 
Scale and Duration 
The ENABLE MRI Study will be conducted in two phases to enroll 500 subjects at 
approximately 70 investigational centers in the United States, Europe, Israel and Asia- 
Pacific.  
Subjects will initially be enrolled into Phase I to undergo a non-diagnostic study required MR 
Scan. Once Phase I is complete, subjects will be enrolled into Phase II where there is no 
requirement to undergo a non-diagnostic study required MR scan. 
Phase I will consist of two cohorts: 

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• Up to 37 subjects will be used for an interim analysis. Of these subjects, the first 20 
who undergo the study required MRI scan and complete the MRI + 1 Month Visit 
will be used for this analysis.  
• The second cohort will consist of subjects who will receive the non-diagnostic study 
required MR scan until 137 CRT-D and 28 VR ICD subjects undergo the study 
required MR scan (complete or incomplete).  
• De novo implants and existing implants may be enrolled in Phase I 
• There will be a non-diagnostic study required MR scan (during the MRI visit) 
• There will be a study required MRI visit and MRI + 1 month visit  
• Spontaneous ventricular tachycardia (VT) and spontaneous VF episodes post MRI 
scan will be collected   
• Post MRI VF induction testing will be performed for subjects who either meet the 
“for cause” VF induction criteria or are enrolled into the VF Induction Sub-study as 
defined in section 12.8.2.       
• Subjects enrolled in Phase I will be followed for up to 3 years 
• Phase I Cohort  completion is anticipated when: 
1. 
137 CRT-D and 28 VR ICD subjects are enrolled and have been through their 
MRI Visit (incomplete or complete MR scan) 
and 
2. 
A total of 25 VF episodes post MRI from 25 different subjects are available 
(as defined in section 12.8.2)  
• BSC will notify sites when enrollments for the VR ICD and CRT-D cohorts are 
complete, and when Phase I is complete. 
• BSC will ensure that a minimum of 50% of Phase I subjects will be enrolled in the 
US 
 
Phase II: Phase II subjects will consist of the following: 
• Phase I subjects who do not have the study-required scan will automatically be rolled 
into Phase II 
• Any subjects enrolled after the completion of Phase I will be considered as Phase II 
subjects 
• Any combination of VR ICDs (DF4), DR ICDs* (IS1/DF4) and CRT-Ds 
(IS1/DF4/IS4) ImageReady Systems may be used.   
o *Note: DR ICD systems may only be used internationally outside the US. 

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• Only existing implants may be enrolled 
• BSC will notify sites when enrollments for Phase II are complete 
Figure 9.1-1shows the study phases and the study design. 
 
  
Figure 9.1-1: ENABLE MRI Study Design 
 
All subjects enrolled in this study must be followed according to the investigational plan 
unless Boston Scientific notifies the Investigator to the contrary or Boston Scientific has 
officially closed the study. The duration of the study is expected to be approximately 5.5 
years. 
9.2 
Justification for the Study Design  
The ENABLE MRI Study is being conducted to collect data to support pre-market regulatory 
agency submissions for approval of the ImageReady System for use in the 1.5T MRI 
environment (Phase I), in geographies where prospective clinical data is required. The study 
data will also be used to support worldwide post-market requirements in certain geographies. 
The study is designed with one interim analysis to support regulatory submissions.   
The study also aims to demonstrate the continued ability of the ImageReady™ MR 
Conditional Defibrillation System to sense and detect VF post MRI scan by collecting and 
analyzing data from spontaneous VF episodes, “for-cause” VF inductions, and from the VF 
induction Sub-study. 
Phase I and Phase II data will be used to evaluate VT/VF sensing after an MR scan, potential 
influence of multiple MR scans on the ImageReady System, Beeper functionality after MR 
scans, and programming of the MRI Protection Mode (see Section 13.2 on ancillary 
analysis).  
Data from the FINELINE II leads will be used to support regulatory approval in geographies 
that do not already have market approval of FINELINE II as an MR Conditional lead. 
10. Subject Selection  
10.1 Study Population and Eligibility  
Subjects enrolled in the ENABLE MRI Study shall be selected from the investigators general 
patient population indicated for an ICD or CRT-D implantation. The Investigator is 
responsible for screening potential subjects and selecting those who meet the eligibility 
criteria for the study as described in Sections 10.2 and 10.3.  

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Patients who consent to be part of the VF induction Sub-study also have to be evaluated for 
the VF Sub-study exclusion criteria at the time of their consent. Subjects enrolled into the 
ENABLE MRI Study who will receive a de novo device may be enrolled into the Sub-study 
up to 14 calendar days after the implant procedure. 
10.2 Inclusion Criteria  
Subjects who meet all of the following criteria (Table 10-1) may be given consideration for 
inclusion in this clinical investigation, provided no exclusion criterion are met (Table 10-2).  
Note:  All study subjects enrolled prior to protocol version AE implementation will need to 
be assessed for the current Inclusion and Exclusion Criteria. More details are provided in 
Section 11.1. 
 
For Inclusion criterion #1, “functional and stable CRT-D or ICD system” will be defined as 
follows: 
 
• Lead impedances for the RA, RV and LV leads are within the acceptable ranges per 
device labeling (please refer to the Physician Guide for details) 
• No evidence of lead fracture or lead dislodgement  
• No evidence of PG malfunction (i.e. error code) 
 
 

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Table 10-1: Inclusion Criteria 
Inclusion 
Criteria 
1. Phase I: Subject is indicated per guidelines and will receive a CRT-D or ICD system 
consisting only of the following MR Conditional components* (OR) Subject is 
implanted with a functional and stable CRT-D or ICD system consisting only of the 
following MR Conditional components* 
Phase II: Subject is implanted with a functional and stable CRT-D or ICD system 
consisting only of the following MR Conditional components* 
*MR Conditional Components 
System must consist only of these PGs and leads listed below (refer to Table 5-1 for 
component model numbers): 
Lead/PG 
International 
(All Market Approved) 
US 
RA Lead 
INGEVITY MRI 
FINELINE II Sterox/Sterox EZ 
FINELINE II Sterox/Sterox EZ 
RV Lead 
RELIANCE 4-FRONT 
RELIANCE 4-FRONT1, ǂ 
ENDOTAK RELIANCE 
ENDOTAK RELIANCE 
LV Lead 
ACUITY X4 
ACUITY X4 1 
Phase I: PG 
• VR ICD  
 
• CRT-D2  
 
PG Header 
Device Name 
PG Header 
Device Name 
VR ICD (DF4),  
CRT-D2 
(IS1/DF4/IS4)  
ORIGEN  
INOGEN 
DYNAGEN 
AUTOGEN 
VR ICD (DF4),  
CRT-D2 
(IS1/DF4/IS4)  
ORIGEN  
INOGEN 
DYNAGEN 
Phase II: PG 
PG Header 
Device Name 
PG Header 
Device Name 
VR ICD (DF4),  
DR ICD2 
(IS1/DF4),  
CRT-D2 
(IS1/DF4/IS4) 
ORIGEN  
INOGEN 
DYNAGEN 
AUTOGEN 
VR ICD (DF4),  
CRT-D2 
(IS1/DF4/IS4) 
ORIGEN  
INOGEN 
DYNAGEN 
1 The  ACUITY X4 and  the RELIANCE 4-FRONT leads may be investigational in the US during 
a portion or the entire duration of the study  
ǂ For the US, only existing RELIANCE 4-FRONT implants will be allowed 
2  Port plug 7145 must be used in DR ICDs and CRT-Ds with no atrial lead   
2. Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left 
or right pectoral region 
3. Subject is able and willing to undergo an MR scan without intravenous sedation 
(Phase I only)* 
*Oral sedation may be used, if necessary, based on medical discretion 
4. Subject is willing and capable of providing informed consent and participating in all 
testing/ visits associated with this clinical study at an approved clinical study center 
and at the intervals defined by this protocol 
5. Subject is age 18 or above, or of legal age to give informed consent specific to state 
and national law 

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10.3 Exclusion Criteria  
Subjects who meet any one of the following criteria (Table 10-2) will be excluded from this 
clinical study.

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Table 10-2: Exclusion Criteria 
Exclusion Criteria 
1. Subject implanted with an ICD or CRT-D pulse generator with battery at 
Explant status 
2. Subject has other active or abandoned implanted cardiac rhythm devices, 
components or accessories present such as pulse generators, leads, lead 
adaptors or extenders 
3. Presence of metallic objects that represent a contraindication to MR imaging at 
the discretion of the Radiologist and impacting the ability to conduct the study 
protocol 
4. Subject needs or will need a medically necessary MR scan, before completing 
the 1-month post-MR follow-up visit (Phase I only) 
5. Subject with: 
• 
A history of syncope related to brady-arrhythmia 
• 
A history of syncope of unknown etiology 
• 
Sinus pauses (Pause > 2 s) 
• 
Permanent or intermittent complete AV block 
• 
Documentation of progressive AV nodal block over time 
• 
Trifascicular block (alternating bundle branch block or PR > 200 ms 
with LBBB or other bifascicular block)   
Note: It is required to run a 12 lead ECG and a 10s rhythm strip to document 
this exclusion criterion. During ECG acquisition, subjects must be in either 
their own intrinsic rhythm or, in subjects with an existing device implant, the 
device must be programmed to VVI 40 ppm. 
6. Subject is not clinically capable of tolerating the absence of pacing or 
Resynchronization therapy support in a supine position for the duration that the 
pulse generator is in MRI Protection Mode, per Physician discretion 
7. Subject is not clinically capable of tolerating the absence of Tachycardia 
therapy support for the duration that the pulse generator is in MRI Protection 
Mode, per Physician discretion 
8. Subjects with a planned RA, RV or LV lead revision or extraction within 30 
days of enrollment (Phase I only) 
9. Subjects with an implanted lead that is planned to be extracted during the study 
implant procedure  
10. Subjects currently requiring dialysis 
11. Subject has a mechanical heart valve 
12. Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) 
13. Subject is currently on the active heart transplant list  

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14. Subject has documented life expectancy of less than 12 months  
15. Subject is enrolled in a concurrent study, with the exception of local mandatory 
governmental registries and observational studies/registries, without the written 
approval from Boston Scientific.  
16. Women of childbearing potential who are or might be pregnant, and will 
receive an ICD or CRT-D pulse generator 
NOTE: Pregnancy tests are required as part of standard routine clinical 
practice at all centers whenever female patients of child bearing potential are 
exposed to x-ray radiation as part of the implant procedure. 
10.3.1 VF Induction Sub-study Exclusion Criteria 
In addition to meeting all of the inclusion criteria and none of the exclusion criteria of the 
ENABLE MRI Study, subjects enrolled in the VF Induction Sub-study must not meet any of 
the following VF Induction Sub-study exclusion criteria.  
Table 10-3: VF Induction Sub-Study Exclusion Criteria 
VF Induction Sub-
Study Exclusion 
Criteria 
1. Unstable heart failure requiring hospitalization in the last 30 calendar days  
2. Unable to tolerate sedation (e.g. IV sedation, general anesthesia) 
3. Planned cardiac revascularization procedure 
4. Right Ventricular Lead R wave is less than 5 mV 
11. Subject Accountability  
11.1 Screening and Point of Enrollment  
11.1.1 Subjects enrolled under previous protocol versions 
All subjects enrolled under previous protocol versions will need to be re-consented. The 
exclusion criterion #5 will need to be evaluated for these patients: 
• Subjects not having performed the MRI visit:  
o If these subjects meet the updated exclusion criterion #5, they should be 
withdrawn from the study and classified as consent ineligible subjects. These 
withdrawn subjects will not count against the enrollment ceiling. 
o If these subjects do not meet the updated exclusion criterion #5: 
 They will continue as part of Phase I and will undergo the non-
diagnostic study required MR scan  
 If they refuse to undergo the non-diagnostic study required MR scan 
(Phase I), they will automatically be rolled onto Phase II unless they 

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chose to withdraw from the study. These withdrawn subjects will not 
count against the enrollment ceiling. 
 
 
• Subjects having performed the MRI visit:  
o If these subjects do not meet the updated exclusion criterion #5, they will 
continue in the study and attend visits as required per protocol. These subjects 
are counting toward the enrollment ceiling. 
o If these subjects meet the updated exclusion criterion #5, this should be 
documented in the subject’s file. These subjects can remain enrolled in the 
study. In case of withdrawal, if possible, such subjects should not be 
withdrawn prior to the MRI + 1 month to ensure safety follow-up within 30 
days post MRI. These subjects are counting toward the enrollment ceiling.  
11.1.2 Subjects enrolled under protocol rev AE and future revisions 
All subjects who complete the informed consent process, sign and date the informed consent 
form will be evaluated for the following criteria: 
• Radiologist approval to undergo MRI scan if metal objects in body (exclusion 
criterion #3) 
• 12 lead ECG & 10s rhythm strip (exclusion criterion #5) 
Subjects who meet these exclusion criteria will be considered Consent ineligible and will not 
count toward the enrollment ceiling. 
Subjects who do not meet these exclusion criteria will be considered enrolled in the 
ENABLE MRI study and will count toward the enrollment ceiling.   
Subjects who are part of the ENABLE MRI study and also provide written, signed and dated 
informed consent to participate in the VF Induction Sub-Study will be considered enrolled in 
the VF Induction Sub-Study.  
 
11.2 Withdrawal  
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented. If a subject withdraws from the 
clinical investigation, the reason(s) shall be reported.  
For US subjects: If such withdrawal is due to problems related to investigational device 
safety or performance, the investigator shall ask for the subject’s permission to follow his/her 
status/condition outside of the clinical study until the implanted investigational devices are 
approved by the FDA or the device is explanted.  

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Reasons for withdrawal include, but are not limited to: 
• Subject who does not receive a Boston Scientific ImageReady MR Conditional 
Defibrillation System (no follow-up requirements) 
• Subject who receive only a partial Boston Scientific ImageReady MR Conditional 
Defibrillation System (see section 11.3.4 for follow-up requirements) 
• Subjects that have a PG or lead changeout that is not a Boston Scientific ImageReady 
MR Conditional Defibrillation System component (See Section 5)   
• Subjects in Phase I who refuse to undergo the study require MR scan and are not 
willing to be rolled into Phase II 
• Subjects already enrolled with previous protocol versions, who have not performed 
the MRI visit and who meet the updated exclusion criterion #5 
• Subjects who fail the heart rhythm monitoring requirements at the MRI visit 
• Physician discretion 
• Subject choice to withdraw consent 
• Lost to follow-up 
• Death 
While study withdrawal is discouraged, subjects may withdraw from the ENABLE MRI 
study and/or the VF Induction Sub-study at any time, with or without reason, and without 
prejudice to further treatment. 
All applicable case report forms up to the point of subject withdrawal and a “Subject Status” 
form must be completed. Subjects who are “lost-to-follow-up” should have documented 
attempts to contact them prior to completion of the “Subject Status” form. 
Additional study data may no longer be collected after the point at which a subject has been 
withdrawn from the study or withdraws his/her consent, for whatever reason. All open 
adverse events should be closed or documented as chronic. Data collected up to the point of 
subject withdrawal may be used. 
11.3 Subject Status and Classification  
Subjects enrolled in the ENABLE MRI study will be placed into one of six classifications, as 
defined below.   
If a subject receives the PG or lead(s) listed in Section 5 after enrollment, they will be treated 
as a de novo. De novo subjects are classified based on sections 11.3.1to 11.3.5.  
11.3.1 Intent 
Intent refers to a subject who has been enrolled, but does not have the lead(s) or PG 
introduced into their body. There are no follow-up requirements for intent subjects. The 

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original informed consent form (ICF) and screening documentation for intent subjects should 
be maintained in the Center’s files.  
11.3.2 Consent ineligible 
Consent ineligible refers to a subject who signed the ICF but meets exclusion criteria #3 or 
#5. As applicable, all adverse events need to be reported up to the point of withdrawal. There 
are no follow-up requirements for consent ineligible subjects. The original informed consent 
form (ICF) and screening documentation for consent ineligible subjects should be maintained 
in the Center’s files. These subjects do not count towards the enrollment ceiling. 
11.3.3 Attempt  
Attempt refers to a subject who 1) has been enrolled in the Study, 2) has had anesthesia 
administered in preparation for the surgical implant procedure, 3) has had the lead(s) and/or 
PG introduced into the subject’s body, but 4) is not successfully implanted with any portion 
of the ImageReady System during the implant procedure (meaning the subject is not 
successfully implanted with either the PG or lead(s)). 
Attempt subjects must be followed 30 ± 7 days post-attempted ImageReady System implant 
to assure there are no associated adverse events, or to assure the resolution of any adverse 
events associated with the attempted ImageReady System implant. 
11.3.4 Partial Implant 
Partial Implant refers to a subject who is implanted with a component of the ImageReady 
System during the implant procedure, but does not end up with a complete ImageReady 
System. Due to the fact that these subjects do not have a full ImageReady System, according 
to the Conditions of Use in the BSC MRI Technical Guide, they shall not receive the MR 
Scan for the ENABLE MRI study.  
• For US subjects: If investigational leads were implanted, the subjects must be 
followed for safety. These subjects must be followed at each time point required for 
the study until the implanted investigational leads are approved by the FDA or the 
device is explanted.   
• If there were no investigational leads implanted, Partial Implant subjects must be 
followed 30 ± 7 days post- ImageReady System implant to assure there are no 
associated adverse events, or to assure the resolution of any adverse events associated 
with the ImageReady System implant, then withdrawn from the study. 
11.3.5 Implant 
Implant refers to a subject who is successfully implanted with the ImageReady System per 
the study protocol. These subjects are followed in accordance with the follow-up schedule 
and included in all analyses of safety and performance. 

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11.3.6 Existing Implant 
Existing Implant refers to a subject who has a complete ImageReady System implanted 
prior to enrollment, per the study protocol. These subjects are followed in accordance with 
the follow-up schedule and included in all analyses of safety and performance. 
11.4 Enrollment Controls  
A total of 500 subjects at up to 70 investigational centers will be enrolled in this study.   
11.4.1 Phase I 
• To support regulatory requirements and an interim analysis, subjects will initially be 
into Phase I until Phase I is stopped. After that, enrolled subjects will be considered 
Phase II subjects. 
• An interim analysis planned for phase I when 20 subjects have completed their 
protocol required scan and MRI +1 Month visit. It is estimated that approximately 37 
subjects (assuming 45% attrition) enrolled into Phase I will contribute to this interim 
analysis.  
• Phase I Cohort completion is anticipated when: 
o 137 CRT-D and 28 VR subjects are enrolled and have been through their MRI 
Visit (complete or incomplete MR scan)  
and 
o A total of 25 VF episodes post MRI from 25 different subjects are available 
from spontaneous episodes, from “for-cause” VF induction, and from the VF 
Induction Sub-study, combined (as defined in section 12.8.2) 
 
• One individual center may not enroll more than 43 subjects for Phase I without prior 
approval from Boston Scientific. 
• A minimum of 50% of total enrollments from the US will be maintained 
• Investigational sites will be notified when enrollment into Phase I are complete.  
   
11.4.2 Phase II 
Sites will be notified by BSC when enrollments into Phase II may begin. Phase II will start at 
the conclusion of Phase I. Phase I patients who do not have the study-required scan will 
automatically be rolled into Phase II. Investigational centers may continue to enroll until the 
total enrollment ceiling of 500 subjects has been reached.  
One individual center may not enroll more than 20% (100 subjects) of the total enrollment 
ceiling of 500 subjects without prior approval from Boston Scientific. 

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11.5 End-of-Study Action Plan 
Boston Scientific Corporation reserves the right to terminate the study, or discontinue 
implanting at any stage but intends to exercise this right only for valid scientific or 
administrative reasons and reasons related to the protection of subjects. In the event of this 
occurrence, BSC will communicate to the investigators of the ENABLE MRI Clinical Study. 
The investigators will be responsible for communicating any information necessary to the 
subjects. BSC will support the physicians by providing recommendations for ensuring the 
safety of the subjects and the handling of any investigational components of the ImageReady 
System in the US until those components are approved by the FDA, which may include, but 
are not limited to: 
• 
Standard of care procedures 
• 
More frequent follow ups of the subject than per standard procedures 
• 
Longer term follow up (beyond length of initial consent) 
• 
Explantation of  RELIANCE 4-FRONT or ACUITY X4 leads upon careful risk-
benefit analysis  
• 
Other possible actions 
If it becomes apparent that any of the investigational products will not be FDA-approved, a 
communication and study action plan for the subjects with those unapproved devices will be 
implemented.   
12. Study Methods  
12.1 Data Collection  
A detailed list of procedures, testing and data collected required at the study visits are 
presented in Table 12-1. The table also has the study visits that are needed per study phase 
and per implanted device status.  
• For Phase I subjects there will be a non-diagnostic study required MR scan (during 
the MRI visit) 
• For Phase I subjects, the MRI and the MRI + 1 Month visits are required.  
• For VF Induction Sub-Study subjects,  VF Induction testing will be performed at the  
MRI + 1 Month Visit 
• For "for cause” VF induction subjects, VF Induction testing will be performed ideally 
at the  MRI + 1 Month Visit or up to 14 calendar days later 
• For de novo implants (phase I), the Implant and Pre-discharge visits are required.  

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Table 12-1: Data Collection Schedule   
Procedure / 
Assessment 
Screening 
and 
Enrollment 
Phase I: 
De novo implants 
only 
Phase I only 
Every 
Three-
Month 
Visits*** 
Every 
Annual 
Visits*  
Additional Visits 
Medically 
necessary MRI 
Implant 
Pre- 
Discharge 
MRI Visit 
MRI  + 1 
Month 
Visit 
Timeframe 
De novo: ≤ 30 
days prior to 
Implant 
 
 
Existing implant  
Implant 
3-72 hours 
from Implant 
De novo: 6-9 
weeks from 
Implant Δ 
 
Existing 
implant: within 
6 weeks from 
Enrollment Δ 
30 ± 7 days 
from MRI 
Visit 
 
 
90 ± 30 
days from 
MRI Visit 
De novo: 365±90 
days* from 
implant 
 
Existing implant: 
365±90 days*  
from Enrollment  
-- 
-- 
Informed consent form 
and process, including 
informed consent 
signature and date 
X** 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
12 lead ECG & 10s 
rhythm strip  
X  
(document 
exclusion #5) 
-- 
-- 
X Pre MRI 
(HR 
monitoring) 
-- 
-- 
-- 
-- 
X Pre MRI 
(HR monitoring) 
Demographics 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Physical assessment 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Medical History,  
Comorbidities, Cardiac 
Disease History,  
Medications 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
ICD/CRT-D system 
implant 
-- 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Device Evaluation 
(includes pace 
thresholds, intrinsic 
amplitudes, 
impedances, RV shock 
impedance) 
-- 
X 
X 
X Pre & Post  
X 
X 
X 
O 
O 

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Procedure / 
Assessment 
Screening 
and 
Enrollment 
Phase I: 
De novo implants 
only 
Phase I only 
Every 
Three-
Month 
Visits*** 
Every 
Annual 
Visits*  
Additional Visits 
Medically 
necessary MRI 
Implant 
Pre- 
Discharge 
MRI Visit 
MRI  + 1 
Month 
Visit 
Timeframe 
De novo: ≤ 30 
days prior to 
Implant 
 
 
Existing implant  
Implant 
3-72 hours 
from Implant 
De novo: 6-9 
weeks from 
Implant Δ 
 
Existing 
implant: within 
6 weeks from 
Enrollment Δ 
30 ± 7 days 
from MRI 
Visit 
 
 
90 ± 30 
days from 
MRI Visit 
De novo: 365±90 
days* from 
implant 
 
Existing implant: 
365±90 days*  
from Enrollment  
-- 
-- 
VF Induction Testing 
(“for-cause” or VF Sub-
study) 
-- 
-- 
-- 
-- 
X**** 
-- 
-- 
-- 
-- 
Beeper Assessment 
-- 
-- 
-- 
X Pre & Post  
-- 
-- 
-- 
-- 
X Pre & Post 
Save All 
-- 
-- 
-- 
X 
X 
 
X 
O 
O 
Printout of device 
settings and history 
-- 
X 
X 
X 
X 
X 
X 
X 
X 
MRI Conditions of Use 
-- 
-- 
-- 
X 
-- 
-- 
-- 
-- 
X 
DICOM file from MR 
scanner  
-- 
-- 
-- 
X 
-- 
-- 
-- 
-- 
O 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Legend:  X = Required; -- = Not required/ Not applicable; O = Optional; Δ Must be at least 6 weeks after any required surgical interventions to the ImageReady 
System;   
* Annual visits will occur at 365 ± 90, 730 ± 90 and 1095 ± 90 days after implant (if de novo) or from enrollment (if existing implant) respectively. 
** The informed consent process and subject signature of the informed consent form will occur before the implant procedure begins.  
*** The first Every 3-month visit will occur 90 ± 30 days after MRI visit. Subsequent Every 3-month follow-up visits will be scheduled every three months (90 days ± 
30 Days) from the previous scheduled study follow-up. If this visit is done, then the data is required. 
**** The “for-cause” VF inductions may be performed up to 14 calendar days after the MRI + 1 Month Visit

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12.2 Study Candidate Screening 
Boston Scientific will collect information to document potential subjects who are considered 
as potential study candidates but are determined not to meet inclusion criteria prior to signing 
informed consent.  
12.3 Informed Consent 
All subjects who complete the informed consent process, sign and date the informed consent 
form will be evaluated for the following criteria: 
• Radiologist approval to undergo MRI scan if metal objects in body (exclusion 
criterion #3) 
• 12 lead ECG and 10s rhythm strip (either from the ECG machine or the BSC PRM) 
(exclusion criterion #5) 
Source documentation for both of these exclusion criteria need to be retained in the patient 
medical file. 
Subjects who meet these exclusion criteria will be considered Consent ineligible and will not 
count toward the enrollment ceiling. 
Subjects who do not meet these exclusion criteria will be considered enrolled in the 
ENABLE MRI study and will count toward the enrollment ceiling.    
In addition, subjects who meet none of the exclusion criteria for the VF Induction Sub-study 
and undergo the VF Induction Sub-Study informed consent process, sign, and date the 
ENABLE MRI VF Induction Sub-study informed consent form are considered enrolled in the 
Sub-study.   
For Phase I de novo implants: Enrollment may occur up to 30 days prior to the implant 
procedure. 
A summary of the data collected at enrollment is described in Table 12-1. The following 
assessments will be performed at Enrollment. 
12.4 Screening and Enrollment Visit 
The data to be collected at enrollment includes: 
• Signed and dated informed consent to participate in the ENABLE MRI study  
• Patient demographic data 
• Physical assessment including height, weight and vital signs 
• Medical history, comorbidities, cardiac disease history and medications.   

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Subjects who consent to participate in the VF Induction Sub-study will provide written 
informed consent. 
A summary of the data collected at enrollment is described in Table 12-2.  
Provide the subject with an EC/IRB approved ENABLE MRI Study identification card. The 
subject should be instructed to show the card at every hospitalization and ER visit.  
12.4.1 Screening and Enrollment Source Data Requirements 
Source data requirements at Screening and Enrollment are described in Table 12-2. 
Table 12-2: Screening and Enrollment Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Informed consent form and process, including 
informed consent signature and date. 
 
12 leads ECG and 10s rhythm strip to document 
exclusion criterion #5 
 
Completed Radiologists Technical Source Form 
(applicable for subjects with metallic implants only) 
 
VF Induction Sub-Study informed consent and process, 
including informed consent signature and date, if 
applicable 
Retain at center 
Demographics, including age, gender, race/ethnicity, 
etc. 
Physical assessment, including weight and height 
Medical History,  Comorbidities, Cardiac Disease 
History,  Medications 
Adverse Events 
12.5 Implant  
For Phase I de novo subjects, the implant procedure will occur either on the same day as 
enrollment, after the subject signs and dates the informed consent form, or up to 30 days 
later.  
The ImageReady System should be implanted and tested per standard procedures and in 
accordance with the Physician’s Manuals for the associated PG and lead(s). To satisfy the 
MRI Conditions of Use (see Section 6), the PG must be implanted in the left or right pectoral 
(subcutaneous or sub-muscular) regions. 
The implant procedure end time is defined as the time of device pocket closure. Record the 
end time in the electronic data capture (EDC) system.  

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Investigators will follow standard of care or standard center practices for the implant of the 
ICD/CRT-D system.  
• For the VR ICD system, an ENDOTAK RELIANCE (DF4) or RELIANCE 4-
FRONT RV8 lead must be successfully implanted unless the subject already has an 
existing functional ENDOTAK RELIANCE (DF4) or RELIANCE 4-FRONT RV 
lead.  
• For the CRT-D system: 
o In the right atrium, a FINELINE II or INGEVITY9 RA lead or Port plug 7145 
must be successfully implanted unless the subject already has an existing 
functional FINELINE II or INGEVITY9 MRI RA lead or Port plug 7145. 
o In the right ventricle, an ENDOTAK RELIANCE (DF4) or RELIANCE 4-
FRONT RV8 lead must be successfully implanted unless the subject already 
has an existing functional ENDOTAK RELIANCE (DF4) or RELIANCE 4-
FRONT RV lead 
o In the left ventricle, an ACUITY X4 LV lead must be successfully implanted 
unless the subject already has an existing functional ACUITY X4 LV lead.  
• A DF-4 or IS-4 port plug cannot be used in place of the RV or LV lead.  
A summary of the data collected at implant are described in Table 12-1. 
12.5.1 Device Evaluation 
All implanted leads will be evaluated through the implanted PG using the test parameters 
listed in Table 12-3: 
• Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3.  
• Sensing amplitude 
• Impedance 
• Shock impedance (RV lead only) 
Record the measurements in the EDC system. 
 
 
                                                 
8 No de-novo RELIANCE 4-FRONT implants will occur in the US 
9 INGEVITY is only available internationally outside of the US 

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Table 12-3:  Test Parameters  
Description 
RA Threshold Test 
RV Threshold 
Test 
LV Threshold Test 
Test Type 
Amplitude 
Amplitude 
Amplitude 
Pulse Width 
(ms) 
0.5 
0.5 
0.5 
Cycles per Step 
3 (minimum) 
3 (minimum) 
3 (minimum) 
Pacing  Lead 
Configuration 
Not Programmable 
Not Programmable 
Per HCP 
 
For MRI and MRI + 1 Month 
visits: The same LV Pacing 
Configuration must be used for 
threshold testing 
 
Impedance 
Tests 
RA Impedance Test 
RV Impedance 
Test 
LV Impedance Test 
Pacing Lead 
Configuration 
Bipolar 
Bipolar 
Same LV configuration as the 
Pacing Test 
 
For MRI and MRI +1 Month 
visits: The same LV Pacing 
Configuration must be used for 
impedance testing 
 
Sensing Tests 
RA Sensing Test 
RV Sensing Test 
LV Sensing Test 
Sensing 
Configuration 
Bipolar 
Bipolar 
Per HCP 
 
For MRI and MRI+1 Month 
visits: The same LV Sensing 
Configuration must be used for 
sensing testing 
Note: Mode, Lower Rate Limit, Amplitude, Paced AV delay and LV Pacing Lead Configuration 
shall be set per physician or HCP discretion. 
 
12.5.1.1 
Manual Right Atrial Threshold Test 
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Otherwise, perform a manual RA threshold test following these steps, unless the testing is 
inhibited by a patient condition (example: subject is in atrial fibrillation): 
1. In the Atrial Threshold Test screen set the Test Type to Amplitude 
2. Mode, Lower Rate Limit, Amplitude and Paced AV delay shall be set per physician 
or HCP discretion 
3. Pulse Width shall be set to 0.5 ms 
4. Cycles per Step shall be set to a minimum of 3  
5. Start the annotated real-time ECG from the PRM, then start the manual RA threshold 
test 
a. A count of 2 non-capture beats at a given voltage level is required to declare 
loss of capture (LOC) 
b. If the subject experiences discomfort during the threshold test due to 
extracardiac stimulation, then stop the test and perform the manual threshold 
test per physician discretion. 
6. When LOC is determined, stop the threshold test. Stop the PRM real-time ECG a 
minimum of 2 seconds after LOC is determined.  
7. Label the PRM ECG with the subject ID#, date, “[Visit name; e.g. Implant, Pre-
Discharge, MRI Visit, MRI + 1Month Visit, etc.] Manual RA threshold test”, attempt 
# (if applicable). 
8. The threshold for the manual RA threshold test is defined as one voltage level above 
the level where the 2 non-captured beats are observed. Record the threshold in the 
EDC system.  
9. If the threshold saved on the PRM does not match the threshold, as defined in step 8, 
then update the RA Pace Threshold in the programmer. 
12.5.1.2 
Manual Right Ventricular Threshold Test 
Perform a manual RV threshold test following these steps: 
1. In the Right Ventricular Threshold Test screen set the Test Type to Amplitude 
2. Mode, Lower Rate Limit, Amplitude and Paced AV delay shall be set per physician 
or HCP discretion 
3. Pulse Width shall be set to 0.5 ms 
4. Cycles per Step shall be set to a minimum of 3  
5. Start the annotated real-time ECG from the PRM, then start the manual RV threshold 
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a. A count of 2 non-capture beats at a given voltage level is required to declare 
loss of capture (LOC) 
b. If the subject experiences discomfort during the threshold test due to 
extracardiac stimulation, then stop the test and perform the manual threshold 
test per physician discretion. 
6. When LOC is determined, stop the threshold test. Stop the PRM real-time ECG a 
minimum of 2 seconds after the LOC is determined.  
7. Label the PRM ECG with the subject ID#, date, “[Visit name; e.g. Implant, Pre-
Discharge, MRI Visit, MRI + 1Month Visit, etc.] Manual RV threshold test”, attempt 
# (if applicable).   
8. The threshold for the manual RV threshold test is defined as one voltage level above 
the level where the 2 non-captured beats are observed. Record the threshold in the 
EDC system. 
9. If the threshold saved on the PRM does not match the threshold, as defined in step 8, 
then update the RV Pace Threshold in the programmer. 
12.5.1.3 
Manual Left Ventricular Threshold Test 
If the subject does not have an active implanted LV lead, then skip to the next section. 
If multiple manual LV threshold tests are performed, then record the manual LV threshold 
test that matches the final programmed LV lead configuration following these steps: 
1. In the Left Ventricular Threshold Test screen set the Test Type to Amplitude 
2. Mode, Lower Rate Limit, Amplitude and Paced AV delay shall be set per physician 
or HCP discretion 
3. Set the pulse width at 0.5 ms   
4. Cycles per Step shall be set to a minimum of 3  
5. Start the annotated real-time ECG from the PRM, then start the manual LV threshold 
test 
a. A count of 2 non-capture beats at a given voltage level is required to declare 
loss of capture (LOC) 
b. If the subject experiences discomfort during the threshold test due to 
extracardiac stimulation, then stop the test and perform the manual threshold 
test per physician discretion. 
6. When LOC is determined, stop the threshold test. Stop the PRM real-time ECG a 
minimum of 2 seconds after the LOC is determined.  

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7. Label the PRM ECG with the subject ID#, date, “[Visit name; e.g. Implant, Pre-
Discharge, MRI Visit, MRI+1month Visit, etc.] Manual LV threshold test”, attempt # 
(if applicable).  
8. The threshold for the manual LV threshold test is defined as one voltage level above 
the level where the 2 non-captured beats are observed. Record the threshold in the 
EDC system. 
9. If the threshold saved on the PRM does not match the threshold, as defined in step 8, 
then update the LV Pace Threshold in the programmer. 
12.5.2 Completing the Implant Visit 
1. Program the device according to physician discretion 
2. Print the ‘Quick Notes’ Report 
12.5.3 Implant Source Data Requirements 
Source data requirements at implant are described in Table 12-4. 
Table 12-4:  Implant Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Device model/serial number 
Retain at center 
Lead model/serial numbers for all implanted leads 
Device Evaluation (pace thresholds, sense amplitudes, impedances, RV 
shock impedance) 
PRM ECG strips from manual threshold tests documenting LOC for all 
implanted leads  
Printout of ‘Quick Notes’ Report 
Adverse Events 
 
12.6 Pre-Discharge 
For Phase I de novo subjects, the Pre-discharge Visit will occur either on the same day as the 
ImageReady System implant procedure, a minimum of 3 hours after pocket closure, or up to 
72 hours after the implant procedure.  
12.6.1 Device Evaluation 
All implanted leads will be evaluated through the implanted PG using the test parameters 
listed in Table 12-3: 
• Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3.  
• Sensing amplitude 

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• Impedance 
• Shock impedance (RV lead only) 
Record the measurements in the EDC system. 
12.6.2 Completing the Pre-Discharge Visit 
1. Program the device according to physician discretion 
2. Print the ‘Quick Notes’ Report 
3. Schedule the MRI follow-up visit 
12.6.3 Pre-Discharge Source Data Requirements 
Source data requirements at Pre-discharge Visit are described in Table 12-5:  
Table 12-5: Pre-Discharge Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Device Evaluation (pace threshold, sense amplitude, impedance, RV shock 
impedance) 
Retain at center 
PRM ECG strips from manual threshold tests documenting LOC for all 
implanted leads  
Printout of ‘Quick Notes’ Report 
Adverse Events 
 
12.7 MRI Visit (Phase I only) 
The MRI follow-up visit consists of data collection and MR scan.  
For Phase I de novo subjects, the visit will occur 6 to 9 weeks (42-63 days) after implant or 
surgical revision of the ImageReady System implant*.   
For Phase I existing implant subjects, the visit will occur within 6 weeks (42 days) from 
enrollment AND at least 6 weeks after implant or surgical intervention* of the ImageReady 
System. For example:  
• If the subject was enrolled with an ImageReady System that was implanted >6 weeks 
before enrollment, the MRI visit must occur within 6 weeks (42 days). 
• If the subject was enrolled with the an ImageReady System that was implanted 2 
weeks (14 days) before enrollment, the MRI visit must occur between 4 – 6 weeks 
(28 to 42 days)  after enrollment. 
*Note: If a subject has had a surgical revision to their ImageReady System (i.e., a lead 
revision/ reposition), and the MRI Visit is unable to be scheduled within the time window, 
the MRI Visit and the MRI + 1 Month Visit are not required. Enter the reason for MRI Visit 
and MRI + 1 Month visit not being done into EDC. 

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Note: For subjects enrolled under prior protocol versions and who have not been through 
their MRI visit, the MRI visit will occur within 6 weeks (42 days) from re-consenting and 
after reconfirmation that they do not meet the exclusion criterion #5  
12.7.1 Device Evaluation Prior to Commencement of MR Scan 
1. All implanted leads will be evaluated through the implanted PG for THREE separate 
consecutive sets of measurements using the test parameters listed in Table 12-3: 
• Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3.  
• Sensing amplitude 
• Impedance 
• Shock impedance (RV lead only) 
2. Test for phrenic nerve stimulation (PNS) and measure the PNS threshold if detected in 
the programmed LV lead configuration 
3. Perform an assessment of Beeper function as defined in section 12.7.1.1. 
4. Print the ‘Quick Notes’ Report 
Record the measurements in the EDC system. 
12.7.1.1 
Assessment of Beeper function  
To test if the Beeper is audible, 
1. Program Magnet Response to Inhibit Therapy 
2. Place the magnet over the PG for a minimum of 5 seconds but not for more than 20 
seconds in a quiet environment. 
• If the Tachy mode is programmed to ‘Monitor + Therapy’: A short beep may be 
heard once every second, as long as the magnet is placed over the PG.  
• If the Tachy mode is programmed to ‘Monitor only’ or ‘OFF’: A continuous beep 
may be heard as long as the magnet is placed over the PG. 
Note: The Magnet Sensor will detect Guidant/Boston Scientific CRM magnets (donut, 
horseshoe or wrist) within 3 cm. The Magnet Sensor will detect a 60 G < field ≤300 G, 
when applied perpendicularly to the surface of the PG, either face.   
3. The subject and the HCP will be asked to indicate whether the Beeper is audible to them.  
4. If not audible, by either the subject or the HCP, a second attempt at assessing Beeper 
function will be performed. The Beeper should be assessed in the alternate Tachy mode 
(as listed in step 2) if tolerated by the subject. 
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12.7.2 Subject Evaluation Prior to Commencement of MR Scan 
12.7.2.1 Confirmation of MRI Conditions of Use 
Subjects must meet the MRI Conditions of Use, comprised of Cardiology and Radiology 
Conditions of Use, as listed in the BSC MRI Technical Guide and Section 6 of this protocol. 
Documentation of both the Cardiology and Radiology MRI Conditions of Use assessment 
must be included. 
Note: Subjects must satisfy the MRI Conditions of Use prior to receiving the study-required 
MR scan; otherwise a protocol deviation shall be assessed. 
 
12.7.2.2 Subject History of Unexplained Syncope 
Prior to the MR Scan, subjects should be questioned or a current medical history review 
should occur to determine if there is any history of unexplained syncope (loss of 
consciousness).  If confirmed, the subject should not proceed with the study-required MR 
scan and be withdrawn from the study. 
 
12.7.2.3 Heart Rhythm Monitoring prior to MRI protection mode programming  
It is required that the heart rhythm be monitored by the site Principal Investigator or a sub-
investigator for all subjects prior to initiation of the MRI Protection Mode and the MR Scan.  
• Monitoring is to be performed in VVI 40 programming 
• Monitor the heart rhythm using the programmer EGRAMs for at least 5 minutes. 
Heart rate and any abnormal rhythms, including incidence of ectopy shall be 
documented.  
o In particular, look for signs of progressive AV nodal block over time, 
permanent or intermittent complete AV block, or trifascicular block 
(alternating bundle branch block or PR > 200 ms with LBBB or other 
bifascicular block) or a paced event (one single paced beat) during this time 
period. Any occurrence of these events will disqualify subjects from 
undergoing the MRI.  
 Such subjects should be withdrawn from the study. 
o Required ECG documentation 
 12 lead ECG and a 10s rhythm strip to be printed at any time during 
the 5 minutes of the monitoring (either from the ECG machine or the 
BSC PRM) 
 Any abnormal rhythms / ectopy shall be documented with a printed 
ECG or rhythm strip if possible. 
 

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12.7.3 MR Scans 
The MR scan must be performed within the guidelines of this protocol and the BSC MRI 
Technical Guide. When differences exist, the ENABLE MRI Study protocol extends the BSC 
MRI Technical Guide. 
MRIs must be performed in 1.5 Tesla, closed bore scanners with body coil excitation. 
Subjects will complete MR scans per the MR scan sequences protocol in Section 28 of this 
protocol. 
Note: Incidental findings are defined as a “finding concerning an individual research 
participant that has potential health or reproductive importance and is discovered in the 
course of conducting research but is beyond the aims of the study10”. The MR scans required 
by the ENABLE MRI Study are not intended for diagnostic purposes. Therefore, they are not 
intended or required to be read by trained radiologists. If the site’s MR technician performing 
the scan determines any incidental findings, or if a site’s procedures dictate that MR scans 
must be read, any incidental findings must be reported to the site’s primary investigator by 
the person who reads the scan. 
Additionally, it is important to note that the Image Artifact core lab (see Section 14.3) will 
not be required or requested to report incidental findings to BSC or the investigator, and BSC 
will not be reviewing any images received for diagnostic or incidental finding purposes. 
Site investigators must make it clear through the patient informed consent process that the 
MR scans required by the ENABLE MRI Study are for research only. They are not intended 
for diagnostic purposes, and will not necessarily be viewed by trained professionals. 
12.7.3.1 Programming MRI Protection Mode  
Prior to undergoing an MR scan, the ImageReady System must be programmed to the MRI 
Protection Mode using the PRM. The PRM is to be kept ON and in MRI Zone I or II as close 
to the MRI room as possible. 
WARNING: The PRM is MR Unsafe and must remain outside the MRI site Zone III (and 
higher) as defined by the American College of Radiology Guidance Document for Safe MR 
Practices11. Under no circumstances should the PRM be brought into the MRI scanner room, 
(Zone IV), or the control room (Zone III). Programming the PG to MRI Protection Mode 
should be done as close to the planned start of the MR scan as possible. 
1. Start monitoring the subject as outlined in section 12.7.3.3 
2. Program the MRI Protection Time-out (nominal setting: 6 hours; programmable 
values are OFF, 3, 6, 9, 12 hours)  
                                                 
10 Wolf SM LF, Nelson CA, Kahn JP, Cho MK, Clayton EW, et al. Managing incidental findings in human 
subjects research: Analysis and recommendations. J Law Med Ethics. 2008;36:219 
11 Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007. 

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3. Program the PG to the MRI Protection Mode 
4. Print the MRI Protection Settings Report. This report documents the MRI Protection 
Mode settings and details.  
a. If the Time-out feature is used, the report includes the exact time and date 
when MRI Protection Mode will expire. If the Time-out feature is used, the 
MRI technologist/radiologist must verify that adequate time remains to 
complete the scan and to exit the MR scanner room. 
Please refer to the BSC MRI Technical Guide for more information regarding PG MRI 
Protection Mode programming and other associated MRI warnings, cautions, and potential 
adverse events. 
12.7.3.2 Heart Rhythm Monitoring after MRI protection mode programming  
It is required that the heart rhythm be monitored by the site Principal Investigator or a sub-
investigator for all subjects after programming MRI protection mode ON and prior to 
initiation of the MR Scan.  
• Monitor the heart rhythm for at least 5 minutes using the monitoring equipment 
screen. Heart rate and any abnormal rhythms, including incidence of ectopy shall be 
documented.  
o In particular, look for signs of progressive AV nodal block over time, 
permanent or intermittent complete AV block, or trifascicular block 
(alternating bundle branch block or PR > 200 ms with LBBB or other 
bifascicular block) or a sinus pause > 2s during this time period. Any 
occurrence of these events will disqualify subjects from undergoing the MRI.  
 For such subjects, MRI protection mode must be turned OFF. These 
subjects should be withdrawn from the study. 
 
12.7.3.3 Monitoring of Subjects during the MRI Protection Mode  
Subjects must be continuously monitored by the site Principal Investigator or a sub-
investigator for the entire duration in which the PG is in MRI Protection Mode. All subject 
monitoring must be documented (visual and auditory cues are acceptable when the subject is 
being connected to the equipment defined below). 
For the entire duration that the PG is in MRI Protection Mode, the following will be 
performed: 
1. Investigational centers must utilize continuous monitoring of all of the following 
a. ECG (minimum of a 3-lead ECG is required) 
b. Pulse oximetry with waveform monitoring (non-impedance based Finger 
plethysmography)  
c. Blood pressure 

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NOTE: Both the ECG and pulse oximeter alarms should be turned to the ON 
position on the monitoring machine for the entire duration of the MR scan.  
2. Ensure that an external defibrillator and medical personnel trained in external 
defibrillation and cardiopulmonary resuscitation (CPR) are present  
3. Subjects must be continuously monitored by the site Principal Investigator or a sub-
investigator trained in monitoring hemodynamic stability using ECG, pulse oximetry 
and blood pressure, along with maintaining normal voice and visual contact. 
4. In addition, for the entire duration of the MR scan, the following will be 
performed: 
a. The heart rate, blood pressure and oxygen saturation levels will be 
documented in 5 ± 2 minutes intervals.  
b. ECG and pulse oximeter alarms must be ON  
c. It is recommended that a rhythm strip is printed at each interval. 
d. If there are any abnormal rhythms, a rhythm strip to document the abnormal 
rhythm should be printed if possible.  
12.7.3.4 MR Scan Sequences Protocol  
Refer to Table 28-1 in Section 28 for the MR Scan Sequences Protocol. 
The following data is required to be collected: 
1. Medications used for sedation in the MR scanner, if applicable  
2. MR Scanner manufacturer and model  
3. Time of MR scan initiation  
4. Time duration for each sequence within the RF intensive and Gradient intensive scans  
5. Total duration of RF intensive scan sequences  
6. Total duration of Gradient intensive scan sequences  
7. Time of MR scan completion  
12.7.3.5 Exiting the MRI Protection Mode  
Upon completion of the MR scan, program the PG out of the MRI Protection Mode by 
interrogating the device using the wand (RF telemetry is disabled in MRI Protection Mode). 
It is recommended to program the PG out of MRI Protection Mode as close to the end of MR 
scan as possible. 
• Document the Time of exiting MRI Protection Mode. 
Note: The PRM is MR Unsafe and must remain outside the MRI site Zone III (and higher). 
Under no circumstances should the PRM be brought into the MRI scanner room, the control 
room, or the MRI site Zone III or IV areas. 

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Upon exiting the MRI Protection Mode, all parameters are restored to pre-MRI Protection 
Mode values with two exceptions:  
• Restoration of function of the Minute Ventilation12 (MV) sensor is delayed. If MV was 
programmed to ON or Passive at the time of entry into MRI Protection Mode, upon exit 
from the mode, an automatic six hour calibration of the sensor will begin. MV-driven rate 
response is not available during this calibration period. If MV-driven rate response is 
desired sooner, a manual calibration can be performed.  
• The Beeper will remain OFF upon exiting MRI Protection Mode.  
12.7.4 Device Evaluation after the MR Scan  
1. All implanted leads will be evaluated within two hours upon exit from the MRI 
Protection Mode through the implanted PG for THREE separate consecutive sets of 
measurements using the test parameters listed in Table 12-3: 
• Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3. 
Sensing amplitude 
• Impedance 
• Shock impedance (RV lead only) 
2. Test for phrenic nerve stimulation (PNS) and measure the PNS threshold if detected in 
the programmed LV lead configuration 
3. Perform an assessment of Beeper function as defined in section 12.7.1.1. After 
performing the assessment of the Beeper, if the Beeper is audible, the user may choose to 
manually re-enable the Beeper. 
Record the measurements in the EDC system. 
12.7.5 Completing the MRI Visit 
1. The PG data must be reviewed to document whether any episodes of polymorphic or 
monomorphic VT or VF that required ATP or shock therapy are present, following 
the MR scan.  
a. If polymorphic or monomorphic VT or VF episodes are present: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters 
and EGMs) using the PRM 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is 
expected to be submitted to Boston Scientific within 5 business days 
using the upload tool in the EDC system 
                                                 
12 Only available internationally outside the US 

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iii. 
If a physical copy of the Selected Episode Report(s) is to be submitted 
(instead of an electronic upload), the copy is expected to be submitted to 
the ECG Core Lab within 5 business days 
2. Program the device according to physician discretion, and indicate if any permanent 
device programming was changed 
3. Print the ‘Quick Notes’ Report 
4. Perform a Save All: 
a. Save device data to a USB using the programmer “Save All” feature 
b. Label the USB with the subject ID#, Date, and “MRI” 
c. Retain the original USB at the center, and a copy is expected to be submitted to 
Boston Scientific within 5 business days using the upload tool in the EDC 
system 
i. 
If a physical copy of the USB is to be submitted (instead of an electronic 
upload) use a PC to make the copy and label it the same way as the 
original. Do not make a copy by using the programmer a second time 
as this will create a new USB with slightly different information 
5. Schedule the MRI+1 month follow-up visit. 
12.7.6 MRI Visit Source Data Requirements 
Source data requirements at the MRI Visit are described in Table 12-6:  
Table 12-6: MRI Visit Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Pre-MR scan:  
• 
Assessment of patient history of unexplained syncope  
• 
Device Evaluation (pace threshold, sense amplitude, 
impedance, RV shock impedance, LV Phrenic 
Stimulation threshold)  
• 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
• 
Assessment of Beeper function  
• 
Printout of ‘Quick Notes’ Report  
• 
Cardiology and Radiology MRI Conditions of Use are 
satisfied  
• 
12 leads ECG & 10s rhythm strip (either from the 
ECG machine or the BSC PRM)  
  
Retain at center 
While PG is programmed to MRI Protection Mode:  
• 
MRI Protection Settings Report 
• 
Heart rate, blood pressure, Oxygen saturation levels, 
and Voice Contact in 5 ± 2 minute intervals 
Retain at center 

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Source Documentation Requirement 
Disposition 
• 
Rhythm strip every 5 ± 2 minutes (recommended) 
• 
Rhythm strips for abnormal rhythms, as applicable 
(recommended)  
• 
Medications used for sedation in the MR scanner, if 
applicable  
• 
MR Scanner manufacturer and model  
• 
Time of MR scan initiation  
• 
Time duration for each sequence within the RF 
intensive and Gradient intensive scans  
• 
Total duration of RF intensive scan sequences  
• 
Total duration of Gradient intensive scan sequences 
• 
Time of MR scan completion  
 
When PG is programmed out of MRI Protection Mode:  
• 
Time of exiting MRI Protection Mode 
Retain at center 
Post-MR scan:  
• 
Device Evaluation (pace threshold, sense amplitude, 
impedance, RV shock impedance, LV Phrenic 
Stimulation threshold)  
• 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
• 
Assessment of Beeper function 
• 
Document if polymorphic or monomorphic VT/VF 
episodes requiring therapy, are present  
• 
Documentation of spontaneous VT/VF episode(s) by 
PRM strips, as applicable: 
o 
‘Selected Episodes Report’ (counters and 
EGMs required) 
o 
‘Arrhythmia Logbook’  
• 
Printout of ‘Quick Notes’ Report  
 
Retain at center 
Adverse Events 
Retain at center 
MR scanner DICOM dump/ report file including items such as 
scan sequence settings and durations as well as calculated scan 
metrics such as whole body average SAR. 
The DICOM file must contain both images and scan 
sequence data. 
Retain the original at the center and submit 
a copy to Boston Scientific  
Save All  
Retain the original at the center and submit 
a copy to Boston Scientific  
 
 

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12.8 MRI + 1 Month Visit (Phase I only) 
The MRI + 1 Month Visit must be performed as a clinic visit and will occur at 30 ± 7 days 
after the MRI Visit.  
12.8.1 Device Evaluation 
1. All implanted leads will be evaluated through the implanted PG for THREE separate 
consecutive sets of measurements using the test parameters listed in Table 12-3: 
• Manual pacing threshold tests, as defined in sections 12.5.1.1, 12.5.1.2 and 12.5.1.3.   
• Sensing amplitude 
• Impedance 
• Shock impedance (RV lead only) 
2. Test for phrenic nerve stimulation (PNS) and measure the PNS threshold if detected in 
the programmed LV lead configuration 
Record the measurements in the EDC system. 
12.8.2 VF Induction 
Subjects who successfully complete the study required MRI scan and either qualify for the 
“for-cause” VF induction or consented to be part of the VF induction Sub-study will undergo 
a VF Induction. 
“For cause” VF induction is required if the below criteria are met at the MRI + 1 Month 
Visit:  
• A reduction in the RV lead R-wave amplitude of > 50% post-MRI, as measured at the 
MRI + 1 Month Visit compared to the pre MRI value collected during the MRI Visit, 
with a RV lead R wave that is greater than or equal to 5 mV post-MRI as measured 
during the MRI + 1 Month Visit 
“For cause” VF inductions are ideally performed at the MRI + 1 Month Visit, but may be 
performed up to 14 calendar days after the MRI + 1 Month Visit.  
Subjects will be assessed for clinical stability prior to performing the VF induction testing 
(both those subjects who qualify for the “for-cause induction and those who are part of the 
VF induction Sub-study), per physician discretion. The following criteria should be 
considered prior to performing VF Induction testing: 
1. Unstable heart failure requiring hospitalization in the last 30 calendar days  
2. Unable to tolerate sedation (e.g. IV sedation, general anesthesia) 
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4. Evidence of lead fracture or lead dislodgment  
5. Evidence of PG malfunction (i.e. error code) 
6. Right Ventricular Lead R wave is less than 5 mV  
Subjects determined to be clinically stable will undergo VF Induction testing according to the 
following procedure: 
1. Subjects will undergo IV sedation or general anesthesia, according to local standard 
of care for VF induction testing.   
2. Program the following settings: 
• 1-Zone, VF 
• Rate = 180 bpm or less. Lower than 180 bpm may be appropriate based on 
patient’s previous history, per physician’s discretion 
• Sensitivity: 0.6 mV or less (more sensitive – 0.15 to 0.6 mV) 
3. Perform the VF induction test through the implanted ICD/CRT-D through the EP 
Tests screen 
4. Select the VF Induction method at the discretion of the physician (e.g. 50 Hz Manual 
Burst, Shock on T, V Fib, etc.) 
a. Begin printing a real-time ECG and electrograms with markers prior to 
starting the induction 
b. Initiate the VF induction testing 
c. If an arrhythmia is induced and the device has not started charging after 16 
seconds, then the physician may choose to apply therapy through alternative 
methods; e.g. Stat Shock or external defibrillation 
d. Upon rhythm termination, stop the ECG and electrograms  
5. If the first induction attempt induces monomorphic or polymorphic VT;  or the VF 
spontaneously terminates prior to charging  
a. Treat as needed 
b. Attempt second VF induction using a different induction method or induction 
parameters (e.g. Shock on T with different Shock Coupling, Fib High longer 
duration etc.) A maximum of two VF induction attempts is allowed per 
subject. A VF Induction attempt is defined as an attempt to induce VF that 
results in an episode entry in the Arrhythmia Logbook, i.e. NSVT, VF/VT that 
spontaneously terminates. 
6. Upload into the EDC all induced episodes within 5 business days 

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a. If a physical copy of induced episode(s) is to be submitted (instead of an 
electronic upload), the copy is expected to be submitted to the ECG Core Lab 
within 5 business days 
When the VF Induction testing is complete, program the device, per physician discretion. 
When 25 VF episodes in 25 subjects post MRI scan are confirmed (combination of 
spontaneous VF episodes, “for-cause” and VF Induction Sub-study VF episodes) by the ECG 
Core Lab, sites will be notified by BSC to stop all VF induction testing. This includes “for-
cause” inductions, and VF Induction Sub-study inductions that were planned but not yet 
completed.  
 
12.8.3 Completing the MRI + 1 Month Visit 
1. The PG data must be reviewed to document whether any new episodes of 
polymorphic or monomorphic VT or VF that required ATP or shock therapy are 
present, following the MRI visit. 
a. If polymorphic or monomorphic VT or VF episodes are present: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters 
and EGMs) using the PRM 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is 
expected to be submitted to Boston Scientific within 5 business days 
using the upload tool in the EDC system 
iii. 
If a physical copy of the Selected Episode Report(s) is to be submitted 
(instead of an electronic upload), the copy is expected to be submitted to 
the ECG Core Lab within 5 business days 
2. Program the device according to physician discretion, and indicate if any permanent 
device programming was changed 
3. Print the ‘Quick Notes’ Report 
4. Perform a Save All: 
a. Save device data to a USB using the programmer “Save All” feature 
b. Label the USB with the subject ID#, Date, and “MRI + 1 month” 
c. Retain the original USB at the center, a copy is expected to be submitted to 
Boston Scientific within 5 business days using the upload tool in the EDC 
system 
i. 
If a physical copy of the USB is to be submitted (instead of an electronic 
upload) use a PC to make the copy and label it the same way as the 

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original. Do not make a copy by using the programmer a second time 
as this will create a new USB with slightly different information. 
5. Schedule the Annual follow-up visit. 
12.8.4 MRI + 1 Month Visit Source Data Requirements 
Source data requirements at MRI+1 month Visit are described in Table 12-7: 
Table 12-7: MRI + 1 Month Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Device Evaluation (pace threshold, sense amplitude, 
impedance, RV shock impedance, LV Phrenic 
Stimulation threshold) 
Retain at center 
PRM ECG strips from manual threshold tests 
documenting LOC for all implanted leads 
VF Induction real-time ECG and electrogram strips, 
if VF induction occurred 
Printout of ‘Quick Notes’ Report and ‘Devices 
Settings Report’ showing the VF induction settings, 
if VF induction occurred 
Documentation of spontaneous VT/VF episode(s) by 
PRM strips, as applicable: 
• 
‘Selected Episodes Report’ (counters and 
EGMs required) 
• 
‘Arrhythmia Logbook’  
Printout of Final ‘Quick Notes’ Report 
Adverse Events 
Save All 
Retain the original at the center and submit a copy to 
Boston Scientific  
 
12.9 Every Three-month Follow ups through Three Years (Recommended) 
For Phase I and Phase II patients with a MR scan (study required MR scan or medically 
necessary MR scan):  
• If the patient is followed on LATITUDE NXT, monitoring of device performance is 
strongly recommended at least every 3 months 
• If the patient is not followed on LATITUDE NXT, an in-clinic follow-up schedule 
of every three months is strongly recommended to monitor device performance   
Timing for each follow up is:  
• First 3-month Follow-up: 90±30 days from MRI visit 

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• Second 3-month Follow-up: 180±30 days from MRI visit 
• Third 3-month Follow-up: 270±30 days, and so on 
12.9.1 Device Evaluation 
1. The standard of care evaluation for device performance is recommended. Record the 
available measurements in the EDC system. 
• Pacing thresholds (if LATITUDE NXT is used, collect thresholds if available) 
• Sensing amplitude 
• Impedance 
• Shock impedance (RV lead only) 
2. If any new episodes of polymorphic or monomorphic VT or VF that required ATP or 
shock therapy are present since the prior study visit: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters 
and EGMs)  
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is 
expected to be submitted to Boston Scientific within 5 business days 
using the upload tool in the EDC system 
iii. 
If a physical copy of the Selected Episode Report(s) is expected to be 
submitted (instead of an electronic upload), the copy must be submitted to 
the ECG Core Lab within 5 business days 
3. Program the device according to physician discretion, if applicable  
4. Print the ‘Quick Notes’ Report 
12.9.2 Every Three-month Visit Source Data Requirements 
Source data requirements at Every Three-month visits are described in Table 12-8. 
Table 12-8: Every Three Month Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Document if polymorphic or monomorphic VT/VF episodes requiring 
therapy, are present  
Documentation of VT/VF episode(s) by PRM strips, as applicable: 
• 
‘Selected Episodes Report’ (counters and EGMs required) 
• 
‘Arrhythmia Logbook’ 
Retain at center 
Printout of ‘Quick Notes’ Report 
Adverse Events 

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12.10  Annual Follow ups through Three Years  
For de novo: Annual follow-ups must be performed as an in-clinic visit, starting at one year 
post implant and continuing until 3 years post implant.  
For existing implants: Annual follow-ups must be performed as a clinic visit, starting at one 
year post enrollment and continuing until 3 years post enrollment. 
Timing for each follow up is:  
• 1 Year Follow-up: 365±90 days 
• 2 Year Follow-up: 730±90 days 
• 3 Year Follow-up: 1095±90 days 
12.10.1 Standard Device Evaluation 
All implanted leads will be evaluated through the implanted PG for: 
• Manual pacing threshold tests (testing parameters per physician discretion) 
• Sensing amplitude 
• Impedance 
• Shock impedance (RV lead only) 
Record the measurements in the EDC system. 
12.10.2 Completing the Annual Visit 
1. For all annual visits after an MR scan, the PG data must be reviewed to document 
whether any new episodes of polymorphic or monomorphic VT or VF that required 
ATP or shock therapy are present since the prior study visit.  
a. If polymorphic or monomorphic VT or VF episodes are present: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters 
and EGMs) using the PRM 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is 
expected to be submitted to Boston Scientific within 5 business days 
using the upload tool in the EDC system 
iii. 
If a physical copy of the Selected Episode Report(s) is to be submitted 
(instead of an electronic upload), the copy is expected to be submitted to 
the ECG Core Lab within 5 business days 

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2. Program the device according to physician discretion  
3. Print the ‘Quick Notes’ Report 
4. Perform a Save All: 
a. Save device data to a USB using the programmer “Save All” feature 
b. Label the USB with the subject ID#, Date, and “Annual” 
c. Retain the original USB at the center, and a copy is expected to be submitted to 
Boston Scientific within 5 business days using the upload tool in the EDC 
system 
i. 
If a physical copy of the USB is to be submitted (instead of an electronic 
upload) use a PC to make the copy and label it the same way as the 
original. Do not make a copy by using the programmer a second time 
as this will create a new USB with slightly different information. 
5. Schedule the next annual follow-up visit. 
12.10.3 Annual Visit Source Data Requirements 
Source data requirements at annual visits are described in Table 12-9. 
Table 12-9: Annual Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Device Evaluation (pace threshold, sense amplitude, impedance, RV 
shock impedance) 
Retain at center 
PRM ECG strips from manual threshold tests documenting LOC for all 
implanted leads 
Document if polymorphic or monomorphic VT/VF episodes requiring 
therapy, are present  
Documentation of VT/VF episode(s) by PRM strips, as applicable: 
• 
‘Selected Episodes Report’ (counters and EGMs required) 
• 
‘Arrhythmia Logbook’ 
Printout of ‘Quick Notes’ Report 
Adverse Events 
Save All 
Retain the original at the center 
and submit a copy to Boston 
Scientific  
 
12.11  Additional Visits 
An Additional Follow-up Visit will be reported when an office/clinic visit identifies a 
reportable event and the device is interrogated (see Section 22.1). If possible, a device 
evaluation and lead measurements should be performed and the results recorded in the EDC 
system. 

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12.11.1 Required Data Collection 
1. Complete the Additional Follow-up form  
2. Collect any adverse event information  
3. Print the ‘Quick Notes’ Report 
12.11.2 Recommended Data Collection 
1. It is recommended to conduct a device evaluation: 
• Manual pacing threshold tests 
• Sensing amplitude 
• Impedance 
• Shock impedance (RV lead only) 
2. For all additional visits after an MR scan, the PG data should be reviewed to document 
whether any new episodes of polymorphic or monomorphic VT or VF that required ATP 
or shock therapy are present since the prior study visit.  
a. If polymorphic or monomorphic VT or VF episodes are present: 
i. 
Print the ‘Arrhythmia Logbook’ and ‘Selected Episodes Report’ (counters 
and EGMs) using the PRM 
ii. 
A copy of the Selected Episode Report(s) with counters and EGMs is 
expected to be submitted to Boston Scientific within 5 business days 
using the upload tool in the EDC system 
iii. 
If a physical copy of the Selected Episode Report(s) is to be submitted 
(instead of an electronic upload), the copy is expected to be submitted to 
the ECG Core Lab within 5 business days 
3. Perform a Save All: 
a. Save device data to a USB using the programmer “Save All” feature 
b. Label the USB with the subject ID#, Date, and “Additional Follow-up” 
c. Retain the original USB at the center, and a copy is expected to be submitted to 
Boston Scientific within 5 business days using the upload tool in the EDC system 
i. 
If a physical copy of the USB is to be submitted (instead of an electronic 
upload) use a PC to make the copy and label it the same way as the 
original. Do not make a copy by using the programmer a second time 
as this will create a new USB with slightly different information. 
Record the measurements in the EDC system for any tests performed. 

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12.11.3 Additional Follow-up Visit Source Data Requirements 
Source data Requirements at Additional Follow-up Visit are described in Table 12-10. 
Table 12-10: Additional Follow-up Source Documentation Requirements  
Source Documentation Requirements 
Disposition 
Device Evaluation (pace threshold, sense amplitude, impedance, RV 
shock impedance), as applicable 
Retain at center 
PRM ECG strips from manual threshold tests documenting LOC for all 
implanted leads 
Document if polymorphic or monomorphic VT/VF episodes requiring 
therapy, are present  
Documentation of VT/VF episode(s) by PRM strips, as applicable: 
• 
‘Selected Episodes Report’ (counters and EGMs required) 
• 
‘Arrhythmia Logbook’ 
Printout of ‘Quick Notes’ Report 
Adverse Events 
Save All, as applicable 
Retain the original at the center 
and submit a copy to Boston 
Scientific  
Text in table that is italicized is recommended   
12.12  Medically Necessary MRI Visits 
During the study, if a subject needs a medically necessary MR scan, BSC recommends the 
subject be directed to have the scan at the Study site. 
Note: In case the medically necessary MR scan is performed at a non-investigational site, all 
efforts must be made to collect the data and adhere to the MRI Conditions of Use. 
Study flow is identical to the MRI visit as described in section 12.7. Some data collection is 
optional for Medically Necessary MRI visit as shown in italic in Table 12-11. 
For medically necessary MRI scans, all activities performed by the site Principal Investigator 
or a sub-investigator at the MRI visit (i.e. heart rhythm monitoring, hemodynamic 
monitoring) can be performed by a trained and qualified Health Care Professional (HCP).  
As for the MRI visit, it is recommended to have a programmer powered ON in Zone II near 
the MRI room in case the patient develops the urgent need for pacing. 
12.12.1 Medically Necessary MRI Visit Source Data Requirements 
Source data Requirements for medically necessary MR scans are described in Table 12-11: 

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Table 12-11: Medically Necessary MRI Visit Source Documentation Requirements 
Source Documentation Requirement 
Disposition 
Pre-MR scan:  
• 
Body Part scanned 
• 
Assessment of patient history of unexplained syncope  
• 
Device Evaluation (pace threshold, sense amplitude, 
impedance, RV shock impedance, LV Phrenic Stimulation 
threshold)  
• 
PRM ECG strips from manual threshold tests documenting 
LOC for all implanted leads 
• 
Assessment of Beeper function  
• 
Printout of ‘Quick Notes’ Report  
• 
Cardiology and Radiology MRI Conditions of Use are 
satisfied  
• 
12 leads ECG & 10s rhythm strip (either from the ECG 
machine or the BSC PRM) 
 
Retain at center 
While PG is programmed to MRI Protection Mode:  
• 
MRI Protection Settings Report 
• 
Time of MR scan initiation  
• 
Time of MR scan completion 
• 
Heart rate, blood pressure, Oxygen saturation levels, and 
Voice Contact in 5 ± 2 minute intervals 
• 
Medications used for sedation in the MR scanner, if 
applicable  
• 
MR Scanner manufacturer and model  
Retain at center 
When PG is programmed out of MRI Protection Mode:  
• 
Time of exiting MRI Protection Mode 
Retain at center 
Post-MR scan:  
• 
Device Evaluation (pace threshold, sense amplitude, 
impedance, RV shock impedance, LV Phrenic Stimulation 
threshold)  
• 
PRM ECG strips from manual threshold tests documenting 
LOC for all implanted leads 
• 
Assessment of Beeper function 
• 
Document if polymorphic or monomorphic VT/VF episodes 
requiring therapy, are present  
• 
Documentation of spontaneous VT/VF episode(s) by PRM 
strips, as applicable: 
o 
‘Selected Episodes Report’ (counters and EGMs 
required) 
o 
‘Arrhythmia Logbook’  
• 
Printout of ‘Quick Notes’ Report  
 
Retain at center 
Adverse Events 
Retain at center 

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MR scanner DICOM dump/ report file including items such as scan 
sequence settings and durations as well as calculated scan metrics 
such as whole body average SAR. 
The DICOM file must contain both images and scan sequence data. 
Retain the original at the center and 
submit a copy to Boston Scientific  
Save All  
Retain the original at the center and 
submit a copy to Boston Scientific  
Text in table that is italicized is recommended   
12.13 Study Completion 
Subjects will be followed until completion of the 3-year annual follow-up visit. In the US, if 
a subject receives an investigational lead(s) that is not approved by the FDA before the 3-
year annual follow-up, then the subject will be followed until the investigation lead(s) is 
approved, explanted, or until study closure. Upon completion of participation in the study, 
subjects will be followed per normal standard of care. 
13. Statistical Considerations  
13.1 Endpoints (Phase I only) 
All Phase I subjects who consent to be part of the VF Sub-study  or require a “for-cause” VF 
induction will contribute to the ancillary analysis of VT/VF assessment. 
13.1.1 Primary Safety Endpoint: MR Scan-Related ImageReady System Complication 
Free Rate 
The primary safety endpoint will be assessed for all subjects who undergo any portion of the 
study-required MR scan sequences. Safety will be confirmed by evaluating the MR scan-
related ImageReady System Complication-free rate (CFR) between the MR Scan and the 
MRI Visit + 1 Month. For the purpose of this endpoint, a MR scan-related ImageReady 
System complication will be defined as those complications that are related to the MR scan 
and ImageReady System. All complications that the site reports as related to the MR scan 
and ImageReady System will be adjudicated by an external committee for relation to the MR 
scan. Complications that are determined to be associated with the MR scan will be 
considered MR scan-related complications and count against this endpoint. 
13.1.1.1 
Hypotheses 
The following hypotheses will be used to evaluate the Primary Safety Endpoint: 
H0: The MR Scan-related CFR rate between MR Scan and MRI Visit + 1 Month ≤ 
90%  
HA: The MR Scan-related CFR rate between MR Scan and MRI Visit + 1 Month > 
90%. 

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13.1.1.2 
Sample Size 
The sample size of 155 CRT-D subjects is driven by primary LV effectiveness endpoint 2.  
Additionally 40 VR ICD subjects will also be enrolled to represent the worst case scenario 
for lead heating.  This results in a total 195 enrolled subjects.  Given the assumed attrition 
rate of 30%, a total of 137 subjects with MR scans are expected. Since a power calculation 
cannot be directly calculated for a one group Kaplan-Meier analysis, an exact test was used. 
A power calculation using sample size of 137 subjects with MR scans was calculated based 
on a one-sided exact test for a single binomial proportion, using SAS Version 9.2 with the 
following assumptions: 
• Performance goal = 90% 
• Expected MR Scan-related CFR rate between MR Scan and MRI visit +1 month = 
97.5% 
• Significance level = 2.5% 
These assumptions result in a power level of 94.3%. 
13.1.1.3 
Statistical Methods 
Endpoint analysis will be performed on all subjects that undergo an MR scan (study sequence 
is initiated), including subjects that have an incomplete scan. However, if a medically 
necessary scan occurs between implant and the MRI + 1 Month Visit, data for that subject 
will not be included in this endpoint. 
The MR Scan-related complication-free rate from the date of the MRI Visit through 31 days 
post-MR scan will be calculated using Kaplan-Meier methodology. The 97.5% one-sided 
lower pointwise confidence limit of the complication-free rate will be calculated via log-log 
methodology and compared to the performance goal of 90% 11, 12,13,14,15. If the lower 
confidence limit exceeds 90%, the null hypothesis will be rejected. 
The Kaplan-Meier methodology was chosen for this endpoint to utilize all available data for 
each subject. Subjects, who did not undergo an MR scan, i.e., the study sequence was not 
initiated, will be considered to have missing data. To assess the robustness of this analysis 
method and the potential impact missing data could have had on the analysis results, a 
tipping point analysis will be conducted that will include enrolled subjects. The tipping point 
analysis will assign each subject with missing data as either having or not having a MR Scan-
related complication. All possible combinations of these patients’ data will be evaluated 
along with the actual observed data to find the point, if any, at which the endpoint is failed. 
13.1.2 Primary RV Effectiveness Endpoint 1: Pre-MR Scan vs. 1 Month Post-MR Scan 
RV Pacing Threshold at 0.5 ms 
Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan will 
be calculated for subjects. Subjects that have an increase in average pacing thresholds ≤ 0.5V 
(at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a 
success. 

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13.1.2.1 
Hypotheses 
The following hypotheses will be used to evaluate the Primary RV Effectiveness Endpoint 1: 
H0: The RV Pacing Threshold Success Rate ≤ 87%  
HA: The RV Pacing Threshold Success Rate > 87%. 
13.1.2.2 
Sample Size 
A sample size of 58 RV leads with paired threshold measurements is required to evaluate 
Primary RV Effectiveness Endpoint 1. This sample size was calculated based on a one-sided 
exact test for a single binomial proportion, using SAS Version 9.2 with the following 
assumptions:  
• Performance goal = 87% 
• Expected RV Pacing Threshold Success = 97% 
• Significance level = 5% 
• Power = 80% 
Given an expected attrition rate of 40%, 97 RV leads are needed, in order to meet the sample 
size of 58 RV leads with paired threshold measurements. 
The 10% margin between the expected performance and the performance goal is based on 
prior confirmatory designs, where a difference in success rates between a control group and 
treatment group of 10% was used in those studies11, 12,13,14,15. With the intended study design 
each subject serves as their own control. 
13.1.2.3 
Statistical Methods 
Multiple RV pacing threshold measurements taken at each of the two visits (MRI Visit and 
the MRI Visit + 1 Month) will be averaged to determine the average RV pacing threshold at 
each visit for each subject. The change in average pacing thresholds will then be calculated 
for each subject and compared to 0.5V to determine success or failure. Subjects that have an 
increase in average pacing thresholds (pre-MR Scan and at the MRI visit + 1 Month follow-
up) ≤ 0.5V will be considered a success. The 95% one-sided lower pointwise confidence 
limit of the RV pacing threshold success rate will be calculated using the one-sided exact 
methodology for a single binomial proportion and compared to the performance goal of 87%. 
If the lower confidence limit exceeds 87%, the null hypothesis will be rejected. 
All variations of RV leads and lead families will be pooled for this endpoint. 
Primary RV Effectiveness Endpoint 1 will be analyzed by per-protocol analysis. The per-
protocol analysis will only include subjects who received an MR Scan, and will not include 
subjects that meet any of the following exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• Fails to meet labeled MRI Conditions of Use 

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• Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
• Has an incomplete scan based on the ENABLE MRI Study MR Scan Sequences 
The per-protocol analysis will consider the subjects without paired RV pacing threshold 
measurements as having missing data, in addition to any subject that meets an exclusion 
listed above. To assess the impact missing data could have had on the analysis results, a 
tipping point analysis will be conducted.  The analysis will assign each subject with missing 
data as either a failure or success. All possible combinations of these patients’ data will be 
evaluated along with the actual observed data to find the point, if any, at which the endpoint 
has failed. 
13.1.3 Primary RV Effectiveness Endpoint 2: Pre-MR scan vs. 1 Month Post-MR Scan 
RV Sensed Amplitude 
Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan will be 
calculated for subjects. Subjects will be considered a success if the average sensed amplitude 
at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value.  
Subjects who have an average pre-scan RV sensed amplitude measurement < 5.0 mV will be 
excluded from this analysis. 
13.1.3.1 
Hypotheses 
The following hypotheses will be used to evaluate the Primary RV Effectiveness Endpoint 2: 
H0: The RV Sensed Amplitude Success Rate ≤ 85%  
HA: The RV Sensed Amplitude Success Rate > 85%. 
13.1.3.2 
Sample Size 
A sample size of 68 RV leads with paired RV amplitude measurements is required to 
evaluate Primary RV Effectiveness Endpoint 2. This sample size was calculated based on a 
one-sided exact test for a single binomial proportion, using SAS Version 9.2 with the 
following assumptions:  
• Performance goal = 85% 
• Expected RV Sensed Amplitude Success = 95% 
• Significance level = 5% 
• Power = 80% 
Given an expected attrition rate of 45%, 124 RV leads are needed, in order to meet the 
sample size of 68 RV leads with paired amplitude measurements. 
The 10% margin between the expected performance and the performance goal is based prior 
confirmatory study designs, where a difference in success rates between a control group and 

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treatment group of 10% was used in those studies11, 12,13,14,15. With the intended study design 
each subject serves as their own control. 
13.1.3.3 
Statistical Methods 
Multiple RV sensed amplitude measurements taken at each of the two visits (MRI Visit and 
the MRI + 1 Month Visit) will be averaged to determine the average RV sensed amplitude at 
each visit for each subject. The percent of subjects meeting the success criteria will be 
calculated. The 95% one-sided lower pointwise confidence limit of the RV sensed amplitude 
success rate will be calculated using the one-sided exact methodology for a single binomial 
proportion and compared to the performance goal of 85%. If the lower confidence limit 
exceeds 85%, the null hypothesis will be rejected. 
All variations of RV leads and lead families will be pooled for this endpoint. 
Primary RV Effectiveness Endpoint 2 will be analyzed by per-protocol analysis. The per-
protocol analysis will only include subjects who received an MR Scan, and will not include 
subjects that meet any of the following exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• Fails to meet labeled MRI Conditions of Use 
• Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
• Has an incomplete scan based on the ENABLE MRI Study MR Scan Sequences 
• Average RV sensed amplitude <5mV pre-MR scan 
The per-protocol analysis will consider the subjects without paired RV sensed amplitude 
measurements as having missing data, in addition to any subject that meets an exclusion 
listed above. To assess the impact missing data could have had on the analysis results, a 
tipping point analysis will be conducted.  The analysis will assign each subject with missing 
data as either a failure or success. All possible combinations of these patients’ data will be 
evaluated along with the actual observed data to find the point, if any, at which the endpoint 
is failed. 
13.1.4 Primary LV Effectiveness Endpoint 1: Pre MR Scan- vs. 1 Month Post-MR Scan 
LV Pacing Threshold at 0.5 ms 
Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR 
scan will be calculated for subjects. Subjects that have an increase in pacing thresholds 
measurements  ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit 
will be considered a success. 
13.1.4.1 
Hypotheses 
The following hypotheses will be used to evaluate the Primary LV Effectiveness Endpoint 1: 
H0: The LV Pacing Threshold Success Rate ≤ 87%  

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HA: The LV Pacing Threshold Success Rate > 87%. 
13.1.4.2 
Sample Size 
A sample size of 68 LV leads with paired threshold measurements is required to evaluate 
Primary LV Effectiveness Endpoint 1. This sample size was calculated based on a one-sided 
exact test for a single binomial proportion, using SAS Version 9.2 with the following 
assumptions:  
• Performance goal = 87% 
• Expected LV Pacing Threshold Success = 97% 
• Significance level = 5% 
• Power = 90% 
Given an expected attrition rate of 40%, 114 LV leads are needed, in order to meet the 
sample size of 68 LV leads with paired threshold measurements. 
The 10% margin between the expected performance and the performance goal is based on 
prior confirmatory study designs. A difference in success rates between a control group and 
treatment group of 10% was used in those studies11, 12,13,14,15. With this intended study design 
each subject serves as their own control 
13.1.4.3 
Statistical Methods 
Multiple LV pacing threshold measurements taken at each of the two visits (MRI Visit and 
the MRI + 1 Month Visit) will be averaged to determine the average LV pacing threshold at 
each visit for each subject. The change in average pacing thresholds will then be calculated 
for each subject and compared to 1.0V to determine success or failure, and the percent of 
subjects meeting the success criteria will be calculated. The 95% one-sided lower pointwise 
confidence limit of the LV pacing threshold success rate will be calculated using the one-
sided exact methodology for a single binomial proportion and compared to the performance 
goal of 87%. If the lower confidence limit exceeds 87%, the null hypothesis will be rejected. 
Primary LV Effectiveness Endpoint 1 will be analyzed by per-protocol analysis. The per-
protocol analysis will only include subjects who received an MR Scan, and will not include 
subjects that meet any of the following exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• Fails to meet labeled MRI Conditions of Use 
• Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
• Has an incomplete scan based on the ENABLE MRI Study MR Scan Sequences 
The per-protocol analysis will consider the subjects without paired LV pacing threshold 
measurements as having missing data, in addition to any subject that meets an exclusion 

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listed above. To assess the impact missing data could have on the analysis results, a tipping 
point analysis will be conducted.  The analysis will assign each subject with missing data as 
either a failure or success. All possible combinations of these patients’ data will be evaluated 
along with the actual observed data to find the point, if any, at which the endpoint has failed. 
13.1.5 Primary LV Effectiveness Endpoint 2: Pre-MR scan vs. 1 Month Post-MR Scan 
LV Sensed Amplitude 
Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan will be 
calculated for subjects. Subjects will be considered a success if the average sensed amplitude 
at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the average pre-MR Scan 
value.  Subjects who have an average pre-scan LV sensed amplitude measurement < 5.0 mV 
will be excluded from this analysis. 
13.1.5.1 
Hypotheses 
The following hypotheses will be used to evaluate the Primary LV Effectiveness Endpoint 2: 
H0: The LV Sensed Amplitude Success Rate ≤ 85%  
HA: The LV Sensed Amplitude Success Rate > 85%. 
13.1.5.2 
Sample Size 
A sample size of 85 LV leads with paired LV amplitude measurements is required to 
evaluate Primary LV Effectiveness Endpoint 2. This sample size was calculated based on a 
one-sided exact test for a single binomial proportion, using SAS Version 9.2 with the 
following assumptions:  
• Performance goal = 85% 
• Expected LV Sensed Amplitude Success = 95% 
• Significance level = 5% 
• Power = 90% 
Given an expected attrition rate of 45%, 155 LV leads are needed, in order to meet the 
sample size of 85 LV leads with paired amplitude measurements. 
The 10% margin between the expected performance and the performance goal is based on 
prior confirmatory study designs, where a difference in success rates between a control group 
and treatment group of 10% was used11, 12,13,14,15.  With the intended study design each 
subject serves as their own control. 
13.1.5.3 
Statistical Methods 
Multiple LV sensed amplitude measurements taken at each of the two visits (MRI Visit and 
the MRI + 1 Month Visit) will be averaged to determine the average LV sensed amplitude at 
each visit for each subject. The percent of subjects meeting the success criteria will be 
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success rate will be calculated using the one-sided exact methodology for a single binomial 
proportion and compared to the performance goal of 85%. If the lower confidence limit 
exceeds 85%, the null hypothesis will be rejected. 
Primary LV Effectiveness Endpoint 2 will be analyzed by per-protocol analysis. The per-
protocol analysis will only include subjects who received an MR Scan, and will not include 
subjects that meet any of the following exclusions: 
• Has a medically necessary scan between implant and the MRI + 1 Month Visit 
• Fails to meet labeled MRI Conditions of Use 
• Experiences a lead-related complication between MRI Visit and the MRI + 1 Month 
Visit 
• Has an incomplete scan based on the ENABLE MRI Study MR Scan Sequences 
• Average LV sensed amplitude <5mV pre-MR scan 
The per-protocol analysis will consider the subjects without paired LV sensed amplitude 
measurements as having missing data, in addition to any subject that meets an exclusion 
listed above. To assess the impact missing data could have had on the analysis results, a 
tipping point analysis will be conducted.  The analysis will assign each subject with missing 
data as either a failure or success. All possible combinations of these patients’ data will be 
evaluated along with the actual observed data to find the point, if any, at which the endpoint 
is failed. 
13.2 Ancillary Assessments 
The ancillary endpoints are not formal endpoints and are not statistically powered.   
13.2.1 Assessment of RV and LV Impedances  
The changes in RV and LV impedances pre-MR scan versus 1 Month post-MR scan (MRI 
Visit and MRI + 1 Month Visit) will be presented in the  study report.  There are no success 
criteria for impedances, so a failure rate will not be presented. 
13.2.2 Assessment of RA lead measurements 
The changes in RA lead measurements including pacing thresholds, sensed amplitudes and 
impedances, between pre- and 1 Month post-MR scan measurements will be presented in the 
study report.  Also a summary by lead family, INGEVITY MRI and FINELINE II, will be 
presented.  There are no success criteria for RA lead measurements, so a failure rate will not 
be presented. 
13.2.3 Assessment on MR Scan Effect on Lead Measurements 
If a subject fails any of the effectiveness endpoints, it may indicate a potential MR scan 
effect on the corresponding lead for that endpoint.  However if the same subject fails both the 
pacing threshold and sensed amplitude effectiveness endpoints, this would represent stronger 
evidence of MR Scan effect on the corresponding lead.  Summaries of the subjects failing 

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both the pacing threshold and sensed amplitude effectiveness endpoints for each chamber 
will be included in the study report. 
13.2.4 Assessment of VT/VF  
In Phase I, VT and VF episodes from the following three sources will be collected and 
analyzed: 
• Spontaneous VT/VF episodes that required therapy 
• VT/VF episodes from “for-cause” VF induction 
• VF Induction Sub-study VT and VF episodes 
The VT/VF episodes will be evaluated by an ECG Core Lab. The performance objective is to 
demonstrate the continued ability of the ImageReady MR Conditional Defibrillation System 
to sense and detect VF post-MR scan (Phase I). Any instances of a detection delay of  ≥5 
seconds above the detection time expected, based on the VF rate and programming, will be 
further evaluated and the analysis will be provided. 
In addition, Boston Scientific plans to collect available spontaneous VT/VF episodes post 
MR scan from Phase I and II subjects over a 3-year follow-up period. The VT/VF episodes 
will be evaluated by an ECG core lab. A summary of the results from the ECG core lab will 
be included in the study report. 
13.2.5 Assessment of Effect of Medically Necessary MR Scans  
Boston Scientific proposes to collect available data on medically necessary MR scans (MNS) 
from Phase I and II subjects over a 3-year follow-up period. A summary of changes in lead 
measurements pre- to post- MNS and any MNS related complications will be presented. 
To assess the additive effect of multiple MR scans, the same summaries will be done for 
subjects with multiple MR scans. 
13.2.6 Assessment of Beeper Function  
As the beeper function may be affected by the MR Scanner static magnet field, beeper 
functionality will be summarized using descriptive statistics, for pre- and post-scan, for both 
the study required MR scans and MNS scans. 
13.2.7 Assessment of Programming the MRI Protection Mode   
In order to understand the use of the MRI Protection Mode, the following time durations will 
be summarized using descriptive statistics for both study-related MR scans and medically 
necessary MR scans: 
• Duration of the PG in the MRI Protection Mode  
• Time from the start of the MRI Protection Mode to the start of the MR scan 
• Time from the end of the MR scan to exiting the MRI Protection Mode  

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13.2.8 Assessment of Image Artifacts for non-medically necessary MR scans  
The image artifact core laboratory will evaluate the MR scan image artifacts in a subset of 
the non-medically necessary MR scan images from Phase I of the study. The results from the 
core lab analysis will be summarized in the study report.  
13.3 Sample Size Summary  
The study will enroll a total of 500 subjects. 
The estimated sample size for Phase I is based on the following assumptions:    
• The sample size for the interim analysis cohort is approximately 37 subjects, in order 
to have 20 subjects who have completed the protocol MRI required scan and 
completed the MRI + 1 Month visit.  This assumes an attrition rate of 45%. The 
interim analysis will be performed when data for 20 subjects who successfully 
complete the MR scan and the MR+1 Month Visit are available.  
• The sample size for the endpoint analyses is based on the MR Scan-related CFR 
endpoint (Primary Safety) as it requires 28 VR-ICD subjects in addition to the 
required 137 CRT-D subjects to undergo the study required MR scan (based on the 
primary LV Effectiveness Endpoint 2).   
The sample size for the whole study was chosen at up to 500 subjects in order to observe 30 
spontaneous VT/VF episodes post MRI scan. 
13.4 General Statistical Methods 
13.4.1 Control of Systematic Error/Bias 
Selection of patients will be made from the Investigator’s usual patient load. All patients 
meeting the eligibility criteria and having signed the ICF will be eligible for enrollment in the 
study. To control for inter-observer variability among sites, an independent Clinical Events 
Committee (CEC) will determine the MR Scan-related ImageReady System complications to 
be used in the analysis of the Primary Safety Endpoint.     
13.4.2 Control of Type I Error 
Each primary effectiveness endpoints can be tested at the significance level of 5% and the 
primary safety endpoint can be tested at the significance level of 2.5% while still maintaining 
the overall type I error level at no greater than 5%. This follows the methodology of the 
Intersection-Union Test (IUT).   
13.4.3 Number of Subjects per Investigative Site 
To avoid any center effect and bias, one center will not be authorized to implant or attempt 
more than 100 subjects (20% of the maximum number of subjects).   
13.5 Data Analyses 
The following data analyses are planned for the ENABLE MRI Clinical Study: 

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13.5.1 Interim Analyses 
No formal interim analyses are planned for the purpose of stopping the study early for 
declaring effectiveness or for futility. The interim analysis being conducted on 20 subjects is 
to support regulatory requirements and submissions. Analysis of each endpoint will be 
performed when all applicable data for that endpoint has been collected.  
13.5.2 Pooling Analyses 
13.5.2.1 
Assessment of Pooling Across Device Type 
The single chamber ICDs and the CRT-Ds are expected to perform similarly regarding any 
effect of MRI on RV pacing threshold or RV sensed amplitude as well MR Scan-related 
complications. Any effects of MRI on tissue surrounding each respective electrode design are 
expected to be proportionally similar. Therefore, device (PG and lead) type will be pooled for 
the analyses of all endpoints. Additionally, analysis will be performed for each of the primary 
safety and effectiveness endpoints 1 and 2 to verify poolability. To assess the impact of 
device type on each endpoint, a likelihood ratio test from a regression model will be 
conducted. The regression model may include additional baseline covariates to attempt to 
adjust for any imbalances between the device type groups, and will examine the effect of 
device type. The following baseline covariates may be considered for inclusion: age, gender, 
height, weight and geography. The likelihood ratio test will compare the log likelihoods 
between a model containing device type as a covariate and a model not containing device 
type as a covariate. The test will be performed at an α equal to 15%. Endpoint results will be 
presented for each device type regardless of the poolability analysis results. 
13.5.2.2 
Assessment of Pooling Across Geographies and Investigational Centers  
In addition to testing the poolability of data by device type, the poolability of data by 
geography and investigational center will be tested. These analyses will be performed to 
determine whether there are differences between the US and international geographies, and 
from center-to-center. 
A minimum of 50% of Phase I patients will be from the US. Center-to-center heterogeneity 
will be assessed for each endpoint by performing random effects logistic regression analyses.  
Centers enrolling 5 subjects or fewer will be combined within region (US versus OUS) into 
pooled sites of 6 or more subjects for the purpose of this pooling analysis. 
Investigational center will be added into the model as a random effect. Centers will be 
deemed to be heterogeneous if the variance of the random center effect is found to 
significantly differ from zero. A significance level of 15% will be used for each test.  
13.5.2.3 
Assessment of Pooling Across protocol versions  
The inclusion/exclusion criteria have been updated with version AE.  The poolability of data 
of subjects enrolled under version AE or later will be compared to subjects enrolled under all 
prior versions of the protocol.  

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To assess the impact of the protocol version on each endpoint, a likelihood ratio test from a 
regression model will be conducted. The regression model may include additional baseline 
covariates to attempt to adjust for any imbalances between the device type groups, and will 
examine the effect of protocol version. The following baseline covariates may be considered 
for inclusion: age, gender, height, weight and geography. The likelihood ratio test will 
compare the log likelihoods between a model containing protocol version as a covariate and a 
model not containing protocol version as a covariate. The test will be performed at an α equal 
to 15%. Endpoint results will be presented for each protocol version regardless of the 
poolability analysis results. 
13.5.3 Subgroup Analyses 
Analyses will be performed for each primary endpoint to determine whether significant 
differences exist in endpoint results between subgroups. The list of subgroups (with 
applicable definitions in parentheses) includes, but is not necessarily limited to: 
• Device Type (Single Chamber ICD vs. CRT-D) – note that this analysis will not be 
done for Primary Effectiveness Endpoint 3 or 4, 
• Sex (Female vs. Male), 
• Geography (International vs. United States), 
• Age (< 65 years vs. ≥ 65 years). 
The subgroup variable will be added to a logistic regression model. For effectiveness 
endpoints, treatment and an interaction term of subgroup and treatment will be added as well. 
A test for significance at the 15% level will be performed. For each subgroup variable in 
which a significant difference exists, the results for each subgroup will be presented 
separately. BSC does not plan to seek labeling for these subgroups based on these analyses. 
13.5.4 Multivariate Analyses 
Analyses of various baseline covariates and their relationship to each endpoint are outlined 
above. For each endpoint, all baseline characteristics found to be significantly associated 
with the outcome will be included as covariates, along with treatment group, in a multivariate 
regression model. The impact of each baseline characteristic’s subgroups will be presented 
along with the multivariate model results.   
13.5.5 Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan approved prior to performing the 
analyses. Changes from the planned statistical methods after performing the analyses will be 
documented in the clinical study report along with a reason for the deviation. 

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14. Data Management  
14.1 Data Collection, Processing, and Review 
Subject data y will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by Medidata. All changes 
made to the clinical data will be captured in an electronic audit trail and available for review 
by Boston Scientific Corporation or its representative. The associated RAVE software and 
database have been designed to meet regulatory compliance for deployment as part of a 
validated system compliant with laws and regulations applicable to the conduct of clinical 
studies pertaining to the use of electronic records and signatures. Database backups are 
performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the EDC system and will 
be issued to the site for appropriate response. Site staff will be responsible for resolving all 
queries in the database. 
14.2 Data Retention 
The Investigator or Investigational site will maintain, at the investigative site, in original 
format all essential study documents and source documentation that support the data 
collected on the study subjects in compliance with ICH/GCP guidelines.  Documents must be 
retained for at least 2 years after the last approval of a marketing application or until at least 2 
years have elapsed since the formal discontinuation of the clinical investigation of the 
product. These documents will be retained for a longer period of time by agreement with 
BSC or in compliance with other local regulations. It is BSC’s responsibility to inform the 
Investigator when these documents no longer need to be maintained. The Investigator will 
take measures to ensure that these essential documents are not accidentally damaged or 
destroyed. If for any reason the Investigator withdraws responsibility for maintaining these 
essential documents, custody must be transferred to an individual who will assume 
responsibility and BSC must receive written notification of this custodial change.  
14.3 Image Artifact Core Laboratory  
An independent Image Artifact core laboratory will evaluate MR scan image artifact in the 
torso region in a subset of the MR scan images collected during Phase I of the study. The 
core lab Radiologist will review a subset of the images from complete scans, based on the 
Scan Sequences Protocol in Section 28.  

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14.4 ECG Core Laboratory  
An independent core laboratory will evaluate VT/VF episodes collected post-MR scan, 
during Phase I and Phase II of the study. An electrophysiologist (EP) will review the 
episodes to assess sensing and detection of the episodes by the PG.  
15. Amendments  
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals (e.g., 
Institutional Review Board (IRB) / Ethics Committee (EC_/ US Food and Drug 
Administration (FDA) / Competent Authority (CA) of the revised clinical investigational 
plan must be obtained prior to implementation. 
16. Deviations  
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC of any deviation from the investigational plan to protect 
the life or physical well-being of a subject in an emergency, and those deviations which 
affect the scientific integrity of the clinical investigation. Such notice shall be given as soon 
as possible, but no later than 5 business days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 business days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using the EDC system. Sites 
may also be required to report deviations to the IRB/EC, per local guidelines and government 
regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, center re-training, or 
discontinuation) will be put into place by the sponsor. 
17. Device Accountability   
This section applies to sites in the US, as the only geography with investigational devices.  
Investigational devices in this study may include the: 
• ACUITY X4 leads, and associated accessory items if those items are distributed 
separately 
o May include de-novo or existing implant 

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• RELIANCE 4-FRONT, and associated accessory items if those items are distributed 
separately 
o May include existing implant only 
 
17.1 Device Accountability for Existing Implants of Investigational Leads  
Subjects with existing implant of investigational lead(s) from another BSC-sponsored IDE 
study (NAVIGATE X4 Study, NCT02071173, G130222) are allowed to enroll into the 
ENABLE MRI Study.  Device accountability is managed by the NAVIGATE X4 Study. 
17.2 Device Accountability for De-Novo Implants of Investigational Leads 
If investigational devices are distributed for this study, they shall be securely maintained, 
controlled, and used only in this clinical study. Current Boston Scientific processes will be 
used to track investigational device allocations during the study.  
The sponsor shall keep records to document the physical location of all investigational 
devices from shipment of investigational devices to the investigation sites until return or 
disposal. 
The Principal Investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the investigational devices, which shall include the 
following 
• Date of receipt 
• Identification of each investigational device (batch number or unique code) 
• Expiry date, as applicable 
• Date or dates of use 
• Subject identification 
• Date on which the investigational device was returned/explanted from subject, if 
applicable 
• Date of return of unused, expired, or malfunctioning investigational devices, if 
applicable. 
Written procedures may be required by national regulations. 
Upon completion of enrollments, or as directed by Boston Scientific, all unused 
investigational products must be returned to Boston Scientific. 

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18. Compliance  
18.1 Statement of Compliance  
This study will be conducted in accordance with applicable regulations and/or guidance per 
country or region including relevant parts of ISO 14155: Clinical Investigation of Medical 
Devices for Human Subjects, Good Clinical Practice, the relevant parts of the ICH 
Guidelines for Good Clinical Practices, ethical principles that have their origins in the 
Declaration of Helsinki, and pertinent individual country laws and regulations. The study 
shall not begin until the required approval/favorable opinion from the IRB/EC and/or 
regulatory authority has been obtained, if appropriate. Any additional requirements imposed 
by the IRB/EC or regulatory authority shall be followed, if appropriate. 
18.2 Investigator Responsibilities 
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with the Clinical Study Agreement, the investigational 
plan/protocol, relevant parts of ISO 14155, ethical principles that have their origins in the 
Declaration of Helsinki, any conditions of approval imposed by the reviewing IRB/EC, and 
prevailing local and/or country laws and/or regulations, whichever affords the greater 
protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• Prior to beginning the study, sign the Clinical Study Agreement and Protocol Signature 
page documenting his/her agreement to conduct the study in accordance with the 
protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the center team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) every 
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• Report to BSC, per the protocol requirements, all SAEs and device deficiencies that 
could have led to a SADE. 
• Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
could have led to a SADE, if required by the national regulations or this protocol or by 
the IRB/EC, and supply BSC with any additional requested information related to the 
safety reporting of a particular event. 
• Maintain the device accountability records and control of the device, ensuring that the 
investigational device is used only by authorized/designated users and in accordance with 
this protocol and instructions/directions for use. 
• Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
monitor and respond to questions during monitoring visits. 
• Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the investigational device when it is used/operated by the subject. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 

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• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
• Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
18.2.1 Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the investigator is responsible for providing appropriate 
training and adequate supervision of those to whom tasks are delegated. The investigator is 
accountable for regulatory violations resulting from failure to adequately supervise the 
conduct of the clinical study.  
18.3 Institutional Review Board/ Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational center will provide to the 
sponsor documentation verifying that their IRB/EC is registered or that registration has been 
submitted to the appropriate agency, as applicable according to national/regulatory 
requirements.   
A copy of the written IRB/EC and/or competent authority approval of the protocol (or 
permission to conduct the study) and Informed Consent Form, must be received by the 
sponsor before recruitment of subjects into the study and shipment of investigational 
product/equipment. Prior approval must also be obtained for other materials related to subject 
recruitment or which will be provided to the subject. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the study 
as required by local/country or IRB/EC requirements. Copies of the Investigator’s reports 
and the IRB/EC continuance of approval must be provided to the sponsor.  
18.4 Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative including Contract Research Organization (CRO) will have access to these 
confidential records. Authorized regulatory personnel have the right to inspect and copy all 
records pertinent to this study. Study data collected during this study may be used by BSC 
for the purposes of this study, publication, and to support future research and/or other 
business purposes. All data used in the analysis and reporting of this study will be without 
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Boston Scientific will keep subjects’ health information confidential in accordance with all 
applicable laws and regulations.  Boston Scientific may use subjects’ health information to 
conduct this research, as well as for additional purposes, such as overseeing and improving 
the performance of its device, new medical research and proposals for developing new 
medical products or procedures, and other business purposes. Information received during 
the study will not be used to market to subjects; subject names will not be placed on any 
mailing lists or sold to anyone for marketing purposes.  
18.4.1 Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed during implant, testing required by the protocol, 
and follow-ups. Support may include HCP training, addressing HCP questions, or providing 
clarifications to HCPs concerning the operation of BSC equipment/devices (including 
programmers, analyzers, and other support equipment). 
At the request of the investigator and while under investigator supervision, BSC personnel 
may operate equipment during implant or follow-up, assist with the conduct of testing 
specified in the protocol, and interact with the subject to accomplish requested activities. 
Typical tasks may include the following. 
• Interrogating the device or programming device parameters to investigator-requested 
settings as well as operating investigational equipment 
• Performing lead diagnostic testing using a Pacing System Analyzer or programmer to 
obtain pacing and sensing thresholds and impedance measurements 
• Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel 
• Assisting with the collection of study data from Pacing System Analyzers, programmers, 
and other equipment 
In addition, BSC personnel may perform certain activities to ensure study quality. These 
activities may include the following. 
• Observing testing or medical procedures to provide information relevant to protocol 
compliance 
• Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following.  
• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject without the approval and 
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• Independently collect critical study data (defined as primary or secondary endpoint data) 
• Enter data in electronic data capture systems or on paper case report forms 
18.5 Insurance  
Where required by local/country regulation, proof and type of insurance coverage by BSC for 
subjects in the study will be obtained. 
19. Monitoring  
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the monitor verifies that study records are 
adequately maintained, that data are reported in a satisfactory manner with respect to 
timeliness, adequacy, and accuracy, and that the Investigator continues to have sufficient 
staff and facilities to conduct the study safely and effectively. The Investigator/institution 
guarantees direct access to original source documents by BSC personnel, their designees, and 
appropriate regulatory authorities. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Investigator and/or 
relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
20. Potential Risks and Benefits   
20.1 Risks Associated with a CRT-D  
Patients participating in this study who will receive a CRT-D system will be consented prior 
to the implant procedure and are subject to the same risks shared by all patients that receive a 
CRT-D system.  
The risks associated with a CRT-D system, including the implant procedure, shall be 
reviewed with subjects prior to enrollment. Refer to the CRT-D Physician’s Technical 
Manual and CRT-D Reference Guide for additional information related to the CRT-D. The 
following risks are shared by all subjects who undergo an implant of a CRT-D device and are 
not unique to the ENABLE MRI Study:  
 
Table 20-1: Potential Adverse Events for Implantation of a Pulse Generator and/ or 
Lead System  
Potential Adverse Events for Implantation of a Pulse Generator and/ or Lead System* 
Air embolism  
Lead dislodgment  

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Potential Adverse Events for Implantation of a Pulse Generator and/ or Lead System* 
Allergic reaction  
Lead fracture  
Arterial damage with subsequent stenosis 
Lead insulation breakage or abrasion  
Bleeding  
Lead perforation 
Bradycardia 
Lead tip deformation and / or breakage  
Breakage/failure of the implant instruments 
Local tissue reaction 
Cardiac tamponade  
Loss of capture 
Chronic nerve damage  
Low amplitude VF signals 
Component failure  
Malignancy or skin burn due to fluoroscopic 
radiation 
Conductor coil fracture 
Myocardial Infarction 
Death  
Myocardial necrosis 
Electrolyte imbalance/ dehydration  
Myocardial trauma (e.g., irritability, injury, tissue 
damage, valve damage) 
Elevated thresholds  
Myopotential sensing  
Erosion  
Oversensing / undersensing  
Excessive fibrotic tissue growth  
Pacemaker-mediated tachycardia (PMT) 
Extracardiac stimulation (muscle/ nerve 
stimulation) 
Pericardial rub, effusion  
Failure to convert an induced arrhythmia 
Pneumothorax 
Fluid accumulation  
Post-shock rhythm disturbances 
Foreign body rejection phenomena  
Pulse generator and/or lead migration 
Formation of hematomas or seromas  
Shunting current during defibrillation with internal or 
external paddles 
Heart block  
Syncope 
Hemorrhage 
Tachyarrhythmias, which include acceleration of 
arrhythmias and early, recurrent atrial fibrillation  
Hemothorax 
Thrombus, thromboemboli 
Inability to defibrillate or pace 
Valve damage 
Inappropriate therapy (e.g., shocks, and 
antitachycardia pacing [ATP] where applicable, 
pacing) 
Vasovagal response 
Incisional pain  
Venous occlusion  
Incomplete lead connection with pulse generator  
Venous trauma (e.g., perforation, dissection, erosion) 
Infection including endocarditis 
Worsening heart failure 
Insulating myocardium during defibrillation with 
internal or external paddles 
 
*From the CRT-D Physician’s Technical Manual and Lead Manuals 
Patients may develop psychological intolerance to a pulse generator system and may 
experience the following: 

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Table 20-2 Potential Adverse Events of a Pulse Generator 
List of Potential Adverse Events of a Pulse Generator 
Dependency 
Fear that shocking capability may be lost 
Depression 
Imagined shocking/Fear of shocking while conscious 
Fear of premature battery depletion 
Fear of device malfunction 
* From the CRT-D Physician’s Technical Manual 
Additionally, potential adverse events associated with the implantation of a coronary venous 
lead system include: 
Table 20-3: Potential Adverse Events for implantation of a Coronary Venous Lead  
List of Potential Adverse Events for Coronary Venous Lead System* 
Allergic reaction to the contrast media 
Prolonged exposure to fluoroscopic radiation 
Adverse reaction to procedure (e.g., bradycardia, 
general, respiratory, hypotension) 
Renal failure from contrast media used to visualize 
coronary veins 
Coronary venous spasm 
 
*From the CRT-D Physician’s Technical Manual and CV lead Physician’s Lead Manual 
20.2 Risks Associated with an ICD  
Patients participating in this study who will receive an ICD system will be consented prior to 
the implant procedure and are subject to the same risks shared by all patients that receive an 
ICD system.  
The risks associated with an ICD system, including the implant procedure, shall be reviewed 
with subjects prior to enrollment. Refer to the ICD physician technical manual and ICD 
reference guide for additional information related to the ICD. The following risks are shared 
by all subjects who undergo an implant of an ICD device and are not unique to the ENABLE 
MRI Study:  
 
Table 20-4: Potential Adverse Events for implantation of a Pulse Generator and/ or 
Lead System  
Potential Adverse Events for Implantation of a Pulse Generator and/ or Lead System* 
Air embolism  
Lead dislodgment  
Allergic reaction  
Lead fracture  
Arterial damage with subsequent stenosis 
Lead insulation breakage or abrasion  
Bleeding  
Lead perforation 
Bradycardia 
Lead tip deformation and / or breakage  
Breakage/failure of the implant instruments 
Local tissue reaction 
Cardiac tamponade  
Loss of capture 
Chronic nerve damage  
Low amplitude VF signals 

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Potential Adverse Events for Implantation of a Pulse Generator and/ or Lead System* 
Component failure  
Malignancy or skin burn due to fluoroscopic 
radiation 
Conductor coil fracture 
Myocardial Infarction 
Death  
Myocardial necrosis 
Electrolyte imbalance/ dehydration 
Myocardial trauma (e.g., irritability, injury, tissue 
damage, valve damage) 
Elevated thresholds  
Myopotential sensing  
Erosion  
Oversensing / undersensing  
Excessive fibrotic tissue growth  
Pacemaker-mediated tachycardia (PMT) 
Extracardiac stimulation (muscle/ nerve 
stimulation) 
Pericardial rub, effusion  
Failure to convert an induced arrhythmia 
Pneumothorax 
Fluid accumulation  
Post-shock rhythm disturbances 
Foreign body rejection phenomena  
Pulse generator and/or lead migration 
Formation of hematomas or seromas  
Shunting current during defibrillation with internal or 
external paddles 
Heart block  
Syncope  
Heart failure following chronic RV apical pacing 
Tachyarrhythmias, which include acceleration of 
arrhythmias and early, recurrent atrial fibrillation  
Hemorrhage 
Thrombus, thromboemboli 
Hemothorax 
Valve damage 
Inability to defibrillate or pace 
Vasovagal response 
Inappropriate therapy (e.g., shocks, and 
antitachycardia pacing [ATP] where applicable, 
pacing) 
Venous occlusion  
Incisional pain  
Venous trauma (e.g. perforation, dissection, erosion) 
Incomplete lead connection with pulse generator  
Worsening heart failure 
Infection including endocarditis 
 
Insulating myocardium during defibrillation with 
internal or external paddles 
 
*From the ICD Physician’s Technical Manual and Lead Manuals  
Patients may develop psychological intolerance to a pulse generator system and may 
experience the following: 
Table 20-5 Potential Intolerance to a Pulse Generator 
List of Potential Intolerance to a Pulse Generator 
Dependency 
Fear that shocking capability may be lost 
Depression 
Imagined shocking/Fear of shocking while 
conscious 
Fear of premature battery depletion 
Fear of device malfunction 
* From the ICD Physician’s Technical Manual 

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20.3 Risks Associated with the Study Device(s)  
The implantable portion of the ImageReady System includes the PG, the pace/ sense lead(s) 
and defibrillation lead. In the US, the ACUITY X4 LV pacing leads and the RELIANCE 4-
FRONT leads may be investigational during a portion or the entire duration of the study. The 
basic safety and effectiveness of these leads are being studied in separate clinical studies for 
the US.  
The non-implantable portion of the ImageReady System includes the 2868 programmer 
software application v3.07 or later.  The MRI Protection Mode provides for simplified device 
programming that is available through multiple programming steps of existing features and 
therefore does not result in additional risk.  
There are no additional risks associated with the ImageReady System, other than those 
included in Sections 20.1 and 20.2. There are additional risks associated with MR scanning 
of the ImageReady System as described in Section 20.4. 
 
20.4 Risks associated with Participation in the Clinical Study 
Phase I subjects will have the added risk of a study-required MRI scan. Phase II subjects and 
Phase I subjects will have the added risks and benefits associated with a MRI scan if they 
decide to undergo a medically necessary MR scan. Potential adverse events associated with 
an MR scan are minimized by assuring that the subject meets the MRI Conditions of Use.  
MRI scanning of patients when the Conditions of Use are met could result in the following 
potential adverse events, as included in the BSC MRI Technical Guide: 
• 
Arrhythmia induction 
• 
Bradycardia 
• 
Patient death 
• 
Patient discomfort due to slight movement or heating of the device 
• 
Syncope 
• 
Worsening heart failure 
MRI scanning of patients when the Conditions of Use are NOT met could result in the 
following potential adverse events, as included in the BSC MRI Technical Guide: 
• 
Arrhythmia induction 
• 
Bradycardia 
• 
Damage to the pulse generator and/or leads 
• 
Erratic pulse generator behavior 
• 
Inappropriate pacing, inhibition of pacing, failure to pace 
• 
Increased rate of lead dislodgement (within six weeks of implant or revision of 
system) 
• 
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• 
Loss of defibrillation therapy 
• 
Pacing threshold changes 
• 
Patient death 
• 
Patient discomfort due to movement or heating of the device 
• 
Physical movement of pulse generator and/or leads 
• 
Sensing changes 
• 
Syncope 
• 
Side effects of pacing at a fixed high rate such as competition with intrinsic rhythms 
and arrhythmias. Competitive pacing may increase the rate of pacing induced 
arrhythmia until the device is reprogrammed. 
• 
Worsening heart failure 
**Note: It is important to note that the risks listed in this section may lead to the subject 
requiring a partial or full pacing system replacement. 
20.4.1 Beeper 
The Beeper may no longer be audible following an MRI scan.  
The beeper provides: (1) an audible patient warning when potential therapy failure is 
detected between scheduled PG checks with a device-following physician, and (2) audible 
feedback to clinical personnel regarding the state of the PG such as, current tachycardia 
mode and when charging for shock therapy.  An inaudible beeper results in an increase of the 
associated risk.   
Refer to the BSC MRI Technical Guide for more information on the Beeper. 
• 
The system proactively disables the programmable and non-programmable Beeper 
options when MRI Protection Mode is programmed. The Beeper will remain Off 
upon exiting MRI Protection Mode. 
• 
In situations where the MRI scan did not occur, the Beeper can be re-enabled after 
exiting MRI Protection Mode. 
• 
Upon subsequent interrogations with a PRM, a notification that the Beeper is disabled 
and the date MRI Protection Mode was last programmed will be provided.  
• 
It is strongly recommended that patients are followed on LATITUDE NXT after 
an MRI scan if they are not already. LATITUDE NXT performs a device check 
daily and provides notification for all safety-related beeper notifications. Otherwise, 
an in-clinic follow-up schedule of every three months is strongly recommended 
to monitor device performance.  
The following are situations that will no longer trigger the Beeper to emit audible tones once 
the device is programmed into MRI Protection Mode. 
 

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Table 20-6: Situations that will no longer trigger audible Beeper tones once the device is 
programmed into MRI Protection Mode 
Programmable Beeper options  
• 
Beep During Capacitor Charge 
• 
Beep When Lead Impedance Out-of-Range 
• 
Beep when Explant is Indicated 
Non-Programmable Beeper 
options 
• 
Application of the patient magnet over the pulse generator in 
certain situations (e.g. confirming Tachycardia Mode) 
• 
Battery capacity depleted (End of Life (EOL)) 
• 
Battery fault alert 
• 
High voltage fault alert 
• 
Reversion of the PG to Safety Core Operation 
• 
PG Reset 
 
20.4.2 Risks Related to VF Induction Testing 
Risks related to the “for cause” or VF Induction Sub-Study testing are outlined below: 
List of Potential Risk Related to VF Induction Testing 
Acceleration/induction of atrial or ventricular 
arrhythmia 
Inappropriate sensing 
Adverse reaction to induction testing 
Signal interference with already implanted heart 
rhythm management device function or standard of 
care equipment 
Allergic/adverse reactions to medications, including 
anesthesia 
Muscle stimulation 
Chest pain (angina) 
Myocardial infarction 
Death 
Reduced cardiac function 
Discomfort/pain during or after testing 
Shunting current during defibrillation with internal or 
external paddles 
Heart Block 
Stroke 
Heart Failure 
Syncope 
Inappropriate pacing of the heart 
Inappropriate shock delivery 
Non-elective Intubation 
 
20.5 Possible Interactions with Concomitant Medical Treatments 
The implantable lead(s) of the ImageReady System contain the steroid DXA, for the purpose 
of helping to reduce tissue inflammation response at the distal electrode. There are no data 
that show there are any drug interactions with this local steroid, or with any other portion of 
the ImageReady System. 
20.6 Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 

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selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
As the Beeper may no longer be audible, it is strongly recommended that patients are 
followed on LATITUDE NXT after an MRI scan if they are not already. Otherwise, an 
in-clinic follow-up schedule of every three months is strongly recommended to monitor 
device performance.  
20.7 Anticipated Benefits 
Subjects may not receive any benefit from participating in this study. However, medical 
science and future patients may benefit from their participation in this clinical study. 
20.8 Risk to Benefit Rationale 
Risk management activities, including hazard analyses and fault tree analysis, have been 
performed on the ImageReady System to identify and analyze known and foreseeable 
hazards (in both normal and fault conditions) and reasonably foreseeable sequences or 
combinations of events that could result from using this product and the risks associated with 
each hazard. Mitigations have been implemented in the design, processes, and/or labeling 
and instructions for use of the product to reduce the residual risk of each hazard as necessary 
and practicable. The hazard analysis has been reviewed and approved and the remaining risks 
are acceptable when weighed against the intended benefits to the patient. 
21. Safety Reporting 
All devices used as part of the ImageReady MR Conditional Defibrillation System will be 
referred to as the study device(s). All reportable events experienced by the study subject after 
informed consent, whether during or subsequent to the procedure, should be reported through 
the EDC system. However, in case of any issues where an alternative method of reporting is 
necessary (i.e. the EDC is not available), please report the event(s) to Boston Scientific by 
sending the AE Notification Form to the following email address: 
enablemri.safety@bsci.com 
 
21.1 Events Reportable by Sites to Sponsor  
The Principal Investigator is responsible for determining the reportability of events.  
Reportable events include the following: 
• All Device Related Adverse Events 

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• All Cardiac Events Related Adverse Events associated with an untoward medical 
occurrence 
o Pre-existing cardiac conditions are not considered reportable unless the 
condition has exacerbated 
• All Study Procedure Related Adverse Events 
• All MRI Scan Related Adverse Events, for both protocol required MR scans and 
medically necessary scans 
• All Adverse Events Related to the use of the MRI Protection Mode  
• All Serious Adverse Events (including death), regardless of causality 
o Planned hospitalizations for pre-existing conditions prior to enrolment are not 
considered a serious adverse event  
o Procedures required by the clinical investigational plan without serious 
deterioration in health are not considered a serious adverse event  
o For centers in Austria cancer must always be reported as a Serious Adverse 
Event 
• All Device Deficiencies 
• Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
previously not defined in the physician manuals 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device, it should be submitted as an adverse event and/or device 
deficiency. 
Events reported to Boston Scientific during the study will be reviewed and reported to 
comply with applicable regulations (relevant parts of ISO 14155: 2011 and/or 21 CFR Part 
812). Investigators will be asked to classify whether an adverse event is considered serious or 
non-serious, whether it is anticipated or unanticipated (meets USADE/ UADE definition) as 
defined in Table 21-1 below, and whether it is considered device or procedure related, as 
defined in section 21.4.2. Any event that is determined to be an unanticipated serious adverse 
device effect (USADE; ISO 14155: 2011) will also be considered an unanticipated adverse 
device effect (UADE; CFR Part 812), as defined in Table 21-1 below. 
Death should not be recorded as an adverse event. Death should be recorded as an outcome 
of only one (1) serious adverse event. 
21.2 Event Definitions and Classification 
Event definitions are provided in Table 21 1, based on ISO 14155-2011 and MEDDEV 
2.7/3 12/2010, and 21 CFR Part 812.  Reportable Events for this study are defined in 
Section 22.1  

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Table 21-1: Event Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, whether or not related to the 
investigational medical device.  
NOTE 1: This includes events related to the investigational medical 
device or comparator. 
NOTE 2: This definition includes events related to the procedures 
involved (any procedure in the clinical investigation plan). 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the investigational medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event related to the use of an investigational medical device 
NOTE 1: This definition includes any adverse event resulting from 
insufficient or inadequate instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the investigational medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event that: 
• Led to death, 
• Led to  serious deterioration in the health of the subject, that either 
resulted in: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient  or prolonged hospitalization of existing hospitalization, 
or 
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function 
• 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 clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
 
Unanticipated Adverse Device 
Effect (UADE) 
 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or 

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Table 21-1: Event Definitions 
Term 
Definition 
Ref: 21 CFR Part 812 
 
 
degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects.   
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
 
 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the risk analysis 
report. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect 
which by its nature, incidence, severity or outcome has been identified in 
the risk analysis report. 
Device Deficiency 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
A device deficiency is any inadequacy of a medical device with respect to 
its identity, quality, durability, reliability, safety or performance. 
NOTE 1: Device deficiencies include malfunctions, misuse or use errors, 
and inadequate labeling. 
 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 
 
Refer to Section 20 for the known risks associated with the study device(s). 
21.3 Unanticipated Adverse Device Effects  
All devices are subject to occasional random problems or failures. These may manifest 
themselves in altered pacing or sensing characteristics. There are wide variations in the 
seriousness of the effects. Refer to the device(s) Physician's Manual for information 
regarding potential adverse effects. 
If the unanticipated adverse device effect is serious or life-threatening, the Investigator is 
required to notify Boston Scientific, the IRB, and other regulatory authorities as required 
(e.g., Competent Authority if European center) as soon as possible, but no later than one 
business day after the Investigator first learns of the effect. For all other unanticipated 
adverse device effects, Boston Scientific and the IRB must be notified within ten business 
days. 
Boston Scientific will conduct an evaluation of all reported adverse events. If the event is 
determined to be an unanticipated adverse device effect, Boston Scientific personnel shall 
notify the Boston Scientific Regulatory department and initiate communication to all 
reviewing IRBs and participating Investigators within ten business days after initial notice is 
received. 
If Boston Scientific determines that an unanticipated adverse device effect presents an 
unreasonable risk to patients, the study shall be terminated. The termination shall occur no 

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later than five days after the termination decision is made and no later than 15 business days 
after Boston Scientific first received notice of the effect. 
21.4 Adverse Event Classification for FDA Reporting  
21.4.1 Observation/Complication 
Reported events will be classified, by BSC personnel or trained authorized representatives as 
a clinical observation or complication; as defined in the Table 21-2. 
Table 21-2: Definition of Observation and Complication 
Clinical Event 
Description 
Observation 
Adverse event that was transient or reversible and corrected with non-invasive 
interventions, such as reprogramming or oral medications, or was resolved with no 
intervention or monitoring 
Complication 
An adverse event that resulted in: death, serious injury* a, correction using invasive 
intervention**, or permanent loss of device functions***. 
 
* Per 21 CFR 803.3(bb): 
1) Serious injury means an injury or illness that: 
i) Is life-threatening; 
ii) Results in permanent impairment of a body function or permanent damage to 
body structure; or 
iii) Necessitates medical or surgical intervention to preclude permanent impairment 
of a body function or permanent damage to a body structure. 
2) Permanent means, for purposes of this subpart, irreversible impairment or damage to a 
body structure or function, excluding trivial impairment or damage. 
** Invasive interventions are those in which treatment necessary to correct the adverse event 
is delivered by cutting or piercing of the skin or placing an instrument in a body cavity to 
provide therapy. Examples of invasive interventions (complication) include: 
• Surgical revision of a lead 
• Electrophysiology study in which an ablation is performed 
• Angiogram in which angioplasty or stent placement is performed 
• Intravenous medications 
• Blood transfusions 
• Intubation to provide respiratory support 

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• Chemical (pharmacologic) Cardioversion with IV sedation (This is a complication 
due to the IV antiarrhythmic medication used for the cardioversion.) 
Invasive procedures that are purely diagnostic in nature should not be considered as a 
complication. Examples of procedures that are invasive, but not considered to be an 
intervention (observation), include: 
• Blood draw for laboratory analysis 
• Cardiac catheterization in which pressures are recorded, but without therapeutic 
interventions 
• Electrophysiology study to map arrhythmias, but without therapeutic intervention 
• Transesophageal echo (TEE) 
• Electrical (external) Cardioversion with IV sedation (the IV sedation used is for 
patient comfort and not part of the treatment) 
Other invasive procedures may occur that are not strictly interventional and done for medical 
convenience rather than medical necessity. These are not considered to be an adverse event 
since they are not related to an undesirable clinical outcome. Examples include: 
• Foley catheter placed in anticipation of a prolonged procedure 
• Intravenous fluids or medications related to a diagnostic procedure 
***Permanent Loss of device Function is where a malfunction occurs in a manner which 
there is compromised therapy. For the purposes of this study the following definitions will be 
utilized: 
• Malfunction: failure of a device to meet its performance specifications, to perform its 
essential function, or otherwise perform as intended.  Performance specifications 
include claims made in the labeling of the device. (i.e. device is  not functioning 
within labeling) 
• Malfunction with compromised therapy – Pulse Generator:  The condition when a 
device is found to have “malfunctioned”, in a manner that compromised pacing or 
defibrillation therapy (including complete loss or partial degradation) while implanted 
and in service.   
o Examples include (but are not limited to): sudden loss of battery voltage; 
accelerated current drain such that low battery was not detected before loss of 
therapy sudden malfunction during defibrillation therapy resulting in aborted 
delivery of therapy; intermittent malfunction where therapy is compromised 
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21.4.2 Adverse Event Type Classification 
An Investigator is required to report all reportable events (as defined in Section 21.1) for this 
study. All adverse events must recorded in the Adverse Event case report form in the EDC 
system,, including an event description, suspected cause, corrective action, and clinical 
outcome for the patient.  
Upon receipt of adverse event information, CRFs are reviewed by BSC personnel or trained 
authorized personnel. During the review process, the adverse event is classified as an 
observation or complication and each event is coded according to the types below. 
Classifications and type descriptions will be included with the adverse event information in 
appropriate submissions to the regulatory agencies. If the opinions between the investigator 
and BSC differ, both opinions will be reported, as appropriate. 
Table 21-3: Adverse Event Types I-V Utilized for BSC AE Classification 
Type 
 
Description 
Type I 
Related to an investigational device, investigational procedure, investigational therapy, or 
procedure related to the implant of the investigational device. 
Type II 
Related to the protocol or procedures specifically related to protocol testing that is not 
standard of care. 
Type III 
Related to commercially available implanted components or commercially available 
features of an investigational device, or the procedure of a commercially available device 
Type IV 
Related to a change in the patient’s condition or to therapies other than delivered by the 
implanted system.   
Type V 
Comments Only 
 
21.4.3 Adverse Event Outcome Status 
Adverse Events when reported are assigned an outcome status by centers (such as 
Recovering/Resolving, Resolved with residual effects, etc.) depending on the nature of the 
event or the corrective action involved. When clinically appropriate, centers should work to 
close events that may not be resolvable during the term of the investigation.  
 
21.5 Subject Death Reporting  
A subject death during the study must be reported to Boston Scientific as soon as possible 
and, in any event, within three calendar days of center notification. The center’s IRB/EC 
must be notified of any deaths in accordance with that center’s IRB/EC policies and 
procedures. 
Notification of death must include a detailed narrative (death letter) that provides 
detailed information describing the circumstances surrounding the death and is signed 
and dated by the Principal Investigator or authorized sub-Investigator. A death 

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narrative in the local language is acceptable, and will be translated to English by BSC 
(signed by an authorized translator). The death narrative must include all of the 
following, if available: 
• Date and time of death 
• Place death occurred 
• Immediate cause of death 
• Rhythm at the time of death, if known (include any available documentation) 
• Whether the death was related to the pulse generator, lead/catheter, clinical 
investigation, procedure, or patient condition 
• Whether or not the death was witnessed 
• Device status and/or activity at the time of death 
• Whether the subject had worsening heart failure 
• Any other circumstances surrounding the death 
• Approximate time interval from the initiating event to death (temporal course) 
• Investigator or co-Investigator signature and date 
Any information listed above that is unavailable or unknown must be specified as 
unavailable or unknown, as applicable, in the narrative. Also submit the following 
documentation: 
If the subject expired in the hospital: 
• A copy of the medical records for that admission (e.g., H & P, consults, test 
results, operative reports, and/or progress notes from the hospital chart) 
• Death certificate (if available) 
• Autopsy report (if applicable) 
If the subject expired outside of the hospital (e.g., home): 
• A copy of the most recent clinic visit (if not already submitted to Boston 
Scientific) 
• Death certificate (if available) 
Whenever possible, the PG should be interrogated. Investigational leads and related Boston 
Scientific system components (e.g., PGs) should be removed intact and returned promptly to 
Boston Scientific for analysis.  
The Clinical Events Committee (CEC) must review information regarding subject deaths, 
refer to section 23.1.  
21.6 
Subject Death Classification 
The following definitions of each category, along with the Epstein article,13 are to be used by 
the Investigator when completing the Death Information section. 

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I.         Primary Organ Cause - The root problem that initiated the terminal event if multiple 
factors were involved, e.g., HF - primary, renal failure - secondary. 
A.  Cardiac 
1.   Arrhythmic 
2.  Pump Failure - Death occurring in a patient with severe heart failure, refractory 
to medical therapy, in whom death is anticipated within days to two months. 
Often such patients are referred for hospice care, comfort care is provided and 
aggressive treatment is curtailed. The terminal event could be sudden and may 
be arrhythmic. This does not change the non-sudden, non-arrhythmic course 
that preceded the terminal event. 
3.   Ischemic 
a.   Acute MI - Symptoms compatible with an acute coronary syndrome (chest 
pain, acute dyspnea etc.), with evidence of myocardial necrosis as defined 
by: 
i. creatinine kinase (CK) ≥ 2x upper limit of normal (ULN)  
and CK MB isoenzyme percent > ULN  
ii. troponin level ≥ 2 x ULN 
Patients with an acute coronary syndrome and diagnostic ST-T wave 
changes (>2 mm ST elevation in two contiguous leads) will be included 
if the death occurs prior to enzyme confirmation. 
b. No Acute MI - Patient has not met the enzymatic or electrocardiographic 
criteria for an acute myocardial infarction. The testing was done and came 
back negative. For example, a patient who survives an unstable angina 
episode long enough to provide documentation that they did NOT have an 
MI, e.g., cardiac enzyme confirmation. 
c. MI Unknown - Myocardial infarction suspected but data to prove or 
disprove are not available. Used to capture the patient who is suspected of 
having a probable MI but dies prior to the MI being documented. For 
example, chest pain > 20 minutes, or chest pain with a nondiagnostic ECG 
(LBBB), or chest pain of unknown duration. 
4.   Other Cardiac 
5.   Unknown 
B.  Noncardiac 
C.  Unknown 
II.        Temporal Course 
A.  Sudden - death that occurred within one hour of onset of symptoms 

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B.  Non-Sudden - death that occurred greater than one hour of onset of symptoms 
C.  Unknown/Presumed Sudden - This category should be used for patients who were 
not expected to die of other causes, and were not witnessed at the time of death. 
There must be documentation of the patient’s condition within 24 hours prior to the 
event and there should be no acute change in the patient’s condition or 
circumstances leading up to the event. An example would be a stable patient who 
dies in his sleep. Patients can have worsening heart failure prior to the event and be 
included in this category, as long as the severity of heart failure does not fit the 
definition of death due to pump failure. 
D. Unknown 
III.      Antecedent Worsening Heart Failure - Patients with signs or symptoms of worsening 
heart failure within the two weeks prior to death or the event that led to death (e.g. 
cardiac arrest and hypoxic encephalopathy from which the patient does not recover). 
In order to avoid recall bias, there must be documentation of a clinical evaluation 
documenting worsening signs or symptoms or a change in medication recommended 
for symptoms of worsening heart failure. 
A.  N/A (Not Applicable) 
B.  Yes 
C.  No 
D.  Unknown - Insufficient information to determine state of heart failure at time of 
the event 
IV.      Death Witnessed - Someone witnessed the death event (in the same room or within 
earshot) 
A.  Yes 
B.  No 
C.  Unknown 
V.       Monitored - The patient rhythm at the onset of the terminal event (just prior to death) 
was documented. This may or may not be related to the actual cause of death. Device 
stored electrograms may not be used for this determination (depending on the study, 
i.e., heart failure). 
A.  Yes 
1. Ventricular Tachyarrhythmia 
2. Bradyarrhythmia 
a.  Sinus Bradyarrhythmia 
b.  High degree AV block with slow ventricular response 

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c.  Asystole 
3.   PEA (Pulseless Electrical Activity) 
4.   Other (AF, SVT, sinus tachycardia, normal sinus rhythm) 
5.   Unknown 
B.  No 
C.  Unknown 
VI.       Operative Relationship 
A.  Pre-Operative - deaths that occur after the consent is signed, but before the 
procedure 
B.  Peri-Operative - deaths that occur ≤ 30 days post-op or prior to hospital discharge 
following any system related surgery including lead and pulse generator revisions.  
C.  Post-Operative - deaths that occur > 30 days post-implant or revision following 
discharge. 
VII.     Procedure Related - includes events during, or as a result of, events from pre-op 
anesthesia through leaving the OR suite, the EP lab, or an office visit. 
A.  Yes 
B.  No 
C.  Unknown 
VIII.    Investigation Related - related specifically to differences in procedure or necessary 
equipment used or implanted used solely for the new or investigational aspects of the 
study. An example would be a coronary sinus perforation from a new left ventricular 
pacing lead introduced via the coronary sinus. 
A.  Yes 
B.  No 
C.  Unknown 
IX.       Pulse Generator Related - includes events associated with pulse generator’s ability 
to detect and treat an arrhythmia. 
A.  Yes 
B.  No - including events where initiating event was nonarrhythmic 
C.  Unknown 
D.  N/A 
X.        Lead/Catheter Related - includes events associated with the lead system’s ability to 
detect and treat an arrhythmia. 

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A.  Yes 
B.  No - including events where initiating event was nonarrhythmic 
C.  Unknown 
21.7 Relationship to Study Device(s) or Procedure 
The Investigator must assess the relationship of the AE to the study device or procedure. See 
criteria in Table 21-4 

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Table 21-4: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event 

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Classification 
Description 
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. 
Unlikely Related 
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. 
Possibly Related 
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 
Related 
The relationship with the use of the investigational device seems relevant and/or the 
event cannot reasonably explained by another cause, but additional information may be 
obtained. 

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Classification 
Description 
Causal 
Relationship 
The serious event is associated with the investigational device or with 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 investigational device use/application or 
procedures; 
- the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational 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 investigational device used for 
diagnosis, when applicable; 
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. 
21.8 Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 21-5. 
Adverse events should always be reported through the EDC system. However, in case of any 
issues where an alternative method of reporting is necessary (i.e. the EDC is not available), 
please report the adverse event to Boston Scientific by sending the AE Notification Form via 
email to the following email address,: 
enablemri.safety@bsci.com 
 
 
Source documentation for UADE/USADE, any SAE/SADE which resulted in subject death 
and BSC requested AE’s can either be uploaded in the EDC system or sent via email when 
available, with the accompanying source document checklist to the following email address,: 
enablemri.safety@bsci.com 
 

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Table 21-5: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
Unanticipated Adverse 
Device Effect / Unanticipated 
Serious Adverse Device 
Effect  
Complete AE eCRF page with all 
available new and updated 
information.  
 
• Within 1 business day of first 
becoming aware of the event. 
• Terminating at the end of the 
study 
Serious Adverse Event 
including Serious Adverse 
Device Effects 
Complete AE eCRF page with all 
available new and updated 
information.  
• Within 3 calendar days of first 
becoming aware of the event 
and as per local/regional 
regulations. 
• Reporting required through the 
end of the study 
Device Deficiencies 
(including but not limited to 
failures, malfunctions, and 
product nonconformities) 
Note:  Any Investigational 
Device Deficiency that might 
have led to a serious adverse 
event if a) suitable action had 
not been taken or b) 
intervention had not been 
made or c) if circumstances 
had been less fortunate is 
considered a reportable event. 
Complete Device Deficiency eCRF 
with all available new and updated 
information.  
• Within 3 calendar days of first 
becoming aware of the event 
and as per local/regional 
regulations. 
• Reporting required through the 
end of the study 
Adverse Event, Adverse 
Device Effect (includes 
device and procedure related 
events), all MRI related 
events. 
Complete AE eCRF page, which 
contains such information as date of 
AE, treatment of AE resolution, 
assessment of seriousness and 
relationship to the device.  
• No later than 10 business days 
after becoming aware of the 
information 
• Reporting required through the 
end of the study  
Abbreviations: AE=adverse event; CRF=case report form; IDE=Investigational Device Exemption; 
UADE=unanticipated adverse device effect 
21.9 Exceptions for Use of Investigational Feature at Non-Investigational Sites – 
US Only 
While geographic stability is necessary at the time of enrollment, it is possible for conditions 
to change for the subject in which continuing follow-up at the investigational center may 
pose a challenge. Every attempt should be made to keep the patient care at the Investigational 
Center and under the care of a trained investigator.  
In order to protect patient safety, use of investigational feature (MRI Protection Mode) at 
non-investigational sites is not allowed without prior sponsor and IRB approval. Notify 
sponsor as soon as possible to obtain approval, as the approval process may take time. Use of 

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the investigational feature at a non-investigational site is considered a protocol deviation and 
needs to be reported appropriately. 
Use of investigational feature will be considered for the following conditions: 
• Subject has sought medical attention at a non-investigational site and software use is 
intended to protect the health and welfare of the subject 
• Health of the subject prevents reasonably safe travel to an investigational site  
• Travel to investigational site presents a significant hardship on the subject (e.g. 
physical distance to an approved investigational site is too great, limited access to 
transportation to the investigational site, subject is under inpatient care, or subject is 
seen frequently for recurring treatment, such as dialysis or chemotherapy, at another 
site and the investigator agrees to allow device interrogations at that site)  
• Subject refuses to return to the investigational center despite being informed of the 
risks associated with seeking follow-up care at a non-investigational location 
• Urgent, unplanned medical attention of study subjects requiring the use of 
investigational software to protect patient safety supersedes such consideration  
Upon use of the investigational feature at a non-investigational site, information is to be 
collected surrounding the circumstances of use of the investigational feature and reported to 
Boston Scientific within 5 business days. 
Required documentation: 
• Completion of the Investigational Software Use Form 
• Completion of the Deviation Form  
21.10 Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and labeling errors) will be documented and reported to BSC. If 
possible, the device(s) should be returned to BSC for analysis. Instructions for returning the 
investigational device(s) will be provided. If it is not possible to return the device, the 
investigator should document why the device was not returned and the final disposition of the 
device. Device failures and malfunctions should also be documented in the subject’s medical 
record. 
In addition, any Investigational Device Deficiency that might have led to a serious adverse 
event if a) suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate should be reported. Following receipt, the 
investigator’s assessment is reviewed by internal BSC personnel. If the opinions between the 
investigator and BSC differ, both opinions will be reported, as appropriate. 

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NOTE: Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not to be reported as adverse events. However, if there is an adverse 
event that results from a device deficiency, that specific event would be recorded on the 
appropriate eCRF. 
21.11 Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
BSC is responsible for reporting adverse event information to all participating investigators 
and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC, and regulatory 
authorities of UADE and SAE as required by local/regional regulations. 
22. Informed Consent   
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
all subjects or their legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable. The ICF must be 
approved by BSC or it’s delegate (e.g. CRO), the center’s IRB/EC, or central IRB, if 
applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative center’s IRB/EC.  Any modification requires approval from BSC prior to use of 
the form.  The ICF must be in a language understandable to the subject and if needed, BSC 
will assist the center in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC approval prior to their use.  Privacy language shall be included in the 
body of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 

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• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the center and a copy of the signed and dated document and 
any other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements (e.g., FDA requirement is within 5 business days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Boston Scientific approval is required if changes to the revised ICF are 
requested by the center’s IRB/EC. The IRB/EC will determine the subject population to be 
re-consented. 
23. Committees  
23.1 Clinical Events Committee 
A CEC is an independent group of individuals with pertinent expertise that reviews and 
adjudicates all of the following, as reported by study investigators for Phase I and II subjects: 
• Events related to the study-required MR scan and ImageReady System between the 
MRI Visit and  MRI + 1 month Visit (safety endpoint) 
• Events related to medically necessary scan(s) and ImageReady System  
• Subject deaths  

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The CEC will review a safety event dossier, which may include copies of subject source 
documents provided by study sites. At the discretion of the sponsor, additional events may be 
sent to the CEC.   
Committee members will include a minimum of three practitioners with training in 
Electrophysiology (EP), and/ or Cardiology with the necessary therapeutic and subject matter 
expertise to adjudicate the event categories outlined above. CEC responsibilities, 
qualifications, membership, and committee procedures are outlined in the CEC charter. 
24. Suspension or Termination  
24.1 Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of subjects.  Investigators, associated IRBs/ECs, and regulatory 
authorities, as applicable, will be notified in writing in the event of study termination. 
24.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
• The occurrence of unanticipated adverse device effects that present a significant or 
unreasonable risk to subjects enrolled in the study. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
• A decision on the part of Boston Scientific to suspend or discontinue development of the 
device. 
24.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC Approval 
Any investigator, or IRB/ EC in the ENABLE MRI Study may discontinue participation in 
the study or withdrawal approval of the study, respectively, with suitable written notice to 
Boston Scientific. Investigators, associated IRBs/ECs, and regulatory authorities, as 
applicable, will be notified in writing in the event of these occurrences. 
24.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating centers by Boston Scientific. 
The IRB/EC and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  

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In the event an IRB or EC terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by Boston Scientific. 
In the event an investigator terminates participation in the study, study responsibility will be 
transferred to a co-investigator, if possible. In the event there are no opportunities to transfer 
investigator responsibility; detailed information on how enrolled subjects will be managed 
thereafter will be provided by Boston Scientific. 
The investigator must return all documents and investigational product to Boston Scientific, 
unless this action would jeopardize the rights, safety, or welfare of the subjects. 
24.4 Criteria for Suspending/Terminating a Study Center 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
center at any time after the study initiation visit if no subjects have been enrolled for a period 
beyond 3 months after center initiation, or if the center has multiple or severe protocol 
violations/noncompliance without justification and/or fails to follow remedial actions. 
In the event of termination of investigator participation, all study devices and testing 
equipment, as applicable, will be returned to BSC unless this action would jeopardize the 
rights, safety or well-being of the subjects. The IRB/EC and regulatory authorities, as 
applicable, will be notified. All subjects enrolled in the study at the center will continue to be 
followed. Detailed information on how enrolled subjects will be managed thereafter will be 
provided by Boston Scientific. The Principal Investigator at the center must make provision 
for these follow-up visits unless BSC notifies the investigational center otherwise. 
25. Publication Policy  
In accordance with the Corporate Policy on the Conduct of Human Subject Research, BSC 
requires disclosure of its involvement as a sponsor or financial supporter in any publication 
or presentation relating to a BSC study or its results. In accordance with the Corporate Policy 
for the Conduct of Human Subject Research, BSC will submit study results for publication 
(regardless of study outcome) following the conclusion or termination of the study. Boston 
Scientific Corporation adheres to the Contributorship Criteria set forth in the Uniform 
Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed. 
• All authorship and contributorship requirements as described above must be followed. 

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• BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
26. Reimbursement and Compensation for Subjects  
26.1 Subject Reimbursement 
Travel and other expenses incurred by subjects as a result of participation in the study will be 
reimbursed in accordance with pertinent country laws and regulations and per the study site’s 
regulations.   
Travel and other expenses incurred by subjects for completing a non-standard of care MRI 
and MRI + 1 month visits in the study will be reimbursed in accordance with pertinent 
country laws and regulations and per the study site’s fee agreement. 
 
26.2 Compensation for Subject’s Health Injury 
Boston Scientific Corporation will purchase an insurance policy to cover the cost of potential 
health injury for study subjects, as required by applicable law.  
27. Abbreviations and Definitions  
27.1 Abbreviations 
Abbreviations are shown in Table 27-1.   
Table 27-1: Abbreviations 
Abbreviation/Acronym 
           Term 
AE 
ASTM 
ATP 
BSC 
CA 
Adverse Event 
American Society for Testing and Materials 
Antitachycardia Pacing 
Boston Scientific Corporation 
Competent Authority 
CEC 
Clinical Events Committee  
CFR 
CFR 
Complication-free rate 
Code of Federal Regulations  
CRF 
Case Report Form 
CRT-D 
DR 
EC 
Cardiac Resynchronization Therapy Defibrillator 
“Dual Chamber” 
Ethics Committee 

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Table 27-1: Abbreviations 
Abbreviation/Acronym 
           Term 
ECG 
eCRF 
EDC 
EGM 
FDA 
FW 
Echocardiography 
Electronic Case Report Form 
Electronic Data Capture 
Electrogram 
Food and Drug Administration 
Firmware 
HCP 
ICD 
Health Care Provider 
Implantable Cardioverter Defibrillator 
ICF 
IDE 
IFU 
IRB 
ISO 
Informed Consent Form 
Investigational Device Exemption 
Instructions for Use 
Institutional Review Board 
International Standards Organization 
MRI 
Ms 
Magnetic Resonance Imaging 
Millseconds 
PG 
Pulse generator 
PNS 
PRM 
PVT 
RA 
RF 
RV 
SADE 
SAE 
SAR 
US 
USB 
USADE 
VF 
VR 
VT 
Peripheral Nerve Stimulation 
Programmer / Recorder / Monitor 
Polymorphic Ventricular Tachycardia 
Right Atrium 
Radiofrequency 
Right Ventricle 
Serious Adverse Device Effect 
Serious Adverse Event 
Specific Absorption Rate 
United States 
Universal Serial Bus 
Unanticipated Serious Adverse Device Effect 
Ventricular Fibrillation 
Single Chamber 
Ventricular Tachycardia 
ZWT 
Zoom Wireless Transmitter 
 
28. MR Scan Sequences Protocol  
This section includes the scan sequences for use in the ENABLE MRI Study for subjects in 
Phase I. 

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28.1 Background 
The MR scan sequences have been selected for their clinical relevance and their intensity as 
regards the RF and time-varying gradient fields the implanted system will be exposed to 
during the scan duration. The scan sequences selected are intended for utilization during a 
total of approximately 30 minutes of imaging (the total duration of time in the bore will be 
approximately one hour). 
28.2 MR Conditional Labeling 
Key aspects of the initial MR Conditional labeling being sought by Boston Scientific for the 
ImageReady System, which affect the types of scan sequences are: 
• 1.5 T, closed-bore MRI machines only 
• No anatomical scan restrictions (e.g. no isocenter scan exclusion zone) 
• Scans up to Normal Operating Mode SAR limits are allowed 
The scan sequences, target anatomical locations and positions of the subjects in the scan are 
selected in order to challenge and evaluate the safety of the ImageReady System for these 
key aspects of the MR Conditional labeling. 
28.3 Notes Regarding the MR Scan 
1. During the course of the imaging, the subject will be located in two unique positions: 
a. In order to maximize RF exposure, RF-intensive scan sequences will be run 
with the thoracic spine anatomical region centered within the bore. This will 
result in the implanted pacing system being located near the center of the 
scanner RF transmit coil, where the transmitted RF fields are strongest. 
b. In order to maximize gradient exposure, gradient-intensive scan sequences 
will be run with the lumbar spine anatomical region centered within the bore. 
This will result in the implanted pacing system being located near the edges of 
the scanner gradient coils where gradient fields are strongest. 
2. External coils are not to be used, in order to prevent unnecessary complexity in 
moving the subject between the two locations in the bore. To maintain consistency 
across scans, the body coil in the MRI scanner is to be used for all scan sequences. 
3. All DICOM files from the scans must be saved as part of the study data. 
4. Notes for RF-intensive scan sequences 
a. A portion of the scan images obtained via the FSE sequences will be 
evaluated for the impact of image artifact near the implanted system on the 
overall clinical utility of the images. As such, a wide field of view (FOV) 
should be used, such as 40-48 cm depending on subject size, in order to image 

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across the torso and include the PG in the image. Additionally, a frequency 
matrix size of 512 pixels should be used.13 
b. FSE sequences are to be T2-weighted, which are sequences that normally 
result in a high whole body average specific absorption rate (SAR). Utilize 
scan sequence parameters that would normally be used in clinical practice. All 
sequences in the RF-intensive section must only be run at Normal Operating 
Mode. Sequence parameters may be altered in order to increase whole body 
average SAR , such as (in addition to the settings mentioned in 4a) increasing 
the turbo factor or number of slices while ensuring the duration of the scan 
sequences is maintained, but must not exceed Normal Operating Mode SAR 
limits. 
c. If any individual sequence in the RF-intensive sequences is not available or 
cannot be run, that sequence must be abandoned and the durations of one or 
more of the other scan sequences increased such that the overall duration of 
the RF-intensive scanning is maintained. 
5. The suggested duration of all sequences are guidelines for the MR Technician 
running the scan. Variations from the suggested duration for each of the individual 
sequences are not to be considered as deviations from the protocol provided the 
overall scan durations for the RF-intensive and gradient-intensive scan regimens are 
adhered to (e.g. 11.5 minutes minimum and a maximum of 14 minutes for the RF-
intensive scan regimen, 17 minutes minimum and a maximum of 21 minutes for the 
gradient -intensive scan regimen). Active scan time must not be greater than 35 
minutes. Pre-scan time does not count towards the required duration. 
 
Table 28-1: Scan Sequence Protocol  
Scan Sequence14 
Suggested Duration per 
Scan Sequence 
Anatomical 
Region 
Centered in 
Bore 
Scanning Mode 
Requirements 
RF-Intensive (*See note 4 above) 
Sagittal Fast Spin Echo T2 
3.5 - 4 minutes 
Thoracic spine Must not exceed Normal 
Operating Mode SAR limits 
Axial Fast Spin Echo T2 
3.5 - 4 minutes 
Coronal Fast Spin Echo T2 
3.5 - 4 minutes 
Single Shot Turbo Spin 
Echo 
1 - 1.5 minutes 
 
Required sub-total = 11.5 - 
14 minutes 
 
Gradient-Intensive 
Axial Diffusion EPI 
2.5 - 3 minutes 
Lumbar spine  
Axial Perfusion EPI 
2.5 - 3 minutes 
                                                 
13 Only images from FSE sequences performed using the FOV and frequency matrix size values specified here 
will be evaluated for the impact of image artifact near the implanted system on the clinical utility of the images. 
14 Scan sequence names may be slightly different depending on scanner manufacturer. 

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Sagittal Diffusion EPI 
2.5 - 3 minutes 
3D Plane Localizer 
30 seconds 
Axial 3D TOF MRA 
5 - 5.5 minutes 
Coronal 3D Bolus MRA 
1 - 1.5 minutes  
Axial Fast Spin Echo T2 
Flair 
3 - 3.5 minutes 
 
Required sub-total = 17 - 
21 minutes 
 
 
Maximum scan time= 35 
minutes 
 
 

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29. Medicare Study Criteria   
The study protocol describes the method and timing of release of results on all pre-specified 
outcomes, including release of negative outcomes and that the release should be hastened if the 
study is terminated early. 
 
Access to clinical study data provides opportunities to conduct further research that may help 
advance medical science and improve patient care. This helps ensure the data provided by 
research participants are used in the creation of knowledge and understanding. To this end, the 
study results on all pre-specified outcomes, including negative outcomes, will be submitted to 
ClinicalTrials.gov not later than one year after the study completion date, where the completion 
date is defined as the date that the final subject was examined or received an intervention for 
purposes of data collection for the primary outcome measure. Results submission could be 
delayed if an extension is granted to the results submission deadline; however, the release of all 
results on pre-specified outcomes will be hastened if the study is terminated early. See also 
Protocol Section 25, Publication Policy. 
 
The study protocol must describe how Medicare beneficiaries may be affected by the device 
under investigation, and how the study results are or are not expected to be generalizable to the 
Medicare beneficiary population. Generalizability to populations eligible for Medicare due to 
age, disability, or other eligibility status must be explicitly described. 
 
Subjects for the ENABLE MRI study will be selected from the investigators general patient 
population indicated for an Implantable Cardiac Defibrillator (ICD) or Cardiac 
Resynchronization Therapy-Defibrillator (CRT-D) device. Therefore it is not anticipated the 
device under investigation will affect Medicare beneficiaries differently than it would the 
Medicare eligible patients found in the investigators general patient population indicated for and 
receiving ICD or CRT-D implantation. With the aging of the US population, expanding 
indications for ICD implantation, and growing evidence favoring device-based therapy over 
antiarrhythmic drugs, data on the utilization and efficacy of ICDs in older patients is becoming 
increasingly important.1 Therefore, the results of this study are expected to be generalizable to 
the Medicare eligible population primarily due to age (E.g., 65 years or older) for beneficiaries 
with implanted cardiac devices. 
 
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