A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Phase: NA
Conditions: ICD, Tachycardia
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express 
written consent of Abbott. 
87173 CIP Posting Cover Page Ver B 
Template 
Page 1 of 1 
 
NCT Number: NCT02877693 
ASIA MRI ICD Study 
A post-market clinical evaluation of St. Jude Medical™ MR Conditional ICD System on patients 
undergoing Magnetic Resonance Imaging 
Study Document No: SJM-CIP-10163 
Version B 
Date: 04-Dec-2017 
 
 
Sponsor  
 
 
St. Jude Medical, Inc. 
        
 
 
 
Suite 1608, 16/F Exchange Tower  
33 Wang Chiu Road, Kowloon Bay, Kowloon,  
Hong Kong  
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 1 of 59 
 
  
 
Project Acronym: ASIA MRI ICD Study 
Project Title: “A post-market clinical evaluation of St. Jude Medical™ MR Conditional ICD 
System on patients undergoing Magnetic Resonance Imaging” 
CRD_889 
Study Document No:  SJM-CIP-10163 
Version: B 
Date: 04-Dec-2017 
Clinical Investigation Plan (CIP) 
 
Sponsor: 
St. Jude Medical (Hong Kong) Ltd. 
Suite 1608, 16/F Exchange Tower  
33 Wang Chiu Road, Kowloon Bay, Kowloon, Hong Kong  
Tel: +852 2996 76 88; Fax: +852 2956 06 22 
Clinical 
Study 
Director 
 
Signature 
 
 
Date 
 
Local sponsor: 
St. Jude Medical India Pvt. Ltd. 
Clinical Coordinating 
Investigator      
 
Pushpawati Singhania Research Institute,  
Press Enclave Marg, Sheikh Sarai II,  
New Delhi, 110017 India  
 
Tel: +91-9810081850 
Signature 
 
 
Date 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 2 of 59 
 
  
 
Table of Contents 
 
1 
Introduction............................................................................................................................................. 5 
2 
Background and Justification for clinical investigation ........................................................................... 5 
3 
Clinical Investigation Design .................................................................................................................. 6 
3.1 
Clinical Investigation Design 
6 
3.2 
Objectives 
6 
3.3 
Endpoints 
7 
3.3.1 
Primary Endpoint ....................................................................................................................... 7 
3.3.2 
Descriptive Endpoints ................................................................................................................ 7 
3.4 
Study Population 
7 
3.4.1 
Inclusion Criteria ........................................................................................................................ 7 
3.4.2 
Exclusion Criteria ....................................................................................................................... 8 
4 
Procedures ............................................................................................................................................. 9 
4.1 
Study Flowchart 
9 
4.2 
Study Procedures 
10 
4.3 
Informed Consent Process 
15 
4.3.1 
Special circumstances for informed consent ........................................................................... 15 
4.4 
Point of Enrollment 
16 
4.5 
Enrollment visit 
16 
4.6 
Scheduled Follow-ups 
16 
4.6.1 MRI Scan Visit ............................................................................................................................. 16 
4.6.2 
One (1) Month Post Scan Visit ................................................................................................ 23 
4.7 
Unscheduled Visits 
24 
4.8 
Complete System Explants 
25 
4.9 
System Revisions 
25 
4.10 
Description of activities performed by Sponsor Representatives 
25 
4.11 
Subject Study Completion 
26 
4.12 
Subject Withdrawal 
26 
4.13 
Requirements for Clinical Laboratories 
27 
4.14 
Study Committees 
27 
4.14.1 
Steering committee .............................................................................................................. 27 
5 
Statistical Considerations ..................................................................................................................... 27 
5.1 
Primary Endpoint 
27 
5.1.1 
Primary Endpoint and Hypothesis ........................................................................................... 27 
5.2 
Descriptive Endpoints 
28 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 3 of 59 
 
  
 
5.3 
Justification of Clinical Investigation Design 
29 
5.4 
Multiplicity Adjustment 
29 
5.5 
Overall Sample Size 
30 
5.6 
Timing of Analysis 
30 
5.7 
Interim Analysis 
30 
5.8 
Statistical Criteria for Termination 
30 
5.9 
Deviations from Statistical Plan 
30 
6 
Device(s) under investigation ............................................................................................................... 30 
6.1 
Device Description and Intended purpose 
31 
6.1.1 
Ellipse ICD ............................................................................................................................... 31 
6.1.2 
Durata Lead ............................................................................................................................. 31 
6.1.3 
Optisure Lead .......................................................................................................................... 31 
6.1.4 
Tendril MRI Lead ..................................................................................................................... 32 
6.2 
Device Handling & Storage 
32 
7 
Risks and Benefits of the clinical study ................................................................................................ 32 
7.1 
Anticipated Adverse Device Effects 
32 
7.1.1 
Risks associated with Clinical Investigation participation ........................................................ 35 
7.2 
Risk Control Measures 
35 
7.3 
Possible interactions with concomitant treatments 
36 
7.4 
Anticipated Benefits 
37 
8 
Requirements for Investigator records and reports ............................................................................. 37 
8.1 
Deviations from CIP 
37 
8.2 
Safety reporting 
37 
8.2.1 
Subject Death .......................................................................................................................... 39 
8.2.2 
Complaints if applicable .......................................................................................................... 40 
8.3 
Source records 
40 
8.4 
Records retention 
40 
9 
Clinical Data Handling .......................................................................................................................... 41 
9.1 
Protection of Personally Identifiable Information 
41 
9.2 
Data Management Plan 
41 
9.3 
Document and Data Control 
41 
9.3.1 
Traceability of Documents and Data ....................................................................................... 41 
9.3.2 
Recording Data ........................................................................................................................ 42 
10 Monitoring ............................................................................................................................................. 42 
11 Compliance Statement ......................................................................................................................... 42 
11.1 
Statement of Compliance 
42 
11.2 
Quality Assurance audits and Regulatory Inspections 
43 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 4 of 59 
 
  
l 
11.3 
Repeated and Serious Non-Compliance 
43 
12 Publication Policy ................................................................................................................................. 43 
13 Suspension or premature termination of the clinical investigation ....................................................... 44 
14 Clinical Investigation Conclusion ......................................................................................................... 45 
Appendix A: CIP Revisions ......................................................................................................................... 46 
Appendix B: Definitions ............................................................................................................................... 47 
Appendix C: Abbreviations .......................................................................................................................... 48 
Appendix D: Declaration of Helsinki ............................................................................................................ 50 
Appendix E: MRI Scan Guidelines .............................................................................................................. 51 
Appendix F: MRI Screening Forms ............................................................................................................. 52 
Appendix G: MRI Hazard Checklist ............................................................................................................. 55 
Appendix- H: Sample Informed Consent ..................................................................................................... 57 
Appendix I: Product Instructions for Use ..................................................................................................... 58 
Appendix J: Bibliography ............................................................................................................................. 59 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 5 of 59 
 
  
 
1 Introduction 
This document is a clinical investigation plan (CIP) for the Asia MRI ICD clinical investigation. This clinical 
investigation is intended to assess the clinical performance of the St. Jude Medical™ MR Conditional ICD 
System in patients undergoing an elective thoracic MRI scan. This clinical investigation is sponsored by 
St. Jude Medical. 
 
2 Background and Justification for clinical investigation 
Magnetic resonance imaging (MRI) is a diagnostic method used to view high quality two and three 
dimensional images of the body.1,2  MRI does not use radiation, has few side effects and is very useful to 
view soft tissue. In 2007, an estimated 27.5 million MRI procedures were performed in the U.S. in 7,195 
hospital and non-hospital sites.3 
 
According to the 2005 World Survey of cardiac pacing and cardioverter defibrillators, 223,425 new 
pacemakers were implanted in the United States in 2005. When compared to a similar survey conducted 
in 2001, the 2005 survey showed an increase in the number of pacemakers and defibrillators implanted 
throughout the world, a trend that is likely to continue into the future.4,5 It is estimated that 50-75% of 
patients with implantable cardiac devices will develop an indication for an MRI scan during the lifetime of 
their device.6    
 
Magnetic resonance imaging systems generate three electromagnetic fields that are used to produce an 
image.  These include a static magnetic field, a time varying gradient magnetic field, and an RF field.  All 
three of these fields interact with implanted devices and could create hazards for the device, the patient, 
or both. Examples of these hazards include unwanted cardiac stimulation, heating near lead electrodes, 
image artifacts, and forces being applied to implanted components.2,7,8  Due to these issues, certain 
currently marketed implantable cardiac device systems, including ICDs,  may be contraindicated for use 
in an MRI environment.  
 
Over the past 10 years, there have been numerous patients with implanted devices who successfully 
underwent magnetic resonance imaging.9-14 
In this post market study, St. Jude Medical plans to assess the clinical performance of the St. Jude 
Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan (1.5T and 
3.0T).   
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 6 of 59 
 
  
 
3 Clinical Investigation Design 
3.1 Clinical Investigation Design 
This clinical investigation is a prospective, multicenter, 2-phase, single arm, Asian study.  
• 
In the 1st phase patients will be enrolled at least 60 days post successful implant with a St. Jude 
Medical™ MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning 
machines. 
• 
In the 2nd phase patients will be enrolled at least 60 days post successful implant with a St. Jude 
Medical™ MR Conditional ICD System approved* for thoracic scan with 3.0 Tesla MRI scanning 
machines. 
*NOTE:  The 2nd phase of this study will start only after receiving appropriate regulatory approval 
for MRI labelling at 3.0T and phase 1 enrollment has completed.  The Sponsor will notify each 
ethics committee and site when Phase 2 may begin. Patient can be enrolled only in one of the 
two phases of the study. 
 
A prospective, multi-center study design was chosen for generalizability of study results by enrolling 
subjects across multiple geographies and sites, with the minimum sample size required to demonstrate 
the safety of St. Jude Medical™ MR Conditional ICD System in an MRI environment with 1.5 Tesla and 
3.0 Tesla scanning machines.   
 
Enrollment of the study is expected to require 36 months. The anticipated duration of the study is 42 
months, depending on the rate of enrollment and regulatory timelines (CE approval of St. Jude Medical™ 
MR Conditional ICD System for thoracic scan with 3.0 Tesla MRI scanning machines for 2nd Phase and 
phase 1 enrollment has completed).  
 
The clinical investigation will enroll at least 396 subjects (198 in each phase) up to 40 centers across 
Asian Countries.  
 
Subjects will be enrolled, undergo the study MRI scans, and followed for one month following the study 
MRI scan.  The minimum duration of each subject’s participation is approximately one month from the 
MRI scan (1 Month Post Scan visit).   
 
3.2 Objectives 
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients 
undergoing an elective thoracic MRI scan. 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 7 of 59 
 
  
 
3.3 Endpoints 
3.3.1 
Primary Endpoint 
Freedom from MRI-scan related complications* related to St. Jude Medical™ MR Conditional ICD System 
from MRI scan visit to 1 month post-MRI scan visit  
*A complication is a serious adverse device effect (SADE) that requires an invasive intervention 
or leads to death. 
 
The primary endpoint analysis will be performed for each study phase separately. 
3.3.2 
Descriptive Endpoints  
• 
Demographics and medical/surgical history such as gender, age, history of smoking, cardiac disease 
history, arrhythmia history, and indication for ICD implant, etc. 
• 
Proportion of SJM high voltage lead implanted with SJM MR Conditional ICD with capture threshold 
increase of ≤ 0.5V @ 0.5ms from pre-MRI scan testing to 1 month post-MRI scan testing  
• 
Proportion of SJM high voltage lead implanted with SJM MR Conditional ICD with sensing amplitude 
decrease of ≤ 50% from pre-MRI scan testing to 1 month post-MRI scan testing 
• 
Average and Peak Specific Absorption Rate (SAR) during MRI scan, MRI visit duration in MRI 
laboratory and total MRI scan duration in MRI laboratory. 
• 
Adverse events and death 
 
3.4 Study Population 
A subject is considered enrolled in the study after he/she signs the study consent, meets all of the 
inclusion criteria and none of the exclusion criteria verified during the enrollment visit. 
 
The study population includes males and females implanted with St. Jude Medical™ MR 
Conditional ICD System. Vulnerable subjects, such as minors or those unable to provide consent, 
are excluded from participating.   
 
3.4.1 
Inclusion Criteria 
To participate in this clinical investigation, the subject must meet all of the following inclusion criteria:  
1. Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 
60 days  
 
2. Subject is willing to undergo an elective MRI scan without sedation 
NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can 
communicate with site personnel during the MRI scan 
3. Subject’s ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms  

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 8 of 59 
 
  
 
4. Subject’s ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the 
sensing amplitude is stable > 4mV 
5. Subject is able to provide informed consent for study participation (legal guardian or legally 
authorized representative is NOT acceptable) 
6. Subject is willing and able to comply with the prescribed follow-up tests and procedures 
7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form) 
3.4.2 
Exclusion Criteria 
To participate in this clinical investigation, the subject must meet none of the following exclusion criteria:  
1. Subject is pacemaker dependent 
2. Subject has a non SJM  MRI compatible endocardial lead implanted or capped 
3. Subject has another existing active implanted medical device, e.g., neurostimulator, infusion 
pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be 
completed. 
4. Subject has a high voltage lead revision incidence < 60 days of the enrollment visit 
5. Subject has other non-MRI compatible device or material implanted 
NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as 
the labeling of these devices allow MRI scans conducted per this protocol 
NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as 
long as the labeling of these devices allow for MRI scans conducted per this protocol 
NOTE: Non-removable dental implants may be included  
6. Subject has a lead extender, adaptor, or capped/abandoned lead 
7. Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational 
device, investigational drug, new indication for a device or drug or additional testing beyond 
standard of care procedures), which could confound the results of this trial as determined by 
SJM.  
8. Subject is pregnant or planning to become pregnant during the duration of the subject’s 
participation in the study 
9. Subject has a life expectancy of less than 12 months due to any condition 
10. Subject has exclusion criteria required by local law (e.g., age) 
 
 
 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 15 of 59 
 
  
 
4.3 Informed Consent Process 
The principal investigator or his/her authorized designee will conduct the Informed Consent Process, as 
required by applicable regulations and the center’s IRB/EC. This process will include a verbal discussion 
with the subject on all aspects of the clinical investigation that are relevant to the subject’s decision to 
participate, such as details of clinical investigation procedures, anticipated benefits, and potential risks of 
clinical investigation participation. During the discussion, the principal investigator or his/her authorized 
designee will avoid any improper influence on the subject and will respect subject’s legal rights. The 
subject shall be provided with the informed consent form that is written in a language that is 
understandable to the subject and has been approved by the center’s IRB/EC. The subject shall have 
adequate time to review, ask questions and consider his/her participation. 
 
If the subject agrees to participate, the Informed Consent form must be signed and dated by the subject 
and by principal investigator or delegated study personnel obtaining the consent. The signed original 
consent will be filed in the subject’s hospital or research charts, and a copy will be provided to the subject. 
 
The principal investigator or his/her authorized designee will document the informed consent process in 
the subject’s hospital and/or research charts. The date of signature will be entered on an appropriate 
Case Report Form (CRF). 
 
Failure to obtain informed consent from a subject prior to clinical investigation enrollment should be 
reported to Sponsor within 5 working days and to the reviewing center’s IRB/EC according to the IRB’s/ 
EC’s reporting requirements. 
 
The principal investigator or his/her authorized designee will inform the subject of any important new 
information about the clinical investigation. 
 
4.3.1 
Special circumstances for informed consent 
Subject unable to read or write, if applicable: Subjects unable to read or write may be enrolled in this 
clinical investigation. Informed consent will be obtained through a supervised oral process. An 
independent witness will be present throughout the informed consent process. The written informed 
consent form and any other information will be read aloud and explained to the prospective subject will 
sign and personally date the informed consent form. The witness also signs and personally dates the 
informed consent form attesting that the information was accurately explained and that informed consent 
was freely given. 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 16 of 59 
 
  
 
4.4 Point of Enrollment 
Subject is considered enrolled in the clinical investigation from the moment the subject has provided a 
written Patient Informed Consent and has been confirmed to meet all inclusion criteria and none of the 
exclusion criteria verified during enrollment visit.  Notification of enrollment to the Sponsor is considered 
to have occurred when the appropriate CRF has been received by the Sponsor. 
If a subject does not meet all inclusion criteria or meets any of the exclusion criteria the subject cannot 
participate in the clinical investigation. The principal investigator is responsible for ensuring all clinical 
investigation data is collected as required per CIP scheduled procedures. 
 
4.5 Enrollment visit  
The subject is considered enrolled after the informed consent is signed.  
 
The principal investigator or delegated study personnel will record enrollment information (name of the 
clinical investigation, date of consent and Inclusion/exclusion information) in the hospital records and 
complete and submit an Enrollment CRF in a timely manner.  
 
Collect data on the subject including demographics and medical/surgical history such as gender, age, 
history of smoking, medical and surgical history, and indication for ICD implant, etc. To ensure the patient 
meets the requirements to undergo the study MRI scan, use the MRI Screening Form as part of the 
enrollment screening.  
 
Data Submission 
Complete and submit the appropriate forms to St. Jude Medical.  Refer to Table-1 Specific Study 
Procedures and Data Collection. 
 
4.6 Scheduled Follow-ups 
After Enrollment visit, subjects will be seen for an MRI Scan Visit which should happen within 30 days 
post enrollment. During the MRI Scan Visit, the pre-MRI scan testing, MRI Scan and Post-MRI scan 
testing should all occur on the same day. Subjects will also be seen 1 Month Post MRI Scan Visit (-7/+14 
days).  
Refer to Table-1 Specific Study Procedures and Data Collection. 
The Enrollment and MRI Scan Visit is allowed, but is not required, to be conducted on the same day.  
 
4.6.1 MRI Scan Visit 
IMPORTANT NOTE: Before the MRI Scan Visit, if the subject underwent a system revision since 
enrollment that resulted in  

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 17 of 59 
 
  
 
• 
implant of a lead or ICD other than St. Jude Medical™ MR Conditional ICD System or 
• 
capping/abandoning a lead 
• 
implant of a non-MRI compatible device or material, or 
• 
any combination above, 
the subject is no longer eligible to undergo the study MRI Scan.  Do not proceed with any of the tests 
listed for the MRI Scan Visit and withdraw the patient. Refer to Section 4.9 System Revisions 
Otherwise, follow the procedures outlined below for the MRI Scan Visit. 
 
4.6.1.1 
Pre-Scan Testing and Device Programming 
 
Pregnancy Testing 
Administer a pregnancy test (per institutional standard) to all female subjects of childbearing potential.  
The pregnancy testing may be done up to 7 days before the MRI scan. Document the results of the test. If 
the subject is pregnant, do not proceed any further and withdraw the patient.  
 
Clearing the Subject for the Study MRI Scan  
In order to safely perform an MRI scan on a subject with the implanted study system, the 
physician/clinician should do the following as stated in the Appendix E: MRI Scan Guideline for St. Jude 
Medical™ MR Conditional ICD System: 
• 
Confirm that the patient has an MR Conditional System   
• 
Confirm that no adverse conditions to MRI scanning are present (e.g. additional hardware)  
• 
Review the potential adverse events 
• 
Generate a report of the patient’s permanently programmed parameters 
• 
Select and Save MRI Settings  
• 
Review the MRI Checklist and Program the MRI Settings using the Merlin® Patient Care System 
(PCS)   
• 
Subject receives the MRI Scan  
• 
Disable MRI Settings Using the Merlin® PCS  
 
The radiologist or staff, a designated radiological member, must determine the subject’s eligibility for an 
MRI scan prior to the MRI scan (per standard of practice). However, the ICD and lead (wires) 
contraindication item on the checklist do not apply if the subject is implanted with St. Jude Medical™ MR 
Conditional ICD Systems. 
 
Complete MRI Screening Form again if the MRI scan visit does not occur the same day as enrollment. 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 18 of 59 
 
  
 
The study MRI Hazard Checklist may be used to document a radiologist or designated member of the 
radiology department has cleared the subject for an MRI scan.  Alternatively, the radiology department 
may use its own hazard checklist in lieu of the study MRI Hazard Checklist. This documentation should 
be maintained with the subject’s medical and/or study records. 
 
Device Assessment and Programming 
Interrogate the ICD, and obtain the following for ventricular lead: 
• 
In-clinic ventricular bipolar capture threshold at a pulse width of 0.5 ms.  Either the manual decrement 
or automatic (in-clinic, programmer-based) method may be used to obtain the capture threshold. 
Note: If the capture threshold is > 2.5V, then the patient does not meet inclusion criteria. 
• 
In-clinic ventricular bipolar sensing amplitude. Either the incremental or the automatic (in-clinic, 
programmer based) method may be used to obtain the sensing threshold.  Note: If the ventricular 
sensing is not measurable (patient has underlying rhythm < 30bpm) and the sensing 
amplitude is < 4mV, then the patient does not meet inclusion criteria. 
• 
In-clinic ventricular bipolar pacing impedance and high voltage lead impedance 
• 
Upload device session record (X-file) through the EDC study site portal 
 
NOTE: RV capture thresholds are not required to be obtained if a high ventricular rate is present (e.g. 
110bpm). If available, sites should use the automatically obtained pacing capture threshold from the most 
recent archival data as a substitute for the in clinic capture threshold. RV sensing measurements are not 
required if the subject’s intrinsic rate has been established to be ≤30 beats per minute, as patient doesn’t 
meet inclusion criteria he/she should be withdrawn from the study.  
 
If the device testing results do not meet the MRI conditions for scanning per the Appendix E: MRI Scan 
Guideline, also see below, or the patient’s sensing threshold is not stable or not measurable or the 
sensing threshold is less than 4mV, the physician may choose to reschedule the subject to return for re-
testing.  The subject’s 1 Month Post MRI Scan Visit will need to be rescheduled to correspond with the 
MRI Scan Visit where the MRI scan was completed.  
 
Review the MRI checklist on the programmer. Verify the following conditions before saving the MRI 
Setting. 
• 
Ventricular Bipolar capture thresholds are stable at  ≤2.5V@ 0.5 ms 
• 
Bipolar pacing lead impedance is within range, i.e.  ≥ 200 and ≤ 2000 ohms 
• 
HVLI is within range, i.e. ≥20 and ≤200 ohms 
• 
No additional hardware (adaptors, extenders, or abandoned leads) 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 20 of 59 
 
  
 
 
Data Submission 
Once required testing has been performed, complete and submit the appropriate forms to St. Jude 
Medical.  Refer to Table-1 Specific Study Procedures and Data Collection 
Upload pre-MRI scan device session records through the EDC study portal.  It is recommended that the 
following device printouts and measurements be maintained at the site. 
o 
FastPath Summary  
o 
Test Results with Freezes, Include Battery & Leads  
o 
Wrap-up Overview with full parameters 
o 
Upload device session record (X-file) through the EDC study site portal 
4.6.1.2 
The MRI Scan 
After confirmation by the electrophysiologist or device specialist that all pre-MRI system checks 
(mentioned above) have been met, subjects will have their MRI scan completed by a radiology staff 
member.  Note: If the patient does not pass the Pre-MRI scan System Check specified above, then 
the patient should not undergo an MRI scan. The patient can be rescheduled to come back to 
repeat the Pre-MRI scan System Check testing within the visit window. 
 
Protocol required MRI scan sequences for each subject undergoing an MRI scan are described in detail 
in Appendix E. It is recommended that the MRI scan be set up on the MRI scanner in advance of the first 
subject scheduled for a study scan to ensure the scan has been appropriately programmed, and to 
provide adequate time to address any questions or issues that may arise. 
 
Subjects will undergo Thoracic MRI scan for the study. The thoracic scan is RF intensive should be set up 
to last about 6 minutes and 15 seconds. The thoracic scan will need to be repeated four times to ensure 
the subject is scanned approximately 25 minutes. 
 
In addition to study specific Thoracic MRI Scan, an optional non-study MRI scan (either a brain, cardiac 
or lumbar scan without administration of contrast agents or sedation) may be run per discretion of 
Investigator to provide a MRI report to subjects. These optional scans will occur after the study scan and 
will not have a scan time greater than 5 minutes. Sites will be provided with a guidance document for 
Optional MRI Scan set-up.   
 
Further details about the set-up, programming and ways to adjust the parameters for MRI scans can be 
found in Appendix E: MRI Scan Guidelines.  

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 21 of 59 
 
  
 
The subject may be in the bore or near the vicinity of the magnet for approximately 60 minutes. The 
actual amount of time the subject will be scanned is approximately 30 minutes (including Optional MRI 
Scan).  
 
In conditions where the time of RF exposure is stretched above 30 minutes, the scan will be interrupted 
and patient will be taken out of the MRI bore. MRI scan can be continued again once waiting period of 30 
minutes is completed.  
 
The MRI scan is not intended to be diagnostic in nature and therefore the administration of contrast fluids 
or sedation are not permitted.  
 
Consult the “MRI Ready Systems Manual: MRI Procedure Information for the St. Jude Medical™ MR 
Conditional System” for guidelines and `precautions related to conducting an MRI scan with the implanted 
study ICD system. 
 
NOTE: MRI scan in this study is being performed to demonstrate performance of St. Jude Medical™ MR 
Conditional ICD System for an MRI scan, and is not meant to be diagnostic in nature. The MRI scan will 
not be read by the radiologist.   
 
 
If subject movement causes distortion on the MRI, do not repeat the MRI scan. 
 
Cardiac Monitoring  
During the entire MRI scan, the subject’s cardiac function must be monitored using pulse oximetry and an 
ECG by a trained electrophysiologist, cardiologist, or Advanced Cardiac Life Support (ACLS) trained 
personnel capable of delivering external cardiac pacing defibrillation and advanced cardiac life support.  
Verbal communication with the subject must also take place to assess and/or confirm any clinically 
significant changes noted in the subject’s oxygen saturation or heart rate, as well as any clinically 
significant complaints not obvious with pulse oximetry.  Record these changes and complaints during the 
MRI scan.   
 
ACLS procedures must be in place to address situations where a life threatening arrhythmia and/or 
hemodynamic collapse occurs.  The programmer must be used outside the American College of 
Radiology (ACR) defined Zone 4 magnet room. If the subject’s hemodynamic function is compromised 
during the MRI scan, discontinue the MRI procedure and take proper measures to restore the subject’s 
hemodynamic function.   
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 22 of 59 
 
  
 
Handling of Subjects Unable to Tolerate an MR Scan  
In cases where the scan cannot be tolerated by the subject, remove the subject from the scanner. Assess 
the subject for possible adverse events, and treat the subject’s reported symptoms according to your 
institution’s standard of practice.  Document the reason for the intolerance. At a minimum, information 
related to the sequence used to perform the scan, the length of time the subject was scanned, and the 
whole body SAR level reached should be collected and submitted to St. Jude Medical. A repeat scan is 
not required to be completed. The subject is not withdrawn from the study. The subject should be 
scheduled to return for their 1 month post MRI scan visit. 
4.6.1.3 
Post- MRI Scan Testing  
 
Device Assessment and Programming 
Following the MRI Scan, remove the subject from the MRI bore.  Interrogate the ICD. Disable the MRI 
Settings. Note: MRI settings must be disabled to ensure that tachyarrhythmia therapy is turned 
back on. Obtain the following for the ventricular lead: 
• 
In-clinic ventricular bipolar capture threshold at a pulse width of 0.5 ms.  Either the manual decrement 
or automatic (in-clinic, programmer-based) method may be used to obtain the capture threshold. 
• 
In-clinic ventricular bipolar sensing amplitude. Either the incremental or the automatic (in-clinic, 
programmer based) method may be used to obtain the sensing threshold.    
• 
In clinic ventricular bipolar lead impedance 
• 
In-clinic High Voltage Lead impedance  
 
NOTE: RV capture thresholds are not required to be obtained if a high ventricular rate is present. RV 
sensing measurements are not required if the subject’s intrinsic rate is established to be ≤30 beats per 
minute.  
 
Reporting of MRI Scan-Related Adverse Device Effects  
An ADE or SADE related to the following should be reported as soon as possible to St. Jude Medical: 
clotting, pulmonary embolism, or heating of the device pocket during the MRI scan.  These events are 
likely to be associated with symptoms occurring during or immediately following the MRI scan and may 
manifest as chest pain, shortness of breath, or changes in vital signs during or immediately following the 
MRI scan.   
 
To ensure all ADEs or SADEs related to or caused by the MRI scan are appropriately captured, before 
starting the scan, verbally instruct the subject to report symptoms of chest pain, shortness of breath or 
pocket discomfort that he/she experiences while being scanned or immediately after exiting the scanner.  
Note changes in vital signs such as changes in heart rate, room air blood oxygen saturation, and/or 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 23 of 59 
 
  
 St. Jude Medical 
respiration rate that occur during the MRI scan that may suggest an ADE or SADE has occurred due to 
clotting, pulmonary embolus or related to lead tip or device pocket heating. 
 
If symptoms during or immediately after the MRI scan suggest that an ADE or SADE has occurred due to 
clotting, pulmonary embolus or related to lead tip or device pocket heating, test to assess possible 
causes. Diagnostic testing may be performed in any order deemed appropriate by the investigator; if any 
test was not performed, provide medical justification for not performing that test: 
(1) A 12-lead ECG  
(2) A 2-view chest X-ray (PA and Lateral). 
(3) Room air blood oxygen saturation 
(4) A transthoracic echocardiogram. 
 
If the subject reports pocket discomfort, ask the subject for additional descriptive information and 
determine if the pocket is discolored or warm to the touch.  ECG, chest x-ray, room air blood oxygen 
saturation, or transthoracic echocardiogram testing are not required to be performed for symptoms 
related to device pocket heating. 
 
Data Submission 
Once required testing has been performed, complete and submit the appropriate forms to St. Jude 
Medical.  Refer to Table-1 Specific Study Procedures and Data Collection.  
 
Export the study MRI scan onto a CD, or other form of electronic media in DICOM format as source 
document. Upload post MRI scan device session records through the EDC study portal.  It is 
recommended that the following device printouts and measurements be maintained at the site. 
o 
FastPath Summary  
o 
Test Results with Freezes, Include Battery & Leads  
o 
Wrap-up Overview with full parameters 
o 
Upload device session record (X-file) through the EDC study site portal 
 
4.6.2 
One (1) Month Post Scan Visit 
Testing 
Interrogate the ICD and obtain the following for the ventricular lead: 
• 
In-clinic ventricular bipolar capture threshold at a pulse width of 0.5 ms.  Either the manual decrement 
or automatic (in-clinic, programmer-based) method may be used to obtain the capture threshold.  
• 
In-clinic ventricular bipolar sensing amplitude. Either the incremental or the automatic (in-clinic, 
programmer based) method may be used to obtain the sensing threshold.    

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 24 of 59 
 
  
 
• 
In clinic ventricular bipolar lead impedance 
• 
In-clinic High Voltage Lead impedance  
Evaluate the subject for ADE & SADE and submit an AE CRF if applicable.  
   
NOTE: RV capture thresholds are not required to be obtained if a high ventricular rate (e.g. 110bpm) is 
present.  If available, sites should use the automatically obtained pacing capture threshold from the most 
recent archival data as a substitute for the in clinic capture threshold. RV sensing measurements are not 
required if the subject’s intrinsic rate is established to be ≤30 beats per minute.  
 
Data Submission 
Once required testing has been performed, complete and submit the appropriate forms to St. Jude 
Medical.  Refer to Table-1 Specific Study Procedures and Data Collection. It is recommended that the 
following device printouts and measurements be maintained at the site. 
o 
FastPath Summary  
o 
Test Results with Freezes, Include Battery & Leads  
o 
Wrap-up Overview with full parameters 
o 
Upload device session record (X-file) through the EDC study site portal 
 
4.7 Unscheduled Visits 
An unscheduled visit is defined as a visit that occurs after Enrollment visit where the subject is seen in 
clinic due to an ADE or, SADE associated with St. Jude Medical™ MR Conditional ICD System.  
Where possible, perform a device interrogation for ventricular lead(s) to obtain:  
• 
In-clinic ventricular bipolar capture threshold at a pulse width of 0.5 ms.   
• 
In-clinic ventricular bipolar sensing amplitude. Either the incremental or the automatic (in-clinic, 
programmer based) method may be used to measure the sensing threshold.    
• 
In-clinic ventricular bipolar lead impedance 
• 
In-clinic High Voltage lead impedance 
 
Data Submission 
Once testing has been performed, complete and submit the appropriate forms to St. Jude Medical.  Refer 
to Table-1 Specific Study Procedures and Data Collection. 
It is recommended that the following device printouts and measurements be maintained at the site. 
o 
FastPath Summary  
o 
Test Results with Freezes, Include Battery & Leads  
o 
Wrap-up Overview with full parameters 
o 
Upload device session record (X-file) through the EDC study site portal 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 25 of 59 
 
  
 
 
4.8 Complete System Explants  
If the subject has the entire ICD system removed at any time during the study, and the subject will not 
receive a replacement St. Jude Medical™ MR Conditional ICD System, follow the subject for 30 days, 
and withdraw the subject from the study.  Complete a Product Out of Service CRF and submit through 
EDC.  A System Revision CRF is not required to be submitted. 
4.9 System Revisions 
In cases where only the device pocket is revised (leads are not repositioned, leads have not been 
disconnected from the ICD), a System Revision CRF is not required to be submitted.  A System Revision 
CRF should be completed for all other types of revisions such as pulse generator replacement, lead 
replacement and lead repositioning. The subject’s follow up schedule is not affected in any way.   
 
A system revision is defined as a replacement of or repositioning of one or more components of the study 
ICD system (ventricular lead, compatible ICD) that occurs after the subject has been consented into the 
study.  Because all components of the study ICD system are market-released, all procedures related to 
the revision should be performed according to standard of care.  The revision may be performed by either 
a study investigator or other clinician qualified to perform such procedures.   
 
Any explanted devices or leads (including damaged leads, lead segments and lead fragments) should be 
returned to St. Jude Medical promptly for analysis.  Document any change to the status of the lead and 
device (e.g. capped, removed) on the Product Out of Service CRF.   
Refer to Table-1 Specific Study Procedures and Data Collection to determine which case report forms 
need to be completed and submitted.   
 
4.10 Description of activities performed by Sponsor Representatives 
Trained sponsor personnel may perform certain activities to ensure compliance to the clinical 
investigational plan and may provide technical expertise. Sponsor field clinical engineers may perform the 
following activities:  
• 
Interrogation of and testing the implanted ICD system at any study visit (scheduled or unscheduled): 
capture threshold, sensing amplitude, pacing impedance and high voltage lead impedance 
measurements,  
• 
Verifying MRI scan parameters on the programmer at the MRI Scan Visit, 
• 
Programming of the ICD per protocol, and/or as directed by the investigator/designee.   
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 26 of 59 
 
  
 
While sponsor representatives may perform these activities, the principal investigator remains responsible 
for ensuring all study data is collected as required per protocol.  Deviations resulting from failure to 
comply with protocol requirements will be reported through completion of a Deviation CRF. 
  
4.11 Subject Study Completion 
The minimum duration of each subject’s participation is approximately one month from the MRI scan (1 
Month Post Scan visit).  When the subject’s participation in the clinical study has been completed the 
subject will return to standard medical care as per physician’s recommendation. 
  
4.12 Subject Withdrawal 
Subjects must be informed about their right to withdraw from the clinical investigation at any time and for 
any reason without sanction, penalty or loss of benefits to which the subject is otherwise entitled. 
Withdrawal from the clinical investigation will not jeopardize their future medical care or relationship with 
the investigator. Subjects will be requested to specify the reason for the request to withdraw. The 
investigator must make all reasonable efforts to retain the subject in the clinical investigation until 
completion of the clinical investigation. 
 
The investigator may decide to withdraw a subject from the clinical investigation at any time if 
participation is no longer medically appropriate or due to other rationale. The subject’s future care will not 
be influenced by this decision. 
 
Reasons for subject’s withdrawal include, but are not limited to:: 
• 
Subject and/or Family Request Withdrew Consent 
• 
Subject Lost to Follow-up  
• 
System Explant with no system replacement (i.e. with another Durata or Optisure lead and Ellipse 
ICD) →Please complete a Product Out of Service Form 
• 
Subject Death → Please complete Death, Product Out Of Service and an Adverse Event Form  
• 
Subject Non-compliance 
• 
Other 
 
If a subject withdraws from the clinical investigation, the site will record reasons for withdrawal, on a 
Withdrawal CRF. 
 
The status of the subject’s condition should be documented at the time of withdrawal. 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 27 of 59 
 
  
 
4.13 Requirements for Clinical Laboratories 
Participating center should have a certified MRI laboratory & radiologist. To full fill the CIP requirement, 
center should be equipped with both 1.5 (For Phase 1) and 3.0 Tesla (For Phase 2) or have an 
associated Laboratory with required study set-up.  
 
4.14 Study Committees 
4.14.1 Steering committee 
The Steering Committee will be used to advise the Sponsor during a clinical investigation, such as in the 
development of the CIP, during the conduct of the study, during data analysis and/or 
presentation/publication of the clinical investigation results.  Membership may include site investigators 
for the clinical investigation under review. 
 
5 Statistical Considerations 
The following section describes the statistical methods for the clinical investigation and justification of the 
design.  
 
5.1 Primary Endpoint 
5.1.1 
Primary Endpoint and Hypothesis  
The primary endpoint is the Freedom from MRI scan-related complications related to St. Jude Medical™ 
MR Conditional ICD System from MRI scan to 1 month post MRI scan 
 
Hypothesis 
The hypothesis is formally expressed as: 
H0: PMRI-Scan ≤ 90% 
Ha: PMRI-Scan > 90%  
Where PMRI-Scan is the freedom from MRI scan-related complications(s) related to St. Jude Medical™ MR 
Conditional ICD System from MRI scan to 1 month post-MRI scan visit. 
 
The hypothesis will be tested at the 2.5% significance level.  The null hypothesis will be rejected if the 
97.5% lower confidence bound (LCB) for PMRI-Scan is greater than 90%.    
5.1.1.1 
Analysis Methodology  
The freedom from MRI scan related complications for the SJM MR Conditional ICD system from MRI 
scan to 1 month Post MRI scan will be estimated using binomial proportion. The 97.5% lower confidence 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 28 of 59 
 
  
 
bound will be calculated by the exact (Clopper-Pearson) method for binomial probabilities. The primary 
endpoint analysis will be performed for each study phase separately. 
5.1.1.2 
Sample Size Determination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
5.1.1.3 
Analysis Populations 
The analysis will be conducted on subjects who meet all of the following criteria: 
• 
Implanted with the SJM MR Conditional ICD system 
• 
Sign informed consent 
• 
Meet the MRI Conditions of Use 
• 
Undergo a MRI scan  
• 
Have 1 month post MRI scan visit or have MRI-scan related complication(s) related to SJM MR 
Conditional ICD system before the 1 month post MRI scan visit 
5.1.1.4 
Subgroup Analysis 
There are no subgroup analyses planned for this study. 
5.1.1.5 
Missing Data 
The primary endpoint will be evaluated with data available. No imputations are planned for missing data 
for primary endpoint.  
5.2 Descriptive Endpoints 
• 
Demographics and medical/surgical history such as gender, age, history of smoking, cardiac 
disease 
history, 
arrhythmia 
history, 
and 
indication 
for 
ICD 
implant, 
etc.  
Continuous variables will be summarized as sample size, mean, standard deviation, 
minimum and maximum. For categorical variables, the counts and percentages of subjects 
will be summarized for each category.  
 
• 
Proportion of SJM high voltage lead implanted with SJM MR Conditional ICD with capture 
threshold increase of ≤ 0.5V @ 0.5ms from pre-MRI scan testing to 1 month post-MRI scan 
testing.  
This proportion will be calculated as number of subjects who had high voltage lead with 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 29 of 59 
 
  
 
capture threshold increased of ≤ 0.5V @ 0.5ms from pre-MRI scan testing to 1 month post-
MRI scan testing divided by total number of subjects who had high voltage lead implanted, 
undergo a MRI scan and with both pre-MRI scan and 1 months Post MRI scan capture 
threshold available.   
 
• 
Proportion of SJM high voltage lead implanted with SJM MR Conditional ICD with sensing 
amplitude decrease of ≤ 50% from pre-MRI scan testing to 1 month post-MRI scan testing.  
This proportion will be calculated as number of subjects who had high voltage lead with 
sensing amplitude decrease of ≤ 50% from pre-MRI scan testing to 1 month post-MRI scan 
testing divided by total number of subjects who had high voltage lead implanted, undergo a 
MRI scan and with both pre-MRI scan and 1 months Post MRI scan sensing amplitude 
available.   
 
• 
Average and Peak Specific Absorption Rate (SAR) during MRI scan, MRI visit duration in 
MRI laboratory and total MRI scan duration in MRI laboratory  
Average and Peak Specific Absorption Rate (SAR) during MRI scan, MRI visit duration in 
MRI laboratory and total MRI scan duration in MRI laboratory will be summarized as mean, 
standard deviation, minimum, median and maximum.  
 
• 
Adverse events and death 
The number of events, number of subjects who encountered the events will be summarized 
for each event category for ADE and SADE separately. The number of death will be 
summarized as counts and percentages for each primary cause.    
 
5.3 Justification of Clinical Investigation Design 
This is a prospective, multi-center study intended to evaluate the safety of SJM MR Conditional ICD 
system in an MRI environment with 1.5 Tesla and 3.0 Tesla scanning machines by demonstrating the 
superiority of freedom of MRI-scan related complications for ICD system from MRI scan to 1 month post 
MRI scan against the performance goal of 90%.  The time point for evaluation the endpoint is designed to 
capture MRI scan related complications related to ICD system which are most likely occurred within one 
month of scan. 
5.4 Multiplicity Adjustment 
The primary endpoint will be evaluated for each phase separately at 2.5% significance level. Therefore, 
no multiplicity adjustment is planned for this study. 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 31 of 59 
 
  
 
connector, 58/65cm length  
Durata 
7122Q/Lead/Active fixation, single 
shock, DF4 connector, 58/65 cm 
length  
SJM 
Outside US 
Market Released 
Optisure 
LDA220Q/Lead/Active fixation, dual 
shock, 
17 
cm 
spacing, 
DF4 
connector, 58/65cm length  
SJM 
Outside US 
Market Released 
Optisure 
LDA210Q/Lead/Active fixation, single 
shock, DF4 connector, 58/65 cm 
length  
SJM 
Outside US 
Market Released 
Tendril MRI 
LPA 1200M/Lead/ Active fixation, 
Bipolar, Pacing 46/52/58cm length 
SJM 
Outside US 
Market Released 
*Apart from the devices listed in Table 4; any other CE-marked St. Jude Medical MRI compatible ICD system market 
released in participating countries approved for Thoracic MRI scan with 1.5 Tesla (1st Phase of enrollment) & 3.0 
Tesla (2nd Phase of enrollment) scanning machines can be used for this clinical investigation.  
 
 
6.1 Device Description and Intended purpose 
6.1.1 
Ellipse ICD 
The Ellipse ICD is supported by the St. Jude Medical Merlin Patient Care System (Merlin PCS) with 
software Model 3650, Software Model 3330 version 20.X (or higher).  The Ellipse ICD is intended to 
provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-
threatening ventricular arrhythmias.   
Instructions for use, storage and handling instructions, preparation for use and any precautions can be 
found in the User’s Manual for the Ellipse ICD. 
 
6.1.2 
Durata Lead 
The Durata Models 7120Q, and 7122Q leads are market-released 7 French, transvenous, steroid eluting, 
bipolar, DF4 compatible (single connector with four electrical terminals), active fixation leads intended for 
permanent sensing and pacing of the right ventricle and the delivery of cardioversion/defibrillation therapy 
when used with a compatible St. Jude Medical pulse generator with a DF4-LLHH or DF4-LLHO lead 
receptacle designation. 
Instructions for use, storage and handling instructions, preparation for use and any precautions can be 
found in the User’s Manual for the Durata lead. 
 
6.1.3 
Optisure Lead 
The Optisure Models LDA220Q and LDA210Q transvenous leads are market-released leads indicated for 
use with compatible pulse generators (refer to the applicable defibrillator manual for system indications). 
They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart.  

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 32 of 59 
 
  
l 
Instructions for use, storage and handling instructions, preparation for use and any precautions can be 
found in the User’s Manual for the Optisure Lead. 
 
6.1.4 
Tendril MRI Lead 
The Tendril MRI Lead Models  LPA 1200M 46/52/58cm length transvenous leads are market-released 
leads indicated for use with compatible pulse generators (refer to the applicable manual for system 
indications). They provide pacing and sensing to the heart.  
Instructions for use, storage and handling instructions, preparation for use and any precautions can be 
found in the User’s Manual for the Tendril MRI Lead. 
 
6.2 Device Handling & Storage 
This study involves use of market approved products. Physicians should consult the User’s manual for 
device handling and storage. 
 
7 Risks and Benefits of the clinical study 
 
7.1 Anticipated Adverse Device Effects 
The below list of anticipated adverse device effects represents the summary of the most common events 
observed and documented in literature associated with the patient medical condition and associated with 
the medical device exposure. 
 
The St. Jude Medical™ MR Conditional ICD System are market-released devices. Risks associated with 
the use St. Jude Medical™ MR Conditional ICD System are anticipated to be comparable to those 
associated with the use of other market-released defibrillation leads, pacing leads, and ICDs. Subjects 
participating in this study are indicated for or implanted with an ICD as part of their standard medical 
management and are subject to the risks associated with these devices independent of the subject’s 
participation in the study. 
 
The St. Jude Medical™ MR Conditional ICD System are being tested in an MRI environment, and 
subjects participating in the study are required to undergo the study MRI scans which are investigational 
for the purposes of investigating the effect the scan has on the implanted ICD system.  The subjects are 
therefore exposed to, but not limited to, an incremental risk of experiencing the events listed below. 
  
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 36 of 59 
 
  
 
In order to safely perform an MRI scan on a subject with the implanted study system, the 
physician/clinician should do the following as stated in the MRI Ready Systems Manual: MRI Procedure 
Information for the St. Jude Medical™ MR Conditional System: 
• 
Confirm that the patient has an MR Conditional System   
• 
Confirm that no adverse conditions to MRI scanning are present (e.g. additional hardware)  
• 
Review the potential adverse events 
• 
Generate a report of the patient’s permanently programmed parameters 
• 
Select and Save MRI Settings  
• 
Review the MRI Checklist and Program the MRI Settings using the Merlin® PCS   
• 
Subject receives the MRI Scan  
• 
Disable MRI Settings Using the Merlin® PCS  
 
After the MRI scan and at the 1 Month Post Scan visit, the ICD will be interrogated to verify appropriate 
ICD function, to evaluate pacing and sensing characteristics, and to assess any adverse events.   
 
Overall, the clinical study design, subject selection process, and procedures developed for scanning and 
monitoring of the subject during the MRI scan have all been designed to minimize risks to the subject.   
 
While steps have been taken to identify and reduce or minimize risks associated with the study MRI scan 
and participation in the study, there may be risks that are unknown at this time. 
 
7.3 Possible interactions with concomitant treatments 
Other than the study MRI scans, there are no treatments that the subject would not otherwise receive as 
part of the subject’s medical management related to having an implanted ICD system.  While an MRI 
scan is not part of the usual treatment regimen for subjects implanted with an ICD, it is an accepted 
imaging modality used in the diagnosis of diseases or other medical condition.  
 
The MRI scanner, methods used to scan the subject (scan sequences), and monitoring procedures in and 
of themselves are not investigational.  As such, there are no anticipated interactions with concomitant 
medical treatments or concurrent medical interventions associated with the study MRI scan. 
 
The device checks at each study visit are standard of care, or involve testing of the device and lead that 
are normally done at a routine device check.  As such, there are no anticipated interactions with 
concomitant medical treatments or concurrent medical interventions associated with the study visits. 
  

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 37 of 59 
 
  
 
7.4 Anticipated Benefits 
The information collected in this clinical investigation will provide further understanding the effects of 
Thoracic MRI scans on ICDs.  Individual subjects will not receive any direct benefit as a result of their 
participation in this investigation. 
 
8 Requirements for Investigator records and reports 
8.1 Deviations from CIP 
A deviation is defined as an event where the clinical investigator, site personnel, Sponsor or Sponsor 
representative did not conduct the clinical investigation according to the CIP. The investigator is not 
allowed to deviate from the CIP, except as specified under emergency circumstances to protect the 
rights, safety and well-being of the subject. 
 
Regulations require Investigators obtain approval from the Sponsor and the IRB/EC (if required) before 
initiating changes in or deviations from the CIP. The Principal Investigator may call or email and discuss 
the potential deviation with the Sponsor. Deviation to the CIP necessary to protect the life or physical 
well-being of a subject shall be documented and reported to the Sponsor and the IRB/EC as soon as 
possible, but no later than 5 working days. 
 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, safety and 
well-being of subjects, since the non-compliance exposes subjects to unreasonable risks. For example, 
failure to adhere to the inclusion/exclusion criteria, failure to perform safety assessments intended to 
detect adverse events. Investigators should seek minimization of such risks by adhering to the CIP. 
 
Regulations require that the PI maintain accurate, complete, and current records, including documents 
showing the date of and reason for every deviation from the CIP.  Relevant information for each deviation 
will be documented as soon as possible on the appropriate CRF. The site will submit the CRF to the 
Sponsor. 
 
8.2 Safety reporting 
The safety reporting performed both by the investigator and Sponsor will start as soon as the study 
procedure begins. This is defined as from the time the subject enrolled under this clinical investigation 
date of signature of the informed consent – or definition of “enrolled” in the CIP).  
  

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 38 of 59 
 
  
 
The safety surveillance and the safety reporting will continue until the last investigational visit has been 
performed, the subject is deceased, the subject/investigator concludes his participation into the clinical 
investigation or the subject withdrawal from the clinical investigation. 
All Adverse Device Effects (serious or non-serious) are to be documented and reported to the sponsor as 
soon as possible after becoming aware of the event. 
 
 
 
Adverse Event (AE) 
 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device under clinical investigation. 
 
This definition includes events related to the investigational medical device or the comparator. 
This definition includes events related to the procedures involved. 
 
Serious Adverse Event (SAE) 
An adverse event that led to: 
• 
Death 
• 
A serious deterioration in the health of the subject, that either resulted in: 
o 
A life-threatening illness or injury OR 
o 
A permanent impairment to a body structure or a body function OR 
o 
An in-patient or prolonged hospitalization OR 
o 
A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function OR 
• 
Fetal distress, fetal death or a congenital abnormality or birth defect 
 
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is not 
considered a serious adverse event. 
 
Adverse Device Effect (ADE) 
An adverse event related to the use of an investigational medical device. 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. 
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational medical device. 
 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 39 of 59 
 
  
l 
 
Additional information may be requested by the Sponsor in order to support the reporting of ADEs or 
SADEs to regulatory authorities as applicable. 
 
NOTE: If an adverse device event is documented at the subject’s last follow up visit, both the notification 
and follow-up information on the AE CRF are to be provided to the sponsor.  
 
Adverse device events will be monitored until they are adequately resolved or the subject has ended 
his/her participation in the trial, whichever comes first. The status of the subject’s condition should be 
documented at each visit. 
 
For the purposes of this clinical investigation the following events will be reported: ADEs, SADEs and 
Death events. 
 
Reportable events shall be submitted to the Sponsor. The Sponsor will ensure that all applicable events 
are reported to the relevant authorities as per regulations.  The sites should notify the Sponsor of 
reportable adverse events by creating and saving the applicable case report form within the electronic 
data capture system.  Additional information may be requested by the Sponsor in order to support the 
reporting of ADEs, SADEs and Deaths to regulatory authorities. The investigator must notify the IRB/EC, 
if appropriate, in accordance with national and local laws and regulations, of the ADEs or SADEs reported 
to the Sponsor.    
 
8.2.1 
Subject Death 
All subject deaths are to be documented and reported to the Sponsor as soon as possible and as per 
local laws and regulations) after becoming aware of the event. 
Should death occur, the investigator is requested to record death information in the hospital records and 
immediately document the information on the Death form. By completing the form the sponsor will be 
notified. 
 
In case of EDC failure, notify Sponsor via AdverseEvent@sjm.com or via Fax (please refer to the 
Investigator Site Binder, for further details about Fax numbers). 
Patient Death can be an outcome of a serious adverse event (SAE). 
• 
All efforts to obtain the details should be made and the Adverse Event form must be completed. 
• 
The patient’s death is an Early Conclusion of the subject’s participation in the investigation. 
Therefore, the investigator is requested to complete the Termination form. 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 40 of 59 
 
  
 
• 
The investigator must notify the EC / IRB, if appropriate, in accordance with national and local laws 
and regulations. 
 
8.2.2 
Complaints if applicable 
A complaint is any written, electronic, or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released 
for distribution. 
 
If the complaint does not involve a reportable adverse event per protocol the investigator should notify the 
SJM Product Surveillance Department through one of the methods listed below as soon as possible after 
becoming aware of a complaint.  
Email address: SVcomplaints@sjm.com 
Toll Free: 800-722-3774 
Direct US: 818-364-1506 
 
Complaints will be collected and reported by St. Jude Medical according to our product reporting process.  
 
8.3 Source records 
Source documents will be created and maintained by the investigational site team throughout the clinical 
investigation. The data reported on the CRFs will be derived from, and be consistent with, these source 
documents, and any discrepancies will be explained in writing. 
The following data needs to be filed in patient file at the site: 
o 
Device interrogation report  
o 
MRI Scan images in DICOM Format 
o 
Other source documents (to support SAEs)  
 
8.4 Records retention 
The Sponsor and the Principal Investigators will maintain the clinical investigation documents as required.  
They will take measures to prevent accidental or premature destruction of these documents.  The 
Principal Investigator or the Sponsor may transfer custody of records to another person/party and 
document the transfer at the investigational site or the Sponsor’s facility. 
 
These documents must be retained by the investigational site for a period of 2 years after clinical 
investigation conclusion (or as per local regulatory requirement) and made available for monitoring or 
auditing by the Sponsor’s representative or representatives of the applicable regulatory agencies. 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 41 of 59 
 
  
 
 
All original source documents must be stored for the longest possible time permitted by the local 
regulations at the hospital, research institute, or practice in question. If archiving of original source 
documents can no longer be maintained at the site, the investigator will notify the Sponsor.  
 
9 Clinical Data Handling 
Overall, the Sponsor will be responsible for the data handling. The Sponsor and/or its affiliates will be 
responsible for compiling and submitting all required reports to governmental agencies. Data will be 
analyzed by the Sponsor and may be transferred to the Sponsor’s locations outside of Asia and/or any 
other worldwide regulatory authority in support of a market-approval application. 
 
9.1 Protection of Personally Identifiable Information 
St. Jude Medical respects and protects personally identifiable information collected or maintained for this 
clinical investigation. The privacy of each subject and confidentiality of his/her information will be 
preserved in reports and when publishing any data. Confidentiality of data will be observed by all parties 
involved at all times throughout the clinical investigation.  All data will be secured against unauthorized 
access. 
 
9.2 Data Management Plan 
A detailed Data Management Plan (DMP) will be established to ensure consistency of handling the data. 
This document will include procedures used for data review, database cleaning, and issuing and resolving 
data queries. If appropriate, the DMP may be updated throughout the clinical investigation duration. All 
revisions will be tracked and document controlled.  
 
CRF data will be captured in a validated electronic database management system hosted by the Sponsor.  
Only authorized site personnel will be permitted to enter the CRF data through the electronic data capture 
(EDC) system deployed by St. Jude Medical. An electronic audit trail will be used to track any subsequent 
changes of the entered data. 
 
9.3 Document and Data Control 
9.3.1 
Traceability of Documents and Data 
The investigator will ensure accuracy, completeness, legibility and timeliness of the data reported to the 
Sponsor on the CRFs and in all required reports. 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 42 of 59 
 
  
 
9.3.2 
Recording Data 
The eCRF will be reviewed by the authorized site personnel. An appropriate comment will be provided for 
any change to data reported on eCRF. 
 
10 Monitoring 
It is the responsibility of the Sponsor of the clinical investigation to ensure the clinical investigation is 
conducted, recorded, and reported according to the approved CIP, subsequent amendment(s), applicable 
regulations, and guidance documents. Monitoring will be conducted according to the St. Jude Medical 
Clinical Monitoring working instruction. 
 
Prior to beginning the clinical investigation, the Sponsor will contact the investigator or designee to 
discuss the clinical investigation and data requirements. A designated monitor will periodically review the 
subject records and associated source documents.  
 
The investigator shall make subject and clinical investigation records available to the clinical monitor for 
monitoring.  
 
Centralized monitoring will occur through routine internal data review.  This monitoring is designed to 
identify missing and inconsistent data, data outliers, and potential CIP deviations that may be indicative of 
site non-compliance.  
 
11 Compliance Statement 
11.1 Statement of Compliance 
This clinical investigation will be conducted in compliance with the most current regional and local laws 
and regulations. Principles of Good Clinical Practice will be followed as based on the most current version 
of the World Medical Association (WMA) Declaration of Helsinki. 
 
The investigator will not start enrolling subjects or requesting informed consent from any subject prior to 
obtaining IRB/EC approval and Competent Authority approval, if applicable, and authorization from the 
sponsor in writing for the clinical investigation. If additional requirements are imposed by the IRB/EC or 
Competent Authority, those requirements will be followed. If any action is taken by an IRB/EC or a 
Competent Authority with respect to the clinical investigation, that information will be forwarded to the 
Sponsor. 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 43 of 59 
 
  
 
As the Sponsor, St. Jude Medical has taken up general liability insurance in accordance with the 
requirements of the applicable local laws. Appropriate country representative will be utilized to understand 
the requirements for the type of insurance that will be provided for subjects, such information will be 
incorporated into the site informed consent, as applicable. If required, additional subject coverage or a 
clinical investigation specific insurance will be provided by the Sponsor. 
 
11.2 Quality Assurance audits and Regulatory Inspections 
The investigator and/or delegate should contact the Sponsor immediately upon notification of a regulatory 
authority inspection at the site. A monitor or designee will assist the investigator and/or delegate in 
preparing for the audit. The Sponsor may perform quality assurance audits, as required. 
 
The Principal Investigator or institution will provide direct access to source data during and after the 
clinical investigation for monitoring, audits, IRB/EC review and regulatory authority inspections, as 
required.  The Principal Investigator or institution will obtain permission for direct access to source 
documents from the subject, hospital administration and national regulatory authorities before starting the 
clinical investigation. 
 
11.3 Repeated and Serious Non-Compliance 
In the event of repeated non-compliance or a one-time serious non-compliance, as determined by the 
Sponsor, a monitor or designee will attempt to secure compliance by one or more of the following actions: 
o 
Visiting the investigator, 
o 
Contacting the investigator by telephone, 
o 
Contacting the investigator in writing, 
o 
Retraining of the investigator. 
 
If an investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or any other 
conditions of the clinical investigation, the Sponsor will either secure compliance or, at its sole discretion, 
terminate the investigator’s participation in the clinical investigation. In case of termination, the Sponsor 
will inform the responsible regulatory authority, as required, and ensure that the IRB/EC is notified, either 
by the Principal Investigator or by the Sponsor. 
 
12 Publication Policy 
The results of the clinical investigation will be submitted, regardless of the outcome of the clinical 
investigation.  
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 44 of 59 
 
  
 
A ‘Publication Agreement’ will be signed between the Principal Investigator and the Sponsor either as a 
separate Publication Agreement or within the Clinical Trial Agreement. 
 
For more information on publication guidelines, please refer to the International Committee of Medical 
Journal Editors (ICMJE) on www.icmje.org. 
 
This clinical investigation and its results will be posted on ClinicalTrials.gov as required.  
 
This clinical investigation will be registered on ClinicalTrials.gov prior to IRB/EC submission. A full report 
of the pre-specified outcomes, including any negative outcomes, will be made public through the 
ClinicalTrials.gov website no later than 12 months after clinical investigation completion, as required by 
Section 801 of the FDA Amendments Act. If this clinical investigation is terminated early, the Sponsor will 
make every effort to hasten the release of the pre-specified outcomes through the ClinicalTrials.gov 
website. 
 
13 Suspension or premature termination of the clinical investigation 
The Sponsor reserves the right to stop the clinical investigation at any stage, with appropriate written 
notice to the investigators, IRB/ ECs and Competent authorities, if required.  
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely terminate 
participation in a clinical investigation at the investigational sites for which they are responsible. The 
investigators will follow the requirements specified in the Clinical Trial Agreement.  
 
If suspicion of an unacceptable risk to subjects arises during the clinical investigation or when so 
instructed by the IRB/EC or regulatory authority, the Sponsor may suspend the clinical investigation as 
appropriate while the risk is assessed.  The Sponsor will terminate the clinical investigation if an 
unacceptable risk is confirmed.  If the Sponsor concludes an analysis of the reasons for the suspension, 
implements the necessary corrective actions, and decides to lift the temporary suspension, the Sponsor 
will inform the Principal Investigators, IRB/EC, or regulatory authority, where appropriate, of the rationale, 
providing them with the relevant data supporting this decision.  Approval from the IRB/EC or regulatory 
authority, where appropriate, will be obtained before the clinical investigation resumes. If subjects have 
been informed of the suspension, the Principal Investigator or authorized designee will inform them of the 
reasons for resumption. 
 
If the Sponsor suspends or prematurely terminates the clinical investigation at an individual 
investigational site in the interest of safety, the Sponsor will inform all other Principal Investigators. 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 45 of 59 
 
  
 
 
If suspension or premature termination occurs, the Sponsor will remain responsible for providing 
resources to fulfill the obligations from the CIP and existing agreements for following up the subjects 
enrolled in the clinical investigation, and the Principal Investigator or authorized designee will promptly 
inform the enrolled subjects at his/her investigational site, if appropriate. 
 
14 Clinical Investigation Conclusion 
The clinical investigation will be concluded when: 
o 
All sites are closed AND 
o 
The Final report has been provided to investigators or the Sponsor has provided formal 
documentation of clinical investigation closure. 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 46 of 59 
 
  
 
Appendix A: CIP Revisions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 47 of 59 
 
  
 
Appendix B: Definitions 
 
Non-study Specific Definitions 
 
 
Adverse Device Effect (ADE) 
An adverse event related to the use of an investigational medical device. 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. 
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational medical device. 
 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
 
Vulnerable Subject 
Vulnerable subject is defined as individual whose willingness to volunteer in a clinical investigation could 
be unduly influenced by the expectation, whether justified or not, of benefits associated with participation 
or of retaliatory response from senior members of a hierarchy in case of refusal to participate 
EXAMPLE Individuals with lack of or loss of autonomy due to immaturity or through mental disability, 
persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic 
minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. 
Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as 
university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members 
of the armed forces, and persons kept in detention. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 49 of 59 
 
  
 
MRI 
NA 
PI 
RDC 
SADE 
SAE 
SAR 
SC  
SJM 
US 
USADE 
VT/VF 
WMA 
Magnetic Resonance Imaging 
Not Applicable 
Principal Investigator 
Remote Data Capture 
Serious Adverse Device Effect 
Serious Adverse Event 
Specific Absorption rate  
Steering Committee 
St. Jude Medical 
United States  
Unanticipated Serious Adverse Device Effect 
Ventricular Tachycardia/Ventricular Fibrillation 
World Medical Association 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 50 of 59 
 
  
 
Appendix D: Declaration of Helsinki 
The most current version of the document will be followed. 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 51 of 59 
 
  
 
Appendix E: MRI Scan Guidelines  
Instructions and guidelines for performing MRI scans for the ASIA MRI ICD Study are kept under 
separate cover, and will be provided to study centers by St. Jude Medical.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 55 of 59 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
  
 
 
  
 
 
 
 
   
 
  
  
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
___) 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 56 of 59 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 57 of 59 
 
  
 
 
Appendix- H: Sample Informed Consent  
(Final Informed Consent Template is kept under separate cover)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 58 of 59 
 
  
 
Appendix I: Product Instructions for Use 
The Product Instructions for Use, User Manual and CE Certificates are kept under a separate cover, and 
will be provided to study centers by St. Jude Medical. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-10163 Ver. B 
Study Name: ASIA MRI ICD 
Clinical Investigation Plan 
 
Template: 86357 Rev. B                                                                                                                                                   Page 59 of 59 
 
  
 
Appendix J: Bibliography 
1. Rogulin A, Schwitter J, Vahlhaus C, Lombardi M, Brugada J, Vardas P, et al. Magnetic resonance 
imaging in individuals with cardiovascular implantable electronic devices. Europace 2008;10:336-346. 
2. Duru F, Luechinger R, Scheidegger M, et al. Pacing in magnetic resonance imaging environment: 
Clinical and technical considerations on compatibility. Eur heart J 2001;22:113-124. 
3. Imv Medical Information Division. 2007 MRI Market Summary Report. Prepared for St. Jude Medical 
June 2008. 
4. Mond H G, Irwin M, Ector H, and Proclemer A. The world survey of cardiac pacing and cardioverter- 
defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society 
(ICPES) Project. PACE 2008 Sep;31(9):1202-12. 
5. Mond H G, Irwin M, Morillo C, Ector H. The world survey of cardiac pacing and cardioverter- 
defibrillators: Calendar year 2001. PACE 2004 Feb;27:955-64 
6. Kalin R and Stanton R. Current Clinical Issues for MRI Scanning of Pacemaker and Defibrillator 
Patients. PACE 2005;28(4):326-328. 
7. Pinski S L and Trohman R G.  Interference in implanted cardiac devices, Part II.  Journal of Pacing 
and Clinical Electrophysiology.  2002 Oct; 25(10): 1496-1509. 
8. Roguin A.  Magnetic resonance imaging in patients with implantable cardioverter-defibrillators and 
pacemakers.  Journal of the American College of Cardiology.  2009 Aug; 54(6): 556-557. 
9. Gimbel J R, Johnson D, Levine P A, Wilkoff  B L. Safe  performance of magnetic resonance imaging 
on five patients with permanent cardiac pacemakers. PACE 1996;19:913-919.  
10. Valhaus C, Sommer T, Lewalter T. et al. Interference with cardiac pacemakers by magnetic 
resonance imaging: Are there irreversible changes at 0.5 Tesla? PACE 2001; 24: 489-495.   
11. Luechinger R, Duru F, Scheidegger, M B, et al. Force and torque effects of a 1.5Tesla MRI scanner 
on cardiac pacemakers and ICDs. PACE 2001; 24:199-205.  
12. Loewy J, Loewy A, and Kendall EJ. Reconsiderations of pacemakers and MR imaging. 
RadioGraphics 2004; 24:1257-1268.  
13. Roguin A, Zviman M M, Meininger G T, et al.  Modern pacemaker and implantable cardioverter 
defibrillator system scan be magnet safe: In vitro and in vivo assessment of safety and function at 
1.5T. Circulation 2004; 110:475-482.  
14. Accent MRI PMA (60067410/A)