A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study
Phase: NA
Conditions: Implantable Defibrillator User
Sponsor: Abbott Medical Devices

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
Reference: 
SJM-CIP-CRD768 
 
 
 
 
 
Sponsor: 
St. Jude Medical, Inc. 
15900 Valley View Court 
Sylmar, CA 91342 
USA 
TEL: (818) 362-6822 
FAX: (818) 364-5814 
MRI Ready IDE Study 
“A Clinical Evaluation of the Durata® or Optisure™ High Voltage Leads and Ellipse® VR ICD 
Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study” 
Clinical Investigation Plan (CIP) 
 
June 17, 2016 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
MRI Ready IDE study 
 
“A Clinical Evaluation of the Durata® or Optisure™ High Voltage Leads and Ellipse VR 
ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) 
Study” 
 
 
Version B 
 
Reference #: SJM-CIP-CRD768 
 
 
I have read and agree to adhere to the clinical investigational plan and all regulatory 
requirements applicable in conducting this clinical study. 
 
 
Principal Investigator 
 
 
Printed name:    
 
 
 
Signature: 
  
 
 
 
Date:    
 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Table of Contents 
 
 
1.0 SYNOPSIS .......................................................................................................................................................... 7 
1.1 STUDY FLOW CHART ..................................................................................................................................... 14 
1.2 STUDY CONTACTS .......................................................................................................................................... 14 
2.0 BACKGROUND AND JUSTIFICATION FOR STUDY ......................................................................... 15 
3.0 RISKS AND BENEFITS OF THE CLINICAL STUDY, INCLUDING ANALYSIS OF RISKS .......... 15 
3.1 DESCRIPTION OF SUBJECT POPULATION ............................................................................................................ 16 
3.2 ANTICIPATED CLINICAL BENEFITS .................................................................................................................. 16 
3.3 ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS .................................................................... 16 
3.4 RESIDUAL RISKS ASSOCIATED WITH THE DEVICE UNDER INVESTIGATION ....................................................... 19 
3.5 RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY ................................................................ 19 
3.6 POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL TREATMENTS AND/OR CONCURRENT MEDICAL 
INTERVENTIONS ................................................................................................................................................... 19 
3.7 STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS ................................................................ 19 
3.8 RISK-TO-BENEFIT RATIONALE ........................................................................................................................ 21 
4.0 STUDY DESIGN .......................................................................................................................................... 21 
4.1 PURPOSE ......................................................................................................................................................... 21 
4.2 STUDY DESIGN AND SCOPE ............................................................................................................................ 21 
4.2.1 Number of Subjects Required to be Included in the Study .................................................................. 22 
4.2.2 Estimated Time Needed to Enroll Subject Population ........................................................................ 22 
4.3 
OBJECTIVES ................................................................................................................................................ 23 
4.3.1 Primary Objectives ................................................................................................................................ 23 
4.4 
ENDPOINTS ................................................................................................................................................. 23 
4.4.1 Primary Safety Endpoint .................................................................................................................... 23 
4.4.2 Primary Efficacy Endpoints ............................................................................................................... 23 
4.4.3 Additional Data .................................................................................................................................. 23 
4.5 SUBJECT SELECTION ...................................................................................................................................... 24 
4.5.1 Inclusion Criteria .................................................................................................................................. 24 
4.5.2 Exclusion Criteria ................................................................................................................................. 24 
4.6 SUBJECT POPULATION ....................................................................................................................................... 25 
4.6.1 Patient Screening .................................................................................................................................. 25 
4.6.2 Point of Enrollment ............................................................................................................................ 25 
4.6.3 Enrollment of Medicare Beneficiaries .................................................................................................. 26 
4.6.4 Vulnerable Population .......................................................................................................................... 26 
4.7 INFORMED CONSENT PROCESS ....................................................................................................................... 26 
4.7.1 General Process .................................................................................................................................... 26 
5.0 DEVICES UNDER INVESTIGATION ...................................................................................................... 27 
5.1 DEVICE DESCRIPTIONS ...................................................................................................................................... 27 
5.1.1 Ellipse ICD ............................................................................................................................................ 27 
5.1.2 Durata Lead ....................................................................................................................................... 28 
5.1.3 Optisure Lead ..................................................................................................................................... 28 
5.2 DEVICE HANDLING & STORAGE ....................................................................................................................... 28 
6.0 PROCEDURES ................................................................................................................................................ 29 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
6.1 STUDY FLOW CHART ..................................................................................................................................... 29 
6.2 PROCEDURES .................................................................................................................................................. 29 
6.3 SCREENING AND INFORMED CONSENT ........................................................................................................... 34 
6.4 BASELINE ........................................................................................................................................................... 34 
6.5 SCHEDULED FOLLOW UPS .............................................................................................................................. 35 
6.5.1 MRI Scan Visit ....................................................................................................................................... 35 
6.5.1.1 Pre-Scan Testing and Device Programming ................................................................................................... 36 
6.5.1.2 Data Submission ............................................................................................................................................. 39 
6.5.2 Situations where the subject does not meet enrollment criteria ........................................................... 39 
6.5.2.1 The MRI Scan ................................................................................................................................................. 41 
6.5.2.2 Post-Scan Testing............................................................................................................................................ 43 
6.5.2.3 Data Submission ............................................................................................................................................. 44 
6.5.3 One (1) Month Post Scan Visit ............................................................................................................. 44 
6.5.3.1 Testing............................................................................................................................................................. 44 
6.5.3.2 Data Submission ............................................................................................................................................. 45 
6.6 VT/VF DATA COLLECTION EFFORT .............................................................................................................. 45 
6.6.1 Induction Testing .................................................................................................................................. 45 
6.6.1.1 Sub Study Induction Testing .......................................................................................................................... 45 
6.6.1.2 Induction testing for clinical reasons ........................................................................................................... 46 
6.6.2 Non-sub study subjects: Review of spontaneous VT/VF episodes ................................................... 46 
6.6.2.1 Data Submission ............................................................................................................................................. 47 
6.7 COMPLETE SYSTEM EXPLANTS ......................................................................................................................... 47 
6.8 SYSTEM REVISIONS ........................................................................................................................................... 47 
6.8.1 Revisions Before the MRI Scan .......................................................................................................... 48 
6.8.2 Revisions After the MRI scan ............................................................................................................. 51 
6.9 UNSCHEDULED FOLLOW UP ..................................................................................................................... 53 
6.9.1 Data Submission .................................................................................................................................. 53 
6.10 NON-STUDY MRI SCANS ................................................................................................................................ 53 
6.10.1 
Data Submission ...................................................................................................................... 54 
6.11 DESCRIPTION OF ACTIVITIES PERFORMED BY SPONSOR REPRESENTATIVES ................................................ 54 
6.12 SUBJECT STUDY COMPLETION ......................................................................................................................... 55 
6.13 ANY KNOWN OR FORESEEABLE FACTORS THAT MAY COMPROMISE THE OUTCOME OF THE CLINICAL 
STUDY OR THE INTERPRETATION OF THE RESULTS ................................................................................................ 55 
6.14 DESCRIPTION OF THE METHODS THAT WILL BE USED TO ADDRESS POTENTIALLY CONFOUNDING FACTORS 
IN THE CLINICAL STUDY DESIGN ............................................................................................................................ 55 
6.15 CRITERIA AND PROCEDURES FOR SUBJECT WITHDRAWAL OR SCREEN FAILURE ........................................ 55 
7.0 COMPLIANCE TO THE CIP ....................................................................................................................... 56 
7.1 STATEMENTS OF COMPLIANCE ....................................................................................................................... 56 
7.2 ADHERENCE TO THE CLINICAL INVESTIGATION PLAN (PROTOCOL DEVIATIONS) ......................................... 57 
7.3 REPEATED AND SERIOUS NON-COMPLIANCE ................................................................................................. 58 
8.0 ADVERSE DEVICE EFFECT .................................................................................................................... 59 
8.1 DEFINITIONS ...................................................................................................................................................... 59 
8.1.1 Medical Device ...................................................................................................................................... 59 
8.1.2 Adverse Device Effect (ADE) ............................................................................................................. 59 
8.1.3 Serious Adverse Device Effect (SADE) ................................................................................................. 60 
8.1.3.1 Unanticipated Adverse Device Effect (UADE) .............................................................................................. 60 
8.1.3.2 Unanticipated Serious Adverse Device Effect (USADE) ............................................................................... 60 
8.1.4 Reporting of MRI Scan-Related Adverse Device Effects ...................................................................... 60 
8.1.5 Complication ......................................................................................................................................... 61 
8.1.6 MRI scan related complication ............................................................................................................. 61 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
8.2 PROCEDURE FOR ASSESSING, RECORDING AND REPORTING ADVERSE DEVICE EFFECTS, SERIOUS ADVERSE 
DEVICE EFFECTS AND UADES (FOR US SITES) AND USADES (FOR OUS SITES): ................................................ 61 
8.2.1 Criteria and guidelines for non-reportable events ............................................................................. 61 
8.2.2 Criteria and guidelines for reportable events .................................................................................... 62 
8.2.3 Preliminary Safety Report ..................................................................................................................... 63 
8.3 SUBJECT DEATH ................................................................................................................................................ 63 
8.3.1 Procedure for recording and reporting subject death ......................................................................... 63 
8.4 COMPLAINT .................................................................................................................................................... 64 
9.0 DATA MANAGEMENT .............................................................................................................................. 64 
9.1 DATA MANAGEMENT PLAN ........................................................................................................................ 65 
9.2 DOCUMENT AND DATA CONTROL .................................................................................................................. 65 
9.2.1 Traceability of documents and data ...................................................................................................... 65 
9.2.2 Recording Data ..................................................................................................................................... 65 
10.0 MONITORING ........................................................................................................................................... 66 
11.0 REGULATORY INSPECTIONS .............................................................................................................. 66 
12.0 STATISTICAL CONSIDERATIONS ...................................................................................................... 67 
12.1 STATISTICAL DESIGN, HYPOTHESES, METHOD AND ANALYTICAL PROCEDURES ........................................... 67 
12.1.1 Primary Safety endpoint ...................................................................................................................... 67 
12.1.2 Primary Efficacy Endpoint #1 (Change in Capture Threshold for Durata and Optisure (RV) Leads) 
....................................................................................................................................................................68 
12.1.3 Primary Efficacy Endpoint #2 (Change in Sensing Threshold for Durata and Optisure (RV) leads) 
....................................................................................................................................................................69 
12.2 SAMPLE SIZE .................................................................................................................................................... 69 
12.2.1 Sample size for primary safety endpoint ........................................................................................... 69 
12.2.2 Sample size for primary efficacy endpoint #1 (Change in capture threshold for Durata or Optisure 
(RV) lead ..................................................................................................................................................... 70 
12.2.3 Sample size for primary efficacy endpoint #2 (Change in sensing threshold in Durata or Optisure 
(RV) lead) .................................................................................................................................................... 70 
12.2.4 Overall Sample Size ............................................................................................................................ 70 
12.2.5 Analysis ............................................................................................................................................... 70 
12.3 PASS/FAIL CRITERIA TO BE APPLIED TO THE RESULTS OF THE CLINICAL STUDY ........................................... 71 
12.4 THE PROVISION FOR AN INTERIM ANALYSIS ................................................................................................... 71 
12.5 CRITERIA FOR THE TERMINATION OF THE CLINICAL STUDY ON STATISTICAL GROUNDS ............................... 71 
12.6 PROCEDURES FOR REPORTING ANY DEVIATION(S) FROM THE ORIGINAL STATISTICAL PLAN ....................... 71 
12.7 THE SPECIFICATION OF SUBGROUPS FOR ANALYSIS ....................................................................................... 71 
12.8 PROCEDURES THAT TAKE INTO ACCOUNT ALL THE DATA ............................................................................ 71 
12.9 THE TREATMENT OF MISSING, UNUSED OR SPURIOUS DATA, INCLUDING DROP-OUTS AND WITHDRAWALS 71 
12.10 THE EXCLUSION OF PARTICULAR INFORMATION FOR THE TESTING OF THE HYPOTHESIS, IF RELEVANT ...71 
12.11 IN MULTI-CENTER STUDIES, THE MINIMUM AND MAXIMUM NUMBER OF SUBJECTS TO BE INCLUDED FOR 
EACH CENTER ....................................................................................................................................................... 71 
13.0 DOCUMENT RETENTION ..................................................................................................................... 72 
14.0 STUDY COMMITTEE .............................................................................................................................. 72 
14.1 CLINICAL EVENTS COMMITTEE (CEC)/VENTRICULAR ARRHYTHMIA EVENT REVIEW COMMITTEE (VAC) 
.........................................................................................................................................................................72 
14.2 DATA SAFETY MONITORING BOARD (DSMB)..........................................................................................73 
14.3 STEERING COMMITTEE ................................................................................................................................. 73 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
15.0 INVESTIGATION SUSPENSION OR TERMINATION ........................................................................ 73 
15.1 PREMATURE TERMINATION OF THE WHOLE CLINICAL STUDY OR OF THE CLINICAL STUDY IN ONE OR MORE 
INVESTIGATIONAL SITES ....................................................................................................................................... 73 
15.2 RESUMING THE STUDY AFTER TEMPORARY SUSPENSION ............................................................................... 75 
15.3 STUDY CONCLUSION .................................................................................................................................... 75 
16.0 PUBLICATION POLICY .......................................................................................................................... 75 
17.0 BIBLIOGRAPHY .......................................................................................................................................... 76 
APPENDIX A: ABBREVIATIONS .................................................................................................................. 77 
APPENDIX B: CIP REVISION HISTORY ....................................................................................................... 78 
APPENDIX C: DECLARATION OF HELSINKI .......................................................................................... 81 
APPENDIX D: REPORT OF PRIOR INVESTIGATIONS ........................................................................... 82 
APPENDIX E: MRI SCAN GUIDELINES ........................................................................................................ 83 
APPENDIX F: MRI SCREENING FORM ...................................................................................................... 84 
APPENDIX G: MRI HAZARD CHECKLIST ................................................................................................ 88 
APPENDIX H: LIST OF CLINICAL INVESTIGATION SITES AND IRB/EC ......................................... 91 
APPENDIX I: SAMPLE INFORMED CONSENT & SUB STUDY CONSENT .......................................... 92 
APPENDIX J: PRODUCT LABELING ........................................................................................................ 111 
APPENDIX K: CASE REPORT FORMS ...................................................................................................... 112 
Table of Tables 
 
Table 1: Study Procedures and Data Collection ........................................................................ 11 
Table 2: Anticipated Events and Anticipated Adverse Device Effects .................................... 17 
Table 3: Unavoidable events related to the MRI Scan ............................................................ 18 
Table 4: Study Device ................................................................................................................ 27 
Table 5: Study Procedures and Data Collection ........................................................................ 30 
Table 6: MRI Parameters ........................................................................................................... 38 
Table 7: Actions for Inclusion/Exclusion Criteria Issues that Occur Post Consent ................. 40 
Table 8: System Revision Scenarios Prior to MRI Scan .......................................................... 49 
Table 9: System Revision Scenarios After MRI Scan .............................................................. 51 
 
 
 
Table of Figures 
 
Figure 1: Study Flow Chart ..................................................................................................... 29 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
1.0 Synopsis 
 
Details 
Title: 
A Clinical Evaluation of the Durata® or Optisure™® High Voltage (HV) Leads and 
Ellipse® VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device 
Exemption (IDE) Study 
Acronym: 
MRI Ready IDE Study 
Purpose: 
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead   and 
Ellipse VR ICD in an MRI environment. 
Objectives: 
Primary Objectives 
• Assess the safety of the right ventricular high voltage lead (Durata or Optisure 
lead) and Ellipse VR ICD in an MRI environment 
• 
Assess the efficacy of the right ventricular high voltage lead (Durata or 
Optisure lead) implanted with the Ellipse VR ICD in an MRI environment 
Endpoints: 
• Safety: Freedom from MRI-scan related complications* related to the Ellipse 
VR ICD involving the Durata or Optisure (RV) lead from MRI scan to 1 month 
post-MRI scan testing 
• Efficacy: Proportion of Durata or Optisure (RV)  leads implanted with the 
Ellipse VR ICD with capture threshold increase of ≤ 0.5V at 0.5ms from pre- 
MRI scan to 1 month post-MRI scan testing 
• Efficacy: Proportion of Durata or Optisure (RV) leads implanted with the 
Ellipse VR ICD with sensing amplitude decrease of ≤ 50% from pre-MRI scan 
testing to 1 month post-MRI scan. 
*A complication is a serious adverse device effect (SADE) that requires an invasive 
intervention or leads to death. 
Note: All references to MRI scan in the protocol refer to the study MRI scan. 
Design: 
This clinical trial is a prospective, multi-center study designed to assess the safety and 
efficacy of the St. Jude Medical Durata/Optisure HV leads and Ellipse VR ICD in an 
MRI environment. Patients will have the Durata or Optisure HV leads implanted with 
a St. Jude Medical Ellipse VR ICD for at least 60 days prior to enrollment. 
A prospective, multi-center study design was chosen for generalizability of study 
results by enrolling subjects across multiple geographies and sites, with the minimum 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Details 
sample size required to demonstrate the safety and efficacy of the Durata or Optisure 
lead with the Ellipse ICD in an MRI environment. 
The total duration of the study is expected to be 1.5 to 2 years. 
The clinical study will be conducted in approximately 60 worldwide centers with the 
majority of the centers in the United States. 
Up to 165 subjects will be enrolled in this study in order to meet minimum target 
requirements for the safety endpoint (141 subjects). The PMA will be submitted to 
FDA when the minimal sample size for each endpoint has been met and a minimum of 
25 subjects with at least one ventricular arrhythmia episode (spontaneous or induced) 
have been adjudicated by the Ventricular Arrhythmia Events Committee . If a 
minimum of 25 subjects have not experienced a ventricular arrhythmia event 
(spontaneous or induced) at this time, SJM will discuss progress of data collection for 
ventricular arrhythmia events with FDA to support the minimum requirements to 
support a pre-market approval (PMA) application. The data from this IDE will be used 
to support a marketing application for MRI labeling for SJM ICDs, CRT-Ds and CRT- 
Ps. 
Subjects will be enrolled, undergo the study MRI scans, and followed through the 
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). 
Subjects that agree to participate in the MRI Ready IDE study will also be approached 
to enroll in a sub study of the MRI Ready IDE study which will involve induction 
testing that is performed after the MRI visit. The induction sub study will be conducted 
at all centers that are willing to participate. 
Ventricular tachycardia (VT) and ventricular fibrillation (VF) events will also be 
collected to characterize ventricular arrhythmia sensing and detection post-MRI. The 
device detected  VT/VF events (induced or spontaneous) will be collected post MRI 
from a minimum of 25 subjects with at least one ventricular arrhythmia episode 
(spontaneous or induced) adjudicated by the Ventricular Arrhythmia Events Committee 
through any one of three methods: 
1. Events obtained during induction testing at any time after the MRI visit, 
including system revision and follow up visits where induction testing was 
performed due to impaired R-wave sensing or other clinical reasons. 
2. Events in subjects who enroll in the sub study, which will involve post MRI 
scan induction testing 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Details 
3.   Subjects who are no
Devices 
used: 
• Durata 7120Q , active fixation, 58/65cm length 
• 
It is p
and sp
ICDs 

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• 
• 
Study 
Population 
A pat
meets
and th
For si
sub st
The st
an Ell
exclud
Inclusion/ 
Exclusion 
Criteria 
Inclus
• 
• 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Details 
• Be 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 
during the MRI scan 
• Capture threshold is stable < 2.5V @ 0.5ms 
• Ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sens
• Be able to provide informed consent for study participation (legal guardian or legally au
acceptable) 
• Be willing and able to comply with the prescribed follow-up tests and procedures 
• Are not contraindicated for an MRI scan (per the MRI Screening Form) 
Exclusion Criteria 
• Have a competitor’s MRI compatible endocardial lead implanted or capped 
• Have another existing active implanted medical device, e.g., neurostimulator, infusion p
allow the MRI scans per this protocol to be completed. 
• Have a lead revision of the Durata/Optisure lead occur < 60 days of the baseline 

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visit 
• Have other non-MRI compatible device or material implanted 
NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included a
MRI scans conducted per this protocol 
NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be inclu
allow for MRI scans conducted per this protocol 
NOTE: Non-removable dental implants may be included 
• Have a lead extender, adaptor, or capped/abandoned lead 
• Enrolled or intend to participate in a clinical drug and/or device study (investigational de
for a device or drug or additional testing beyond standard of care procedures), which cou
determined by SJM. 
• Pregnant or planning to become pregnant during the duration of the subject’s participatio
• Have a life expectancy of less than 12 months due to any condition 
• 
Patients with exclusion criteria required by local law (e.g., age) 
Data 
See Study Procedures and Data Collection Table 
Collection 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Table 1: Study Procedures and Data Collection 
 
Study Visit 
Visit Window 
Study Procedures and Data Collection 
NA 
Up to or same day 
as Baseline 
• 
Screen patient for enrollment eligibility 
• 
Obtain informed consent(s) 
[All patients that agree to participate in the study will sign 
the main study consent. For sites that are participating in 
the sub study, subjects will be approached with the main 
study consent and the sub study consent] 
Baseline 
The latter of : 
• 
60 days after 
lead implant 
And 
• 
60 days after 
most recent 
lead revision, 
if applicable 
• 
Obtain medical and surgical history 
• 
Collect demographic information 
• 
Document indication for implant of ICD 
• 
Obtain ICD system information: model and serial number 
of implanted Ellipse ICD system, and if applicable, most 
recent lead revision information. 
• 
Complete MRI Screening Form 
MRI Scan Visit 
Post Baseline 
(Within 30 days 
post baseline). 
The pre-MRI 
scan, MRI and 
post MRI scan 
procedures 
should occur on 
the same day. 
Pre-MRI Scan testing 
• 
Assess inclusion/exclusion criteria 
• 
Screen, clear and prep subject for MRI scan 
• 
Complete MRI screening form (if MRI scan visit does not 
occur the same day as baseline) 
• 
Complete MRI Hazard Checklist 
• 
Administer pregnancy test – can be done up to 7 days 
before MRI scan 
• 
Interrogate device 
• 
Perform capacitor maintenance 
• 
Obtain in-clinic Durata or Optisure lead measurements: 
bipolar capture, sense, pacing and HVLI impedances1,2 
• 
Setup and activate MRI Settings 
During MRI Scan 
• 
Monitor subject with ECG, pulse oximetry, and verbal 
communication 
Post-MRI scan testing 
• 
Interrogate device 
• 
Deactivate MRI Settings 
• 
Obtain in-clinic Durata or Optisure lead measurements: 
bipolar capture, sense, pacing and HVLI impedances 1,2 
• 
Evaluate subject for Adverse Device Effect (ADE), 
Serious Adverse Device Effect (SADE), Unanticipated 
Adverse Device Effect (UADE) events, Unanticipated 
Serious Adverse Device Effect (USADE for OUS sites) 
and submit an AE CRF (as applicable). 
• 
Report deviations, death, screening failure/withdrawal and 
out of service as applicable 
• 
Submit MRI scan results, e.g. scan time, sequences used, 
etc. 
• 
Upload device session records through the EDC study site 
portal 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Study Visit 
Visit Window 
Study Procedures and Data Collection 
1 Month Post MRI Scan Visit 
30 days after 
• 
Interrogate device 
MRI scan 
( - 7/+14 days) 
• 
Obtain in-clinic Durata or Optisure lead measurements: 
bipolar capture, sense, pacing and HVLI impedances 1,2 
• 
Evaluate subject for ADE, SADE, UADE (for US sites) or 
USADE (for OUS sites) events and submit an AE CRF (as 
applicable). 
• 
Report deviations, death, withdrawal and out of service as 
applicable 
• 
Upload device session records through the EDC study site 
portal 
Sub study induction testing 
Can occur any 
• 
Conduct induction therapy testing (e.g. DC Fibber method) 
time after the 
• 
Evaluate subject for ADE, SADE, UADE (for US sites), 
MRI scan visit 
USADE (for OUS sites) events and submit an AE CRF (as 
(Suggest that 
applicable). 
testing occurs 
within 30 days 
after MRI scan 
visit: 
- 7/+14 days ) 
• 
Report deviations, death, withdrawal and out of service as 
applicable 
• 
Upload device session records through the EDC study site 
portal 
Review of 
Subjects on 
Capture events as 
• 
Merlin.net records will be reviewed by SJM for 
spontaneous 
Merlin.net 
they occur any 
spontaneous VT/VF 
VT/VF episodes 
(non-sub study 
time after the 1 
month post MRI 
• 
Review of records will end upon notification from SJM 
subjects) 
scan visit 
Subjects 
Every 3 months 
• 
Non-Merlin.net subjects: Follow up by phone with subject 
not on 
post baseline ± 30 
and screen medical records for VT/VF since last visit. 
Merlin.net 
days 
Obtain the device data related to that VT/VF episode. 
• 
Follow up phone calls will end upon notification from 
SJM. 
System Revision (if applicable) 
Can occur any 
• 
Interrogate device 
time after 
baseline 
• 
Obtain applicable in-clinic lead measurements: bipolar 
capture1, sense2, pacing and HVLI impedances for cases 
where the lead was repositioned, or was replaced with 
another Durata/ Optisure lead, or where the ICD was 
replaced with another Ellipse ICD. 
• 
NOTE: If the device replacement/revision of the Ellipse 
VR device occurs post MRI visit and the Durata/Optisure 
lead remains in its original location, then induction testing 
may occur and the session records related to induction 
testing should be uploaded. 
• 
Evaluate subject for ADE, SADE, and UADE (for US 
sites) or USADE (for OUS sites) events and submit an AE 
CRF (as applicable). 
• 
Report deviations, death, withdrawal and out of service as 
applicable 
• 
Upload device session records through the EDC study site 
portal 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1Durata or Optisure lead capture thresholds are not required 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. 
2Durata or Optisure lead sensing measurements are not required if the subject’s intrinsic rate has been 
established to be at or below 30 beats per minute. 
Study Visit 
Visit Window 
Study Procedures and Data Collection 
Unscheduled (if applicable) 
Any time after the 
MRI scan visit 
(where the  
subject is seen in 
clinic due to an 
ADE, SADE or 
UADE associated 
with the Durata 
or Optisure or 
Ellipse ICD or 
for follow up 
related to the 
collection of 
VT/VF episodes) 
• 
Interrogate device. 
• 
Obtain applicable in-clinic Durata or Optisure lead 
measurements: bipolar capture, sense, pacing and HVLI 
impedances1,2 
• 
If an unscheduled visit occurs prior to the 1 month post 
MRI visit, evaluate subject for ADE, SADE, and UADE 
(for US sites) or USADE (for OUS sites) events and 
submit an AE CRF (as applicable). If an unscheduled 
event occurs after the 1 month post MRI visit, then the AE 
events do not need to be submitted. 
• 
If a subject experiences reduced R waves and undergoes 
induction testing or undergoes induction testing for another 
clinical reason after the MRI visit, then an induction  
testing form will be submitted. 
• 
Report deviations, death, withdrawal and out of service as 
applicable 
• 
Upload device session records through the EDC study site 
portal 
Non-Study MRI Scan (if 
applicable) 
Any time after 
enrollment 
through the 
conclusion of the 
subject’s 
participation, 
excluding the 
MRI scan 
performed during 
the MRI scan 
visit. 
Perform medically required MRI scan. Where possible: 
Before scan 
• 
Complete MRI Hazard Checklist 
• 
Interrogate device 
• 
Perform capacitor maintenance 
• 
Obtain lead measurements: bipolar capture, sense, pacing 
and HVLI impedances 
• 
Enable MRI Settings 
During MRI Scan 
• 
Monitor subject with ECG, pulse oximetry, and verbal 
communication 
After MRI scan 
• 
Evaluate subject for adverse events 
• 
Interrogate device 
• 
Disable MRI Settings, and program device back into 
permanent settings 
• 
Obtain lead measurements: bipolar capture, sense, pacing 
and HVLI impedances 
• 
Report AEs, deviations, death, withdrawal, out of service 
and device deficiency information, as applicable 
• 
Document results of MRI scan, e.g. scan time, sequences 
used, lapses in subject monitoring, etc. 
• 
Upload device session records through the EDC study site 
portal 

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MRI Scan Visit 
(within 30 days of 
baseline) 
Implanted for at least 60 
days with Durata or Optisure 
lead and an Ellipse ICD 
Informed Consent 
• 
Main study 
• 
Substudy (if applicable) 
Baseline 
Will pt undergo 
induction testing? 
No 
Yes 
Collection 
of induced 
ventricular 
arrhythmias 
(VT/VF) 
Participation Complete after completing 1 Month Post-MRI Scan Visit 
and when a minimum of 25 pts with at least 1 
ventricular arrhythmia episode (spontaneous or induced) are 
adjudicated by the Ventricular Arrhythmia Events Committee 
Pts not on Merlin.net: 
 
 Pts on Merlin.net: 
Phone follow up every 3 
Capture VT/VF events as 
months post baseline 
they occur through remote 
until SJM notification 
 
follow up until SJM 
notification 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
1.1 Study Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.2 Study Contacts 
Nicole Harbert 
Clinical Manager 
St. Jude Medical 
6901 Preston Road 
Plano, TX 75024 
Phone: (972) 526-4841 
Fax: 1-877-430-9720 
Email:nharbert@sjm.com 
Substudy 
induction testing 
OR 
clinical reason for 
induction testing 
(system revision, 
reduced R waves, 
etc.) 
1 Month 
Post MRI 
Scan Visit 
1 Month Post MRI 
Scan  Visit 
Collection of spontaneous 
ventricular arrhythmias 
(VT/VF) 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
2.0 Background and Justification for Study 
Magnetic resonance imaging (MRI) is a diagnostic method 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.9,10,11,12,13 
 
In this study, St. Jude Medical plans to investigate the Durata®/Optisure™ leads implanted 
with an Ellipse® VR ICD in an MRI environment. 
 
The study intends to enroll patients indicated for or who have been implanted with a Durata 
or Optisure lead and an Ellipse VR ICD to evaluate the effects of an MRI scan on these 
devices.  This evaluation will be performed in a prospective, multi-center, non-randomized, 
single arm clinical trial.  This design was chosen to generalize the study results by enrolling 
subjects across multiple geographies and varying types of sites, and to allow for the smallest 
sample size needed to demonstrate the safety and efficacy of the Durata or Optisure lead with 
the Ellipse VR ICD in an MRI environment. 
 
 
3.0 Risks and Benefits of the Clinical Study, including Analysis of Risks 
It is estimated that 50-75% of the patients with implantable cardiac devices will develop an 
indication for an MRI scan during the lifetime of their device. The information gathered in 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
this study will add to the understanding of treatment options for patients with the Durata or 
Optisure lead and Ellipse ICD devices who need to have an MRI scan performed. 
 
There are no direct benefits to the patient as a result of their participation in this study. All 
patients may be more closely monitored by their physician. 
 
3.1 Description of subject population 
This study intends to enroll subjects implanted with the Durata or Optisure lead and Ellipse 
VR ICD, as described under the Device Descriptions section of this document. This 
population includes males and females 18 years of age or older. 
 
3.2 Anticipated clinical benefits 
For the purposes of this study, an MRI Setting has been created, and will be enabled in the 
Ellipse VR ICD for the study MRI scan.  The MRI Setting allows for the programming of 
pre-specified parameters that can be saved, and utilized for MRI scanning without the need to 
individually program individual parameters every time a subject needs to undergo an MRI 
scan; the parameters in the MRI Setting are also all individually available, programmable 
parameters in the Ellipse ICDs. 
 
Additionally, the study will potentially show that MRI scans can be safely completed in 
subjects implanted with these leads and devices resulting in MRI conditional labeling of 
these systems implanted in the subjects. 
 
3.3 Anticipated adverse events and adverse device effects 
The Durata or Optisure lead and the Ellipse VR ICD are market-released devices. Risks 
associated with the use of the Durata or Optisure lead and the Ellipse VR ICD 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 Durata or Optisure lead and the Ellipse VR ICD 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. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Table 2: Anticipated Events and Anticipated Adverse Device Effects 
 
Event 
Mitigation 
Potential MRI Related Events 
• Lead electrode heating and tissue damage 
resulting in loss of sensing or capture or 
both 
• Lead heating resulting in thrombus 
formation or embolism 
• Device heating resulting in tissue damage 
in the implant pocket or subject 
discomfort or both 
• Induced currents on leads resulting in 
continuous capture, VT/VF, 
hemodynamic collapse, or all three 
• Damage to the device or leads causing: 
a. the system to fail to detect or treat 
irregular heartbeats 
b. the system to treat the subject’s 
condition incorrectly 
• Damage to the functionality or mechanical 
integrity of the device resulting in the 
inability of the device to communicate 
with the programmer 
• Movement or vibration of the device or 
leads 
• Lead dislodgment 
• Competitive pacing and potential for 
VT/VF induction due to ambulatory 
asynchronous pacing in MRI mode 
• Pulmonary Embolism 
These risks are mitigated through the 
selection of investigators who are 
qualified by training and/or experience to 
evaluate and treat subjects implanted with 
an ICD system. 
In addition, study investigators will be 
trained on the study protocol to ensure the 
proper procedures are followed to assure 
subject safety during the study MRI scan. 
This includes continuous monitoring of 
the subject using pulse oximetry, ECG 
and verbal communication during the 
scan. 
Advanced Cardiac Life Support (ACLS) 
procedures will be in place to address 
situations where a life threatening 
arrhythmia and/or hemodynamic collapse 
occurs.  The programmer will 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, the MRI scan will be stopped, and 
proper measures will be taken to restore 
the subject’s hemodynamic function. 
Potential ICD Related Events 
• Refer to the Ellipse user’s manual for a 
full list of potential adverse events 
The Ellipse VR ICD is a market-released 
ICD. The adverse events associated with 
this ICD are the same as those associated 
with other market-released ICDs. 
These risks are mitigated through the 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Event 
Mitigation 
selection of investigators who are 
qualified by training and/or experience to 
evaluate and treat subjects implanted with 
an ICD. 
Potential Lead Related Events 
• Refer to the Durata and Optisure lead 
user’s manual for a full list of potential 
adverse events 
The Durata and Optisure leads are market 
released transvenous, steroid-eluting 
defibrillation leads.  The adverse events 
associated with these leads are the same as 
those associated with other market- 
released transvenous defibrillation leads. 
These risks are mitigated through the 
selection of investigators who are 
qualified by training and/or experience to 
evaluate and treat subjects implanted with 
an ICD system. 
 
 
In addition, subjects may also experience unavoidable events related to the MRI scan. An 
unavoidable event is an event related to the MRI scan that is expected to occur for a 
projected duration in all subjects. Unavoidable events are not reportable unless the condition 
worsens or continues beyond the time frame listed below. Unavoidable events do not need to 
be reported on an adverse event form if they are resolved within the time frame specified. 
These events are expected to occur with any MRI scan, including the study MRI scans. 
 
Table 3: Unavoidable events related to the MRI Scan 
 
Event 
Time Frame post – MRI scan 
• Claustrophobia 
• During MRI scan 
• Mild diaphoresis 
• During and < 1 hour post MRI scan 
• Sensation of bodily warmth 
• During and < 1 hour post MRI scan 
• Sensation of warmth at device pocket not 
arising to the level of discomfort 
• During and < 1 hour post MRI scan 
• Hearing impairment 
• < 24 hours 
• Body stiffness related to immobility 
• < 48 hours 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
3.4 Residual risks associated with the device under investigation 
All risk regions were evaluated, and all the system risks were deemed acceptable. While 
steps have been taken to identify risks associated with the study MRI scan and participation 
in the study, there may be risks that are unknown at this time. 
 
3.5 Risks associated with participation in the clinical study 
Potential risks associated with the study MRI scan are the same as or comparable to those 
associated with MRI scans of an implanted medical device powered by a battery or other 
electrical source of power including, but not limited to, those listed in the Adverse Events 
and Adverse Device Effects section of the protocol. 
 
Potential risks associated with the induction sub study are the same as or comparable to the 
risks associated with induction testing that may occur during device implant. 
 
3.6 Possible interactions with concomitant medical treatments and/or concurrent 
medical interventions 
Other than the study MRI scan, 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. 
 
3.7 Steps that will be taken to control or mitigate the risks 
The risks associated with MRI scanning of subjects implanted with implantable active 
medical devices have been identified through clinical evaluation, including an exhaustive 
literature search. 
 
Risks normally associated with ICDs and transvenous leads will be minimized in the study 
by selecting investigators who are experienced in treating subjects implanted with ICDs, 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
evaluating implanted ICD systems, and who are trained in the MRI Ready IDE Study. 
Subjects will be actively monitored during the study scan using verbal communication, ECG, 
and continuous pulse oximetry monitoring. The investigator or other ACLS-certified 
personnel who have been trained on the study protocol will be present during the study MRI 
scan to address cases of asystole or hemodynamic collapse that may occur during the study 
MRI scan. In addition, because the study MRI scan is not meant to be diagnostic in nature, 
contrast agents will not be used, thereby eliminating the risk of allergic or adverse reactions 
to contrast agents. 
 
Risks will also be minimized by careful assessment of each subject prior to enrollment.  After 
enrollment, subjects in the study will be followed as specified in this CIP to monitor the 
condition of the implanted system and the battery after the subject has undergone 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 MRI Procedure Information for 
the St. Jude Medical® MR Conditional pacing 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 due to the investigational nature of this study. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
3.8 Risk-to-benefit rationale 
There may be no direct clinical benefit to the subject for participating in this study; no direct 
therapy is being provided as part of the study procedures, i.e. the study MRI scan. However, 
these data will help to establish the safety and efficacy of the Durata or Optisure lead and the 
Ellipse VR ICD in an MRI environment, which, upon approval, will provide patients who 
need an ICD to have the option to be safely scanned should these patients need to undergo an 
MRI in the future. 
 
 
4.0 Study Design 
 
4.1 Purpose 
The intent of this IDE study is to evaluate the safety and efficacy of the Durata or Optisure 
lead and Ellipse VR ICD that have undergone an MRI scan. The patient population under 
study includes patients indicated for or who have been implanted with a Durata or Optisure 
lead and an Ellipse VR ICD. 
 
4.2 Study Design and Scope 
The study intends to enroll patients, including Medicare beneficiaries, who have been 
implanted with a Durata or Optisure lead and Ellipse VR ICD to evaluate the effects of an 
MRI scan on the aforementioned devices.  The evaluation will be performed as part of a 
regulated, prospective, multi-center, non-randomized, single-arm clinical trial.  This design 
was chosen for generalizability of study results by enrolling subjects across multiple 
geographies and varying types of sites, with the minimum sample size required to 
demonstrate the safety and efficacy of the Durata or Optisure lead and the Ellipse ICD in an 
MRI environment. 
 
Subjects that agree to participate in the MRI Ready IDE study will also be approached to 
enroll in a sub study of the MRI Ready IDE study which will involve induction testing that is 
performed post MRI visit. 
 
Ventricular tachycardia (VT) and ventricular fibrillation (VF) events will also be collected to 
characterize ventricular arrhythmia sensing and detection post-MRI. A minimum of 25 
device detected VT/VF events (induced or spontaneous) will be collected post MRI from a 
minimum of 25 subjects with at least one ventricular arrhythmia episode (spontaneous or 
induced) adjudicated by the Ventricular Arrhythmia Events Committee through any one of 
three methods: 
1. Events obtained during induction testing at any time after the MRI visit, including 
system revision and follow up visits where induction testing was performed due to 
impaired R-wave sensing or other clinical reasons. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
2. Events in subjects who enroll in the sub study, which will involve post MRI induction 
testing 
3.   Subjects who are not enrolled in the sub study will be followed via Merlin.net or 
phone call every 3 months post baseline visit to collect potential spontaneous VT/VF 
episodes after the MRI visit. The data collection effort will end upon notification 
from SJM. 
Data collected to demonstrate safety of the Durata or Optisure lead and the Ellipse VR ICD 
include MRI scan related complications and deaths resulting from the study MRI scan.  Data 
collected to demonstrate efficacy of the study devices include changes in the device’s capture 
and sensing thresholds from the pre-MRI scan testing to 1-Month post MRI testing. 
 
4.2.1 Number of Subjects Required to be Included in the Study 
The maximum number of subjects in the study is 165. A maximum of 41 (25% of the 
total, if the total subjects enrolled = 165) subject enrollments will be allowed per 
center. 
 
A patient will be considered enrolled in the main study after he/she signs the main 
study consent, meets all of the inclusion and none of the exclusion criteria verified 
during the pre-MRI testing, and the MRI Settings have been programmed. 
 
4.2.2 Estimated Time Needed to Enroll Subject Population 
Enrollment in this clinical study is expected to take approximately 12 months. The 
anticipated duration of this study is 1.5 to 2 years, depending on the rate of 
enrollment and regulatory timelines. 
 
The minimum duration of each subject’s participation, if he/she undergoes an MRI 
scan, in the study is 23 days.  All subjects will have the Durata or Optisure lead 
implanted for at least 60 days prior to enrollment. 
 
The following study visits will occur after enrollment: 
 
• MRI scan/Post Scan testing 
• 1 Month Post Scan visit 
 
The MRI Scan should take place no sooner than 60 days post lead implant or lead 
revision procedure where the Durata or Optisure lead was implanted or repositioned. 
The 1 Month Post Scan visit is based on the MRI Scan Visit. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
A data collection effort to collect VT/VF events will also take place. For subjects on 
Merlin.net, the Merlin.net records will be reviewed for spontaneous VT/ VF events. 
Subjects not on Merlin.net will be contacted by phone and their medical records will 
be screened every 3 months for VT/VF events since the last visit. The data collection 
effort will end upon notification from SJM. 
 
4.3 Objectives 
4.3.1 Primary Objectives 
The primary objectives of this study are to assess the safety and efficacy of the Durata 
or Optisure lead and Ellipse VR ICD in an MRI environment. 
 
4.4 Endpoints 
4.4.1 Primary Safety Endpoint 
Safety for the Ellipse VR ICD involving the Durata and Optisure leads will be 
evaluated in terms of: 
• Freedom from MRI scan-related complications for the Ellipse VR ICD 
involving Durata or Optisure (RV) lead from MRI scan to 1 month post-MRI 
scan testing is greater than 90% 
4.4.2 Primary Efficacy Endpoints 
Efficacy of the Durata and Optisure leads involving the Ellipse VR ICD will be 
evaluated in terms of: 
• Proportion of Durata or Optisure (RV) leads implanted with the Ellipse VR 
ICD with capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 
1 month post-MRI scan testing is greater than 90% 
• Proportion of Durata or Optisure (RV) leads implanted with the Ellipse VR 
ICD with sensing amplitude decrease of ≤ 50% from pre-MRI scan testing to 
1 month post-MRI scan is greater than 87% 
4.4.3 Additional Data 
The following data will also be collected. 
• Demographics: gender, age, ethnicity, race, cardiac disease history, 
arrhythmia history, indication for ICD implant, history of smoking, etc. 
• Device electrical measurements at the MRI Scan Visit (before and after the 
scan) and at the 1 Month Post Scan Visit 
• ADE, SADE, UADE/USADE 
• Mortality 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• Number of non-study related MRI scans 
• Proportion of VT/VF episodes with significant detection delay assessed from 
device-detected VT/VF episodes (induced or spontaneous) with stored 
electrogram available 
• Summarize number of subjects that returned to usual programming after the 
MRI scan and number of subjects, if any, experiencing delays in 
reprogramming 
4.5 Subject Selection 
A subject, who meets all of the inclusion criteria, and none of the exclusion criteria, is 
eligible to participate in this study. 
To participate in this clinical study, the subject must meet all of the following inclusion 
criteria: 
4.5.1 Inclusion Criteria 
1. Are implanted with the Durata or Optisure lead for at least 60 days (can include 
patients with Durata or Optisure lead for ≥ 60 days OR patients with a new Ellipse 
VR ICD and/or Durata/Optisure lead implanted for at least 60 days) 
2. Are implanted with an Ellipse VR ICD pectorally 
3. Be 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 
4. Capture threshold is stable at < 2.5V@0.5ms 
5. Ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and 
the sensing amplitude is > 4mV 
6. Be able to provide informed consent for study participation (legal guardian or 
legally authorized representative is NOT acceptable) 
7. Be willing and able to comply with the prescribed follow-up tests and procedures 
8. Is not contraindicated for an MRI scan (per the MRI Screening Form) 
 
 
Subjects are not eligible for clinical study participation if they meet any of the following 
exclusion criteria: 
4.5.2 Exclusion Criteria 
1. Have a competitor’s MRI compatible endocardial lead implanted or capped 
2. Have 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. 
3. Have a lead revision of the Durata/Optisure lead occur < 60 days of the baseline 
visit 
4. Have other non-MRI compatible device or material implanted 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
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 
5. Have a lead extender, adaptor, or capped/abandoned lead 
6. 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. 
7. Pregnant or planning to become pregnant during the duration of the subject’s 
participation in the study 
8. Have a life expectancy of less than 12 months due to any condition 
9. Patients with exclusion criteria required by local law (e.g., age) 
 
 
4.6 Subject Population 
4.6.1 Patient Screening 
All patients presenting at the investigational site may be screened by a member of the 
investigational team previously trained on the CIP and delegated to do so. 
 
Patients who do not meet the inclusion/exclusion criteria will not be eligible to 
participate in this study. 
 
Patients meeting the inclusion/exclusion criteria will be fully informed about the 
study and asked to review and sign informed consent. In case the subject agrees, a 
duly signed and dated Patient Informed Consent will be obtained. 
 
Subjects will be approached with the main study consent at all study centers. For 
centers that are participating in the induction sub study, subjects will be approached 
with the main study consent and the sub study consent so they may make an informed 
decision about both the study and the sub study. 
 
4.6.2 Point of Enrollment 
Subjects are considered enrolled after the main study consent has been signed (Refer 
to section 4.7 for the Informed Consent Process), it has been verified during the MRI 
pre-scan visit that the subject meets all of the inclusion and none of the exclusion 
criteria, and the MRI Settings have been programmed. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
4.6.3 Enrollment of Medicare Beneficiaries 
This clinical study will enroll Medicare beneficiaries and therefore conforms to all 
standards of Medicare coverage requirements.  Section 3.0 describes how all enrolled 
subjects, including Medicare beneficiaries, may be affected by the device under 
investigation.  Subjects enrolled in the clinical study are expected to be consistent 
with the Medicare population based on age and as such the study results are expected 
to be generalizable to the Medicare population. 
 
4.6.4 Vulnerable Population 
This clinical study will be conducted in a vulnerable population only when the study 
cannot be carried out in non-vulnerable populations. At the current time, this study 
does not allow, and will not include vulnerable patients for enrollment into the study. 
4.7 Informed Consent Process 
4.7.1 General Process 
Prior to enrolling in the clinical study and sub study and conducting study-specific 
procedures, all subjects will be consented, as required by applicable regulations and 
the center’s IRB/EC.  Informed consent must be obtained from each subject prior to 
any study related procedures. Each consent form must be signed and dated by the 
subject and by the person obtaining the consent. 
 
In order to participate in the sub study, the subject must consent to both the main 
clinical study and sub study. 
 
The principal investigator or his/her authorized designee will conduct the Informed 
Consent Process. This process will include a verbal discussion with the subject on all 
aspects of the clinical study and sub study that are relevant to the subject’s decision to 
participate in the clinical study and sub study. 
 
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.  Failure to obtain informed consent from a subject prior to study enrollment 
should be reported to St. Jude Medical within 5 working days and to the reviewing 
center’s IRB/EC/ consistent with the center’s IRB/EC reporting requirements. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
5.0 Devices Under Investigation 
5.1 Device Descriptions 
In this IDE study, patients must have the St. Jude Medical market-released Durata or 
Optisure high voltage leads  implanted with a market released St. Jude Medical Ellipse VR 
ICD for at least 60 days prior to enrollment. 
 
Table 4: Study Device 
 
Device 
Model 
Type 
Investigational 
or Market 
Released 
Country 
Description 
Ellipse VR 
CD1411-36QC 
ICD 
Market Released 
US 
Single chamber ICD 
Ellipse VR 
CD1411-36Q 
ICD 
Market Released 
US 
Single chamber ICD 
Ellipse VR 
CD1311-36Q 
ICD 
Market Released 
US 
Single chamber ICD 
Ellipse VR 
CD1377-36QC 
ICD 
Market Released 
Outside the 
US 
Single chamber ICD 
Ellipse VR 
CD1377-36Q 
ICD 
Market Released 
Outside the 
US 
Single chamber ICD 
Durata 
7120Q 
Lead 
Market Released 
US and 
Outside the  
US 
Active fixation, dual shock, 
17 cm spacing, DF4 
connector, 58/65cm length 
Durata 
7122Q 
Lead 
Market Released 
US and 
Outside the  
US 
Active fixation, single 
shock, DF4 connector, 
58/65cm length 
Optisure 
LDA220Q 
Lead 
Market Released 
US and 
Outside the 
US 
Active fixation, dual shock, 
17 cm spacing, DF4 
connector, 58/65cm length 
Optisure 
LDA210Q 
Lead 
Market Released 
US and 
Outside the 
US 
Active fixation, single 
shock, DF4 connector, 
58/65cm length 
 
 
5.1.1 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. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
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. 
 
5.1.2 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. 
 
5.1.3 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. 
 
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. 
 
5.2 Device Handling & Storage 
This study involves use of market approved products. The study procedure i.e. MRI scan, is 
considered investigational in nature. Physicians should consult the User’s manual for device 
handling and storage. 

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MRI Scan Visit 
(within 30 days of 
baseline) 
Implanted for at least 60 
days with Durata or Optisure 
lead and an Ellipse ICD 
Informed Consent 
• 
Main study 
• 
Substudy (if applicable) 
Baseline 
Will pt undergo 
induction testing? 
No 
Yes 
Collection 
of induced 
ventricular 
arrhythmias 
(VT/VF) 
Participation Complete after completing 1 Month Post-MRI Scan Visit 
and when a minimum of 25 pts with at least 1 
ventricular arrhythmia episode (spontaneous or induced) are 
adjudicated by the Ventricular Arrhythmia Events Committee 
Pts not on Merlin.net: 
 
 Pts on Merlin.net: 
Phone follow up every 3 
Capture VT/VF events as 
months post baseline 
they occur through remote 
until SJM notification 
 
follow up until SJM 
notification 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
6.0 Procedures 
6.1 Study Flow Chart 
 
 
 
Figure 1: Study Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2 Procedures 
The clinical study will be conducted in accordance with the CIP.  All parties participating in 
the conduct of the clinical study will be qualified by education, training, or experience to 
perform their tasks and this training will be documented appropriately. 
Substudy 
induction testing 
OR 
clinical reason for 
induction testing 
(system revision, 
reduced R waves, 
etc.) 
1 Month 
Post MRI 
Scan Visit 
1 Month Post MRI 
Scan  Visit 
Collection of spontaneous 
ventricular arrhythmias 
(VT/VF) 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
The clinical study will not commence until St. Jude Medical receives written approval from 
the IRB/EC and relevant regulatory authorities and all required documents have been 
collected from the site(s). 
 
All required study procedures at each specified interval are outlined in the sections below. 
Refer to Table 5: Study Procedures and Data Collection for an overview of the required study 
procedures at each interval or study visit. 
 
Table 5: Study Procedures and Data Collection 
 
 
Study Visit 
Visit Window 
Study Procedures and Data 
Collection 
Forms and CRFs 
NA 
Up to or same day as 
Baseline 
• Screen patient for enrollment 
eligibility 
• Obtain informed consent(s) 
[Main study consent & sub study 
consent, if applicable] 
• Signed and Dated 
Patient Informed 
Consent Form(s) 
Baseline 
The latter of : 
• 
≥60 days after 
implant AND 
• 
≥60 days after 
most recent lead 
revision, if 
applicable 
• Obtain medical and surgical 
history 
• Collect demographic information 
• Document indication for implant 
of ICD 
• Obtain ICD system information: 
model and serial number of 
implanted Ellipse ICD system, and 
if applicable, most recent lead 
revision information. Collect 
demographic information 
• Complete MRI Screening Form 
• Baseline CRF 
• MRI Screening Form 
MRI Scan Visit 
Post Baseline 
(Within 30 days post 
baseline). 
The pre-MRI scan, 
MRI and post MRI 
scan procedures 
should occur on the 
same day. 
Pre-MRI scan testing 
• 
Assess inclusion/exclusion 
criteria 
• 
Screen, clear and prep subject 
for MRI scan 
• 
Complete MRI screening Form 
if MRI scan visit does not occur 
the same day as baseline) 
• 
Complete MRI Hazard 
Checklist 
• 
Administer pregnancy test – can 
be done up to 7 days before 
MRI scan 
• 
Interrogate device 
• 
Perform capacitor maintenance 
• 
Obtain in-clinic Durata or 
Optisure lead measurements: 
bipolar capture, sense, pacing 
• MRI Hazard Checklist 
• Pre-MRI Scan CRF 
• MRI Scan CRF 
• MRI Survey Form 
If applicable: 
• 
MRI Screening 
Form 
• 
AE CRF 
• 
Deviation CRF 
• 
Death CRF 
• 
Withdrawal CRF 
• 
Product Out of 
Service CRF 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Study Visit 
Visit Window 
Study Procedures and Data 
Collection 
Forms and CRFs 
and HVLI impedances1,2 
• 
Set up and Activate MRI 
Settings 
During MRI Scan 
• 
Monitor subject with ECG, 
pulse oximetry, and verbal 
communication 
Post MRI scan testing 
• 
Interrogate device 
• 
Deactivate MRI Settings 
• 
Obtain in-clinic Durata or 
Optisure lead measurements: 
bipolar capture, sense, pacing 
and HVLI impedances1,2 
• 
Evaluate subject for ADE, 
SADE, UADE (for US sites) or 
USADE (for OUS sites) events 
and submit an AE CRF (as 
applicable). 
• 
Report deviations, death, 
withdrawal and out of service, 
as applicable 
• 
Submit MRI scan results, e.g. 
scan time, sequences used, etc. 
• 
Upload device session records 
through the EDC study site 
portal 
1 Month Post MRI Scan Visit 
30 days after MRI 
scan (-7/+14 days) 
• Interrogate device 
• Obtain in-clinic Durata or Optisure 
lead measurements: bipolar 
capture, sense, pacing and HVLI 
impedances1,2 
• Evaluate subject for ADE, SADE, 
UADE (for US sites) or USADE 
(for OUS sites) events and submit 
on AE CRF (as applicable). 
• Report deviations, death, 
withdrawal and out of service as 
applicable 
• Upload device session records 
through the EDC study site portal 
• Follow Up CRF 
If applicable: 
• 
AE CRF 
• 
Deviation CRF 
• 
Death CRF 
• 
Withdrawal CRF 
• 
Product Out of 
Service CRF 
• 
Induction Testing 
CRF 
Sub study induction testing 
Can occur any time 
after the MRI scan 
visit (Suggest that 
testing occurs within 
30 days after MRI 
scan 
• Conduct induction therapy testing 
(e.g. DC Fibber method). Method 
of induction is physician 
preference.) 
• Evaluate subject for ADE, SADE, 
and UADE (for US sites) or 
• Induction Testing 
CRF 
If applicable: 
• 
AE CRF 
• 
Deviation CRF 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Study Visit 
Visit Window 
Study Procedures and Data 
Collection 
Forms and CRFs 
(-7 days/+14 days) 
USADE (for OUS sites) events 
and submit on AE or CRF (as 
applicable). 
• Report deviations, death, 
withdrawal and out of service as 
applicable 
• Upload device session records 
through the EDC study site portal 
• 
Death CRF 
• 
Withdrawal CRF 
• 
Product Out of 
Service CRF 
Review of 
spontaneous 
VT/VF events 
episodes (non-sub 
study subjects) 
Subjects on 
Merlin.net 
Capture events as 
they occur any time 
after the 1 month 
post MRI scan visit 
• Merlin.net records will be 
reviewed by SJM for spontaneous 
VT/VF 
• Review of records will end upon 
notification from SJM 
• Not applicable 
Subjects not 
on Merlin.net 
Every 3 months post 
baseline ± 30 days 
• Follow up by phone with subject 
and screen medical records to find 
out if a VT/VF arrhythmia has 
occurred since last visit. Obtain the 
device data related to that VT/VF 
episode. 
• Follow up visits will end upon 
notification from SJM. 
• Follow Up Phone Call 
CRF 
If applicable: 
• 
AE CRF 
• 
Deviation CRF 
• 
Death CRF 
• 
Withdrawal CRF 
• 
Product Out of 
Service CRF 
Unscheduled (if applicable) 
Any time after the 
MRI scan visit 
(where the subject is 
seen in clinic due to 
an ADE, SADE or 
UADE associated 
with the Durata or 
Optisure or Ellipse 
ICD or for follow up 
related to the 
collection of VT/VF 
episodes) 
• Interrogate device. 
• Obtain applicable in-clinic Durata 
or Optisure lead measurements: 
bipolar capture, sense, and pacing 
and HVLI impedances, 1,2 if 
possible 
• If an unscheduled visit occurs prior 
to the 1 month post MRI visit, 
evaluate ADE, SADE, UADE (for 
US sites) or USADE (for OUS 
sites) events and submit an AE 
CRF (as applicable). If an 
unscheduled event occurs after the 
1 month post MRI visit, then the 
AE events do not need to be 
submitted. 
• If a subject experiences reduced R 
waves and undergoes induction 
testing or undergoes induction 
testing for another clinical reason 
after the MRI visit, then an 
induction testing form will be 
submitted. 
• Follow Up CRF 
• AE CRF 
If applicable: 
• 
Deviation CRF 
• 
Death CRF 
• 
Screening 
Failure/Withdrawal 
CRF 
• 
Product Out of 
Service CRF 
• 
Induction Testing 
CRF 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Study Visit 
Visit Window 
Study Procedures and Data 
Collection 
Forms and CRFs 
• Report deviations, death, 
withdrawal and out of service, as 
applicable 
• Upload device session records 
through the EDC study site portal 
Non-Study MRI Scan (if 
applicable) 
Any time after 
enrollment through 
the conclusion of the 
subject’s 
participation in the 
study, excluding the 
MRI scan performed 
during the MRI scan 
visit. 
Perform medically required MRI 
scan. Where possible: 
Before scan 
• 
Complete MRI Hazard 
Checklist 
• 
Interrogate device 
• 
Perform capacitor maintenance 
• 
Obtain lead measurements: 
bipolar capture, sense, pacing 
and HVLI impedances 
• 
Enable MRI Settings 
During MRI Scan 
• 
Monitor subject with ECG, 
pulse oximetry, and verbal 
communication 
After MRI scan 
• 
Evaluate subject for adverse 
events 
• 
Interrogate device 
• 
Disable MRI Settings, and 
program device back into 
permanent settings 
• 
Obtain lead measurements: 
bipolar capture, sense, pacing 
and HVLI impedances 
• 
Report AEs, deviations, death, 
withdrawal, out of service and 
device deficiency information, 
as applicable 
• 
Document results of MRI scan, 
e.g. scan time, sequences used, 
lapses in subject monitoring, 
etc. Upload device session 
records through the EDC study 
site portal 
• Non-Study MRI Scan 
CRF 
If applicable: 
• 
MRI Hazard 
Checklist 
• 
AE CRF 
• 
Deviation CRF 
• 
Death CRF 
• 
Withdrawal CRF 
• 
Product Out of 
Service CRF 
System Revision (if applicable) 
Can occur any time 
after baseline 
• Interrogate device 
• Obtain applicable in-clinic lead 
measurements: bipolar capture1, 
sense2, pacing, and HVLI 
impedances for cases where the 
lead was repositioned, or was 
replaced with another Durata or 
• System Revision CRF 
If applicable: 
• 
AE CRF 
• 
Deviation CRF 
• 
Death CRF 
• 
Screening 
Failure/Withdrawal 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1Durata or Optisure lead capture thresholds are not required 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. 
2Durata or Optisure lead sensing measurements are not required if the subject’s intrinsic rate has been 
established to be at or below 30 beats per minute. 
 
 
6.3 Screening and Informed Consent 
Consider all patients for participation in this study regardless of gender.  Screen patients as 
outlined by the inclusion/exclusion criteria. Obtain informed consent from the patient. The 
principal investigator or delegated study personnel are responsible for screening all potential 
subjects to determine subject eligibility for the study. 
 
6.4 Baseline 
The baseline visit must occur the latter of: 
• 
≥60 days after lead implant AND 
• 
≥60 days after most recent lead revision, if applicable 
 
Collect data on the subject including demographics and medical/surgical history such as 
gender, age, ethnicity, race, cardiac disease history, arrhythmia history, and indication for 
ICD implant, etc. To ensure the patient meets the requirements to undergo the study MRI 
Study Visit 
Visit Window 
Study Procedures and Data 
Collection 
Forms and CRFs 
Optisure lead, or where the ICD 
was replaced with another Ellipse 
VR ICD. 
• NOTE: If the device 
replacement/revision of the Ellipse 
VR device occurs post MRI visit 
and the Durata/Optisure lead 
remains in its original location, 
then induction testing may occur 
and the session records related to 
induction testing should be 
uploaded. 
• Evaluate ADE, SADE, UADE (for 
US sites) or USADE (for OUS 
sites) events and submit an AE 
CRF (as applicable). 
• Report deviations, death, screening 
failure/withdrawal and out of 
service as applicable 
• Upload device session records 
through the EDC study site portal 
CRF 
• 
Product Out of 
Service CRF 
• 
Induction Testing 
CRF 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
scan, use the MRI Screening Form as part of the enrollment screening. Prior lead 
measurements may be used to evaluate inclusion criteria at the baseline visit. 
 
6.5 Scheduled Follow Ups 
After baseline and within 30 days post baseline, subjects will be seen for an MRI Scan Visit. 
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). 
 
All subjects will also be evaluated for spontaneous VT/VF episodes.  If the patient is on 
Merlin.net, then Merlin.net records will be reviewed by SJM for spontaneous VT/VF. If the 
patient is not on Merlin.net, then the patient will be contacted by phone and/or the patient’s 
medical records will be reviewed to find out if VT/VF has occurred since the last visit. The 
Merlin.net record review and phone follow up will end when SJM has collected a minimum 
of 25 subjects with at least one ventricular arrhythmia episode (spontaneous or induced) 
adjudicated by the Ventricular Arrhythmia Events Committee. 
Refer to these visits in Table 5 for specific study procedures and data collection; the Baseline 
and MRI Scan Visit is allowed, but is not required, to be conducted on the same day. 
 
Definition of enrollment: 
The patient will be considered enrolled in the study after the main study consent is signed by 
the patient, it has been verified during the MRI visit that the subject meets all of the inclusion 
and none of the exclusion criteria, and the MRI Settings have been programmed. 
 
6.5.1 MRI Scan Visit 
IMPORTANT NOTE: Before the MRI Scan Visit, if the subject underwent a system 
revision since enrollment that resulted in 
• implant of a lead or ICD other than the Durata or Optisure lead, or the Ellipse 
ICD, 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. The patient is a screen failure. Refer to 
Section 6.8 System Revisions for further details. 
 
Otherwise, follow the procedures outlined below for the MRI Scan Visit. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
6.5.1.1 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. The subject is a screen failure for the study. 
 
Clearing the Subject for the Study 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 MRI 
Procedure Information for the St. Jude Medical® MR Conditional pacing 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 
 
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 the St. Jude Medical Durata or Optisure lead 
with Ellipse VR ICD (see Table 4 for full details). 
 
Complete MRI Screening Form again if the MRI scan visit does not occur the same 
day as baseline. 
 
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 the Durata or Optisure lead: 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• In-clinic 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 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 bipolar pacing and high voltage lead impedance 
 
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. 
 
If the device testing results do not meet the MRI conditions for scanning per the MRI 
Procedure manual (also see below), or the patient’s sensing threshold is 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. 
• 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) 
 
Save the MRI Setting after the MRI Checklist has been reviewed, using the 
parameters listed in Table 6: MRI Parameters. Perform all other applicable tests and 
procedures. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Table 6: MRI Parameters 
 
Parameters 
Selectable Options 
Nominal Values 
MRI Mode* 
VOO 
Pacing Off 
Pacing off 
MRI Base Rate 
30-100 bpm, in steps of 5 bpm 
n/a 
MRI RV Pulse Configuration 
Bipolar 
n/a 
MRI RV Pulse Amplitude 
5.0 V, 7.5 V 
n/a 
MRI RV Pulse Width 
1.0 msec 
n/a 
Tachy settings 
Disabled 
Disabled 
*Note: When MRI Settings are enabled, sensing is disabled. Determine whether or 
not the subject requires pacing support during the MRI scan. When pacing support is 
needed, set the MRI Mode to the asynchronous pacing mode (VOO). When pacing 
support is not needed, set the MRI Mode to Pacing Off. 
 
Some subjects may be susceptible to cardiac arrhythmia induced by competitive 
pacing when an asynchronous MRI Mode is selected. For these subjects, it is 
important to select an appropriate MRI pacing rate to avoid competitive pacing and 
then minimize the duration of the asynchronous pacing operation. 
 
In MR Conditional ICDs, tachytherapy is disabled when the MRI settings are 
programmed. 
 
After the electrical measurements for the RV lead have been taken, capacitor 
maintenance has been performed, the MRI Checklist (on the programmer) verified 
and the MRI Setting saved, activate the MRI parameters. 
 
Setting up Pulse Oximetry and ECG 
Set up pulse oximetry and an ECG per standard of care. 
 
Place the oximetry clip on the subject’s finger or other any other appendage that 
results in valid pulse oximetry readings. Position MRI compatible surface electrodes 
on the subject to ensure the subject’s heart rate can be continuously monitored during 
the scan. During the MRI scan, periodically record heart rate, and blood oxygen 
saturation levels.  Visually examine the ECG during the MRI scan. Note any 
abnormalities observed in the cardiac rhythm (Refer to Life–threatening Ventricular 
Arrhythmia and Asystole Assessment below). After the MRI scan, remove the subject 
from the MRI field. 
 
Definition of enrollment: 
The patient will be considered enrolled in the study after the main study consent is 
signed by the patient, it has been verified during the MRI visit that the subject meets 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
all of the inclusion and none of the exclusion criteria, and the MRI Settings have been 
programmed. 
 
The following documentation activities should be performed after the subject has 
been consented. 
 
• Record enrollment information (name of the study, date of consent and 
inclusion/exclusion information) in the subject’s medical and/or study records 
• Complete and submit the Baseline and Pre-MRI CRFs in a timely manner 
(recommended within 5 days) 
• Notification of enrollment to the sponsor will take place when the sponsor 
receives the Pre-MRI Scan CRF Form indicating that the MRI Settings has 
been enabled. 
 
6.5.1.2 Data Submission 
Once required testing has been performed, complete and submit the appropriate forms 
to St. Jude Medical.  Refer to Table 5: Study Procedures and Data Collection 
 
Upload the 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 Device MRI summary report 
 
6.5.2 Situations where the subject does not meet enrollment criteria 
If a subject does not meet all inclusion criteria or meets any of the exclusion criteria, 
the subject cannot participate in the study and cannot be enrolled. 
 
In case the subject was already consented to participate in the study, but did not meet 
inclusion/exclusion criteria, the following actions will be taken (Table 7).  The 
EC/IRB and CA/FDA should be notified of deviations according to each respective 
entity’s guidelines. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Table 7: Actions for Inclusion/Exclusion Criteria Issues that Occur Post Consent 
 
Issues where patient was consented, but did 
not meet inclusion/exclusion criteria 
Action 
If the MRI Scan Visit has not yet taken place and 
the MRI Settings was not programmed 
• Document consenting information (name of the study, 
date of consent and inclusion/exclusion) in the subject’s 
medical and/or study records 
• Submit the Baseline CRF and Screening Failure CRF. 
The subject is a screen failure. 
If the MRI Pre-Scan Visit has taken place, the 
MRI Settings was NOT programmed and the 
study MRI scan was NOT completed (e.g. 
Subject changed their mind about undergoing 
MRI scan, etc.) 
• Document enrollment (name of the study, date of 
consent and inclusion/exclusion), MRI Scan Visit and 
study MRI scan information in the subject’s medical 
and/or study records 
• Complete the Baseline Form 
• Complete the Pre-MRI Scan Form 
• Note that the subject did not have the MRI Settings 
programmed on the pre-MRI CRF. 
• Submit the Screening Failure CRF. The subject is a 
screen failure. 
If the MRI Pre-Scan Visit has taken place, the 
MRI Settings WERE programmed but the study 
MRI scan was NOT completed (e.g. Subject 
changed their mind about undergoing MRI scan, 
etc.) 
• Document enrollment (name of the study, date of 
consent and inclusion/exclusion), MRI Scan Visit and 
study MRI scan information in the subject’s medical 
and/or study records 
• Complete the Baseline Form 
• Complete the Pre-MRI Scan Form 
• Complete deviation for inclusion/exclusion criteria not 
met 
• Complete the Withdrawal CRF. The patient is 
withdrawn. 
If the MRI Pre-Scan Visit has taken place, the 
MRI Settings were programmed AND the study 
MRI scan has been performed 
• Document enrollment (name of the study, date of 
consent and inclusion/exclusion), MRI Scan Visit and 
study MRI scan information in the subject’s medical 
and/or study records 
• Complete the Baseline Form 
• Complete the Pre-MRI Scan Form and MRI Scan Form 
• Complete deviation for inclusion/exclusion not met 
• Continue to follow the subject through the 1 Month Post 
MRI Scan Visit. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
6.5.2.1 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 two different scans for the study, both of which will expose the 
ICD to extreme scanning conditions:  (1) a thoracic scan that is RF intensive, and (2) 
a head scan that is gradient intensive.  The thoracic scan should be set up to last about 
6 minutes and 15 seconds, and the head scan should be set to get as close as possible 
to 5 minutes without being under 5 minutes. The thoracic scan will need to be 
repeated 4 times to ensure the subject is scanned approximately 25 minutes.  Further 
details about the set-up, programming and ways to adjust the parameters for MRI 
scans can be found in Appendix E. 
 
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 about 30 
minutes: 25 minutes for the thoracic scan, and 5 minutes for the head scan. 
 
These two MRI scans are not intended to be diagnostic in nature and therefore the 
administration of contrast fluids or sedation, or the application of water and fat 
saturation techniques 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: The non-clinical study MRI scan in this study is being performed to 
demonstrate safety and MRI compatibility of the Durata or Optisure lead and 
Ellipse ICD 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. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Cardiac Monitoring 
During the entire MRI scan, the subject’s cardiac function must be monitored using 
pulse oximetry and an ECG by an MRI Ready IDE study 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. 
 
Life–threatening Ventricular Arrhythmia and Asystole Assessment  
Monitoring of spontaneous ventricular arrhythmias and asystole must be conducted 
via an ECG and pulse oximetry during the MRI scans. Any sustained ventricular 
arrhythmias or asystole (see definition below) must be documented on an Adverse 
Event form. Non-sustained ventricular tachycardias (NSVT) or premature ventricular 
contractions (PVCs) do not need to be reported as an adverse event. However, if an 
arrhythmia reproducibly occurs (occurring more than once during the study scan) 
while the subject is actively being scanned, report the event on an Adverse Event 
form. 
 
Definitions: 
• Sustained Ventricular Arrhythmia: Heart Rate >150bpm for > 30 seconds 
with depolarization originating in the ventricles 
• Asystole: A standstill > 6 seconds in electrical activity of the heart (i.e., no 
heart rate for 6 seconds or more) 
 
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 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
study. The subject should be scheduled to return for their 1 month post MRI scan 
visit. 
 
6.5.2.2 Post-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 
Durata or Optisure lead: 
• In-clinic 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 bipolar sensing amplitude. Either the incremental or the automatic 
(in-clinic, programmer based) method may be used to obtain the sensing 
threshold. 
• In clinic bipolar lead impedance 
• In-clinic HVLI impedance 
 
NOTE: RV capture thresholds are not required to be obtained if a high ventricular 
rate 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. 
 
Reporting of MRI Scan-Related Adverse Device Effects 
An ADE or SADE related to the following should be reported as soon as possible, but 
no later than 10 working days, 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 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. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
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 EKG 
(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.  EKG, 
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. 
 
Sites should report an ADE or SADE if the subject experiences a significant rise in 
pacing threshold (1.25V @0.5ms or greater) from pre-MRI scan to one month post- 
MRI scan. 
 
6.5.2.3 Data Submission 
Once required testing has been performed, complete and submit the appropriate forms 
to St. Jude Medical.  Refer to Table 5: Study Procedures and Data Collection 
 
Export the study MRI scan onto a CD, or other form of electronic media in DICOM 
format, and send to St. Jude Medical. 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 
6.5.3 One (1) Month Post Scan Visit 
6.5.3.1 Testing 
Interrogate the ICD and obtain electrical measurements for the Durata or Optisure 
lead. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• In-clinic 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. If a significant rise in pacing threshold 
(1.25V @0.5ms or greater) from pre-MRI scan to one month post MRI scan 
has occurred, then complete an AE form. 
• In-clinic bipolar sensing amplitude. Either the incremental or the automatic 
(in-clinic, programmer based) method may be used to obtain the sensing 
threshold. 
• In-clinic Bipolar lead pacing impedance 
• In-clinic HVLI impedance 
 
Evaluate the subject for ADE, SADE, and UADE (for US sites) or USADE (for OUS 
sites) and submit an AE CRF CRF if applicable. Note if any spontaneous VT/VF 
episodes occurred on the Follow up CRF. 
 
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. 
 
6.5.3.2 Data Submission 
Once required testing has been performed, complete and submit the appropriate forms 
to St. Jude Medical.  Refer to Table 5: 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 
 
6.6 VT/VF Data Collection Effort 
6.6.1 Induction Testing 
6.6.1.1 Sub Study Induction Testing 
Subjects that will participate in the induction testing sub study signed the consent for 
this sub study prior to or during the baseline visit of the MRI Ready IDE study. For 
sub study subjects, suggest that testing occurs within 30 days after MRI scan visit 
(-7/+14 days ). 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
Conduct induction testing. The method of induction is physician preference 
 
Evaluate subject for ADE, SADE, and UADE (for US sites) or USADE (for OUS 
sites) events and submit on AE CRF (as applicable). Report deviations, death, 
withdrawal, and out of service as applicable 
 
Upload the device session records from the induction therapy testing. 
 
6.6.1.1.1 Data Submission 
Once required testing has been performed, complete and submit the 
appropriate forms to St. Jude Medical. Refer to Table 5: Study Procedures 
and Data Collection 
 
6.6.1.2 Induction testing for clinical reasons 
If a subject experiences reduced R waves or has other clinical needs for induction 
testing during a follow up visit after the MRI, then the physician may decide if the 
subject would benefit from induction testing. 
 
A single induction test may be completed. The method of induction is physician 
preference. 
 
Evaluate subject for ADE, SADE, and UADE (for US sites) or USADE (for OUS 
sites) events and submit on AE CRF (as applicable). Report deviations, death, 
withdrawal, and out of service as applicable 
 
Upload the device session records from the induction therapy testing. 
 
6.6.1.2.1 Data Submission 
Once required testing has been performed, complete and submit the 
appropriate forms to St. Jude Medical. Refer to Table 5: Study Procedures 
and Data Collection. 
 
6.6.2 Non-sub study subjects: Review of spontaneous VT/VF episodes 
All enrolled subjects that are not enrolled in the sub study will also be followed via 
Merlin.net to capture events as they occur any time after the 1 month post MRI scan 
visit or phone call every 3 months post baseline for subjects that are not on Merlin.net 
to collect potential spontaneous VT/VF episodes that occur after the MRI visit. 

Page 49 of 113 
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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
If the subject is on Merlin.net and experienced a VT/VF episode, then the episodes 
will be collected by SJM from session records at the 1 month post MRI visit and from 
Merlin.net as they occur any time after the 1 month post MRI scan. 
If the subject is not on Merlin.net, then the site will contact the subject by phone 
every 3 months post baseline ± 30 days to find out if the subject has experienced a 
VT/VF tachyarrhythmia. If the subject has experienced a VT/VF tachyarrhythmia, 
then the subject will be asked to visit the clinic so that the session records may be 
obtained. 
The review of Merlin.net records and/or follow up phone calls to subjects will end 
when SJM has collected  a minimum of 25 subjects with at least one ventricular 
arrhythmia episode (spontaneous or induced) adjudicated by the Ventricular 
Arrhythmia Events Committee or until notification from SJM. 
 
 
6.6.2.1 Data Submission 
Once required testing has been performed, complete and submit the appropriate forms 
to St. Jude Medical. Refer to Table 5. 
If an ADE, SADE, and UADE (for US sites) or USADE (for OUS sites) events has 
occurred, submit an AE CRF (as applicable).  Report withdrawal and out of service as 
applicable. Upload device session records through the EDC study site portal (as 
applicable). 
 
 
6.7 Complete System Explants 
If the subject has the entire Ellipse VR ICD system removed at any time during the 
study, and the subject will not receive a replacement Ellipse 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. 
 
6.8 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. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
6.8.1 Revisions Before the MRI Scan 
A system revision is defined as a replacement of or repositioning of one or more 
components of the study ICD system (Durata or Optisure lead, Ellipse VR 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 5: Study Procedures and Data Collection to determine which case 
report forms need to be completed and submitted. 
 
Refer to Table 8: System Revision Scenarios Prior to MRI Scan below to determine 
what actions need to be performed. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used without the express written 
consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Table 8: System Revision Scenarios Prior to MRI Scan 
 
System Revisions that 
occur prior to MRI Scan 
Action 
Data Submission 
Revisions where the 
Ellipse ICD system is still 
implanted: 
• Durata or Optisure lead 
or the Ellipse ICD is 
repositioned or replaced, 
AND 
• The Ellipse AND Durata 
or Optisure lead are still 
implanted, AND 
• No other non-MRI 
compatible material has 
been implanted 
Obtain (if possible): 
o 
In-clinic bipolar capture threshold at a pulse 
width of 0.5 ms for the applicable lead(s). Either 
the manual decrement or automatic (in-clinic, 
programmer based) method may be used to obtain 
the capture threshold. 
o 
In-clinic bipolar sensing amplitude for the 
applicable lead(s). Either the incremental or the 
automatic (in-clinic, programmer based) method 
may be used to obtain the sensing threshold. 
o 
In clinic Bipolar lead pacing impedance for the 
applicable lead 
o 
In clinic HVLI impedance for the applicable lead 
o Retain the subject in the study.  If the MRI scan 
visit has not occurred yet, then wait at least 60 
days from the successful revision before 
completing the MRI scan visit. If the MRI scan 
visit has occurred, then follow the subject through 
the 1 Month Post Scan visit. 
Complete and submit the appropriate forms to St. 
Jude Medical.  Refer to Table 5: 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 
Revisions where the 
Ellipse ICD system is not 
retained and the MRI 
Settings have not been 
The patient is a screen failure. 
Document consenting information (name of the 
study, date of consent and inclusion/exclusion) in 
the subject’s medical and/or study records. 
Submit the Baseline CRF and Screening Failure 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used without the express written 
consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
programmed 
• Durata or Optisure or 
the Ellipse ICD was 
explanted but was not 
replaced with another 
Durata or Optisure or 
the Ellipse ICD, and/or 
• 
A non-MRI 
compatible material(s) 
or device(s) was 
implanted 
CRF. Submit Deviation, Product Out of Service, or 
Death CRFs if applicable. 
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 
Revisions where the 
Ellipse ICD system is not 
retained and the MRI 
Settings were programmed 
• Durata or Optisure or 
the Ellipse ICD was 
explanted but was not 
replaced with another 
Durata or Optisure or 
the Ellipse ICD, and/or 
• 
A non-MRI 
compatible material(s) 
or device(s) was 
implanted 
The patient will be withdrawn from the study. 
Document consenting information (name of the 
study, date of consent and inclusion/exclusion) in 
the subject’s medical and/or study records. 
Submit the Baseline CRF, Pre-MRI CRF, and 
Withdrawal CRF. Submit Deviation, Product Out of 
Service, or Death CRFs if applicable. 
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 

Page 51 of 113 
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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
6.8.2 Revisions After the MRI scan 
All subjects are enrolled in the study once the subject signs the main study consent, 
meets all of the inclusion criteria and none of the exclusion criteria, and the MRI 
Settings are enabled. If a system revision occurs after the MRI scan, then the subject 
will remain in the study until the subject completes the 1 Month Post Scan visit. 
 
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 9: System Revision Scenarios After MRI Scan below to determine 
what actions need to be performed. 
 
Note: If a system revision occurs after the MRI scan visit, sites are encouraged to 
complete induction testing on the new Ellipse VR ICD during the procedure to assist 
in the collection of VT/VF episodes. Sites will be notified when a minimum of 25 
subjects with at least one ventricular arrhythmia episode (spontaneous or induced) 
adjudicated by the Ventricular Arrhythmia Events Committee have been collected.. 
 
Table 9: System Revision Scenarios After MRI Scan 
 
System Revisions that occur 
after the MRI Scan 
Action 
Data Submission 
Revisions where the Ellipse 
ICD system is still implanted 
• The Ellipse and Durata or 
Optisure lead are still 
implanted, BUT 
• A non-MRI compatible 
material(s) or device(s) has 
been implanted 
OR 
Revisions where the Ellipse 
ICD system is still implanted 
• Durata or Optisure lead or 
the Ellipse ICD is 
repositioned or replaced, 
AND 
• The Ellipse AND Durata or 
Optisure lead are still 
implanted, AND 
Obtain (if possible): 
• In-clinic bipolar capture threshold 
at a pulse width of 0.5 ms for the 
applicable lead(s).  Either the 
manual decrement or automatic (in- 
clinic, programmer based) method 
may be used to obtain the capture 
threshold. 
• In-clinic bipolar sensing amplitude 
for the applicable lead(s). Either the 
incremental or the automatic (in- 
clinic, programmer based) method 
may be used to obtain the sensing 
threshold. 
• In clinic bipolar lead pacing 
impedance for the applicable lead(s) 
• In clinic HVLI impedance for the 
applicable lead 
• Note: If an enrolled patient 
Once required testing has been 
performed, complete and submit the 
appropriate forms to St. Jude 
Medical.  Refer Table 5: Study 
Procedures and Data Collection 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• No other non-MRI 
compatible material has been 
implanted 
undergoes a revision of the Ellipse 
VR device after the MRI visit and 
the Durata/Optisure lead remains in 
its original location, then induction 
testing could be performed during 
the system revision on the new 
Ellipse VR ICD. 
• Continue to follow the patient until 
the subject completes the 1 Month 
Post scan visit. 
Revisions where the 
Durata/Optisure lead is not 
retained 
• Durata or Optisure lead is 
replaced with another lead, 
AND 
• The Ellipse VR ICD is still 
implanted, AND 
• A non-MRI compatible 
material(s) or device(s) has 
been implanted 
Follow the subject for 30 days post 
system revision and then withdraw the 
subject from the study. 
Document consenting information 
(name of the study, date of consent 
and inclusion/exclusion) in the 
subject’s medical and/or study 
records. 
Submit the Baseline CRF, and Pre- 
MRI CRF, MRI CRF, System 
Revision CRF and Withdrawal CRF. 
Submit Deviation, Product Out of 
Service, Adverse Event or Death 
CRFs if applicable. 
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 
Revisions where the Ellipse 
ICD is not retained 
• Ellipse VR ICD is replaced 
with another Ellipse VR ICD, 
AND 
• Durata or Optisure lead is 
still implanted, AND 
• A non-MRI compatible 
material(s) or device(s) has 
been implanted 
Continue to follow the subject until 
the subject completes the 1 Month 
Post scan visit. 
Once required testing has been 
performed, complete and submit the 
appropriate forms to St. Jude 
Medical.  Refer Table 5: Study 
Procedures and Data Collection 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
6.9 Unscheduled Follow Up 
An unscheduled visit is defined as a visit that occurs after the MRI Scan Visit where the 
subject is seen in clinic due to an ADE, SADE or UADE associated with the Durata or 
Optisure or Ellipse ICD or for follow up related to the collection of VT/VF episodes. Where 
possible, perform a device interrogation for the applicable lead(s) to obtain: 
• In-clinic bipolar capture threshold at a pulse width of 0.5 ms. 
• In-clinic bipolar sensing amplitude. Either the incremental or the automatic 
(in-clinic, programmer based) method may be used to measure the sensing 
threshold. 
• In-clinic Bipolar lead impedance 
• In-clinic HVLI lead impedance 
 
6.9.1 Data Submission 
Once testing has been performed, complete and submit the appropriate forms to St. 
Jude Medical.  Refer Table 5: 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 
 
6.10 Non-Study MRI Scans 
A non-study MRI scan is defined as an MRI scan occurring at any time following enrollment 
up to the conclusion of the subject’s participation in the study, excluding the MRI scan 
performed during the MRI Scan Visit. Non-study MRI scans should be performed per each 
center’s standard of care. 
 
For non-study MRI scans performed at the study center, the same safety data collection and 
safety precautions outlined at the MRI Scan Visit should be followed. However, if 
procedures or data are not followed or collected as presented on the non-study MRI Case 
report form during a non-study MRI scan, it will not be considered a protocol deviation. 
 
MRI Scan Analysis 
The MRI scan should be reviewed for obvious abnormalities by a radiologist, and reported to 
the subject’s physician (per standard of care by the facility performing the MRI scan). 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
The following data should be collected, and reported to St. Jude Medical for non-study MRI 
scans. 
• 
Date of scan 
• 
Type of scan performed 
• 
Documentation of any Adverse Device Effects 
• 
Device diagnostics, if available 
• 
MRI Scan report, if available 
• 
Fast Path Summary, if available 
 
6.10.1 Data Submission 
If the subject undergoes a non-study MRI scan at any time during the study, complete 
and submit the appropriate forms to St. Jude Medical. 
 
Upload device session records, if applicable and available, through the EDC study 
site portal. Device session records may also be sent to St. Jude Medical CRMD, 
Sylmar, CA. 
 
It is recommended that the following forms, device printouts and measurements be 
maintained at the site. 
• 
MRI Hazard Checklist 
• 
FastPath Summary 
• 
Test Results with Large Freezes, Include Battery & Leads 
• 
Wrap-up Overview with full parameters 
 
6.11 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, sense, pacing and HVLI measurements, 
• Verifying MRI scan parameters on the programmer at the MRI Scan Visit or 
Non-Study MRI visit, 
• Programming of the ICD per protocol, and/or as directed by the 
investigator/designee. 
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. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
6.12 Subject study completion 
The minimum duration of each subject’s participation is approximately one month from the 
MRI scan (1 Month Post Scan visit).  The VT/VF data collection effort will continue until a 
minimum of 25 subjects with at least one VT/VF episode (spontaneous or induced) has been 
adjudicated by the Ventricular Arrhythmia Events Committee.  SJM will notify sites when 
the VT/VF data collection effort has ended. 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. 
 
6.13 Any Known or Foreseeable Factors that May Compromise the Outcome of 
the Clinical Study or the Interpretation of the Results 
All foreseeable factors that may compromise the outcome have been taken into account by 
the clinical study design and well defined subject selection criteria. 
 
6.14 Description of the Methods that will be used to Address Potentially 
Confounding Factors in the Clinical Study Design 
The efficacy endpoints are change in bipolar ventricular capture and sensing threshold from 
pre-MRI scan to 1 Month Post Scan for the RV high voltage lead implanted with the Ellipse 
VR ICD. Each subject therefore acts as his/her own control. Therefore, there is no concern 
for confounding factors for the efficacy endpoint. 
 
6.15 Criteria and Procedures for Subject Withdrawal or Screen Failure 
Subjects must be informed about their right to withdraw from the study at any time and for 
any reason without sanction, penalty or loss of benefits to which the subject is otherwise 
entitled and withdrawal from the study will not jeopardize their future medical care or 
relationship with the investigator. Subjects will be asked to specify the reason for the 
termination, but have the right not to answer. 
 
The investigator may decide to withdraw a subject from the study at any time with 
reasonable rationale. The subject’s future care will not be influenced by a decision, voluntary 
or otherwise, to withdraw from the study. All reasonable efforts should be made to retain the 
subject in the clinical study until completion of the study. 
 
Reasons for subject’s withdrawal include, but are not limited to: 
 
• Subject refuses to continue participating in the study 
• Subject is deceased (cause must be documented) 
• Subject’s non-compliance 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• Subject’s participation is terminated by the PI or investigator, although the 
subject consented, since participation is no longer medically appropriate 
• Subject is ‘lost to follow up’: Subject does not adhere to the scheduled follow 
up visits but has not explicitly requested to be withdrawn from the clinical 
study. (This does not apply to missed visits). Site personnel should at all times 
make all reasonable efforts to locate and communicate with the subject in 
order to achieve subject compliance to the scheduled follow up visits: 
1. 
A subject will be considered ‘Lost to Follow Up’ after a 
minimum of 2 phone calls of a physician or delegate at the 
investigational site to the subject or contact. These 2 phone calls need 
to be documented in the subject’s hospital records. 
2. 
If these attempts are unsuccessful, a certified letter should be 
sent to the subject’s last known address or general practitioner (GP) and 
a copy of this letter should be maintained in the subject’s hospital 
records. 
 
If a subject withdraws from the clinical study, the site will record the subject’s reasons for 
withdrawal, on a Withdrawal CRF. 
 
When subject withdrawal from the clinical study is due to an adverse event the subject will 
be followed until resolution of that adverse event or determination that the subject’s 
condition is stable. The status of the subject’s condition should be documented at the time of 
withdrawal. 
 
Screening Failure: A subject may also become a screen failure based if the subject’s 
participation ended prior to enrollment in the study.  Refer to section 6.5.2 Situations where 
the subject does not meet enrollment criteria and 6.8.1 Revisions Before the MRI Scan. 
Complete a Screening Failure CRF for screen failure subjects and note that the subject is a 
screen failure. 
 
7.0 Compliance to the CIP 
7.1 Statements of Compliance 
The study will be performed in accordance with the most current versions of the World 
Medical Association (WMA) Declaration of Helsinki, ISO14155 and any regional and/or 
national regulations and will be compliant to this International Standard and any regional and 
national regulations, as appropriate. 
 
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 study. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
In case additional requirements are imposed by the IRB/EC or Competent Authority, those 
requirements will be followed, if appropriate. If any action is taken by an IRB/EC, and 
regulatory requirements with respect to the study, that information will be forwarded to St. 
Jude Medical. 
 
As 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 informed consent, as applicable 
 
If required, additional subject coverage or a study specific insurance will be provided by the 
Sponsor as well. 
 
7.2 Adherence to the Clinical Investigation Plan (Protocol Deviations) 
A deviation is defined as an event where the clinical investigator, site personnel, sponsor or 
sponsor representative did not conduct the clinical study according to the Clinical 
Investigational Plan, IRB/EC requirements or the Investigator Agreement. The investigator is 
not allowed to deviate from the CIP, except as specified under emergency circumstances. 
 
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: these criteria are 
specifically defined by the Sponsor to exclude subjects for whom the device is not beneficial 
and the use involves unreasonable risks. This may be considered failure to protect the rights, 
safety and well-being of the enrolled subject. Similarly, failure to perform safety assessments 
intended to detect adverse events may be considered failure to protect the rights, safety and 
well-being of the enrolled subject. Investigators should seek minimization of such risks by 
adhering to the CIP. 
 
Simultaneously, in the event that adhering to the CIP exposes the subject to unreasonable 
risks, the investigator is also required to protect the rights, safety and well-being of the 
subject by intentionally deviating from the requirements of the CIP, so that subjects are not 
exposed to unreasonable risks. 
 
It is the responsibility of the investigator to provide adequate medical care to a subject 
enrolled in a study. 
 
Regulations require that the PI maintain accurate, complete, and current records, including 
documents showing the date of and reason for every deviation from the Clinical 
Investigational Plan.  Relevant information for each deviation will be documented on a 
Deviation Case Report Form. The site will submit the CRF to St. Jude Medical. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
Regulations require Investigators obtain approval from St. Jude Medical and the IRB/EC [as 
required] before initiating changes in or deviations from the protocol, except when necessary 
to protect the life or physical well-being of a subject in an emergency. Under emergency 
circumstances, deviations from the CIP to protect the rights, safety and well-being of human 
subjects may proceed without prior approval of the sponsor and the EC. Such deviations shall 
be documented and reported to the sponsor and the EC as soon as possible, but no later than 5 
working days. 
 
Prior approval must be requested when the PI anticipates, contemplates, or makes a 
conscious decision to depart from the CIP, except when unforeseen circumstances are 
beyond the investigator’s control (e.g. a subject who fails to attend a scheduled follow-up 
visit, a subject is too ill to perform a CIP-required test, etc.). All deviations, including those 
beyond the investigator’s control, must be reported on a CRF. 
 
To obtain approval, the Principal Investigator may call or email and discuss the potential 
deviation with St. Jude Medical or designee prior to initiating any changes. 
 
All deviations must be reported to appropriate regulatory authorities in specified timelines (if 
appropriate). 
 
Investigator will notify St. Jude Medical and the reviewing IRB/EC within 5 working days 
of: 
• Any deviation to protect the life or physical well-being of a subject in an 
emergency 
• Any failure to obtain informed consent 
 
Investigators or the designee must notify St. Jude Medical, Inc. as soon as possible and 
complete the Deviation CRF. 
 
The Investigator is required to adhere to local regulatory requirements for reporting 
deviations to IRB/EC. 
 
7.3 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 Clinical Research Associate or clinical representative will 
attempt to secure compliance by one or more of the following actions: 
• Visiting the investigator 
• Contacting the investigator by telephone 
• Contacting the investigator in writing 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• 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 study, the Sponsor will either secure compliance or, at 
its sole discretion, terminate the investigator’s participation in the clinical study. 
 
 
8.0 Adverse Device Effect 
8.1 Definitions 
8.1.1 Medical Device 
Any instrument, apparatus, implement, machine, appliance, implant, software, 
material or other similar or related article 
 
(a) Intended by the manufacturer to be used, alone or in combination, for human 
beings for one or more of the specific purpose(s) of 
• 
Diagnosis, prevention, monitoring, treatments or alleviation of disease, 
• 
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury, 
• 
Investigation, replacement, modification, or support of the anatomy or of a 
physiological process, 
• 
Supporting or sustaining life, 
• 
Control of conception, 
• 
Disinfection of medical devices and 
 
(b) Which does not achieve its primary intended action in or on the human body by 
pharmacological, immunological or metabolic means, but which may be assisted in 
its intended function by such means 
 
8.1.2 Adverse Device Effect (ADE) 
An adverse device effect is 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. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
8.1.3 Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a 
serious adverse event: 
• 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 
 
• 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. 
 
 
8.1.3.1 Unanticipated Adverse Device Effect (UADE) 
As defined in 21 CFR §812.3, unanticipated adverse device effects (UADE) are 
defined as any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence in the 
clinical investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects. 
 
If an unanticipated adverse device effect occurs, the investigator must notify St. Jude 
Medical and the IRB/MEC immediately, but no later than 10 working days of the 
investigator’s knowledge of the event, as required by 21 CFR §812.150. St. Jude 
Medical will take any steps necessary to investigate the event, and will be responsible 
for notifying FDA and all other participating IRBs/MECs and investigators. 
 
8.1.3.2 Unanticipated Serious Adverse Device Effect (USADE) 
A serious adverse device effect which by its nature, incidence, severity or outcome 
has not been identified in the current version of the risk analysis report. 
 
8.1.4 Reporting of MRI Scan-Related Adverse Device Effects 
An ADE or SADE related to the following should be reported as soon as possible, but 
no later than 10 working days, to St. Jude Medical: clotting, pulmonary embolism, or 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
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, follow the instructions in section 
6.5.2.2 above. 
 
8.1.5 Complication 
A complication is defined as an SADE that requires an invasive intervention or leads 
to death. 
 
8.1.6 MRI scan related complication 
A complication is deemed to be MRI related if it is caused by or related to the 
interaction between the RV high voltage lead, Ellipse VR ICD and the MRI system 
that occurs during the MRI scan and includes the time the subject is within the 5 
Gauss line of the MRI system, or up through the subject’s 1 month post MRI scan 
follow up visit. The MRI scan related complications will be based on the CEC 
adjudication data. 
8.2 Procedure for assessing, recording and reporting adverse device effects, 
serious adverse device effects and UADEs (for US sites) and USADEs (for 
OUS sites): 
 
Safety surveillance within this study and the safety reporting, both performed by the 
investigator, starts as soon as the subject is enrolled in the study. Enrollment occurs after the 
subject signs the main study consent, meets all of the inclusion and none of the exclusion 
criteria verified during the pre-MRI testing, and the MRI Settings have been programmed. . 
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 study or the subject/investigator withdraws the subject from the study, 
except as otherwise specified in the CIP. 
 
Once the patient completes the pre-MRI visit testing and the MRI Settings have been 
programmed according to the protocol, all adverse device effects (whether serious or not- 
serious) UADEs and USADEs will be collected  and reported to the Sponsor on an Adverse 
Event case report form through the EDC system. 
 
8.2.1 Criteria and guidelines for non-reportable events 
Except as otherwise noted in the CIP, the following events are not reportable to the 
sponsor: 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• Events not related to the procedure to remove, replace or reposition the study 
lead or ICD. 
• Unavoidable events, as listed in Table 3: Unavoidable events related to the 
MRI Scan that resolve within the timeframes specified 
 
8.2.2 Criteria and guidelines for reportable events 
Records relating to the subject’s subsequent medical course must be maintained and 
submitted (as applicable) to the Sponsor until the event has subsided or, in case of 
permanent impairment, until the event stabilizes and the overall clinical outcome has 
been ascertained. Adverse events will be monitored until they are adequately 
resolved.  The status of the subject’s condition should be documented at each visit. 
The investigator will report the event to the IRB/EC per their reporting requirements. 
Reportable events to sponsor are considered: 
• ADEs,  SADEs, and UADEs (for US sites) and USADEs (for OUS sites) 
caused by or associated with the study MRI scan (except unavoidable events 
related to the MRI scan) 
• Unavoidable ADEs whose conditions worsen or continue beyond the time 
frame listed in the Unavoidable events tables. 
• 
All ADEs, SADEs and UADEs(for US sites)/USADEs (for OUS sites) that 
are not associated with the MRI scan 
 
All above events will be reported to the Sponsor, as soon as possible, but no later than 
72 hours of first learning of the event. A list of foreseeable adverse events and 
anticipated adverse device effects include, but are not limited to, those listed in Table 
2: Anticipated Events and Anticipated Adverse Device Effects. Refer to section 3.3 
for full details. 
 
The Sponsor will ensure that all adverse events are reported to the relevant authorities 
as per regulations. The description of the adverse event, date of the adverse event, 
treatment and resolution of the reportable adverse events will be reported, as 
applicable, to the relevant authorities per regulations. Additional information may be 
requested, when required, by the Sponsor in order to support the reporting of AE 
CRFs to regulatory authorities. 
 
The investigator must notify the IRB, if appropriate, in accordance with national and 
local laws and regulations, of the AE CRFs reported to the Sponsor. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
8.2.3 Preliminary Safety Report 
A preliminary report of all adverse event data will be sent to FDA by the Sponsor 
after the first 20 subjects complete their one month post MRI scan visit. In addition, 
the Sponsor will also report to the FDA if five or more subjects experience a 
worsening of pacing capture threshold, as defined by the primary endpoint. 
8.3 Subject Death 
8.3.1 Procedure for recording and reporting subject death 
All subject deaths are to be documented and reported to the sponsor within 72 hours 
after becoming aware of the event. 
 
The Clinical Events Committee (CEC) (see section 14.1) reviewing adverse device 
effects noted in sections 8.1.2-8.1.6for the study will also review and classify all 
potential subject deaths.  All subject deaths that occur during this investigation must 
be reported to St. Jude Medical as soon as possible. Notification of death should 
include a detailed statement of the pertinent events and be signed by the investigator 
in addition to the appropriate case report forms (Death CRF, Withdrawal CRF, and 
Product Out of Service CRF). It is the investigator’s responsibility to notify the IRB 
per the IRB policy. Details of death and the following information, if available, 
should be provided in a letter to St. Jude Medical by the investigator summarizing the 
subject’s course since enrollment in the study: 
 
• Date and time of death 
• Place death occurred (e.g. hospital, nursing home, subject’s home) 
• If death was witnessed 
• Identification of the rhythm at the time of death, if known (include any 
available documentation) 
• Cause of death 
• Any other circumstances surrounding the death 
• Approximate time interval to death from the initiating event. 
• Autopsy report (if performed) 
• Whether it was device and/or procedure related 
• Whether it was related to the study 
• Device configuration at the time of death 
 
If any of the above information is not available, provide an explanation in the death 
narrative of what attempts (and how many) were made to obtain the information, and 
the outcome of those attempts. At a minimum, two (2) phone calls should be placed, 
followed by a certified letter, to the subject’s next of kin. Provide clinical notes and 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
witness statements. If possible, interrogate the ICD. Retrieve and print all episode 
diagnostics, IEGMs, and programmed parameters. 
 
Every attempt should be made to explant the ICD and/or leads intact. Any explanted 
devices or leads should be returned to St. Jude Medical for analysis promptly. In the 
event that the device is not explanted, the above procedure must be followed to 
retrieve the data. The reason the ICD and/or lead(s) are not being returned to St. Jude 
Medical must be stated clearly on the case report form. 
 
8.4 Complaint 
A complaint is defined as an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. Complaints may be submitted from the 
time of consent through the end of the study. 
 
If a complaint involves an adverse device effect category or death as described in the 
protocol (section 8.1-8.3), then the investigator shall notify the Sponsor by completing the 
adverse event or death case report form as applicable and must provide the Sponsor with all 
necessary documentation needed. 
 
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. 
 
 
9.0 Data Management 
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 the US and/or any other worldwide regulatory authority in support of a market- 
approval application. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
St. Jude Medical respects and protects personally identifiable information that we collect or 
maintain. As part of our commitment, St. Jude Medical is certified in the U.S. - European 
Union Framework and U.S. – Swiss Safe Harbor Framework Agreements regarding human 
resources and subject clinical trial personal information. 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 study. All data will be secured against unauthorized access. 
 
An electronic data capture (EDC) system will be used to collect data and store data specified 
in the CIP. This data collection includes all data points found on the electronic case report 
forms (eCRFs) for the study. The EDC system may also be used to upload source documents 
related, but not limited to AE CRFs and deaths. 
 
The Principal Investigator or institution will provide direct access to source data during and 
after the clinical study 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 study. 
 
9.1 Data Management Plan 
A detailed Data Management Plan (DMP) will be established to ensure consistency of data 
collection. 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 study duration. All revisions will be tracked and document controlled. 
 
CRF data will be captured in a validated electronic database management Oracle Clinical 
system hosted by St. Jude Medical. Only authorized site personnel will be permitted to enter 
the 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. 
 
9.2 Document and Data Control 
9.2.1 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. 
 
9.2.2 Recording Data 
Source documents will be created and maintained by the investigational site team 
throughout the clinical study. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
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. 
 
All data reported for the study must be substantiated with source documentation in the 
subject’s medical records, clinic records or other forms of documentation provided by 
or approved by Sponsor. 
 
The CRFs will be validated (eCRF) by the authorized site personnel. . 
 
10.0 Monitoring 
It is the responsibility of St. Jude Medical as the sponsor of the study to ensure the study is 
conducted, recorded, and reported according to the approved protocol, subsequent 
amendment(s), applicable regulations, and guidance documents. Monitoring will be 
conducted according to the St. Jude Medical Clinical Monitoring standard operating 
procedure. 
 
Prior to beginning the study, St. Jude Medical will contact the investigator or designee to 
discuss the study and data requirements. A St. Jude Medical monitor will periodically review 
the subject records and associated source documents. 
 
The investigator shall make subject and study records available to the clinical monitor for 
monitoring. 
 
 
11.0 Regulatory Inspections 
The investigator and/or delegate should contact St. Jude Medical immediately upon 
notification of a governmental agency inspection at the site. A clinical monitor or designee 
will assist the investigator and/or delegate in preparing for the audit. 
 
An investigator who has authority to grant access will permit authorized governmental 
agency employees, at reasonable times and in reasonable manner, to enter and inspect any 
establishment where devices are held (including any establishment where devices are used or 
where records or results are kept). 
 
An investigator, or any person acting on behalf of such a person with respect to the study, 
will permit authorized governmental agency employees, at reasonable times and in 
reasonable manner, to inspect and copy all records relating to the study. 
 
An investigator will permit authorized governmental agency employees to inspect and copy 
records that identify subjects, upon notice that governmental agency has reason to suspect 
that adequate informed consent was not obtained, or that reports required to be submitted by 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
the investigator, to the Sponsor or IRB/EC have not been submitted or are incomplete, 
inaccurate, false or misleading. 
 
 
12.0 Statistical considerations 
The following section presents statistical considerations for the study.  Additional details on 
statistical analyses are maintained in a separate Statistical Analysis Plan (SAP). 
 
12.1 Statistical design, hypotheses, method and analytical procedures 
Note: In the statistical section  below, all references to MRI are referring to the study 
MRI scan. 
12.1.1 Primary Safety endpoint 
The primary safety endpoint #1 is: Freedom from MRI scan-related complications 
related to the Ellipse VR ICD involving Durata or Optisure (RV) lead from MRI scan 
to 1 month post MRI scan testing. 
 
Hypothesis 
The hypothesis is formally expressed as: 
 
H0: pS ≤ 90% 
Ha: pS > 90% 
 
where pS is the freedom from MRI scan-related complications(s) for the Durata or 
Optisure RV lead from MRI scan to 1 month after the MRI scan. 
 
Analysis 
The primary analysis will be conducted on subjects who meet all of the following 
criteria: 
 
• Implanted with St. Jude Medical Durata or Optisure (RV) Lead 
• Sign informed consent 
• Meet the MRI Conditions of Use 
• Undergo a Study MRI scan 
• Have 1 month post-MRI scan visit or have MRI-scan related complication(s) 
for the Ellipse VR ICD involving Durata or Optisure RV lead before the 1 
month post MRI visit 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
The hypothesis will be tested at the 2.5% significance level. The null hypothesis will 
be rejected if the 97.5% lower confidence bound for pS is greater than 90%.   The 
97.5% lower confidence bound will be calculated by the exact (Clopper-Pearson) 
method for binomial probabilities. 
 
12.1.2 Primary Efficacy Endpoint #1 (Change in Capture Threshold for Durata 
and Optisure (RV) Leads) 
The primary efficacy endpoint #1 is the proportion of Durata or Optisure (RV) leads 
implanted with the Ellipse VR ICD with capture threshold increase of ≤ 0.5V at 
0.5ms from pre-MRI scan to 1 month post-MRI scan testing. 
 
Hypothesis 
Success is defined as ventricular capture threshold increase of ≤ 0.5V at 0.5ms for the 
Durata or Optisure (RV) lead from pre-MRI scan testing to 1 month post-MRI scan. 
The hypothesis is formally expressed as: 
H0: pE1 ≤ 90% 
Ha: pE1 > 90% 
 
where pE1 is the probability of success. 
 
Analysis 
The primary analysis will be conducted on subjects who meet all of the following 
criteria: 
• 
Implanted with the Durata or Optisure RV lead and Ellipse VR ICD 
• 
Sign Informed consent 
• 
Meet the MRI Conditions of Use 
• 
Undergo a Study MRI scan 
• 
Have MRI visit data for right ventricular capture threshold 
• 
Have 1 month post-MRI scan visit data for RV capture threshold 
• 
Have not undergone any VR ICD lead repositioning or replacement since the 
MRI scan up to 1 month post-MRI scan 
 
The hypothesis will be tested at the 2.5% significance level. The null hypothesis will 
be rejected if the 97.5% lower confidence bound for pE1 is greater than 90%. The 
97.5% lower confidence bound will be calculated by the exact (Clopper-Pearson) 
method for binomial probabilities 

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Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
12.1.3 Primary Efficacy Endpoint #2 (Change in Sensing Threshold for Durata 
and Optisure (RV) leads) 
The primary efficacy endpoint #2 is the proportion of Durata or Optisure (RV) leads 
implanted with the Ellipse VR ICD with sensing amplitude decrease of ≤ 50% from 
pre-MRI scan testing to 1 month post-MRI scan. 
 
Hypothesis 
Success is defined as ventricular sensing amplitude decrease of ≤ 50% from pre-MRI 
scan testing to 1 month post-MRI scan. The hypothesis is formally expressed as: 
 
H0: pE2 ≤ 87% 
Ha: pE2 > 87% 
 
where pE2 is the probability of success. 
 
Analysis 
The primary analysis will be conducted on subjects who meet all of the following 
criteria: 
• 
Implanted with the Durata or Optisure RV lead and Ellipse VR ICD 
• 
Sign informed consent 
• 
Meet the MRI Conditions of Use 
• 
Undergo a Study MRI scan 
• 
Have MRI visit data for RV sensing threshold 
• 
Have 1 month post-MRI scan visit data for RV sensing threshold 
• 
Have not undergone any VR ICD lead repositioning or replacement since the 
MRI scan up to 1 month post-MRI scan 
• 
Have an intrinsic heart rate ≥ 30 beats per minute at the time of ventricular 
capture threshold measurements 
 
The null hypothesis will be tested at the 2.5% significance level. The null hypothesis 
will be rejected if the 97.5% lower confidence bound for pE2 is greater than 87%. The 
97.5% lower confidence bound will be calculated by the exact (Clopper-Pearson) 
method for binomial probabilities. 
 
12.2 Sample size 
12.2.1 Sample size for primary safety endpoint 
In the St. Jude Medical Accent MRI pacemaker IDE study, the results of which were 
submitted in PMA 60067410/A, and another manufacturer’s study involving an MRI 
conditional pacemaker, the complication-free rate was observed to be 100%.16,14 
Therefore, the sample size is calculated under the conservative assumption of 

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Clinical Investigational Plan 
 
complication-free rate of 97%.  Under this assumption, a sample size of 141 subjects 
will provide 90% power to reject the null hypothesis at a 2.5% significance level. 
The sample size was calculated using the exact binomial method in SAS® v9.4. 
 
12.2.2 Sample size for primary efficacy endpoint #1 (Change in capture 
threshold for Durata or Optisure (RV) lead 
In the St. Jude Medical Accent MRI pacemaker IDE study, the results of which were 
submitted in PMA 60067410/A, the proportion of leads with an increase in threshold 
≤0.5 volts from pre-MRI scan testing to 1-Month  after the MRI scan was 100%.1,2. 
Therefore, the sample size is calculated under the conservative assumption of 98% for 
the endpoint.  Under this assumption, a sample size of 85 subjects will provide 80% 
power to reject the null hypothesis at a 2.5% significance level. The sample size was 
calculated using the exact binomial method in SAS® v9.4. 
 
12.2.3 Sample size for primary efficacy endpoint #2 (Change in sensing threshold 
in Durata or Optisure (RV) lead) 
In the St. Jude Medical Accent MRI pacemaker IDE study, the results of which were 
submitted in PMA 60067410/A, the proportion of leads with ‘ventricular sensing 
amplitude decrease of ≤ 50% from pre-MRI scan testing to 1-Month after the MRI 
scan,’ was approximately 97%. Therefore, the sample size is calculated under the 
conservative assumption of 95% success rate for the ventricular sensing threshold 
endpoint.  Under this assumption, a sample size of 118 subjects will provide 80% 
power to reject the null hypothesis at a 2.5% significance level. The sample size was 
calculated using the exact binomial method in SAS® v9.4. 
 
12.2.4 Overall Sample Size 
Up to 165 subjects will be enrolled in this study in order to meet minimum target 
requirements for primary safety endpoint #1. The sample size estimate of 165 
subjects is based on 15% attrition rate. (141/0.85=165). 
 
12.2.5 Analysis 
The dataset will be frozen for analysis when 141 subjects have completed the 1 month 
post MRI visit and a minimum of 25 subjects with at least one ventricular arrhythmia 
event (spontaneous or induced) are adjudicated by the Ventricular Arrhythmia Events 
Committee. If a minimum of 25 subjects have not experienced a ventricular 
arrhythmia event (spontaneous or induced) at this time, SJM will discuss progress of 
data collection for ventricular arrhythmia events with FDA to support the minimum 
requirements to support a pre-market approval (PMA) application. 

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Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
12.3 Pass/fail criteria to be applied to the results of the clinical study 
The study will be considered successful if the primary safety and two primary efficacy 
endpoints are met. 
 
12.4 The provision for an interim analysis 
There are no planned interim analyses for the study 
 
12.5 Criteria for the termination of the clinical study on statistical grounds 
There is no planned termination for the study based on statistical grounds. 
 
12.6 Procedures for reporting any deviation(s) from the original statistical plan 
Refer to the statistical analysis plan for this study. 
 
12.7 The specification of subgroups for analysis 
Refer to the statistical analysis plan for this study. 
 
12.8 Procedures that take into account all the data 
Refer to the statistical analysis plan for this study. 
 
12.9 The treatment of missing, unused or spurious data, including drop-outs and 
withdrawals 
Refer to the statistical analysis plan for this study. 
 
12.10 The exclusion of particular information for the testing of the hypothesis, if 
relevant 
Refer to the statistical analysis plan for this study. 
 
12.11 In multi-center studies, the minimum and maximum number of subjects to 
be included for each center 
A minimum of 1 subject and a maximum of 41 subjects may be included at each center 
participating in the study. 

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Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
13.0 Document Retention 
St. Jude Medical and the Principal Investigators will maintain the clinical study documents as 
required by St. Jude Medical, Inc. and applicable regulatory requirements.  They will take 
measures to prevent accidental or premature destruction of these documents. The Principal 
Investigator or St. Jude Medical may transfer custody of records to another person/party and 
document the transfer at the investigational site or at St. Jude Medical’s facility. 
 
These documents must be retained by the investigational site for a period of 2 years after 
clinical study conclusion and made available for monitoring or auditing by St. Jude 
Medical’s representative or representatives of the FDA and other applicable regulatory 
agencies.  The Principal Investigator must ensure the availability of source documents from 
which the information on the case report forms was derived. 
 
14.0 Study Committee 
14.1 Clinical Events Committee (CEC)/Ventricular Arrhythmia Event Review 
Committee (VAC) 
The CEC is responsible for providing an independent review and adjudication of CIP pre- 
defined clinical events.  The CEC will consist of at least 3 members. The CEC will be 
comprised of independent and unblinded physicians that are not investigators, DSMB 
members  or steering committee members in the trial. St. Jude Medical will appoint members 
of the CEC and the chairperson. St. Jude Medical may facilitate the CEC meeting, but will 
not be voting members. 
 
Reportable events to be collected under this protocol will be adverse device effects outlined 
in sections 8.1.2-8.1.6. The CEC will base their final adjudication on the information 
provided on the case report forms, medical records, and their clinical knowledge and 
experience. The CEC will also review and classify all subject deaths under this protocol. The 
primary function, responsibilities and membership of the CEC will be described in detail in a 
CEC charter . 
 
The Ventricular Arrhythmia Event Review Committee (VAC) will review all device detected 
VT and VF episodes with a stored electrogram available and non-sustained VT/VF episodes 
of at least 16 beats. The members of the CEC will also be members on the VAC. 
 
VT/VF episodes with at least 4 intervals ≥ 300ms, with 1 interval ≥ 600 ms, or with the pre- 
detection time lasting more than 10 seconds, will be evaluated by the VAC for ventricular 
arrhythmia undersensing and amount of detection delay. A clinically significant detection 
delay is defined as ≥ 5 seconds. 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
14.2 Data Safety Monitoring Board (DSMB) 
The DSMB is an independent committee responsible for monitoring study conduct, progress, 
and reviewing accumulated data to inform the sponsor of any circumstances that might 
compromise subject safety or data integrity.  The DSMB will recommend at the end of each 
meeting whether to continue, modify or terminate the study. Membership will not include 
steering committee members, CEC members or site investigators for the study under review. 
 
The primary function, responsibilities and membership of the DSMB will be described in 
detail in a DSMB charter. 
 
14.3 Steering Committee 
The Steering Committee will be used to advise the sponsor during a clinical study, such as in 
the development of the study CIP, during the conduct of the study, during data analysis 
and/or presentation/publication of the study results. 
 
15.0 Investigation Suspension or Termination 
15.1 Premature termination of the whole clinical study or of the clinical study in 
one or more investigational sites. 
The Sponsor reserves the right to stop the study at any stage, with appropriate written notice 
to the investigator. 
 
Possible reasons for early termination of the study by the sponsor, either at local, national or 
international level, may include, but are not limited to: 
 
• The device/therapy fails to perform as intended 
• Occurrence of UADE which cannot be prevented in future cases 
• Sponsor’s decision 
• Request from Regulatory bodies 
• Request of Ethics Committee(s) 
• Concern for subject safety and welfare 
• Failure to secure subject Informed Consent prior to any investigational 
activity 
• Failure to report unanticipated adverse device effects within 72 hours to St. 
Jude Medical and the EC 
• Repeated non-compliance with this CIP or the Clinical Trial Agreement 
• Inability to successfully implement this CIP 
• Violation of the Declaration of Helsinki 2008 (refer to Appendix C) 

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Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• Violation of applicable national or local laws and regulations 
• Falsification of data, or any other breach of ethics or scientific principles 
• Loss of or unaccounted use of investigational device inventory 
The study will be terminated according to applicable regulations. 
The investigator may also discontinue participation in the clinical study with appropriate 
written notice to the Sponsor. 
 
Should either of these events occur, the investigator will return all documents to the sponsor; 
provide a written statement as to why the premature termination has taken place and notify 
the IRB/EC and/or the Competent Authority (if applicable). Follow-up for all enrolled 
subjects will be as per CIP requirements. 
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely 
terminate participation in a clinical study at the investigational sites for which they are 
responsible. 
 
If suspicion of an unacceptable risk to subjects arises during the clinical study or when so 
instructed by the IRB/EC or regulatory authority, St. Jude Medical may suspend the clinical 
study as appropriate while the risk is assessed. St. Jude Medical will terminate the clinical 
study if an unacceptable risk is confirmed. 
 
St. Jude Medical will consider terminating or suspending the participation of a particular 
investigational site or investigator in the clinical study if monitoring or auditing identifies 
serious or repeated deviations on the part of an investigator. 
 
If suspension or premature termination occurs, the terminating party will justify its decision 
in writing and promptly inform the other parties with whom they are in direct 
communication.  The Principal Investigator and St. Jude Medical will keep each other 
informed of any communication received from IRB/EC or regulatory authority. 
 
If for any reason St. Jude Medical suspends or prematurely terminates the study at an 
individual investigational site, St. Jude Medical will inform the responsible regulatory 
authority, as appropriate, and ensure that the IRB/EC are notified, either by the Principal 
Investigator or by St. Jude Medical.  If the suspension or premature termination was in the 
interest of safety, St. Jude Medical will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, St. Jude Medical 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 study, and the Principal Investigator or 

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Clinical Investigational Plan 
 
authorized designee will promptly inform the enrolled subjects at his/her investigational site, 
if appropriate. 
 
15.2 Resuming the study after temporary suspension 
When St. Jude Medical concludes an analysis of the reasons for the suspension, implements 
the necessary corrective actions, and decides to lift the temporary suspension, St. Jude 
Medical will inform the Principal Investigators, IRB/EC, or regulatory authority, where 
appropriate, of the rationale, providing them with the relevant data supporting this decision. 
 
Concurrence will be obtained before the clinical study resumes from the IRB/EC or 
regulatory authority where appropriate. 
 
If subjects have been informed of the suspension, the Principal Investigator or authorized 
designee will inform them of the reasons for resumption. 
 
15.3 Study Conclusion 
The study will be concluded when: 
• All sites are closed AND 
• The Final report generated by St. Jude Medical has been provided to sites or 
St. Jude Medical has provided formal documentation of study closure 
 
 
16.0 Publication Policy 
The results of the clinical study will be submitted, whether positive or negative for 
publication. 
 
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. 
 
Upon receiving IDE approval from the FDA, this clinical study will be registered on 
ClinicalTrials.gov.  A full report of the pre-specified outcomes, including any negative 
outcomes, will be made public through the ClinicalTrials.gov website according to the 
requirements of Section 801 of the FDA Amendments Act.  If this clinical study is 
terminated early, the Sponsor will make every effort to accelerate the release of the pre- 
specified outcomes through the ClinicalTrials.gov website. 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
17.0 Bibliography 
A literature search was conducted to obtain information relevant to implanted active medical 
devices, including ICDs, and MRI scanning to characterize and understand the effects of 
MRI scanning on ICDs.  A list of the bibliographic references pertaining to this study can be 
found in the References section of this document. 

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Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Appendix A: Abbreviations 
 
Abbreviation 
Term 
ADE 
AE 
ANZ 
ASADE 
CA 
CCI 
CEC 
CIP 
CRF 
CPRB 
DMP 
DSMB 
EC 
ECG 
eCRF 
EDC 
EMEA 
GP 
IB 
ICMJE 
IRB 
ISB 
ISO 
MP 
NA 
OUS 
PI 
POA 
RDC 
SADE 
SAE 
SC 
SJM 
USADE 
WMA 
Adverse Device Effect 
Adverse Event 
Australia – New Zealand 
Anticipated Serious Adverse Device Effect 
Competent Authority 
Clinical Coordination Investigator 
Clinical Events Committee 
Clinical Investigational Plan 
Case Report Form 
Clinical Project Review Board 
Data Management Plan 
Data Safety Monitoring Board 
Ethics Committee 
Electrocardiogram 
Electronic Case Report Form 
Electronic Data Capture 
Europe, Middle East, Africa 
General Practitioner 
Investigator Brochure 
International Committee of Medical Journal Editors 
Institutional Review Board 
Investigator Site Binder 
International Organization for Standardization 
Monitoring Plan 
Not Applicable 
Outside the United States 
Principal Investigator 
Power of Attorney 
Remote Data Capture 
Serious Adverse Device Effect 
Serious Adverse Event 
Steering Committee 
St. Jude Medical 
Unanticipated Serious Adverse Device Effect 
World Medical Association 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Appendix B: CIP Revision History 
 
Revision History 
 
Amendment 
Number 
Version Date 
Rationale 
Details 
Not 
Applicable 
A 
06Nov2015 First release of 
CIP. 
First document controlled version of 
protocol submitted to FDA 14Nov2015. 
Not 
Applicable 
B 
11Jan2016 
Protocol 
revised based 
on feedback 
from FDA 
• Usage of registered trademark and 
unregistered trademark symbols revised 
for applicable devices 
• Modified the synopsis and protocol to 
indicate that the PMA will be submitted to 
FDA when both the minimum sample size 
for each endpoint has been met and a 
minimum of 25 subjects with at least one 
ventricular arrhythmia episode has been 
adjudicated by the Ventricular Arrhythmia 
Events Committee. 
• Added note to synopsis stating that all 
references to MRI scan in the protocol 
refer to the study MRI scan 
• Clarified that ventricular events consist 
of Ventricular tachycardia (VT) and 
Ventricular Fibrillation (VF). 
• Added wording that VT/VF events will 
include follow up visits where R-wave 
sensing is impaired. 
• Added additional data to be collected in 
Section 4.4.3 to include the number of 
subjects that returned to usual 
programming after the MRI scan and the 
number of subjects, if any, experiencing 
delays in reprogramming 
• Added wording within the Study 
Procedures and Data Collection table to 
clarify that among sites participating in 
the sub study, subjects will be approached 
with both the main study and sub study 
consents. 
• Added MRI Survey Form and Induction 
Testing Form to Table 5. 
• Removed “if MRI scan visit does not 

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Clinical Investigational Plan 
 
Amendment 
Number 
Version Date 
Rationale 
Details 
occur the same day as baseline” when 
referring to the Hazard checklist required 
as part of Pre-MRI Scan testing. 
• Added a Non-study MRI Scan form (if 
applicable) to account for medically 
required MRI scans. 
• Added wording for sites to use the 
automatically obtained pacing capture 
threshold from most recent archival data 
as a substitute for the in-clinic threshold, 
if a high ventricular rate was present 
during in-clinic interrogation. 
• Updated Study Flow Chart 
• Clarified Subject Inclusion criteria #1 to 
reinforce that eligible patients can include 
those with the Durata/Optisure lead ≥ 60 
days 
• Added wording within the VT/VF Data 
Collection Effort section to indicate that if 
a subject consented in the main study has 
impaired R wave sensing after the MRI 
scan visit or other clinical reason for 
induction testing, then the physician may 
choose to complete induction testing for 
that subject. 
• Within Pre-scan device assessment, 
removed typo regarding Bipolar lead 
impedance. 
• Added wording to clarify when the MRI 
Parameters table should be used. 
• Added wording and updated the 
definition of a reproducibly occurring 
arrhythmia in MRI Scan section 6.5.2.1. 
• Added wording in Scheduled Follow Up 
section to clarify that all subjects will be 
evaluated for spontaneous VT/VF 
episodes. 
• Added wording in Scheduled Follow 
Ups section to clarify that a minimum of 
25 subjects with at least one VT/VF 

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Clinical Investigational Plan 
 
Amendment 
Number 
Version Date 
Rationale 
Details 
episode will be adjudicated by the 
Ventricular Arrhythmia Events 
Committee. 
• Added a note in the Post-Scan Testing 
section to reinforce that MRI settings 
must be disabled to ensure that 
tachyarrhythmia therapy is turned back 
on. 
• Added Section 6.10 for Non-study MRI 
scans 
• Added wording in Section 6.12 to clarify 
the duration of sub study data collection. 
• Added Section 8.2.3 to include a 
Preliminary Report after the first 20 
subjects complete the one month post 
MRI scan visit and/or if at least 5 subjects 
experience a worsening of pacing capture 
threshold, defined by the primary 
endpoint. 
• Added note in section 12 specifying that 
references to MRI refer to the study MRI 
scan. 
• Added Section 12.2.5 for Analysis 
• Added wording to include a combined 
committee (Clinical Events 
Committee/Ventricular Arrhythmia Event 
Review Committee) to review adverse 
device effects, deaths and ventricular 
arrhythmia events. 
• Revised Appendix F: MRI Screening 
Form to update the numbering of the 
questions and addition of the subject ID 
example. 
• Added site name, subject ID, and date of 
completion to Appendix G: MRI Hazard 
Checklist. 
• Modified Appendix I: Sample Informed 
Consent & Sub study consent. 

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Appendix C: Declaration of Helsinki 
The most current version of the document will be followed. 

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Clinical Investigational Plan 
 
Appendix D: Report of Prior Investigations 
The report of prior investigations is kept under separate cover and is available upon request. 
 
The purpose of the IB/RPI is to provide the Principal Investigator with sufficient safety or 
performance data from pre-clinical studies or clinical studies to justify human exposure to the 
investigational device specified in the CIP. 
 
The IB/RPI will be updated throughout the course of the clinical study as significant new 
information becomes available (e.g. a significant change in risk, etc.) 
 
The Principal Investigators will acknowledge the receipt of the IB and all subsequent 
amendments, and will keep all information confidential. 

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Appendix E: MRI Scan Guidelines 
Instructions and guidelines for performing MRI scans for the MRI Ready IDE Study are kept 
under separate cover, and will be provided to study centers by St. Jude Medical. 

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Appendix F: MRI Screening Form 

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Clinical Investigational Plan 
 
MRI Screening Form 
 
Site Name: 
Site Subject ID:   
 
(E.g. US1234-0567) 
Questions to ask Subject / Assess Subject for: 
YES NO 
General Enrollment Screening 
A YES must be answered for questions 1-9 for the subject to be considered for enrollment. 
1. 
Do you have an Ellipse VR ICD implanted in your chest? 
2. 
Do you have a Durata or Optisure lead implanted for at least 60 days? 
3. 
Are you willing to undergo an MRI scan without sedation? (ensure subject is not claustrophobic)? 
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 
4. 
Is the subject’s capture threshold < 2.5V @0.5ms 
5. 
Can the subject’s ventricular sensing threshold be measured (patient has underlying rhythm > 30bpm)? 
6. 
Is the subject’s ventricular sensing threshold  > 4mV? 
7. 
Can you provide consent to participate in the study on your own? That is, can you sign and date a consent 
form on your own? You cannot use a legally authorized representative (LAR). 
8. 
Are you able to come in to the clinic or office for an MRI scan, and can you come back for follow up 
visits as needed? 
9. 
Are you able to fit in the MRI bore without any part of your body coming into contact with the magnet 
façade inside the MRI bore? 
A NO must be answered for questions 10-19 for the subject to be considered for enrollment. 
10.  Do you have a non-St. Jude Medical lead in your body? 
11. Do you have an 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 in your body? 
12.  Has your ICD lead been revised < 60 days prior to the baseline visit? 
13. Do you have anything implanted that is metallic (wires, devices, clips, staples, rods, pins, screws, plates, 
dentures, braces, etc.) that would prevent you from getting an MRI scan? 
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 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Questions to ask Subject / Assess Subject for: 
YES NO 
14. Do you have a lead extender or adaptor implanted? 
15. Does the subject have a capped or abandoned lead? 
16. Are you participating in any other studies that include investigational products or drugs, or require you to 
receive medical or surgical treatment that is not part of your normal and usual medical treatment? 
17. Are you pregnant or are you planning on getting pregnant while participating in this study? 
18.  Is the subject expected to live less than 12 months from now? 
19. Are there any local laws or regulations that would exclude this subject from participating in this study, 
e.g. age limits >18 years? 
MRI Scan Medical History 
A NO must be answered for questions 20-31 for the subject to be considered for enrollment, unless otherwise 
clarified that subject remains eligible for the study MRI scan. 
20. Have you ever had an MRI examination before and had a problem? 
21. If YES, please describe: 
22. If YES, does problem disqualify subject from participating? Explain: 
23. Have you ever had a surgical operation or procedure of any kind? 
24.  If YES, list all prior surgeries and dates (if known): 
25. Did surgery result in any material or devices that is metallic (wires, devices, clips, staples, rods, pins, 
screws, plates, dentures, braces, etc.) 
26. List all metallic materials or devices: include MFG and model 
27. Does the implanted metallic material or device prevent the subject from undergoing the study MRI scan, 
e.g. materials or devices MRI are NOT compatible at ≥2 W/kg? 
28. Have you ever been injured by a metal or foreign object (e.g., bullet, BB, shrapnel, lamp, rod, welding 
supplies) or have metal in your eyes? 
29.  If YES, do you still have the metal or object in you? 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
 
Complete this form for each subject at the baseline visit. Complete the MRI Screening Form again at the MRI scan visit   
does not occur the same day as baseline. This form may be used to supplement medical records to support subject’s eligibility 
for enrollment and ability to undergo a study MRI scan at the time of enrollment. If YES has been answered to any of the 
questions above, has it been verified that the subject is currently eligible for enrollment and an MRI scan according to the 
protocol requirements? 
□ Yes, the subject IS eligible for a study MRI scan(s). 
□ The subject is NOT eligible for a study MRI scan(s). 
Do not enroll subject into study. 
Study Personnel Completing Form: 
Print Name: 
Signature: 
Date:  
 
Questions to ask Subject / Assess Subject for: 
YES  NO 
30. Do you have any drug allergies that would prevent you from getting the study MRI scan, e.g. valium or 
similar? Food and other allergies do not apply. 
31. If YES, please list drugs 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Appendix G: MRI Hazard Checklist 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
MRI Hazard Checklist 
Site Name: 
Site Subject ID:   
 
(E.g. US1234-0567) 
Date of Form Completion:   
 
□ Check this box if a site specific checklist was used. Remainder of form does not need to be completed.   
The standard form used by the MRI department at the site may be used in lieu of completing this form. If one 
is used, provide a copy to Cardiology for maintenance in the study records. Include the subject ID and Date 
that form was completed. 
 
The following may be harmful to the subject during the study MRI scan or may interfere with 
the MRI examination. Please mark on the drawings provided the location of any metal inside 
the subject’s body or site of surgical operation. 
 
A Yes or No must be provided for every item. Please indicate if the subject has any of the 
following.  If Yes is checked, provide MFG and model for the device or material implanted. 
 
YES   NO 
  
Any type of electronic, mechanical or magnetic implant 
  
Cardiac pacemaker 
  
Aneurysm clip(s) 
  
Implantable cardiac defibrillator (Ellipse ICD specified in the MRI Ready IDE CIP is OK) 
  
Neurostimulator 
  
Biostimulator (Type 
_) 
  
Any type of internal electrode(s) or wire(s) (Durata and Optisure, lead specified in MRI Ready IDE CIP is OK) 
  
Cochlear implant 
  
Hearing aid 
  
Implanted drug pump (e.g. insulin, Baclofen, chemotherapy,   pain medication) 
  
Halo vest 
  
Spinal fixation device 
  
Spinal fusion procedure 
  
Any type of coil, filter, or stent (Type 
) 
  
Any type of metal object (e.g., shrapnel, bullet, BB) 
  
Artificial heart valve 
  
Penile implant 
  
Artificial eye 
  
Eyelid spring 
  
Any type of implant held in place by a magnet (Type 
) 
  
Any type of surgical clip or staple 
  
Any I.V. access port (e.g. Broviac, Port-a-Cath, Hickman, Picc line) 
  
Medication patch (e.g., Nitroglycerine, nicotine) 
  
Shunt 
  
Artificial limb or joint (What and where 
_) 
  
Tissue expander (e.g., breast) 
  
Removable dentures, false teeth or partial plate 
  
Diaphragm, IUD, Pessary (Type 
) 
  
Surgical mesh (Location 
_) 
  
Body piercing (Location 
) 
  
Wig, hair implants 
  
Tattoos or tattooed eyeliner 
  
Radiation seeds (e.g., cancer treatment) 
  
Any implanted items (e.g., pins, rods, screws, nails, plates, wires) 

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Radiology Personnel Completing Checklist 
• 
Print Name: 
Signature 
Date:  
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
  
Any hair accessories (e.g., bobby pins, barrettes, clips) 
  
Jewelry 
  
Any other type of implanted item (Type 
) 
 
 
Instructions for patients 
1. 
You are urged to use the ear plugs or headphones that we supply for use during your MRI examination since some 
patients may find the noise levels unacceptable and the noise levels may affect your hearing. 
2. 
Remove all jewelry (e.g., necklaces, pins, rings). 
3. 
Remove all hair pins, bobby pins, rings). 
4. 
Remove all dentures, false teeth, partial dental plates. 
5. 
Remove all hearing aids. 
6. 
Remove eyeglasses. 
7. 
Remove your watch, pager, cell phone, credit and bank cards, and all other cards with a magnetic strip. 
8. 
Remove body piercing objects. 
9. 
Use gown, if provided, or remove all clothing with metal fasteners, zippers. 
 
 
 
Hazard Checklist for Radiology Personnel 
 
 
The following items are not permitted to be used during the study MRI scan. 
 
• 
Endotracheal tube 
• 
Foley catheter with temperature sensor and/or metal clip 
• 
Swan-Ganz catheter 
• 
Rectal probe 
• 
Extraventricular device 
• 
Esophageal probe 
• 
Arterial line transducer 
• 
Tracheotomy tube 
• 
Guidewires 
Subject attests that the above information is correct to the best of subject’s knowledge.  Subject has read or has had contents 
read to subject, understands the entire contents of this form, and had the opportunity to ask questions regarding the 
information on this form. 
Subject signature  
 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Appendix H: List of Clinical Investigation Sites and IRB/EC 
A list of Clinical Investigational sites and IRB/EC is kept under a separate cover and is 
available upon request. 

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Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Appendix I: Sample Informed Consent & Sub study consent 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
STUDY TITLE AND NUMBER 
A Clinical Evaluation of the Durata® or Optisure™ High 
Voltage Leads and Ellipse® VR ICD Undergoing 
Magnetic Resonance Imaging, an Investigational Device 
Exemption (MRI Ready IDE) Study 
SPONSOR 
St. Jude Medical, Inc. (SJM) 
PRINCIPAL INVESTIGATOR 
SITE NAME 
 
 
 
 
Introduction 
 
You are being asked to take part in this research study evaluating the Durata or Optisure 
High Voltage Leads implanted with the Ellipse ICD in an MRI environment because you 
currently have an Ellipse ICD and Durata or Optisure high voltage lead implanted and may 
be willing to  undergo an MRI scan. 
 
This form explains why this research is being done and what your role will be if you decide 
to participate.  This form also talks about the possible risks that may happen if you take part 
in this study. This study is sponsored by St. Jude Medical. This company manufactures 
medical devices intended to treat various medical conditions. 
 
Please read this form, and ask your study doctor any questions you may have about the study 
so that your questions may be answered before you decide if you want to take part in the 
study.  Please take your time and talk about this information with your family, friends, or 
family doctor. 
 
This consent form may contain some words that you do not understand.  It is important that 
you understand what is in this form.  It will explain the different activities you will be asked 
to do or participate if you take part in the research study and what the risks might be; whether 
or not you do take part is entirely your choice. Please ask the study doctor or the study staff 
to explain any words or information that you do not understand. 
 
If you decide you want to take part in the research project, you will be asked to sign the 
consent section before any study-related activities are performed. By signing it you are 
telling us that you: 
• 
Understand what you have read 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• 
Consent to take part in the research project 
• 
Consent to have the tests and treatments that are described 
• 
Consent to the use of your personal and health information as described. 
 
Taking part in this study is entirely voluntary. If you don’t wish to take part, you don’t have 
to. You will receive the best possible care whether or not you take part in the study. 
Refusing participation will not involve any penalty or loss of benefit. If you decide to take 
part in this study, you must sign your name at the end of this form. No research activity can 
be performed until you sign this form. 
 
What is the purpose of this study? 
 
The purpose of this study is to demonstrate the safety and effectiveness of the Durata or 
Optisure high voltage lead with the Ellipse ICD in an MRI environment. In order to evaluate 
the safety and effectiveness of your devices in an MRI environment, you will be asked to 
undergo an MRI scan. 
 
Please note: The MRI is not meant to be diagnostic in nature. There are no guarantees that 
results will be provided to you, nor will these results be provided to your physician(s) for 
review. 
 
What is the device being tested? 
 
The Durata and Optisure high voltage leads and Ellipse ICD have been approved for use by 
the Food and Drug Administration (FDA) and TUV are commercially available. This IDE 
study is testing the ability for the Durata or Optisure high voltage lead and Ellipse ICD (this 
is referred to as the ICD system) to safely undergo an MRI scan. 
 
What will be requested from you if you take part in this study? 
 
This research study includes a screening/qualification phase to determine if you are a good 
candidate for the study.  Your doctor or other study personnel will ask you medically related 
questions, such as whether or not you’ve had any MRI scans in the past, and whether you 
have been implanted with a Durata or Optisure high voltage lead and Ellipse ICD for at least 
60 days.  Other questions you may be asked include: 
 
• Age 
• Gender 
• Past medical history 
• Past surgical history 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• Whether you have any type of permanent implants (for example, staples, 
wires, pins, rods, screws, plates, cardiac stents, insulin pumps, meshes, 
dentures, braces, etc.) that are metallic 
• Whether you’ve had any accidents or been injured by metallic objects 
 
In order to participate in this study, you must meet all the inclusion criteria and none of the 
exclusion criteria to safely undergo an MRI scan for this study. Based on your answers and 
your medical history, your doctor will decide if you qualify to take part in the MRI Ready 
IDE Study.  If you do not qualify for the study, your participation will end. 
 
If your doctor determines that you qualify, and you decide to take part in this study, the 
procedure(s) described below will be performed. Your doctor may decide that you do not 
need an MRI scan and not taking part in this study would be better for you. 
 
There may be a representative from the sponsor at your study visits and the representative 
may carry out some of the study procedures.  The study doctor may direct a representative 
from the sponsor to collect information from your implanted device.  At the study doctor’s 
direction, the sponsor representative may also program your device or run tests to see if your 
device is working as expected.  The sponsor’s representative will work under the direction of 
your study doctor or other care provider. 
 
The figure below describes the research activities involved in this trial. These visits are 
experimental and would not occur if you do not choose to participate in this trial: 
 
 
  
 
 
You will be required to have your implanted lead(s) and ICD tested in the same way as a 
regular device check-up.  These device tests will be done at the following visits: 
 
• MRI Scan Visit 
• 1 Month Post MRI Scan Visit 
SJM collects 
electrical 
measurements 
from a minimum 
of 25 pts 
Either 
automatically from 
Merlin.net or a 
phone call/clinic 
Baseline 
Patient signs 
Informed Consent 
form 
1 Month Post 
MRI visit 
Patient device 
check 
MRI visit 
Patient receives 
MRI scan for the 
study 
Pre- 
MRI 
scan 
Device 
check 
MRI 
Scan 
Post- 
MRI 
scan 
Device 
check 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• Collection of additional electrical measurements – SJM may automatically 
collect electrical measurements (remote follow up) from Merlin.net after the 1 
month post MRI scan visit.  If you are not on Merlin.net, then you may be 
called by the site every 3 months to check on the status of your device. When 
SJM has collected electrical measurements from a minimum of 25 patients, 
then the remote follow up/phone calls will end for all patients. 
 
You may also need to return for additional visits not listed above if your lead(s) and/or ICD 
need to be repositioned or replaced. Your study doctor or study personnel will work with 
you to schedule those extra visits if they are needed. 
 
The section below describes the procedures that will occur. 
1. MRI Scan Visit 
Before the MRI Scan: 
• A pregnancy test will be given (for women of child bearing age).  If you are pregnant, 
you will be withdrawn from the study. 
• Before the actual MRI scan, your ICD device will be tested using a programmer in 
the same way as at a regular clinical check-up. You should not feel any discomfort 
during this procedure. The following information will be collected. 
a. Capture threshold (how much energy it takes to make your heart beat) 
b. Sensing threshold (how well your ICD can sense your heart beat) 
c. Pacing impedance of your implanted lead 
d. High voltage lead impedance of your implanted lead 
• A member of your study doctor’s staff or the radiological team will ask you a series 
of questions (MRI Screening Form and MRI Hazard Checklist) to make sure you 
meet the safety requirement to receive the MRI scan. 
• You may be asked to undress, and put on a gown for the MRI scan. 
• You may be asked to come back another day if your test results do not meet the 
criteria for you to be scanned.  The MRI Scan Visit will be repeated if this happens. 
 
During the MRI Scan: 
• Once you are cleared to have an MRI scan, you will be placed on a padded table and 
positioned for your exam. Electrodes (sticky pads) will be placed on your chest, and 
the electrodes will be connected to an electrocardiogram machine (ECG). The ECG 
allows the MRI staff to monitor your heart rhythm during the exam. 
• A pulse oximeter will be placed on your finger tip.  The pulse oximeter is a painless 
finger clip used to measure the amount of oxygen in your body. This allows the 
doctor to see how much oxygen content is in your blood during the MRI. 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• A soft padded coil may be placed at the area where the pictures will be taken. 
Another coil may be placed on or behind your head. 
• The table on which you are lying will be moved to the center of the MRI magnet, 
which looks like a short narrow tube. Even though the tube is open, some people feel 
confined in small places. If this bothers you, please notify the MRI staff. 
• During the exam, you will be monitored. The MRI staff is able to see and hear you. 
You will be able to hear the MRI staff, too. 
• When MRI pictures are taken, radio signals and magnetic fields are used to generate 
an image. When this happens, it is normal for the MRI machine to make loud, 
banging, and clicking noises. You may be asked to wear earplugs or headphones for 
your comfort during the exam. 
• You may feel warm during the scan. This is expected.  If you feel discomfort or have 
pain in the area where your ICD is implanted, please let your study doctor or other 
study staff know. 
• When the MRI exam is finished, you will be taken out of the MRI magnet and the 
pulse oximeter and ECG electrodes will be removed. 
 
After the MRI Scan: 
• After you have your scan, your device will be tested using a programmer. Your 
device settings may be adjusted if changes occurred during the MRI. This device 
testing is done the same way as at a regular clinical check-up.  You should not feel 
any discomfort while your device is being tested. The following information will be 
collected. 
a. Capture threshold (how much energy it takes to make your heart beat) 
b. Sensing threshold (how well your ICD can sense your heart beat) 
c. Pacing impedance of your implanted lead 
d. High voltage lead impedance of your implanted lead 
 
2. 1 Month Post MRI Visit 
• A sponsor representative may also program your device or collect information from 
your device under a physician’s supervision. 
• Your ICD device will be tested using a programmer in the same way as at a regular 
clinical check-up. You should not feel any discomfort during this procedure.  The 
following information will be collected. 
a. Capture threshold (how much energy it takes to make your heart beat) 
b. Sensing threshold (how well your ICD can sense your heart beat) 
c. Pacing impedance of your implanted lead 
d. High voltage lead impedance of your implanted lead 
 
3. Non-Study MRI Scans (if applicable) 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Should you need a MRI scan performed for specific medical reasons after the study MRI 
scan visit was performed until the completion of your participation in the study, then the 
procedures listed in the MRI scan visit above may also occur during the non-study MRI 
scan. 
 
Your study participation may end following the successful completion of the 1 month post 
MRI visit. If further electrical measurements are needed from your device, then SJM may 
automatically collect electrical measurements (remote follow up) from Merlin.net after the 1 
month post MRI scan visit.  If you are not on Merlin.net, then you may be called by the site 
every 3 months and asked questions about your health history from the time of your baseline 
visit. The phone call will last approximately 15 minutes. The phone calls will occur until 
SJM receives electrical measurements from a minimum of 25 enrolled study participants. 
 
How long will the study last? 
If you agree to take part in the study, your involvement will last approximately 6 months. 
You will be asked to return to the clinic 2-3 times. Your MRI scan visit may take up to three 
hours to complete and your one month post MRI scan visit will take approximately 30 
minutes. If you are asked to receive the 3 month follow up phone calls, then these calls will 
take approximately 15 minutes as well. 
 
Up to 165 people will take part in this research at approximately 60 sites worldwide, with a 
majority of the centers located within the United States. 
 
What are the possible risks and discomforts? 
 
There are risks, discomforts, and inconveniences associated with any research study to you 
(or to an embryo, unborn child or nursing infant if you become pregnant).  These deserve 
careful thought. 
 
While in the study, you will receive an MRI scan. The risks and adverse effects of the MRI 
scan are listed below but they will vary from person to person. You should talk with the 
study doctor if you have any questions. 
 
Risks associated with MRI scans of patients with Cardiac Devices: 
 
a) Potential MRI Scan Adverse Events: 
• Claustrophobia (fear of enclosed spaces) 
• Mild diaphoresis (sweating) 
• Hearing impairment (difficulty hearing) 
• Sensation of bodily warmth 
• Sensation of warmth at device pocket not arising to the level of discomfort 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
• Body stiffness related to immobility 
 
There will be emergency personnel and equipment on hand for your safety. Please tell the 
study doctor, nurse or technician if you experience any unusual sensations or discomfort 
during the scan. 
 
b) Potential ICD System Adverse Events: 
• Lead electrode heating and tissue (heart muscle) damage, resulting in loss of 
sensing or capture or both: A portion of the lead may heat up causing damage 
to the heart muscle resulting in the loss of some of the device’s electrical 
functions. 
• Lead heating resulting in a blood clot or blockage of a blood vessel 
• Device heating resulting in tissue damage in the implant pocket or patient 
discomfort or both 
• Induced currents on leads resulting in continuous capture (continuous pacing 
of the heart), VT/VF (abnormal beating of the lower heart chambers), 
hemodynamic collapse (blood circulation failure), or all three 
• Damage to the device or leads causing: 
o the system to fail to detect or treat irregular heartbeats 
o the system to treat the patient’s condition incorrectly 
• Damage to the functionality or mechanical integrity of the device resulting in 
the inability of the device to communicate with the programmer 
• Movement or vibration of the device or leads 
• Lead dislodgment (lead comes loose from the heart) 
• When the ICD is in MRI mode, it paces independent of the natural heart 
rhythm.  This pacing may happen at the same time of a natural heart beat and 
may cause VT/VF (abnormal beating of the lower heart chambers). 
• Syncope (fainting) due to loss of pacing if no pacing support is programmed 
with MRI settings 
• Pulmonary embolism (blockage of the lung’s blood vessel) 
• Death due to untreated spontaneous arrhythmia because tachyarrhythmia 
therapy is disabled when MRI settings are programmed 
 
These risks would also apply if you undergo a non-study MRI scan. 
 
There may be other risks or discomforts to you (or to an embryo, unborn child or nursing 
infant if you become pregnant) that are not known at this time. If important information is 
learned during the course of this research study, your doctor will be notified by St. Jude 

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Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Medical.  Your doctor will discuss with you important new information that is learned during 
the course of this study that may affect your condition or willingness to continue to take part 
in this research study. 
 
What are the risks for women of childbearing age? 
 
If you are a woman who is able to become pregnant, it is expected that you will use an 
effective method of birth control to prevent exposing a fetus to a potentially dangerous agent 
with unknown risk.  If you are pregnant or currently breast feeding, you may not participate 
in this study. You understand that if you are pregnant, if you become pregnant, or if you are 
breast-feeding during this study, you or your child may be exposed to an unknown risk. 
 
If you are pregnant or plan to become pregnant in the next 2 months, you should discuss your 
participation with your study doctor.  Patients who become pregnant while taking part in the 
study should contact the study doctor right away. 
 
What are the possible benefits to you or others? 
 
If you decide to take part in this study, you may benefit from the ability to safely undergo 
MRI scans with an implanted Durata or Optisure lead and Ellipse ICD, but there is no 
guarantee that this will happen.  The information gathered in this study will add to the 
understanding of treatment options for patients with this ICD system who need to have an 
MRI scan performed. 
 
If you do not want to take part in this study, what other options are available to you? 
 
Your study doctor will discuss other options available to you, such as your choice not to take 
part in this study. 
 
If you choose to take part in this study, what are the costs? 
 
For all patients enrolled in the study, the cost of the MRI scan performed at the MRI visit, and 
the cost of the device check performed at the 1 Month Post MRI visit will be covered through 
the study. 
 
However, you and your insurance provider are responsible for all Routine Costs associated with 
this study.  Routine Costs are costs that are covered by Medicare/Country specific insurance 
system in connection with studies such as this one, even if Medicare/Country specific insurance 
system is not your insurance provider. Generally, Routine Costs include items and services 
required to insert a study device into your body; items or services reasonably necessary to treat 
complications that may result from this study; and items and services that would typically be 
provided to you even if there were no clinical trial. Routine Costs typically do not include the 

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Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
study device (although some exceptions exist) and items and services provided only to collect 
data for the study. 
 
All Routine Costs will be billed to your insurance provider, but there is no guarantee that your 
insurance provider will cover all Routine Costs. Even where such insurance coverage is 
provided, you may still have to pay some costs such as copayments, coinsurance, or deductibles 
for the covered items or services.  You should contact your insurance provider to discuss its 
coverage policy for items or services provided during a research study. 
 
You should also contact your insurance provider to discuss the coverage options available 
following completion of the study.  Because the treatment being investigated is not currently 
approved, insurance may not pay for clinic visits or device-related surgery once you have exited 
the study.  Where post-trial insurance coverage is not available, you might have expenses as a 
result of being in this study even after the study has been completed. Ask your study doctor to 
discuss the coverage options available. Otherwise, you might have unexpected expenses from 
being in this study. 
 
Will you receive payment for taking part in this study? 
You will receive a payment of $100 for the MRI scan visit to help cover the costs of travel, 
time, meals, and parking related to your participation in the research study. 
 
What if the device needs to be removed? 
 
In the event your ICD system or any part has to be removed, it will be returned to St. Jude 
Medical for analysis. Should you withdraw from this study and choose to have your ICD 
system or any part of it removed, the cost will be your responsibility. 
 
In the event of your death, your implanted ICD system may be removed and returned to St. 
Jude Medical for analysis. The study doctor will get your family’s approval prior to 
removing the device. 
 
What if you are injured because of this study? 
 
If you suffer any injuries, illnesses, or complications as a direct result of participation in this 
study, conducted in accordance with the study protocol, treatment for that injury including 
surgery, first aid, and emergency care will be available as needed. The hospital or clinic where 
you receive treatment will bill your insurance provider for Routine Costs (as defined in the 
section above entitled “If you choose to take part in this study, what are the costs?”), although 
you may have to pay some costs such as copayments, coinsurance, or deductibles for the covered 
items or services. 
 
The Sponsor will pay for all non-Routine Costs associated with reasonable and necessary 
treatment of injuries, undesirable side effects, or adverse reactions directly resulting from 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
participation in this study, so long as you followed all study instructions. The Sponsor will not 
cover the cost of injuries resulting from participation in the study to the extent that they are 
caused by your failure, or that of the hospital or study doctor, to follow study instructions or 
other negligence, the natural progression of an underlying condition (whether diagnosed or not) 
or pre-existing condition, or events that would have been expected using currently approved 
therapies for your condition. 
 
However, signing this consent form in no way limits your legal rights against the Sponsor, 
investigators, or anyone else, and you do not release the study doctors or participating 
institutions from their legal and professional responsibilities. 
 
During the study, if you experience any injuries, illnesses, or complications from taking part in 
this study, please contact Dr. 
_ at 
- 
- 
_. 
 
What are your rights if you decide to take part in this study? 
 
Your signature on this consent form means that you have received information about this 
research study and that you agree to be a part of the study. 
 
You may stop taking part in the study at any time without penalty or loss of benefits to which 
you are otherwise entitled.  If you wish to stop taking part in this research study for any 
reason, you should contact Dr. 
at 
- 
- 
. 
 
If you do withdraw your consent during the study, the study doctor and relevant study staff 
will not collect additional personal information from you, although personal information 
already collected will be retained to ensure that the results of the research project can be 
measured properly and to comply with the law.  You should be aware that data collected by 
the sponsor up to the time you withdraw will be part of the study results. 
 
Your study doctor or designee will discuss with you what follow-up is required if you decide 
to withdraw, or are withdrawn from the study before the study is finished. 
 
Your doctor or the sponsor of the study (St. Jude Medical, Inc.) may also stop your participation 
in the study at any time, without your consent, for any reason. 
 
How will your information be kept confidential? 
 
If you decide to take part in this study, your medical records and personal information will be 
kept confidential to the extent allowed by federal, state, and local law. A special code (number 
combination) will be used to identify your personal health information. However, information 
from the study may be exported to countries where different data protection laws apply, 
including the United States (US).  The data protection laws in other countries may be less strict 
than those of your country. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
If you decide to participate in the study, the study sponsor and others who work with the study, 
such as the study staff and Institutional Review Board (IRB) / Ethics Committee (EC) will see 
health information about you. The IRB/EC is a group of people who perform independent 
review of research as required by laws governing this type of research. 
 
U.S. Food and Drug Administration (FDA), relevant international regulatory authority and/or 
national competent authority or other regulatory agencies, EC/IRB and sponsor’s representative 
may inspect and copy your medical records. 
 
The information collected about you may be used in several ways. Information about you and 
your health that might identify you may be given to others to carry out the research study. Your 
study doctor may use some of the information in making decisions about your care. 
 
The sponsor may use the information in any of the following ways: 
• To analyze and make conclusions about the results of the study, 
• In documents sent to the government agencies throughout the world including the U.S. 
Food and Drug Administration (FDA) to request approval to market the Durata® or 
Optisure™ lead and Ellipse® ICD as MR Conditional, 
• For reporting undesirable events to the FDA and other government health agencies, 
• To provide overall study results to other study doctors, including in publications, 
• To conduct new medical research, to reanalyze the study results in the future or to 
combine your information with information from other studies, 
• To develop new medical products and procedures, and other product-development 
related activities. 
 
Your name will not be provided for publications in medical journals. While using the 
information in these ways, the sponsor may give study data to its affiliated companies in the U.S. 
or other countries. The sponsor may also share the information with its business partners or 
companies it hires to provide study-related services. Information received during the study will 
not be used for any mailing lists or sold to anyone for marketing purposes. 
 
Your permission for the use, retention, and sharing of your identifiable health information will 
expire when FDA/regulatory body approval of the study is obtained. At that time the research 
information not already in your medical record will not be given to the sponsor. 
 
A description of this clinical study will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At most, 
the Web site will include a summary of the results.  You can search the Web site at any time. 
Please note information may not be available on ClinicalTrials.gov until the study is completed 
and the device is marketed. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
Who can you contact for study information? 
If you have any questions about the study or taking part in this study, please contact Dr. 
  
 at 
- 
- 
. 
 
In addition, if you have any concerns, complaints or questions about your rights as a research 
patient or an injury that you believe is a research-related, please contact: 
Name of person at IRB/EC: 
Title of person at IRB/EC: 
IRB/EC phone number: 
IRB/EC email, if known: 
 
 
 
 
Consent and authorization for participation in this study 
Taking part in this study is entirely voluntary. You are making a decision on whether or not 
to take part in the research study.  Your signature indicates that you have read the 
information in this form and have decided to take part in the research study. You will be 
given a signed copy of this form to keep. 
 
I have read all of the above information in this consent and authorization form. I have had the 
opportunity to ask questions and have received answers concerning areas I did not understand. 
 
I willingly give my consent to participate in this study and to comply with the procedures 
related to it. 
 
I confirm that my relevant anonymized personal data collected during the study will be used 
in the analysis and communicated in publications. 
 
I understand that I am free to refuse to participate in the proposed study, without giving any 
reason and without my medical care or legal rights being affected. 
 
I understand that I am free to withdraw from the proposed study at any time, without giving 
any reason, without my medical care or legal rights being affected. 
 
I give my permission to representatives from the sponsor, the IRB/EC and the regulatory 
authorities to access my medical records. 
 
I understand that my personal physician will be informed of my participation in this research 
study. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
 
 
 
 
 
If participant is unable to read: 
I have attended the entire informed consent discussion. I attest that the information in the 
consent form and any other written information was accurately explained to, and apparently 
understood by the patient. Informed consent was freely given by the patient. 
 
 
Impartial Witness Name 
(please print) 
Signature 
Date    
 
Name of Person Obtaining 
Consent (please print) 
 
Signature 
Date   
 
Name of Participant (please print) 
  
 
Signature 
Date   
 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Patient Informed Consent Addendum: Sub Study 
 
A CLINICAL EVALUATION OF THE DURATA® OR OPTISURE™ HIGH 
VOLTAGE LEADS AND ELLIPSE VR ICD UNDERGOING MAGNETIC 
RESONANCE IMAGING, AN INVESTIGATIONAL DEVICE EXEMPTION 
(MRI READY IDE) STUDY 
 
Introduction 
You were asked to and agreed to participate in the MRI Ready IDE research study because 
you have an implanted Durata® or Optisure™ high voltage lead and Ellipse® ICD and were 
willing to undergo an MRI scan. 
 
You are being asked to take part in this research sub study evaluating the ability of your 
implantable cardioverter-defibrillator (ICD) to shock your heart out of an abnormal heart 
rhythm. 
 
This consent addendum explains why this research sub study is being done and what your 
role will be if you decide to participate.  This form also talks about the possible risks that 
may happen if you take part in this study.  The study is sponsored by St. Jude Medical. This 
company manufactures medical devices intended to treat various medical conditions.  Please 
refer to your main consent form for other information such as your rights as a study 
participant. 
 
Please read this form, and ask your study doctor any questions you may have about the 
research study so that your questions may be answered before you decide if you want to take 
part in the study.  Please take your time and talk about this information with your family, 
friends, or family doctor. 
 
Taking part in this research study is entirely voluntary.  If you don’t wish to take part, you 
don’t have to.  You will receive the best possible care whether or not you take part in the 
study.  Refusing participation will not involve any penalty or loss of benefit. You may stop 
taking part in the study at any time without penalty or loss of benefits to which you are 
otherwise entitled. Your study doctor or designee will discuss with you what follow-up is 
required if you decide to withdraw, or are withdrawn from the study before the study is 
finished.  If you decide to take part in this study, you must sign your name at the end of this 
form. No research study activity can be performed until you sign this form. 
 
Purpose 
The purpose of this research sub study is to test your ICD’s ability to deliver appropriate 
shock to treat ventricular fibrillation after undergoing an MRI scan. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
What is being tested? 
Your ICD treats abnormally fast heart rates.  Ventricular fibrillation (VF) and ventricular 
tachycardia (VT) are types of fast irregular rhythm that begins in the lower chambers 
(ventricles) of the heart.  In VT, the heart beats fast, but it beats at a regular rate. If VT is not 
treated, it can lead to VF which is when the heart beats fast and irregular.  In VF, the heart 
beats too rapidly and cannot deliver oxygen-rich blood to vital organs.  If the supply of 
oxygen-rich blood is reduced, loss of consciousness and death may occur unless the blood 
supply is restored. 
 
Treating the heart with appropriate electrical pulses often can restore a normal heart rhythm. 
To treat VT or VF, the ICD delivers a high energy electrical pulse, which is known as a 
defibrillation shock.  Defibrillate means to return your unnatural twitching of the heart 
muscle to a correct rhythm. 
An electrical pulse or shock delivered from the ICD through 
leads (thin insulated wires) to the heart can stop the fast heart rhythm and restore normal 
function. 
 
What will be requested from you if you take part in this research study? 
The section below describes the procedures that will occur. All patients who agree to take 
part in this sub study will undergo defibrillation threshold (DFT) testing. During this 
procedure, your study doctor will stimulate your heart to VF and then shock it back to normal 
rhythm with your ICD. 
 
You will be anesthetized in the hospital and your heart will be induced to VF or VT (your 
doctor will decide which method is best) and shocked to see whether the shock delivered to 
the heart will stop an abnormally fast heart rate. Two external defibrillating pads may be 
placed on your body during testing for backup defibrillation. After all of the testing is 
complete and the ICD device is determined to be in good working order, your ICD device 
will be programmed as needed. 
 
The DFT testing will occur in the hospital after the MRI visit. The figure below describes 
the research activities involved in this sub study, in relation to your existing participation in 
the MRI Ready IDE trial.  These visits are experimental and would not occur if you do not 
choose to participate in this trial: 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
 
 
 
How long will the study last? 
If you agree to take part in the research study, your involvement will be approximately a 
minimum of 2 hours. You will not be asked to return to the hospital unless your physician 
requires it. 
 
Up to 25 people will take part in this research study at about 40 sites. 
 
What are the possible discomforts and risks? 
Additional risks to you are associated with having an increased number of ventricular 
tachycardia and ventricular fibrillation episodes.  The risks could be a failure to stop the 
arrhythmia and risks associated with a longer procedure time. 
 
Your doctor will review the risks related to DFT testing. These risks include but are not 
limited to: 
• An increased number of fast heart beats and irregular heartbeats during the 
induction testing. There could be a failure to stop the irregular heartbeat 
during the induction testing. 
• Discomfort during the procedure 
• Need for an outside shock to restart the heart during the induction testing in 
rare instances 
• Stroke in very rare instances 
• Death in very rare instances 
 
There may be other risks to you that are not known at this time. 
Any time after the MRI visit 
Patient device check + DFT 
Testing 
Enrollment in Sub 
Study 
Patient signs Informed 
Consent form 
Baseline 
Patient signs 
Informed Consent 
form for main study 
MRI visit 
Patient receives 
study MRI scan 
Pre- 
MRI 
scan 
Device 
check 
MRI 
Scan 
Post- 
MRI 
scan 
Device 
check 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
If you are pregnant or currently breast feeding, you may not participate in this sub study. 
You understand that if you are pregnant, if you become pregnant, or if you are breast-feeding 
during this study, you or your child may be exposed to an unknown risk. If you are pregnant 
or plan to become pregnant in the next 2 months, you should discuss your participation with 
your study doctor. Patients who become pregnant while taking part in the study should 
contact the study doctor right away. 
 
If you do not want to take part in this portion of the study, what other 
options are available to you? 
Your doctor will discuss other options available to you, including not participating in this sub 
study. 
 
If you choose to take part in this study, what are the costs? 
 
The cost of the DFT testing performed after the MRI scan visit will be covered by St Jude 
Medical. 
 
Will you receive payment for taking part in this study? 
You will receive a payment of $250 for the DFT testing to help cover the costs of travel, 
time, meals, and parking related to your participation in the research study. 
 
This research study is being sponsored and funded in the United States, by St Jude Medical. 
St Jude Medical may benefit financially from this research study if, for example, the project 
assists St Jude Medical to obtain approval for a new device. 
 
In addition, if knowledge acquired through this research study leads to discoveries that are of 
commercial value to St Jude Medical, the study doctors or their institutions, there will be no 
financial benefit to you or your family from these discoveries. 
 
[Name of institution] will be compensated by St Jude Medical for undertaking this research 
study. No member of the research study team will receive a personal financial benefit from 
your involvement in this research study (other than their ordinary wages). 
 
What are the possible benefits to you or to others? 
 
The information gathered in this study will add to the understanding of treatment options for 
patients with your implanted device system who have had or need to have an MRI scan 
performed. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
The sponsor of this study is paying for cost of data capture and items that are not deemed 
standard of care/routine care in the study. St. Jude Medical will pay the study center where 
the study is being conducted. 
 
Signature 
You are making a decision on whether or not to take part in this sub study. Your signature 
indicates that you have read the information in this form and have decided to take part in 
the sub study of the MRI Ready IDE trial. You will be given a signed copy of this form to 
keep. 
 
 
 
 
If participant is unable to read: 
I have attended the entire informed consent discussion. I attest that the information in the 
consent form and any other written information was accurately explained to, and apparently 
understood by the patient. Informed consent was freely given by the patient. 
 
 
Impartial Witness Name 
(please print) 
Signature 
Date    
 
Printed Name of Patient 
Signature of Patient 
Date 
Print Name of Person Obtaining Consent 
Signature of Person Obtaining Consent 
Date 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Appendix J: Product Labeling 
The product labeling for the investigational device, instructions for use and packaging are 
kept under a separate cover, and will be provided to FDA in the IDE application. 

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This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, 
disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
Appendix K: Case Report Forms 
The case report forms for the study are kept under a separate cover, and are available upon 
request. 

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disclosed or used without the express written consent of St. Jude Medical 
 
 
 
Study Document No: SJM-CIP-10110 
Ver. B 
Study Name: MRI Ready IDE Study 
Clinical Investigational Plan 
 
 
References 
 
 
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)