Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
Phase: NA
Conditions: Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Sponsor: Abbott Medical Devices

 
Investigational Plan 
MRI Study 
 
 July 10, 2014  
 
CONFIDENTIAL 
 60028820/K 
 
  
 
 
 
 
 
 
I
NVESTIGATIONAL PLAN 
FOR THE 
 
 
 MRI Study 
Accent MRI™ Pacemaker and Tendril MRI™ Lead IDE Study  
 
 
IDE Number: G100096 
 
July 10, 2014 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 2 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Table of Contents 
 
 
REVISION CHANGE HISTORY ...................................................................................................................... 5 
 INTRODUCTION..................................................................................................................................... 
13 
 PURPOSE 
.................................................................................................................................................. 
13 
 DESCRIPTION OF DEVICE .................................................................................................................. 
14 
 CLINICAL PROTOCOL 
......................................................................................................................... 
16 
4.1 STUDY DESIGN AND SCOPE 
..................................................................................................................... 
16 
4.2 OBJECTIVES/S
TUDY ENDPOINTS 
............................................................................................................. 
20 
4.2.1 Primary Lead Safety Endpoints 
.................................................................................................... 
20 
4.2.1.1 Freedom from RA lead-related complications in the acute period 
.......................................................... 
20 
4.2.1.2 Freedom from RV lead-related complications in the acute period 
.......................................................... 
20 
4.2.1.3 Freedom from RA lead-related complications in the chronic time period 
............................................... 
22 
4.2.1.4 Freedom from RV lead-related complications in the chronic time period 
............................................... 
22 
4.2.2 Primary MRI Safety Endpoint: Freedom from MRI Scan-Related complications 
........................ 
23 
4.2.3 Primary MRI Efficacy Endpoints 
.................................................................................................. 
25 
4.2.3.1 Proportion of patients free of atrial capture threshold increase of > 0.5V at 0.5ms from  before and to 
one month after the MRI scan 
................................................................................................................................. 
25 
4.2.3.2 Proportion of patients free of ventricular capture threshold increase of > 0.5V at 0.5ms from before to 
one-month after the MRI scan 
................................................................................................................................. 
25 
4.2.3.3 Proportion of patients with atrial sensing amplitude decrease of < 50% and a sensing amplitude at 1-
month post MRI visit of > 1.5mV 
........................................................................................................................... 27 
4.2.3.4 Proportion of patients with ventricular sensing amplitude decrease of < 50% and a sensing amplitude at 
1-month post MRI visit of > 5mV 
........................................................................................................................... 27 
4.2.4 Secondary Endpoints 
.................................................................................................................... 
30 
4.2.4.1 Freedom from system-related complications 
........................................................................................... 30 
4.2.4.2 Bipolar atrial capture threshold at the MRI visit ..................................................................................... 31 
4.2.4.3 Bipolar ventricular capture threshold at the MRI visit ............................................................................ 
31 
4.2.4.4 Additional Secondary Endpoint Analyses 
............................................................................................... 31 
4.2.5 Sub-group Analyses 
...................................................................................................................... 
32 
4.2.6 Additional Data ............................................................................................................................ 
32 
4.2.7 Definitions to be used in the MRI study 
........................................................................................ 
33 
4.3 PATIENT SELECTION ............................................................................................................................... 
35 
4.3.1 Inclusion Criteria ......................................................................................................................... 
35 
4.3.2 Exclusion Criteria 
......................................................................................................................... 
35 
4.4 STUDY PROCEDURES 
............................................................................................................................... 
36 
4.4.1 Enrollment Requirements ............................................................................................................. 
39 
4.4.1.1 Enrollment 
............................................................................................................................................... 39 
4.4.2 Implant Procedures ...................................................................................................................... 
39 
4.4.2.1 Lead Placement and Testing 
.................................................................................................................... 39 
4.4.3 Unsuccessful Implant 
.................................................................................................................... 
41 
4.4.4 Complete System Explants 
............................................................................................................ 
42 
4.4.5 Follow-Up Requirements – Lead Safety 
....................................................................................... 
42 
4.4.5.1 System Revisions 
.................................................................................................................................... 43 
4.4.5.2 Pre-Discharge 
.......................................................................................................................................... 44 
4.4.5.3 2 Month Visit (Post Implant) 
................................................................................................................... 45 
4.4.5.4 6 Month Visit (Post Implant) 
................................................................................................................... 47 
4.4.5.5 12 Month Visit (Post Implant) (and every 6 months thereafter) 
.............................................................. 
48 
4.4.5.6 Unscheduled Follow-up Visits 
................................................................................................................ 49 
4.4.6 Follow-Up Requirements – MRI Visits 
......................................................................................... 
50 
4.4.6.1 MRI-Related Visit Windows 
................................................................................................................... 51 
4.4.6.2 Enrolling Patients into the MRI Phase of the Study 
................................................................................ 
51 
4.4.6.3 Scheduling the MRI Visit 
........................................................................................................................ 52 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 3 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
4.4.6.4 System Revisions Before the MRI Visit: Scenario One 
.......................................................................... 
52 
4.4.6.5 System Revisions Before the MRI Visit: Scenario Two.......................................................................... 
54 
4.4.6.6 MRI Visit ................................................................................................................................................ 55 
4.4.6.7 1 Month Post-MRI Visit 
.......................................................................................................................... 64 
4.4.6.8 Non-Study MRI Scan 
.............................................................................................................................. 65 
 PROTOCOL DEVIATIONS ................................................................................................................... 
66 
 ADVERSE EVENTS ................................................................................................................................ 
67 
6.1 DATA SAFETY MONITORING BOARD (DSMB) 
........................................................................................ 
70 
 OTHER REPORTED EVENTS .............................................................................................................. 
71 
 DEATHS 
.................................................................................................................................................... 
71 
 WITHDRAWALS 
..................................................................................................................................... 
72 
 RISK ANALYSIS 
................................................................................................................................. 
72 
 INVESTIGATOR INFORMATION 
.................................................................................................. 73 
 MONITORING PROCEDURES ........................................................................................................ 
74 
 LABELING 
........................................................................................................................................... 
75 
 CONSENT MATERIALS ................................................................................................................... 
75 
 IRB INFORMATION 
.......................................................................................................................... 
75 
 OTHER INSTITUTIONS.................................................................................................................... 
75 
 RECORDS AND REPORTS 
............................................................................................................... 
76 
17.1 CUSTODY 
........................................................................................................................................... 
76 
17.2 RETENTION PERIOD 
............................................................................................................................ 
76 
 PUBLICATION.................................................................................................................................... 
76 
 APPENDIX A: MRI SCREENING CHECKLIST ........................................................................... 
77 
 APPENDIX B: MRI SCAN SEQUENCES 
........................................................................................ 
82 
 APPENDIX C: PATIENT INFORMED CONSENT 
...................................................................... 
111 
 APPENDIX D: PATIENT INFORMED CONSENT ADDENDUM: MRI CONSENT 
............... 
120 
 APPENDIX E: MRI CONDITIONAL NOTIFICATION TO PATIENTS .................................. 
127 
 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 4 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Table of Tables 
 
 
Table 1: Schedule of Evaluations Summary: MRI Lead Safety 
............................................. 37 
Table 2: Schedule of Evaluations Summary: MRI-Related Visits 
......................................... 38
 
Table 3: Study Time Interval Windows – Lead Safety 
........................................................... 42
 
Table 4: Study Time Interval Windows – MRI-Related Visits 
.............................................. 51
 
Table 5: MRI Parameters 
........................................................................................................ 58
 
Table 6: Unavoidable AEs related to the Implant Procedure ................................................. 68 
Table 7: Unavoidable AEs related to the MRI Scan 
............................................................... 68
 
Table 8: GE MRI Scanner – 4 W/kg Whole Body SAR Non-Clinical Sequences 
................. 83
 
Table 9: Philips MRI Scanner – 4 W/kg Whole Body SAR Non-Clinical Sequences 
........... 85
 
Table 10: Siemens MRI Scanner – 4 W/kg Whole Body SAR Non-Clinical Sequences 
....... 86
 
Table 11: GE MRI Scanner – 2 W/kg Whole Body SAR Non-Clinical Sequences 
............... 94
 
Table 12: Philips MRI Scanner – 2 W/kg Whole Body SAR Non-Clinical Sequences 
......... 96
 
Table 13: Siemens MRI Scanner – 2 W/kg Whole Body SAR Non-Clinical Sequences 
....... 97
 
Table 14: GE MRI Scanner – MRI Study Clinical Sequences 
............................................. 108
 
Table 15: Philips MRI Scanner – MRI Study Clinical Sequences 
....................................... 109
 
Table 16: Siemens MRI Scanner – MRI Study Clinical Sequences 
..................................... 110
 
 
 
 
Table of Figures 
 
 
Figure 1: Accent™ MRI Pacemaker System X-Ray Markers 
................................................ 15
 
Figure 2: Lead Safety Phase Flow Diagram 
........................................................................... 18
 
Figure 3: MRI Phase Flow Diagram 
....................................................................................... 19
 
Figure 4: RF Sequence Scanning and Cooling Segments 
....................................................... 89 
 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 13 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 Introduction 
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 the 
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.
7 
Examples of these hazards include unwanted cardiac stimulation, heating near lead 
electrodes, image artifacts, and forces being applied to implanted components.
2,8,9  
Due to these issues, currently marketed pacemaker systems may be contraindicated 
for use in an MRI environment.  
 
In initial MRI studies involving patients implanted with cardiac devices, there were 
anecdotal reports of device malfunction or patient death associated with an MRI 
scan.
10  None of these deaths occurred during physician supervised procedures.
11  
Over the past 10 years, there have been numerous patients with implanted devices 
who successfully underwent magnetic resonance imaging.12,13,14,15,16  Although many 
patients with implanted devices have undergone MRI scans successfully and without 
incident, physicians and regulators have made the point that “failing to identify an 
adverse event is not equivalent to demonstrating safety – especially when only a 
limited number of patients are studied”.
17, 18  In order to validate that MRI scans are 
safe for patients with implantable cardiac devices, these devices need to be 
specifically designed and developed to mitigate the hazardous interactions in an MRI 
environment. St. Jude Medical has developed a system, the Accent MRI™ system, 
comprised of the Accent™ device and the Tendril MRI™ lead, and an investigational 
MRI Activator™, designed to mitigate such interactions.   
 
 Purpose 
The intent of this IDE study is to evaluate the safety and efficacy of the implanted 
Accent MRI™ system, which includes the investigational St. Jude Medical Tendril 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 14 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
MRI™ lead and Accent MRI™ pacemaker.  An MRI Activator™, also 
investigational, will be used in conjunction with the Accent MRI system.  The MRI 
Activator is a handheld device that allows the user to enable and disable the MRI 
Setting, as well as check the status of the MRI Setting in the pacemaker.  The patient 
population under study includes patients with a standard bradycardia pacing 
indication. 
 
 Description of Device 
In this IDE study, the investigational St. Jude Medical Tendril MRI™ lead will be 
implanted with the investigational Accent MRI pacemaker Model PM2218 and 
Model PM1224 or other models with similar functionality; devices implanted outside 
the United States will utilize different device models. The Accent MRI pacemaker is 
supported by the St. Jude Medical Merlin Patient Care System (Merlin PCS) with 
software Model 3330 version 11.1 .1(or higher).  The investigational system includes 
the Accent MRI pacemaker and Tendril MRI™ lead.  The MRI Activator Device 
(Model EX4000 or higher) or programmer can program the Accent MRI pacemaker 
into and out of the MRI Setting. The MRI Activator is also investigational.   
 
The Accent MRI pacemaker is based on the market approved Accent pacemaker. All 
commercially available features of the Accent pacemaker are included in the MRI 
device. However, the Patient Notifier feature is permanently disabled if the patient 
has an MRI scan.   
 
The MRI pacemaker has new hardware and firmware to prevent unintended 
stimulation due to electromagnetic fields created by the MRI scanner. The new 
hardware and firmware include 
• Reduction in feed-through capacitance to mitigate gradient-induced stimulation 
• Addition of a band-stop filter (MR filter assembly) to limit the ingress of MRI-
specific frequencies which otherwise could result in RF rectification and/or other 
interference. 
 
The device shape and size is modified to accommodate the MRI filter assembly.  The 
Accent MRI pacemaker also has a unique MRI radiopaque x-ray marker – see Figure 
1 below. 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 15 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Figure 1: Accent™ MRI Pacemaker System X-Ray Markers 
 
 
 
Due to the noise created by the MRI environment, sensing must be disabled for the 
duration of an MRI scan. Therefore, firmware and programmer software will include 
the capability to program the device to MRI conditionally safe settings. The MRI 
Mode will provide the physician with two options – either asynchronous pacing or 
pacing off.  The MRI Setting consists of nonprogrammable and programmable pacing 
parameters.  The Merlin PCS programmer software will include: 
 
• Ability for the user to pre-set the MRI parameters in advance and save these in the 
device as an “MRI Setting” 
• Checklist feature allowing the user to confirm that the system meets all conditions 
required for safe MRI scanning 
• Capability to program the device into MRI Setting, out of MRI Setting, and back 
into the previously programmed settings 
• Ability to set an MRI Ready status in the device for future use with the MRI 
Activator  
• Collection of diagnostics from the MRI Setting (time in MRI setting, etc.) and 
display via MRI-related reports. 
 
The Tendril MRI lead is an endocardial, bipolar, active fixation lead with an IS-1 
connector based on the currently marketed Tendril™ Model 1888TC lead.  The 
Tendril MRI lead incorporates filters to mitigate MRI induced RF tissue heating near 
the lead electrodes.  It has a radiopaque identification marker built into the connector 
end allowing the physician to identify the lead as MRI compatible via x-ray.  The 
lead’s body has a co-axial design and uses MP35N coils and an Optim outer 
insulation.  The lead has been designed to fit through an 8F introducer without a 
retained guide wire and is available in lengths of 46, 52 and 58 cm. 
 
In addition to the programmer, the external MRI Activator is a handheld device that 
allows the user to enable or disable the MRI Setting in the Accent MRI pacemaker if 
the checklist conditions have been verified and the use of the MRI Activator has been 
approved and enabled by the physician.  The MRI Activator hardware is based on the 
commercially available St. Jude Medical Confirm® Patient Activator hardware.  The 
MRI Activator firmware will include the capability to program the MRI Setting on 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 16 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
and off, and back into the previously programmed settings if the pacemaker has been 
made MRI ready. 
 
 Clinical Protocol 
4.1 Study Design and Scope 
This is a prospective, multi-center, clinical study designed to evaluate the 
safety and efficacy of the Accent MRI System in a patient population 
indicated for implant of a pacemaker within and outside of the MRI 
environment.  
 
The study will be conducted at a minimum of 60 centers and a maximum of 
80 centers worldwide.  The minimum requirement for completing this study is 
800 patients. A maximum of 120 (15% of the total) enrollments will be 
allowed per center.  It is anticipated that at least 30% of enrollments will 
include patients implanted with the Tendril MRI lead in the right atrium. 
 
Within the MRI environment, The Accent MRI system will be evaluated in 
conjunction with the MRI Activator.  The MRI Activator performance will be 
evaluated qualitatively during this phase of the study.  Up to 363 patients, 
including patients who were randomized to the MRI Control Group in 
previous versions of the investigational plan, will be enrolled in this phase of 
the study.   
 
Enrollment in the MRI clinical study is expected to take approximately 12 
months. The anticipated duration of this study is 32 to 34 months, depending 
on the rate of enrollment.  All patients will be implanted with an Accent MRI 
pacemaker and a Tendril MRI lead. Devices implanted outside the United 
States will utilize different device model numbers.   
 
The following study evaluations will occur after implant:   
 
• Post implant follow up (pre-discharge) 
• 2 month visit (post implant, in-office) 
• 6 month visit (post implant, in-office) 
• 12 months visit (post implant, in-office) 
• Every 6 months post implant until study completion 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 17 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
MRI visits will consist of: 
 
• MRI visit which includes:  
 Pre-MRI scan testing  
 MRI scan  
 post MRI testing  
• 1 month post MRI visit  
 
The schedule of follow up visits for the lead safety component of the study is 
based on the date of implant of the Accent MRI System. The follow up 
schedule for the MRI visit is based on the date of implant or revision of an 
MRI lead until the MRI visit; the MRI visit should take place no sooner than 
one week after the 2 month post implant or system revision procedure where 
the Tendril MRI lead was implanted, repositioned or replaced. The one month 
post MRI follow up visit is based on the MRI visit.  
 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 20 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
4.2 Objectives/Study Endpoints 
The primary objectives of this study are to assess the safety and efficacy of the 
Accent MRITM system in a patient population that is indicated for a 
pacemaker. 
 
Primary Endpoints 
Lead Safety 
Safety of the Tendril MRI™ lead will be evaluated in terms of freedom from 
RA and RV lead-related complications for the acute (implant to 2 month visit) 
and chronic (2 month visit through the 12 month visit) timeframes.   
 
MRI Safety  
The safety of the Accent MRI system will be evaluated in terms of freedom 
from MRI scan related complications in the month following the MRI scan. 
 
Lead Efficacy 
Efficacy of the Tendril MRI™ lead will be evaluated in terms of the change in 
bipolar atrial and ventricular capture and sensing thresholds before and after 
the MRI scan. 
 
Secondary Endpoints 
Safety 
Safety of the Accent MRITM system will be evaluated in terms of freedom 
from system-related complications through the 12 month visit.   
 
Efficacy 
Efficacy of the Tendril MRI™ lead will be evaluated in terms of the bipolar 
atrial and ventricular capture thresholds at the MRI Visit. 
4.2.1 Primary Lead Safety Endpoints 
4.2.1.1 Freedom from RA lead-related complications in the acute period  
4.2.1.2 Freedom from RV lead-related complications in the acute period 
The lead safety endpoint will be assessed separately for the RA and 
RV leads and for an acute (implant to 2 months) period. 
 
The hypothesis is formally expressed as: 
 
H0: Freedom from lead related complications from implant up to 2 
month visit ≤ 92% 
Ha: Freedom from lead related complications from implant up to the 2 
month visit > 92%  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 21 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 
The objective performance criterion of 92% used for this objective 
denotes the minimum level of adequate safety for the RA or RV leads 
in the acute time period.  This endpoint will be tested separately for the 
RA and the RV leads.  Only those complications occurring by the 2 
month visit and adjudicated by the Clinical Events Committee as RA 
lead or RV lead complications will be used in the estimation of these 
endpoints. 
 
Sample Size 
Simulation was used to calculate the sample size requirements for 
testing the Kaplan-Meier estimated survival probability for the 
freedom-from-complication endpoint.  The SCORE Registry, 
containing patients who were implanted with a St. Jude Medical RA 
and RV market approved Tendril™ family of leads, was used to 
estimate freedom from lead related complications in the acute time 
period.  Using these estimates derived from the SCORE Registry data, 
the expected proportion of patients free from RA lead related 
complications from implant to 2 months is 0.995 with 95% lower 
confidence bound of 0.994. Similarly, for the RV lead, the expected 
proportion of patients free from RV lead related complications from 
implant to 2 months is 0.993 with 95% lower confidence bound of 
0.991.  Taking a conservative expected complication free rate of 0.97, 
with a study size of 800 RV leads and 400 RA leads patients and a 
Type 1 error rate for the acute time period hypothesis test of α = 0.025 
for a one-sided test, the power is greater than 98%. 
 
Patient Group  
All patients that have had an attempted implant or a successful implant 
of an Accent MRI system will be included in this endpoint.  
 
Patients who are lost to follow-up or withdrawn prior to the 2 month 
follow-up visit due to an RA or RV lead related complication will be 
analyzed as having experienced a complication at the date the 
complication occurred.  Patients who withdraw for reasons unrelated 
to an RA or RV lead related complication will be censored at the date 
of withdrawal. 
   
Analysis 
The desired outcome is to reject both null hypotheses for the RA and 
RV endpoints.  The RA and RV hypothesis will be tested separately.  
The null hypothesis for the RA or RV endpoints will be rejected at the 
2.5% significance level if the 95% lower limit of a two-sided 
confidence interval for the freedom from RA or RV lead-related 
complications by 2 months is greater than 92%.  The confidence 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 22 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
interval will be constructed using the log-log transformation of the 
event free estimate at 2 months. 
 
4.2.1.3 Freedom from RA lead-related complications in the chronic time 
period 
4.2.1.4 Freedom from RV lead-related complications in the chronic time 
period 
The lead safety endpoint will be assessed separately for the RA and 
RV leads for the chronic (2 months through the 12 month visit) time 
period. 
 
The hypothesis is formally expressed as: 
 
H0: Freedom from lead related complications from the 2 month 
through the 12 month visit ≤ 95% 
Ha: Freedom from lead related complications from the 2 month 
through the 12 month visit > 95% 
 
The objective performance criterion of 95% used for this objective 
denotes the minimum level of adequate safety for the RA or RV leads 
in the chronic time period.  This endpoint will be tested separately for 
the RA and the RV leads.  Only those complications occurring by the 
12 month visit and adjudicated by the Clinical Events Committee as 
RA lead or RV lead complications will be used in the estimation of 
these endpoints. 
 
Sample Size 
Simulation was used to calculate the sample size requirements for 
testing the Kaplan-Meier estimated survival probability for the 
freedom-from-complication endpoint.  The SCORE Registry, 
containing patients who were implanted with an RA and RV market 
approved Tendril™ family of leads, was used to estimate freedom 
from lead related complications in the chronic time period.  Using 
these estimates derived from the SCORE registry data, the expected 
proportion of patients free from RA lead related complications from 2 
months post-implant through 12 months is 0.996 with a 95% lower 
confidence bound of 0.994.  Similarly, for the RV lead, the expected 
proportion of patients free from RV lead related complications from 2 
months post-implant through 12 months is 0.998 with 95% lower 
confidence bound of 0.997. Taking a conservative expected 
complication free rate of 0.98, with a study size of 800 RV leads and 
400 RA leads patients and a Type 1 error rate for the chronic time 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 23 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
period hypothesis test of α = 0.025 for a one-sided test, the power is 
greater than 98% for the RV leads and greater than 85% for the RA 
leads. 
 
Patient Group  
All patients who have had an attempted implant or a successful 
implant of an Accent MRI system will be included in this endpoint.  
 
Patients who are lost to follow-up or withdrawn prior to the 12 month 
follow-up visit due to an RA or RV lead related complication will be 
analyzed as having experienced a complication at the date of the 
complication.  Patients who withdraw for reasons unrelated to an RA 
or RV lead related complication will be censored at the date of 
withdrawal. 
   
Analysis 
The desired outcome is to reject both null hypotheses for the RA and 
RV endpoints.  The RA and RV hypothesis will be tested separately.  
The null hypothesis for the RA or RV endpoints will be rejected at the 
2.5% significance level if the 95% lower limit of a two-sided 
confidence interval for the freedom from RA or RV lead-related 
complications between 2 months and 12 months is greater than 95%.  
The confidence interval will be constructed using the log-log 
transformation of the event free estimate at 12 months. 
 
4.2.2 Primary MRI Safety Endpoint: Freedom from MRI Scan-
Related complications 
An MRI Scan-Related complication is a complication caused by the 
interaction between the investigational pacing system and the MRI 
system that occurs during the MRI scan, including the time the patient 
is within the 5 Gauss line of the MRI system, up through the patient’s 
1 month post MRI visit.  In addition, complications occurring due to 
the patient’s MRI programming will be considered MRI scan related 
by the Clinical Events Committee (CEC). 
 
The hypothesis is formally expressed as: 
 
H0:  Proportion of patients who are free from MRI scan-related 
complications between the MRI scan and one month post MRI 
visit ≤ 90% 
Ha: Proportion of patients who are free from MRI-scan related 
complications between the MRI scan and one month post MRI 
visit > 90%  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 24 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 
The comparison criterion of 90% used for this objective denotes the 
minimum level for adequate safety following the MRI scan.  
Complications that can be attributed to the MRI scan are expected to 
occur within one month of the scan.19  Therefore, assessing this 
objective one month post-MRI scan will capture all MRI scan-related 
complications following the MRI scan procedure. 
 
Sample Size 
  The expected proportion of patients free from complications under 
the null hypothesis is 0.90, and the Type 1 error rate is set at α = 0.025 
for the one-sided test. Assuming the portion of patients free from 
complications of.0.97, a sample size of 133 MRI patients provides a 
power level of 90% for this endpoint.   
 
In another manufacturer’s study involving an MRI conditional 
pacemaker, the complication free rate as observed to be 100%.19  
Therefore, an assumption of 97% complications-free rate is assumed in 
the sample size calculation. 
 
The objective will be evaluated using a one-sided z-test with variance 
of the test statistic based on the hypothesized value of 0.90 for the 
binomial proportion.  The desired outcome is to reject the null 
hypothesis.  
  
  
 
Patient Group  
All patients implanted with the Accent MRI system who  undergo an 
MRI scan and have completed their 1 month post MRI visit, or have an 
MRI-related complication before the end of the 1 month post MRI 
visit date will be included in the analysis of this endpoint.   
  
 
Analysis 
The analysis will be conducted on the per-protocol (PP) population.  
The per-protocol population includes patients who meet the following 
criteria: 
• Successfully implanted with the Accent MRI system  
• Have MRI visit data  
• Meet the MRI Conditions of Use 
• Received an MRI scan  
• Have 1-month post MRI visit data 
 
All individual primary safety endpoints must be successful (reject the 
null hypothesis at the α = 2.5% level) for the safety endpoint to be 
successful. 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 25 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 
A supporting analysis will also be performed using all patients who 
undergo an MRI scan For this analysis, each missing data point will be 
replaced by a failure one at a time.  Each time a new failure is added 
the analysis will be re-run.  This continues until either all missing data 
has been replaced with a failure or the test becomes non-significant 
(i.e. the interpretation of the results changes).  The proportion of 
missing data that would need to be a failure in order to change the 
analysis results will be reported and discussed. 
 
4.2.3 Primary MRI Efficacy Endpoints  
4.2.3.1 Proportion of patients free of atrial capture threshold increase of 
> 0.5V at 0.5ms from  before and to one month after the MRI scan  
4.2.3.2 Proportion of patients free of ventricular capture threshold 
increase of > 0.5V at 0.5ms from before to  one-month after the 
MRI scan   
The hypothesis is formally expressed as: 
 
H0:  Proportion of patients with threshold increase of ≤ 0.5V at 0.5ms 
from before to one month post MRI visit ≤ 90% 
 H
a: Proportion of patients with a threshold increase of≤0.5V at 0.5ms 
form before to one month post MRI visit > 90%  
 
The desired outcome is to reject the null hypothesis.  The null 
hypothesis is rejected at 2.5% significance level if the lower bound of 
the two-sided 95% confidence bound on the proportion of patients 
with a threshold increase of ≤ 0.5V at 0.5ms from before to one month 
post MRI visit is greater than 90%.   
 
 
Sample Size 
A success (Post-MRI scan Threshold – Pre-MRI scan Threshold)
 is 
defined as a patient who experiences an increase in threshold less than 
or equal to 0.5 volts at the 1 month post-MRI visit compared to their 
pre-MRI testing (MRI visit). In this case post MRI capture Threshold 
≤ pre MRI capture Threshold + 0.5 volts. 
 
The % of Success (Post-MRI scan Threshold – Pre-MRI scan 
Threshold) is defined as the number of patients with successes divided 
by the analyzable patients. 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 26 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
In another manufacturer’s study involving an MRI conditional 
pacemaker, the proportion of patients with an increase in threshold less 
than or equal to 0.5 volts at the 1 month post-MRI visit compared to 
their pre-MRI testing was 100%.
19 Therefore, an assumption of 98% of 
successes (Post MRI scan-Pre-MRI scan threshold) in the atrium and 
ventricle is assumed in the sample size calculation.  
 
A sample size of 93 patients provides 90% power to demonstrate a 
success rate greater than 90% for the atrial and ventricular endpoints, 
respectively, at the 2.5% significance level.  
 
Analysis 
The analysis will be conducted on the per-protocol population.  The 
per-protocol population includes patients who meet the following 
criteria: 
• Successfully implanted with the Accent MRI system  
• Have MRI visit data  
• Meet the MRI Conditions of Use 
• Received an MRI scan  
• Have 1 month post MRI visit data 
• Have a pacing threshold difference not exceeding 0.5 V at 0.5 
ms between the two-month and MRI visit device pre-check, in 
cases where the MRI visit occurs approximately 9-12 weeks 
after the implant or system revision procedure since such short-
term variability in pacing performance can be indicative of an 
abnormal lead/tissue interface that could confound analyses of 
MRI related effects. 
• Have an atrial lead to be included in the ‘% success (change in 
atrial capture threshold)’ endpoint analysis and/or a ventricular 
lead to be included in the ‘% success (change in ventricular 
capture threshold)’ endpoint analysis 
• Are not in AF at the time of atrial capture threshold 
measurements.  Note: If atrial arrhythmias persist throughout 
the visit window for the MRI and/or 1 Month Post MRI visit, 
and no atrial capture threshold value can be obtained either at 
the MRI and/or 1 Month Post MRI visit, measured atrial 
capture threshold values from the next nearest timed visit may 
be substituted. 
 
The proportion of patients not experiencing increases of 0.5V at 0.5ms 
for both atrial and ventricular capture thresholds will be calculated 
separately along with the associated 2.5% lower confidence bound.  
The lower bound for both of these proportions will be compared to the 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 27 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
OPC of 90%.  The endpoints will be considered successful if the lower 
bound is greater than 90%. 
 
Additional Analyses 
A sensitivity analysis of the endpoint will be conducted using the ITT 
population, where both a worst and best case analysis will be 
performed.  The worst case analysis will consist of treating all missing 
data as failures.  The best case analysis will treat all missing data as 
successes.  
 
4.2.3.3 Proportion of patients with atrial sensing amplitude decrease of < 
50% and a sensing amplitude at 1-month post MRI visit of > 
1.5mV  
The hypothesis for the atrial sensing threshold is formally expressed 
as: 
 
H0:  Proportion of patients with an atrial sensing amplitude decrease of 
< 50% and atrial sensing amplitude at 1-month post MRI visit of 
>1.5 mV ≤ 85%    
 
Ha:  Proportion of patients with an atrial sensing amplitude decrease of < 
50% and atrial sensing amplitude at 1-month post MRI visit of > 1.5 mV 
> 85%  
 
The null hypothesis is rejected at 2.5% significance level if the lower 
bound of the two-sided 95% confidence interval on the proportion of 
patients with an atrial sensing amplitude decrease of < 50% and atrial 
sensing amplitude at 1-month post MRI visit of > 1.5mV  is greater 
than 85%.   
 
4.2.3.4 Proportion of patients with ventricular sensing amplitude decrease 
of < 50% and a sensing amplitude at 1-month post MRI visit of > 
5mV  
The hypothesis for the ventricular sensing threshold is formally 
expressed as: 
 
H0: Proportion of patients with a ‘ventricular sensing amplitude 
decrease of < 50% and ventricular sensing amplitude at 1-month 
post MRI visit of >5 mV’ ≤ 87%   
Ha:  Proportion of patients with a ‘ventricular sensing amplitude 
decrease of < 50% and atrial sensing amplitude at 1-month post 
MRI visit of > 5 mV’ >87% 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 28 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
The null hypothesis is rejected at 2.5% significance level if the lower 
bound of the two-sided 95% confidence interval on the proportion of 
patients with a ‘ventricular sensing amplitude decrease of < 50% and 
ventricular sensing amplitude at 1-month post MRI visit of  >5mV’ is 
greater than 87%.   
 
Sample Size 
A success is defined as a patient who experiences a decrease in sensing 
amplitude not exceeding 50%, and a sensing amplitude not less than 5 
mV for ventricular measurements and not less than 1.5mV  for atrial 
measurements at the 1 month post-MRI visit  from the pre-MRI testing 
(at MRI visit).  
 
The % of Success (Post-MRI scan Amplitude – Pre-MRI scan 
Amplitude) is defined as the number of patients with successes divided 
by the number of analyzable patients.  
 
In another manufacturer’s study involving MRI conditional 
pacemaker, proportion of patients with ‘sensing amplitude decrease of 
< 50% and atrial sensing amplitude at 1-month post MRI visit of > 
1.5mV’ was approximately 93%. In the same study, the proportion of 
patients with ‘sensing amplitude decrease of < 50% and ventricular 
sensing amplitude at 1-month post MRI visit of > 5mV’ was 
approximately 95%.
19  Therefore, an assumption of 93% for successes 
in the atrium and 95% successes in the ventricle is assumed  
 
A sample size of 165 patients provides 90% power for the atrial 
endpoint and 138 patients provides 90% power for the ventricular 
endpoint at the 2.5% significance level.  
  
 
Analysis 
The analysis will be conducted on the per-protocol population.  The 
per-protocol population includes patients who meet the following 
criteria: 
• Successfully implanted with the Accent MRI™ system 
• Have MRI visit data  
• Meet the MRI Conditions of Use 
• Received an MRI scan (if in the MRI group) 
• Have 1-month post MRI visit data 
• Have a pacing threshold difference not exceeding 0.5V 
between the two-month and three month post-implant (MRI 
scan pre-check),  in cases where the MRI visit takes place 
approximately 9-12 weeks after an implant or system revision 
procedure since such short-term variability in pacing 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 29 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
performance can be indicative of an abnormal lead/tissue 
interface that could confound analyses of MRI related effects. 
• Have a pre-MRI/pre-waiting period sensing amplitude greater 
than or equal to 5.0 mV in the ventricle or greater than or equal 
to 1.5 mV in the atrium.  
• Have an atrial lead to be included in the ‘% success (change in 
atrial sensing amplitude)’ endpoint analysis and/or a 
ventricular lead to be included in the ‘% success (change in 
ventricular sensing amplitude)’ endpoint analysis 
• Are not in AF at the time of atrial sensing amplitude 
measurements 
• Have an intrinsic heart rate ≥ 30 beats per minute at the time of 
ventricular and/or atrial capture threshold measurements 
 
The proportion of patients not experiencing an atrial sensing amplitude 
decrease of < 50% and atrial sensing amplitude at 1-month post MRI 
visit of >1.5 mV will be calculated.  The associated 2.5% lower 
confidence bound will also be derived.  This lower bound will be 
compared to the OPC of 85% and the endpoint will be considered 
successful if the lower bound is greater than 85%. 
 
The proportion of patients not experiencing a ventricular sensing 
amplitude decrease of < 50% and ventricular sensing amplitude at 1-
month post MRI visit of > 5 mV will be calculated.  The associated 
2.5% lower confidence bound will also be derived.  This lower bound 
will be compared to the OPC of 87% and the endpoint will be 
considered successful if the lower bound is greater than 87%. 
 
All individual primary efficacy endpoints must be successful (reject 
the null hypothesis at the α = 2.5% level) for the efficacy endpoint to 
be successful. 
 
Additional Analyses 
The same additional analyses described above in section 4.2.3.1 and 
4.2.3.2 will be completed for this endpoint if required. 
 
The overall success for the primary endpoints is achieved if all 
primary safety and primary efficacy endpoints are successful. 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 30 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
4.2.4 Secondary Endpoints  
The secondary endpoints will be assessed only if all primary safety 
and efficacy endpoints were significant.  The secondary endpoints will 
be tested sequentially in the order of: system related complications at 
12 months, followed by the atrial capture threshold at the MRI visit, 
and finally the mean ventricular capture threshold at the MRI visit.  At 
the point where a secondary endpoint fails to achieve significance, all 
further testing of secondary endpoints will stop. 
 
4.2.4.1 Freedom from system-related complications  
The hypothesis is formally expressed as:  
 
H0: Freedom from system related complications through the 12 month 
visit ≤ 80% 
Ha: Freedom from system related complications through the 12 month 
visit > 80%  
  
 
The desired outcome is to reject the null hypotheses.  The null 
hypothesis will be rejected at the 5% significance level if the 95% 
lower confidence limit for the freedom from system related 
complications at 12 months is greater than 85%.   
 
Simulation was used to calculate the sample size requirements for 
testing the Kaplan-Meier estimated survival probability for the 
freedom-from-complication endpoint.  The expected proportion of 
patients free from system related complications at 12 months is 0.975 
(95% CI: 0.924, 0.992) using data from the VICTORY pulse generator 
IDE study (G050191).  For a study size of 800 patients and a Type 1 
error rate for the hypothesis test of α = 0.05 for a one-sided test, the 
power is greater than 98%. 
 
Patient Group  
All patients that have had an attempted implant or a successful implant 
of an Accent MRI system will be included in this endpoint.  
 
Patients who are lost to follow-up or withdrawn prior to the 12 month 
follow-up visit due to a system related complication will be analyzed 
as having experienced a complication at the date of withdrawal.  
Patients who withdraw for reasons unrelated to a system related 
complication will be censored at the date of withdrawal. 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 31 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
4.2.4.2 Bipolar atrial capture threshold at the MRI visit 
The hypothesis is formally expressed as:  
 
H0: The proportion of patients with atrial capture threshold ≤2.0V at 
MRI visit is ≤ 85% 
Ha: The proportion of patients with atrial capture threshold is ≤2.0V at 
MRI visit > 85% 
 
The proportion of patients with atrial capture threshold ≤2.0V at the 
MRI visit endpoint will be evaluated using a one-sided z-test, with 
variance calculated using the OPC of 85% at the α = 2.5% level. The 
desired outcome is to reject the null hypothesis. 
 
Patient Group  
All patients implanted with the Tendril MRI™ lead with pre-MRI 
testing atrial capture threshold measurements at the MRI visit. 
 
4.2.4.3 Bipolar ventricular capture threshold at the MRI visit    
The hypothesis is formally expressed as:  
 
H0: The proportion of patients with ventricular capture threshold ≤ 2.0 
V at MRI visit is ≤ 85% 
Ha: The proportion of patients with ventricular capture threshold ≤2.0 
V at MRI visit is > 85% 
 
The proportion of patients with ventricular capture threshold ≤2.0V at 
MRI visit endpoint will be evaluated using a one-sided z-test with 
variance calculated using the OPC of 85% at the α = 2.5% level. The 
desired outcome is to reject the null hypothesis. 
 
Patient Group  
All patients implanted with the Tendril MRI™ lead with pre-MRI 
ventricular capture threshold measurements at the MRI visit.  
 
4.2.4.4 Additional Secondary Endpoint Analyses  
As supporting analyses for each of the three secondary endpoints, a 
tipping point analysis will be provided.  In sequential fashion, each 
missing data point will be replaced by a “failure” after which the 
analysis will be re-run.  This continues until either all missing data has 
been replaced with a “failure” or the test becomes non-significant (i.e. 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 32 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
the interpretation of the results changes).  The proportion of missing 
data that would need to be a failure in order to change the analysis 
results will be reported and discussed. 
 
4.2.5 Sub-group Analyses  
Gender Analysis 
The primary and secondary endpoints will be re-analyzed comparing 
the estimates for males and females.  All relevant summary statistics 
will be reported.   
 
Additionally, for the primary endpoints of freedom from RV/RA lead 
related complications in both the acute and chronic timeframes, a 
Kaplan-Meier analysis comparing freedom from lead complications 
between males and females will be provided.  Note that with the large 
sample size associated with these endpoints, clinically irrelevant 
differences may be detected.  This same type of analysis will also be 
done on the endpoint of freedom from MRI scan related 
complications. 
 
All comparisons of gender  will be done at the 0.15 level of 
significance. 
4.2.6 Additional Data  
• Ability to identify radiopaque identification marker on the 
pacemaker and lead through X-ray review by a cardiologist and 
radiologist 
• Adverse Events – system, lead, and implant procedure related 
events (not including the primary safety endpoint) 
• Atrial and ventricular bipolar capture thresholds immediately 
after MRI scan 
• Atrial and ventricular unipolar capture thresholds before and 
after the MRI scan 
• Atrial and ventricular bipolar lead impedance through the 1 
month post MRI visit 
• Atrial and ventricular bipolar sensing thresholds immediately 
after MRI scan 
• Cardiac medications 
• Challenges and lessons learned in communication between the 
MRI/Radiology and Cardiology teams 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 33 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• Demographics: gender, age, ethnicity, race, cardiac disease 
history, arrhythmia history, indication for pacemaker implant, 
history of smoking, etc. 
• Inadequate equipment availability during MRI scan 
• Incidence of aberrant or undesirable behavior of the device 
while in the MRI mode. 
• Incidence of MRI related arrhythmias and asystole  
• Lead handling characteristics 
• Loss or lapses in patient monitoring during the MRI scan 
• Mortality 
• MRI Activator performance and usability 
• MRI image qualitative analysis; St. Jude Medical will provide 
data on the image quality/presence of artifact for the first 20 
MRI scans performed. Each participating site will be asked to 
submit the first five MRI scans performed (up to 5 scans 
maximum) until 20 total scans have been submitted.   
• Number of non-study related MRI scans 
• Preliminary study phase small cohort - St. Jude Medical will 
summarize the adverse event data on the first 44 patients who 
complete the one month post MRI scan (29 MRI, 15 Control). 
This summary will be provided to the FDA. 
 
4.2.7 Definitions to be used in the MRI study 
Abnormal Lead Pacing Impedance:  Measured pacing impedances 
with values ≤ 200 Ω or ≥ 2000 Ω 
 
Adverse Event:  Any unfavorable clinical event which impacts, or has 
the potential to impact the health or safety of a patient caused by or 
associated with a study device or intervention. Adverse events are 
classified as complications or observations. 
 
Complication:  An adverse event caused by or associated with the 
study device, system component(s), and or procedure that requires 
invasive intervention (e.g. lead dislodgment requiring repositioning).   
 
Cardiac Tamponade:  Confirmed or suspected accumulation of fluid 
in the pericardial space  
 
Cardiac Perforation:  An excursion of the lead through the cardiac 
muscle.  Signs and symptoms of a perforation by an intra-cardiac lead 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 34 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
may include radiographic evidence of excursion of the lead into the 
pericardial sac, abnormal echocardiography indicative of a perforation, 
the accumulation of fluid in the pericardium, cardiac tamponade, or 
patient symptoms such as chest pain and discomfort   
 
Diaphragmatic/Phrenic Nerve Stimulation:  Electrical activation of 
the diaphragm muscle by the device output pulse. The abrupt 
diaphragmatic contraction is noted clinically as hiccups associated 
with each pacing stimulus. The pacing stimulus may stimulate the 
diaphragm either directly or indirectly via the phrenic nerve. 
 
Elevated Pacing Thresholds:  Pacing thresholds > 2.0 V at 0.5 ms at 
implant.  Following lead maturation at 6-8 weeks, an increase in 
pacing thresholds of 1.2 V at 0.5 ms or greater between visits.  This 
definition is intended to serve as a guideline and it is understood that 
individual patients may have unique situations  
 
Lead Dislodgement:  The movement of a pacing lead from its 
originally implanted position resulting in elevated pacing thresholds or 
a decrease in sensing 
 
Lead Fracture:  A break in a conduction coil of a pacing or 
defibrillation lead typically evidenced by an increase in impedance, 
intermittent or complete loss of capture, intermittent or complete loss 
of sensing, noise on the intra-cardiac electrogram and visual signs of 
conductor coil fracture on x-ray  
 
Lead Insulation Damage:  A disruption to the integrity of the lead 
insulation without disruption of the conductor coil.  An insulation 
break may be indicated by a drop in impedance, and can cause loss of 
capture or sensing problems  
 
Loss of Capture:  The inability of the device’s output pulse to result 
in depolarization and contraction of the appropriate cardiac chamber. 
Causes include insufficient stimulus strength, separation of the 
electrode from the myocardium and placement of the stimulating 
electrode in contact with a non-responsive portion of the myocardium 
such as scar tissue. Delivery of an output pulse at a time when the 
myocardium is physiologically refractory is not loss of capture, since 
capture is not physiologically feasible 
 
Loss of Sensing:  A condition in which the pulse generator is unable 
to sense intrinsic cardiac signals 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 35 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Observation: An adverse event caused by or associated with the study 
device, system component(s), and or procedure that does not requires 
invasive intervention (e.g. oversensing or loss of pacing capture 
requiring reprogramming).  
 
Oversensing:  The detection of inappropriate electrical signals by the 
pulse generator’s sense amplifier. These signals, such as 
myopotentials, electromagnetic interference, T waves or crosstalk 
between atrial and ventricular channels, must be of sufficient duration 
to interfere with normal device function  
 
Pneumothorax:  An accumulation or suspected accumulation of air in 
the pleural cavity 
 
Undersensing: The failure of the pulse generator to sense P or R 
waves, causing delivery of inappropriately timed, asynchronous or 
competitive output pulses. Undersensing can sometimes be corrected 
by programming the device to a more sensitive setting, i.e., decreasing 
the millivolt value 
 
4.3 Patient Selection 
4.3.1 Inclusion Criteria 
Eligible patients will meet all of the following: 
 
1. Have an approved indication per ACC/AHA/HRS guidelines for 
implantation of a pacemaker  
2. Will receive a new pacemaker and lead  
3. Be willing to undergo an elective MRI scan without sedation 
4. Be able to provide informed consent for study participation (legal 
guardian is NOT acceptable) 
5. Be willing and able to comply with the prescribed follow-up tests 
and schedule of evaluations 
6. *Is not contraindicated for an MRI scan (per the pre-MRI safety 
screening form) 
4.3.2 Exclusion Criteria  
Patients will be excluded if they meet any of the following: 
 
1.  Have an existing pacemaker or ICD. A new pacemaker and lead is 
required for enrollment  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 36 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
2. *Have an existing active implanted medical device, e.g., 
neurostimulator, infusion pump, etc.  
3. *Have a non-MRI compatible device or material implanted (e.g., 
intracranial aneurysm clip, non-MRI compatible devices or 
material, metals or alloys, etc.) 
4. Have a lead extender or adaptor 
5. Be unable to fit in MRI bore; will come into contact with the 
magnet façade inside the MRI bore. 
6. Have a prosthetic tricuspid heart valve 
7. Are currently participating in a clinical investigation that includes 
an active treatment arm 
8. Are allergic to dexamethasone sodium phosphate (DSP)  
9. Are pregnant or planning to become pregnant during the duration 
of the study 
10. Have a life expectancy of less than 12 months due to any condition 
11. Patients with exclusion criteria required by local law (e.g., age) 
12. Are unable to comply with the follow up schedule 
 
*Applies only to those patients who will participate in the MRI 
portion of the study. 
 
4.4 Study Procedures 
All required study procedures at each specified interval are outlined in the 
sections below. Refer to Table 1 and Table 2 for an overview of the required 
study procedures at each interval or study visit.   
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 37 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Table 1: Schedule of Evaluations Summary: MRI Lead Safety  
 
Evaluation 
Cardiology Staff 
Standard Study Visits 
Enrollment 
Implant 
Post Implant 
(Pre-Discharge) 
2 month post 
implant visit 
6 month visit  
12 month visit  
Every 6 months 
until Study 
Completion 
Informed Consent & Inclusion/ Exclusion Evaluation 
√ 
 
 
 
 
 
 
Cardiovascular history 
√ 
 
 
 
 
 
 
Cardiac medications 
√ 
 
√ 
√ 
√ 
√ 
√ 
Pre-MRI Safety Screening  (MRI Safety Screening 
Form) 
√ 
 
 
 
 
 
 
Bipolar capture threshold testing @ 0.5msec, bipolar 
sensing amplitude & lead impedance for RA and RV 
leads * 
 
√ 
√ 
√ 
√ 
√ 
√ 
Chest X-ray (PA and lateral view of final lead 
placement) 
 
 
√ 
 
 
 
 
X – ray analysis by cardiologist and radiologist 
 
 
√ 
 
 
 
 
* Note: RA lead measurements are not required if a single chamber device is implanted. RA capture and sensing 
thresholds are not required if a patient is in atrial fibrillation or atrial flutter.  
 
RA/RV sensing measurements are not required if the patient’s intrinsic rate has been established to be below 30 
beats per minute. RV capture thresholds are not required if a high ventricular rate is present.     
 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 39 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
4.4.1 Enrollment Requirements 
4.4.1.1 Enrollment 
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. Collect data on the patient 
including gender, age, ethnicity, race, cardiac disease history, cardiac 
medications, arrhythmia history, smoking history, and indication for 
pacemaker implant. It is required that the pre-MRI safety screening 
form be completed as part of the enrollment screening for all patients 
to ensure there are no current contraindications for an MRI scan; this 
will apply to all patients agreeing to participate in the MRI portion of 
the study of the study (see Appendix A). Patients who meet the 
inclusion, and do not meet the exclusion criteria, sign an IRB approved 
informed consent and have an attempted implant will be considered 
enrolled in the study. 
 
Once eligibility screening is completed, informed consent has been 
obtained, and the Accent MRI system has been implanted, or an 
attempt was made to implant the system (refer to the Implant 
Procedures section for further details), complete and submit the forms 
listed under the Implant Procedures to St. Jude Medical via Electronic 
Data Capture (EDC).   
 
4.4.2 Implant Procedures 
Perform the device and lead implant procedure according to standard 
of care. Do not implant a dual chamber device with only one lead. 
Consult the User
's Manual for implantation guidelines, appropriate 
lead/device connections and general handling information. The 
Accent MRI system will be considered successfully implanted if, at a 
minimum, the Accent MRI pacemaker and a Tendril MRI lead are 
implanted.   
  
 
4.4.2.1 Lead Placement and Testing 
Implant one Tendril MRI™ Lead (Model LPA1200M) in the right 
ventricle and one in the right atrium for dual chamber pacemakers. 
Implant one Tendril MRI™ lead in the right ventricle for single 
chamber pacemakers. The physician can use any appropriate delivery 
system that is legally marketed from St. Jude Medical or any other 
manufacturers.  
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 40 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• Only Tendril MRI™ leads are permitted (abandoned leads, 
additional leads and non-Tendril MRI™ leads are not 
permitted). If non-Tendril MRI™ leads are implanted, 
complete a protocol deviation form.  
• Use of lead extenders or adaptors is not permitted. If used, 
complete a protocol deviation form.  
• The atrial or ventricular port cannot be plugged. If either port is 
plugged, complete a protocol deviation form.  
 
After the lead(s) are connected to the device, obtain the following 
electrical measurements for the RA and/or RV leads.   
 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter. 
 
 RA/RV sensing measurements are not required if the patient’s 
intrinsic rate has been established to be below 30 beats per minute. RV 
capture thresholds are not required if a high ventricular rate is 
present. 
 
Data Submission 
Once required testing has been completed at the Implant Visit, 
complete and submit the forms listed below to St. Jude Medical.  
Upload device session records through the EDC study site portal.  
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
• Enrollment Form 
• Implant Form 
• Medication Log 
• Adverse Event Form, if applicable 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 41 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
  
4.4.3 Unsuccessful Implant 
Unless the implant will be re-attempted, for patients who have an 
unsuccessful implantation of a St. Jude Medical Accent MRI system, 
follow the patient for a period of 30 days for adverse events, and then 
withdraw the patient. The physician must document the nature of the 
unsuccessful implant on the implant form. Only those individuals who 
are successfully implanted with the Accent MRI system are permitted 
to undergo an MRI scan.  
 
Data Submission 
Once information has been collected and required testing has been 
completed at the Implant Visit, complete and submit the forms listed 
below to St. Jude Medical. If applicable, upload device session records 
through the EDC study site portal.  Device session records may also be 
sent to St. Jude Medical, CRMD Sylmar, CA. 
 
• Implant Form 
• Medication Log  
• Withdrawal Form 
• Adverse Event Form, if applicable 
• Protocol Deviation Form, if applicable 
• Product Out of Service Form,  if applicable 
• Death Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site.   
• FastPath Summary, if applicable 
• Test Results with Large Freezes, Include Battery & Leads, if 
applicable  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 43 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
4.4.5.1 System Revisions 
A system revision is defined as capping a lead, plugging a port, 
repositioning or explanting (with or without replacement) of the 
implanted pacemaker and/or leads.  
 
If the patient undergoes a system revision that results in:  
• a complete Accent MRI system explant with replacement of 
another Accent MRI system within the same procedure, OR 
• replacement of one or more MRI components with another 
MRI component(s), OR 
• repositioning of one or more MRI leads,  
• capping of the MRI or any other implanted lead(s),  
• plugging of a port, or 
• implant of a non-MRI lead or device, OR  
• any combination above, AND 
• at least 1 MRI component is still implanted, 
perform the testing as outlined in section 4.4.2.1.  Only MRI leads that 
are repositioned or newly implanted during the revision procedure 
need to be tested.  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 Form.  
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate has been established to be below 30 beats per minute. RV capture 
thresholds are not required if a high ventricular rate is present    
 
 
Data Submission 
Complete a Protocol Deviation form for each of the applicable items: 
capping of lead, implant of a non-MRI component, plugging a port.  
Complete and submit the forms listed below to St. Jude Medical. 
Upload device session records through the EDC study site portal.  
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
• System Revision Form 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 44 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• Adverse Event Form, if applicable   
• Deviation Form, if applicable 
• Product Out of Service Form, if applicable   
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site.   
 
• FastPath Summary 
• Test Results with Large Freezes, Include Battery & Leads 
• Wrap-up Overview with full parameters 
 
Retention and Follow Up 
Retain the patient in the study. Follow the patient as outlined in Table 
1.  
 
4.4.5.2 Pre-Discharge 
A Posterior/Anterior (P/A) and Lateral view chest x-ray of the final 
lead position must be obtained at pre-discharge to confirm the 
presence of MRI radiopaque identification markers on the leads and 
pacemaker, ensure that the radiopaque identification markers are easily 
identifiable, and to ensure no lead dislodgment or lead fracture is 
present. The x-ray must be reviewed by a radiologist and cardiologist.  
 
• Fluoroscopic, printed angiographic pictures or other methods to 
confirm lead placement are not to be used as an alternative to 
the Posterior/Anterior (P/A) and Lateral view x-rays. 
• Follow-up chest x-rays are recommended in the case of a lead 
revision per standard of practice.  
 
Document cardiac medications. Evaluate the patient for adverse 
events. Perform a device interrogation, and obtain the following 
electrical measurements for the RA and/or RV leads.  
 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 45 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 
 RA/RV sensing measurements are not required if the patient’s 
intrinsic rate has been established to be below 30 beats per minute. RV 
capture thresholds are not required if a high ventricular rate is 
present.    
 
Data Submission 
Once required testing has been performed, complete and submit the 
forms listed below to St. Jude Medical.  If an adverse event has 
occurred since the Implant, complete an Adverse Event Form. Upload 
device session records through the EDC study site portal.  Device 
session records may also be sent to St. Jude Medical, CRMD Sylmar, 
CA. 
 
• Pre-Discharge Follow Up Form 
• Adverse Event Form, if applicable 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
 
4.4.5.3 2 Month Visit (Post Implant) 
Document cardiac medications. Evaluate the patient for adverse 
events. Perform a device interrogation, and obtain the following 
electrical measurements for the RA and/or RV leads.  
 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 46 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate is established to be below 30 beats per minute. RV capture 
thresholds are not required if a high ventricular rate is present.   
  
If required testing was unable to be performed within the protocol 
specified criteria (e.g., 0.5 ms pulse width for capture thresholds) 
please reschedule the patient to return for re-testing.  If possible, bring 
the patient back for re-testing within the visit window.  
 
Data Submission 
Once required testing has been performed, complete and submit the 
forms listed below to St. Jude Medical.  If an adverse event has 
occurred since the Implant, complete an Adverse Event Form. Upload 
device session records through the EDC study site portal.  Device 
session records may also be sent to St. Jude Medical, CRMD Sylmar, 
CA. 
 
• Follow Up Form 
• Medication Log 
• Adverse Event Form, if applicable 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 47 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 
4.4.5.4 6 Month Visit (Post Implant) 
Document cardiac medications. Evaluate the patient for adverse 
events. Perform a device interrogation, and obtain the following 
electrical measurements for the RA and/or RV leads.  
 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate is established to be below 30 beats per minute. RV capture 
thresholds are not required if a high ventricular rate is present.    
 
Data Submission 
Once required testing has been performed, complete and submit the 
forms listed below to St. Jude Medical.  If an adverse event has 
occurred since the last study visit, complete an Adverse Event Form. 
Upload device session records through the EDC study site portal.  
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
• Follow Up Form 
• Medication Log 
• Adverse Event Form, if applicable 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 48 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
 
4.4.5.5 12 Month Visit (Post Implant) (and every 6 months thereafter) 
The 12 month visit must be completed in-office.  Document cardiac 
medications. Evaluate the patient for adverse events. Perform a device 
interrogation, and obtain the following electrical measurements for the 
RA and/or RV leads.  
 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate is established to be below 30 beats per minute. RV capture 
thresholds are not required if a high ventricular rate is present.      
 
For the 12 Month Visit, if required testing was unable to be performed 
within the protocol specified criteria (e.g., 0.5 ms pulse width for 
capture thresholds) please reschedule the patient to return for re-
testing.  If possible, bring the patient back for re-testing within the visit 
window.  
 
Data Submission 
Once required testing has been performed, complete and submit the 
forms listed below to St. Jude Medical.  If an adverse event has 
occurred since the last study visit, complete an Adverse Event Form. 
Upload device session records through the EDC study site portal.  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 49 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
• Follow Up Form 
• Medication Log 
• Adverse Event Form, if applicable 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
 
4.4.5.6 Unscheduled Follow-up Visits 
An unscheduled visit is defined as a visit between two specified study 
interval visits where the patient is seen in clinic due to an adverse 
event associated with the Accent MRI system.  Where possible, 
document cardiac medications, and perform a device interrogation to 
obtain the following electrical measurements for the RA and/or RV 
leads.  
 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 50 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate is established to be below 30 beats per minute. RV capture 
thresholds are not required if a high ventricular rate is present.       
 
Data Submission 
Complete and submit the forms listed below to St. Jude Medical 
Upload device session records through the EDC study site portal.  
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
• Follow Up Form 
• Medication Log, if applicable 
• Adverse Event Form 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
 
4.4.6 Follow-Up Requirements – MRI Visits 
Patients participating in the MRI portion of the study will be seen at 
the following intervals: 
 
• System Revisions, if applicable  
• MRI visit 
• 1 Month post MRI visit 
 
The MRI visit is based on the date of the successful implant or 
successful revision of the MRI lead. Please refer to section 4.4.6.2 on 
when to enroll subjects into the MRI portion of the study, and section 
4.4.6.3 on when to schedule the MRI visit.  The 1 month post MRI 
visit is based on the date of the MRI visit.   
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 52 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• MRI Discontinuation Form, if applicable 
 
It is recommended that the following completed forms be maintained 
at the site: 
• MRI Safety Screening Form  
• MRI Hazard Checklist 
 
4.4.6.3 Scheduling the MRI Visit 
Schedule the MRI visit no sooner than one week after the 2 month post 
implant visit or successful system revision procedure where the MRI 
lead was repositioned or implanted (refer to sections 4.4.6.4 and 
4.4.6.5 to determine whether the patient is eligible for a study MRI 
scan after the patient’s MRI system has been revised). 
 
4.4.6.4 System Revisions Before the MRI Visit: Scenario One 
If the patient undergoes a system revision that results in:  
• a complete Accent MRI system explant with replacement of 
another Accent MRI system within the same procedure, OR 
• replacement of one or more Accent MRI system components 
with another Accent MRI system component(s), OR 
• repositioning of one or more MRI leads,  
perform the testing as outlined in section 4.4.2.1.  Only MRI leads that 
are repositioned or newly implanted during the revision procedure 
need to be tested.  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 Form.  
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate is established to be below 30 beats per minute.  RV capture 
thresholds are not required if a high ventricular rate is present. 
 
Data Submission 
Complete and submit the forms listed below to St. Jude Medical. 
Upload device session records through the EDC study site portal.  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 53 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
• System Revision Form 
• Adverse Event Form, if applicable   
• Product Out of Service Form, if applicable   
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site.   
 
• FastPath Summary 
• Test Results with Large Freezes, Include Battery & Leads 
• Wrap-up Overview with full parameters 
 
Retention and Follow Up 
Retain the patient in the MRI component of the study. Schedule and 
perform a follow up visit 2 months after the system revision date.  
Schedule the MRI visit no sooner than one week after the 2 month post 
implant visit or successful system revision procedure where the MRI 
lead was repositioned or implanted
, and schedule the 1 Month Post 
MRI visit accordingly.   The patient is still a candidate to undergo the 
study MRI scan after the system revision procedure if all of the items 
below are met: 
 
• The patient has a complete Accent MRI™ system implanted  
• All leads and pacemaker are implanted for more than 9 weeks  
• Bipolar capture thresholds are stable at ≤ 2.5V @ 0.5 ms 
• Bipolar pacing lead impedances are within range, i.e. ≥ 200 
and ≤ 2000 ohms  
• Patient undergoes another chest X-ray to ensure no lead 
dislodgment or lead fracture is present and that the pacemaker 
and lead are labeled with the radiopaque identification marker. 
Note: The cardiologist and radiologist must confirm the 
presence of MRI radiopaque identification markers on the 
leads and PG only if a new MRI lead and/or device was 
implanted 
• There are no abandoned/capped non-Tendril MRI™ leads from 
the previous implant/explant 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 54 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
4.4.6.5 System Revisions Before the MRI Visit: Scenario Two 
If the patient undergoes a system revision that results in:  
• capping of the MRI or any other implanted lead(s),  
• plugging of a port, or 
• implant of a non-MRI lead or device, OR  
• any combination above, AND 
• at least 1 MRI component is still implanted 
perform the testing as outlined in section 4.4.2.1.  Only MRI leads that 
are repositioned or newly implanted during the revision procedure are 
required to be tested.  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 changes to 
the status of the lead and device (e.g. capped, removed) on the Product 
Out of Service form.    
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 
 RA/RV sensing measurements are not required if the patient’s 
intrinsic rate is established to be below 30 beats per minute. RV 
capture thresholds are not required if a high ventricular rate is 
present.     
 
 Data Submission 
Complete a Protocol Deviation form for each of the applicable items: 
capping of lead, implant of a non-MRI component, plugging a port.  
Complete and submit the forms listed below to St. Jude Medical. 
Upload device session records through the EDC study site portal.  
Device session records may also be sent to St. Jude Medical CRMD 
Sylmar, CA. 
 
• System Revision Form 
• MRI Discontinuation Form 
• Protocol Deviation Form 
• Product Out of Service Form 
• Adverse Event Form, if applicable   
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 55 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
It is recommended that the following device printouts and 
measurements be maintained at the site.   
 
• FastPath Summary 
• Test Results with Large Freezes, Include Battery & Leads 
• Wrap-up Overview with full parameters 
 
Retention and Follow Up 
Discontinue the patient from the MRI component of the study by 
completing an MRI Discontinuation form.  However, retain the patient 
in the lead safety portion of the study. Bring the patient back for 
follow up as outlined in Table 1 for the 2 Month visit, if applicable, 
and all remaining study visits for the lead safety portion of the study.  
 
4.4.6.6 MRI Visit  
IMPORTANT NOTE: For patients participating in the MRI portion 
of the study, prior to the MRI visit, if the patient underwent a system 
revision that resulted in  
• capping of the MRI lead(s),  
• plugging of a port, or 
• implant of a non-MRI lead or device, OR  
• any combination above, 
the patient is not eligible to undergo a study MRI Scan.  Do not 
proceed with any of the tests listed for the MRI Visit.  If not already 
done, discontinue the patient from the MRI component of the study.  
Refer to section 4.4.6.5 for further details. 
 
Otherwise, follow the procedures outlined below for the MRI Visit. 
 
Cardiac Medications and Pregnancy Testing 
Document all cardiac medications. Administer a pregnancy test to all 
female patients of childbearing potential. 
 
Pre-MRI Scan: Pacemaker Device Measurements 
Evaluate the patient for adverse events. Perform a device interrogation, 
and obtain the following electrical measurements for the RA and/or 
RV leads.  
 
• Manual unipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 56 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter. If the RA 
capture and sensing thresholds could not be obtained due to a 
patient’s atrial fibrillation or flutter, and if the patient’s atrial 
fibrillation or flutter is transient, for data analysis purposes, the 
pacing capture threshold and sensing threshold from the next study 
visit, if available, will be used. 
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate is established to be below 30 beats per minute. RV capture 
thresholds are not required if a high ventricular rate is present.      
 
If required testing was unable to be performed within the protocol 
specified criteria (e.g., 0.5 ms pulse width for bipolar capture 
thresholds, the change in the ventricular and/or atrial bipolar capture 
threshold is > 0.5 V at 0.5 ms since the last study visit), please 
reschedule the patient to return for re-testing.  The patient’s follow up 
schedule may need to be revised depending on the nature of the 
missing data. Please contact St. Jude Medical personnel to 
determine if the patient’s follow up schedule needs to be revised. 
Do not proceed any further with the procedures below.  
 
 
Data Submission 
Once required testing has been performed, complete and submit the 
forms listed below to St. Jude Medical.  If an adverse event has 
occurred since the last study visit, complete an Adverse Event Form. 
Upload device session records through the EDC study site portal.  
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
• MRI Visit Follow Up Form 
• Medication Log 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 57 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• Adverse Event Form, if applicable 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
 
If all device measurements were obtained per protocol, proceed with 
the rest of the procedures as indicated below. 
 
Pre-MRI Safety Screening Assessment 
Prior to the MRI scan, complete an MRI Safety Screening assessment 
to ensure compliance with inclusion/exclusion criteria for the study for 
patients who previously have not consented to participate in the MRI 
Phase of the  study.  For patients who were previously randomized to 
the MRI Control Group, the MRI Safety Screening assessment does 
not need to be completed again. (Please see Appendix A). The 
radiologist or a designated radiological staff member must determine 
the patient’s eligibility for an MRI scan prior to the MRI scan (per 
standard of practice). However, the pacemaker contraindication item 
on the checklist does not apply if the patient is implanted with the St. 
Jude Medical Accent MRI system and is currently enrolled in this 
clinical study.  
 
Complete the following forms: 
• MRI Safety Screening Form (only applies to newly consented 
patient who did not previously receive a randomization 
assignment under prior versions of the protocol). 
• MRI Hazard Checklist 
 
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 
• Device and Leads are labeled for MRI 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 59 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Note: the St. Jude Medical Merlin programmer and MRI Activator are 
not MRI safe and must be used for programming purposes outside of 
the American College of Radiology (ACR) defined Zone 4 (magnet 
room).   
 
Set up pulse oximetry and an ECG per standard of care. Capture a real-
time ECG/EGM at 25mm/sec.   
 
The MRI scans are not intended to be diagnostic in nature and 
therefore the administration of contrast fluids or sedation, or the 
application of saturation bands or water and fat saturation techniques 
are not permitted. Multiple MRI scans will be conducted for a total 
magnet duration of approximately 60 minutes.  Please review 
Appendix B for MRI scan sequences. 
 
During the MRI scan sequences, if patient movement causes distortion 
(documented by a radiologist) on the MRI, the MRI scan will not be 
repeated (the scan is not meant to be diagnostic) unless it is a clinical 
scan sequence being performed for image artifact assessment for the 
MRI study. 
 
Position MRI compatible surface electrodes to continuously monitor 
the patient’s heart rate.  During the MRI scan, for monitoring 
purposes, take pulse oximetry measurements and an ECG.  Visually 
examine the ECG during the MRI scan.  Note any abnormalities 
observed in the cardiac rhythm. After the MRI scan, remove the 
patient from the MRI field. 
 
Pre-MRI Scan System Checks Summary  
• Verify that all items on the pre-MRI safety screening form are 
satisfied for the patient 
• Patient must have a St. Jude Medical Accent MRI lead system 
implanted, which can be verified by the Patient ID card, patient 
records, or the radiopaque identification markers on the 
pacemaker and leads as shown on X-ray.  
• The Tendril MRI lead(s) have stable bipolar capture thresholds 
at ≤ 2.5 V@ 0.5 ms.  
• Only Tendril MRI leads are allowed (No additional hardware – 
adaptors, extenders, or abandoned leads) 
• Leads are electrically intact. Check that no lead fractures or 
other damage to the leads has occurred. Bipolar pacing lead 
impedance is within range, i.e. ≥ 200 and ≤ 2000 ohms 
• Patient is not pregnant (All women of child bearing age must 
undergo a pregnancy test prior to the MRI Scan) 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 60 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 
MRI Scan 
After confirmation by the electrophysiologist or device specialist that 
all pre-MRI system checks (mentioned above) have been met, patients 
will have their MRI scan completed by a radiology staff member.  
Protocol required MRI scan sequences for each patient undergoing an 
MRI scan are described in detail in Appendix B.  
 
Non-Clinical MRI Scans 
The goal is to have the patient complete all aspects of testing in 
Appendix B for the non-clinical scans. Multiple MRI scans will be 
conducted, and the patient may be in the bore or near the vicinity of 
the magnet for a total magnet duration of approximately 60 minutes. 
The minimum amount of scan time that the patient needs to complete 
is 30 minutes. Consult the MRI procedure information manual for 
guidelines and precautions. 
 
NOTE: The non-clinical MRI scan is being performed to demonstrate 
safety and MRI compatibility of the Accent MRI system for an MRI 
scan, and is not meant to be diagnostic in nature. The MRI scan will 
not be read by the radiologist.   
 
Clinical MRI Scans 
In addition to the non-clinical MRI scan, at least 20 clinical scans will 
be performed to collect information on image quality and artifact as 
outlined in Appendix B.  Depending on the area being scanned, the 
scan duration time is approximately 5-10 minutes.  Consult the MRI 
procedure information manual for guidelines and precautions. 
 
The clinical MRI scan is being performed to assess image quality and 
artifact.  The MRI scan should be reviewed for obvious abnormalities 
by a radiologist, and reported to the patient’s physician (per standard 
of care by the facility performing the MRI scan). A copy of the 
documentation of the abnormality discovered on the MRI scan should 
be kept in the patient’s file.  The review of the MRI scan is not meant 
to be diagnostic.   
 
Cardiac Monitoring during the MRI scan 
During the entire MRI scan, the patient’s cardiac function must be 
monitored using pulse oximetry and an ECG by an Accent MRI 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 patient must also take place to assess and/or 
confirm any clinically significant changes noted in the patient’s 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 61 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
oxygen saturation or heart rate, as well as any clinically significant 
complaints not obvious with pulse oximetry.  Record these changes 
and complaints during the 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 patient’s hemodynamic 
function is compromised during the MRI scan, discontinue the MRI 
procedure and take proper measures to restore the patient’s 
hemodynamic function.   
 
Life–threatening Ventricular Arrhythmia and Asystole 
Assessment 
Monitoring of spontaneous ventricular arrhythmias and asystole must 
be conducted via an ECG during the MRI scans. Any sustained 
ventricular arrhythmias or asystole 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 one time) while the patient is actively being 
scanned, report the event on an Adverse Event form. 
 
Definitions: 
• Sustained Ventricular Arrhythmia: Heart Rate  >150bpm for > 
30 seconds 
• Asystole: A standstill > 6 seconds in electrical activity of the 
heart (i.e., no heart rate for 6 seconds or more) 
 
Handling of Patients Unable to Tolerate an MR Scan  
In cases where the scan cannot be tolerated by the patient, remove the 
patient from the scanner. Assess the patient for possible adverse 
events, and treat the patient’s reported symptoms according to your 
institution’s standard of practice.  Note the reason for the intolerance. 
At a minimum, information related to the sequence used to perform the 
scan, the length of time the patient 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. 
 
Test the patient’s device as outlined below.  
 
Post-MRI Scan Testing 
Immediately following the MRI scan, restore the original programmed 
values on the pacemaker by pressing the red button on the MRI 
Activator.  Interrogate the pacemaker and confirm the original 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 62 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
programmed values have been restored.  Obtain the following 
electrical measurements for the RA and/or RV leads.  
 
• Manual unipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter.  
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate is established to be below 30 beats per minute. RV capture 
thresholds are not required if a high ventricular rate is present.    
 
Reporting of MRI Scan-Related Adverse Events  
Adverse events 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 adverse events related to or caused by the MRI scan are 
appropriately captured, before starting the scan, verbally instruct the 
patient 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, blood pressure, room air blood oxygen 
saturation, and/or respiration rate that occur during the MRI scan that 
may suggest an AE has occurred due to clotting, pulmonary embolus 
or related to lead tip or device pocket heating. 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 63 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
If symptoms during or immediately after the MRI scan suggest that an 
AE 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 patient reports pocket discomfort, ask the patient 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 AE if the patient experiences a significant rise in 
pacing threshold (as defined in section 4.4.6.6 of the study protocol) 
from pre-MRI scan to one month post-MRI scan.   
 
Data Submission 
Once required testing has been performed, complete and submit the 
forms listed below to St. Jude Medical.  If an adverse event has 
occurred since the last study visit, complete an Adverse Event Form. 
Upload device session records through the EDC study site portal.  
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
If possible, export the study MRI scan onto a CD, DVR or other form 
of electronic media, and send to St. Jude Medical. 
 
• MRI Scan Group Testing Form 
• MRI Survey Form 
• MRI Scan Image for image artifact/image quality analysis (St. 
Jude Medical will notify sites of when to submit the scan) 
• Adverse Event Form, if applicable 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 64 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
 
 
4.4.6.7 1 Month Post-MRI Visit  
For all patients enrolled in the MRI portion of the study, document 
cardiac medications. Evaluate the patient for adverse events. Perform a 
device interrogation, and obtain the following electrical measurements 
for the RA and/or RV leads.  
 
• Manual unipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Manual bipolar capture threshold at a pulse width of 0.5 ms 
using the Decrement Threshold test method. Pace at least three 
cycles per step, and confirm at least three consecutive beats 
have capture before recording the capture threshold results. 
• Bipolar sensing amplitude using the Incremental Test Method. 
Set the required sensed beats to at least 3 cycles per step. 
Confirm at least three consecutive beats are sensed before 
recording the sensing threshold results. 
• Bipolar lead impedance 
 
Note: RA lead measurements are not required if a single chamber 
device is implanted. RA capture and sensing thresholds are not 
required if a patient is in atrial fibrillation or atrial flutter. If the RA 
capture and sensing thresholds could not be obtained due to a 
patient’s atrial fibrillation or flutter, and if the patient’s atrial 
fibrillation or flutter is transient, for data analysis purposes, the 
pacing capture threshold and sensing threshold from the next study 
visit, if available, will be used. 
 
RA/RV sensing measurements are not required if the patient’s intrinsic 
rate is established to be below 30 beats per minute. RV capture 
thresholds are not required a high ventricular rate is tracking present.   
 
If required testing was unable to be performed within the protocol 
specified criteria (e.g., 0.5 ms pulse width for capture thresholds) 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 65 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
please reschedule the patient to return for re-testing.  If possible, bring 
the patient back for re-testing within the visit window.  
 
Data Submission 
Once required testing has been performed, complete and submit the 
forms listed below to St. Jude Medical.  If an adverse event has 
occurred since the last study visit, complete an Adverse Event Form. 
Upload device session records through the EDC study site portal.  
Device session records may also be sent to St. Jude Medical, CRMD 
Sylmar, CA. 
 
• Follow Up Form 
• Medication Log 
• Adverse Event Form, if applicable 
• Protocol Deviation Form, if applicable 
• Product  Out of Service Form, if applicable 
• Death Form, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following device printouts and 
measurements be maintained at the site. 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
 
4.4.6.8 Non-Study MRI Scan 
A non-study MRI scan is defined as a scan occurring at any time 
following enrollment up to the completion of the study, excluding the 
MRI scan performed during the MRI 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 visit 
should be followed. However, if procedures or data are not followed or 
collected as presented on the non-study MRI 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 patient’s physician (per standard of 
care by the facility performing the MRI scan).  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 66 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 
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 Events 
• Device diagnostics, if available 
• MRI Scan report, if available 
• Fast Path Summary, if available 
 
Data Submission 
If the patient undergoes a non-study MRI scan at any time during the 
study, please complete and submit the forms listed below 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. 
 
• Non-study MRI Scan Form 
• Adverse Event Form, if applicable 
• Death, if applicable 
• Withdrawal Form, if applicable 
 
It is recommended that the following forms, device printouts and 
measurements be maintained at the site. 
• MRI Safety Screening Form  
• MRI Hazard Checklist 
• FastPath Summary  
• Test Results with Large Freezes, Include Battery & Leads  
• Wrap-up Overview with full parameters 
 
 Protocol Deviations 
Investigators are required to adhere to the investigational plan, signed Investigator’s 
Agreement, applicable federal (national) or state/local, laws and regulations, and any 
conditions required by the IRB/MEC or applicable regulatory authorities. 
 
A protocol deviation is used to describe situations in which the clinical protocol was 
not followed.  All deviations from the investigational plan must be reported to St. 
Jude Medical per 21 CFR §812.150.  In addition, all deviations must be reported to 
the reviewing IRB per the IRB’s reporting requirements.  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 67 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 
The investigator must notify St. Jude Medical and the reviewing IRB of any deviation 
from the investigational plan to protect the life or physical well-being of a patient in 
an emergency as soon as possible, but not later than 5 working days after the 
deviation has occurred, or no later than 5 working days after the investigator becomes 
aware of the deviation.   
 
 Adverse Events 
A Clinical Events Committee (CEC) will review and adjudicate all Adverse Events.  
The CEC will base their final adjudication on the information provided on the case 
report forms, medical records, and their clinical knowledge and experience.  
 
Adverse events (AEs) are any unfavorable clinical event which impacts, or has the 
potential to impact the health or safety of a patient caused by or associated with a 
study device or intervention. Adverse events will be classified as complications or 
observations.  
 
Complications: Adverse events that require invasive intervention (e.g. lead 
dislodgment requiring repositioning). 
 
Observations: Adverse events that can be managed without invasive intervention 
(e.g., oversensing or loss of pacing capture, which is remedied by reprogramming of 
the pacemaker).  
 
Should an adverse event occur, complete an Adverse Event form and submit to St. 
Jude Medical. Report the adverse event to the IRB/MEC per the IRB/MEC policy. 
Any explanted devices or leads should be returned to St. Jude Medical for analysis.  
 
Unavoidable AE: An unavoidable AE is defined as an adverse event related to the 
implant procedure or the MRI scan that is expected to occur for a projected duration 
in all patients.  Unavoidable AEs are not reportable unless the condition worsens or 
continues beyond the time frame listed below.  Unavoidable AEs, listed below, do not 
need to be reported if they are resolved within the time frame specified. 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 68 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Table 6: Unavoidable AEs related to the Implant Procedure 
Event 
Time Frame post-Implant 
Anesthesia related nausea/vomiting 
<24 hours 
Low-grade fever (<100 degree Fahrenheit fever or < 
37.8 degree Celsius 
< 48 hours 
Pocket site/incision pain 
< 72 hours 
Mild to moderate bruising/ecchymosis at pocket site 
< 72 hours 
Sleep problems (insomnia) 
< 72 hours 
Back pain related to laying on the table 
< 72 hours 
 
 
Table 7: Unavoidable AEs 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 
Hearing impairment 
< 24 hours 
Body stiffness related to immobility 
< 48 hours 
 
 
Definitions of AE relatedness: 
 
Pacing system related: An AE that results from the presence or performance of 
the system under investigation. 
 
Implant procedure related: An AE that occurs due to the implant procedure. 
 
MRI scan related: An AE which is caused by the interaction between the 
investigational pacing system and the MRI system that occurs during the MRI scan 
and includes the time the patient is within the 5 Gauss line of the MRI system and up 
through the patient’s 1 month post MRI scan follow up visit.  In addition, AE’s 
occurring due to the patient’s MRI programming will be considered MRI scan 
related. 
 
Potential MRI System Adverse 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 patient 
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: 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 69 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• the system to fail to detect or treat irregular heartbeats   
• 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 
• Competitive pacing and potential for VT/VF induction due to ambulatory 
asynchronous pacing in MRI mode 
• Pulmonary Embolism 
 
Potential Pacing System Adverse Events: 
• Air embolism 
• Body rejection phenomena 
• Cardiac tamponade or perforation 
• Hematoma, bleeding hematoma, seroma 
• Formation of fibrotic tissue; local tissue reaction 
• Inability to interrogate or program due to programmer or device malfunction 
• Infection/erosion 
• Interruption of desired pulse generator function due to electrical interference 
either electromyogenic or electromagnetic 
• Loss of capture or sensing due to lead dislodgement or reaction at the 
electrode/tissue interface 
• Loss of desired pacing and/or sensing due to lead displacement, body reaction at 
electrode interface, or lead malfunction (fracture or damage to insulation) 
• Lead malfunction due to conductor fracture or insulation degradation 
• Loss of normal pacemaker function due to battery failure or component 
malfunction 
• Pacemaker migration, pocket erosion 
• Pectoral muscle stimulation 
• Phrenic nerve or diaphragmatic stimulation 
• Pneumothorax/hemothorax 
• Endocarditis 
• Excessive bleeding 
• Induced atrial or ventricular arrhythmias 
• Myocardial irritability 
• Pericardial effusion 
• Pericardial rub 
• Pulmonary edema 
• Rise in threshold and exit block 
• Valve damage 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 70 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
Potential lead related adverse events 
• Cardiac tamponade 
• Diaphragmatic/phrenic nerve stimulation 
• Embolism 
• Excessive bleeding 
• Induced ventricular ectopy 
• Infection 
• Loss of pacing and/or sensing due to dislodgement or mechanical malfunction of 
the pacing lead 
• Thrombosis 
 
Complications reported with direct subclavian venipuncture include pneumothorax, 
hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, 
thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, 
death. 
 
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 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 patients.   
 
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. 
 
Should St. Jude Medical determine, either through physician reports or in-house 
testing, that an unanticipated adverse event presents an unreasonable risk to 
participating patients, St. Jude Medical will suspend the clinical investigation and 
notify all participating investigators, IRBs/MECs and the FDA.  
6.1 Data Safety Monitoring Board (DSMB) 
An independent, unblinded DSMB will be established to review safety data.  
The DSMB will consist of at least 3 members with study-related backgrounds.  
Members will include at least one statistician, one cardiologist and one 
radiologist or cardiologist with MRI experience.  St. Jude Medical will 
appoint members of the DSMB and the chairperson. St. Jude Medical may 
facilitate the DSMB meeting, but will not be voting members. 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 71 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 Other Reported Events 
Other Reported Events are any other clinical event that is submitted by the 
investigator which is not caused by or associated with the study device and/or system 
component(s) and/or defined as an Adverse Event in section 6.0.  
 
 Deaths 
A Mortality Committee will review and classify all patient deaths.  All patient 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 (Patient Death form, Patient Withdrawal form, and Product Out of Service 
form). It is the investigator’s responsibility to notify the IRB/MEC per the IRB/MEC 
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 patient’s 
course since enrollment in the study: 
 
• Date and time of death 
• Place death occurred (e.g. hospital, nursing home, patient’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 patient’s next of kin. Provide clinical notes and 
witness statements. If possible, interrogate the pacemaker. Retrieve and print all 
episode diagnostics, IEGMs, and programmed parameters. If applicable, the 
pacemaker should then be programmed OFF.  
 
Every attempt should be made to explant the pacemaker and/or leads intact. Any 
explanted devices or leads should be returned to St. Jude Medical for analysis 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 72 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
promptly. In the event that the device is not explanted, the above procedure must be 
followed to retrieve the data. The reason the pacemaker and/or lead(s) are not being 
returned to St. Jude Medical must be stated clearly on the case report form. 
 
 Withdrawals 
Withdrawal is defined as termination of participation of a patient from a clinical trial. 
All reasonable efforts should be made to retain the patient in the clinical trial until 
completion of the clinical trial. Reasons for withdrawal include, but are not limited to 
the following: 
• Patient Death  
• Patient and/or Family Request 
• Patient Lost to Follow-Up: Patient will be considered “lost to follow-up” after a 
minimum of 2 documented phone calls by personnel at the investigational center 
to the patient or emergency contact and a certified letter is sent to the last known 
address 
• Patient Participation terminated by Investigator 
• Sponsor Request 
• Unsuccessful Implant 
• If a system explant occurs without replacement of an Accent MRI™ system and 
an MRI scan has not been performed after implant.   
 
A WITHDRAWAL Case Report Form should be completed and sent to St. Jude 
Medical CRMD, Sylmar, CA.   
 
 Risk Analysis 
The risks associated with the use of the Accent MRI™ system are anticipated to be 
comparable to those associated with the use of other currently available pacemakers 
and leads. Patients participating in this study are indicated for a pacemaker as part of 
their standard medical management and are patient to the risks associated with these 
devices (refer to Section 6.0). 
 
Risks normally associated with pacemakers, transvenous leads and their implant 
procedure will be minimized in the MRI study by selecting investigators who are 
experienced in treating patients indicated for pacemakers, who have experience with 
the procedures required to implant pacemakers and leads, and who are trained in the 
Accent MRI Pacemaker and Tendril MRI Lead IDE Study. In addition, investigators 
will be actively involved in the implantation and follow-up of the patients implanted 
with the pacemaker system. 
 
Risks will be minimized by careful assessment of each patient prior to, during and 
after implant of the pacemaker.  After implantation, patients in the MRI study will be 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 73 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
followed at regular intervals to monitor the condition of the implanted system and the 
battery.  At each follow up, the pacemaker must be interrogated to verify appropriate 
pacemaker function and to evaluate pacing and sensing characteristics and to assess 
any adverse events.   
 
In order to safely perform an MRI scan on a patient with the Accent MRI system, the 
physician/clinician should do the following as stated in the MRI Procedure 
Information for the St. Jude Medical® MR Conditional pacing system: 
 
• Review the MRI Conditional Contraindications   
• Review the MRI Procedure Considerations  
• Verify the Presence of Additional Hardware   
• Select and Save MRI Setting  
• Review the Checklist and Enable MRI Setting Using the Merlin® PCS   
• Review the Checklist and Enable the Use of the St. Jude Medical MRI 
Activator® handheld device   
• Patient receives the MRI Scan  
• Disable MRI Setting Using the Merlin® PCS  
 
Also, during the MRI scans the Patients will be monitored by a health care 
professional to further reduce risks. 
 
 Investigator Information 
This clinical investigation will be conducted by investigators with experience and/or 
willingness to be trained in the use of the device therapy for the treatment of 
bradyarrhythmias and an MRI Environment. A principal investigator should have 
experience in and/or will be responsible for: 
 
• Conducting the clinical investigation in accordance with the signed 
agreement with St. Jude Medical, the investigational plan, all 
applicable FDA regulations (21 CFR Parts 50, 54, 56, 812), GCP 
guidelines, and any conditions of approval imposed by the IRB/MEC 
• Providing signed Investigator/Co-Investigator (s) Agreement  
• Providing signed Financial Disclosure Form for Clinical Investigators  
• Providing IRB/MEC Approved Informed Consent  
• Collection and archiving of data obtained pursuant to the requirements 
of the investigational plan during the course of the study and after the 
study has been completed 
• Strict adherence to the Investigational Plan testing requirements.  

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 74 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
• Screening and selecting appropriate Patients 
 
It is acceptable for the principal investigator to delegate one or more of the above 
functions to an associate or co-investigator, however, the principal investigator 
remains responsible for the proper conduct of the clinical investigation, complying 
with the investigational plan and collecting all required data. In clinical investigations 
involving active implantation of an investigational product, the investigation is not 
transferable to other implant centers attended by the investigator unless prior approval 
is obtained from St. Jude Medical. 
 
 Monitoring Procedures 
St. Jude Medical will serve as the “sponsor” of the MRI Study clinical investigation.  
It is the responsibility of St. Jude Medical as the “sponsor” of the study to ensure 
proper monitoring of the investigation and to see that all the clinical requirements are 
met. 
 
Prior to beginning the study, a St. Jude Medical monitor will contact the investigator 
or designee to discuss the investigational plan and to review the data requirements in 
detail. A St. Jude Medical monitor will visit the investigator or designee periodically 
during the study to monitor progress, to assist in gathering the required data and to 
answer any questions. During these visits, the clinical monitor will review the 
patient’s records to verify that all records and files are up to date, and to assure 
compliance with all requirements of the protocol and FDA regulations.  
 
The investigator will make patient and study records available to the clinical monitor 
for periodic inspection. Clinical monitoring will be conducted under the St. Jude 
Medical standard operating procedure 9.4.3 (Clinical Monitoring Procedure).  
 
Responsibility for overall study management will be held by the Sr. VP of Clinical 
Affairs, St. Jude Medical, CRMD.   
 
Clinical Affairs 
St. Jude Medical CRMD 
15900 Valley View Court 
Sylmar, CA 91342 
TEL: 
 
FAX: 
 
 
FDA Inspections 
The investigator and /or designee should contact St. Jude Medical in Sylmar, CA 
within 24 hours upon being notified of an impending FDA inspection. A clinical 
monitor may assist and review study documentation with the investigator and/or 
designee to prepare for the audit. 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 75 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 
An investigator shall permit authorized FDA employees, at reasonable times and in a 
reasonable manner, to enter and inspect any establishment where investigational 
devices are used and to inspect and copy all records relating to an investigation. 
 
An investigator shall permit authorized FDA employees to inspect and copy records 
that identify patients, upon notice that FDA has reason to suspect that adequate 
informed consent was not obtained, or that reports required to be submitted by the 
investigator to the sponsor or IRB have not been submitted or are incomplete, 
inaccurate, false, or misleading. 
 
 Labeling 
(Please refer to User’s Manual and MRI Procedure Information document)  
 
 Consent Materials 
See attached consent in Appendix C. 
 
Failure to obtain informed consent from a patient prior to study enrollment should be 
reported to St. Jude Medical within 5 working days and to the reviewing IRB 
consistent with the IRB’s reporting requirements. 
 
 IRB Information 
IRB approval for the study and informed consent will be required prior to beginning 
the study. A copy of the IRB approval and corresponding informed consent must be 
forwarded to St. Jude Medical prior to authorization of the institution to begin the 
study.  Any withdrawal of IRB approval should be reported to St. Jude Medical 
within 5 working days of the withdrawal of approval. 
 
Institutional Review Board (IRB) for participating Institutions 
A list of IRBs for Institutions participating in the Clinical Investigation will be 
provided upon request. 
 
 Other Institutions 
The name and address of each institution, at which a part of the investigation may be 
conducted, that has not been identified under IRB information, will be provided upon 
request. 
 

 
  
  
  
 
Investigational Plan 
MRI Study 
Page 76 
July 10, 2014 
 
CONFIDENTIAL 
60028820/K 
 
 Records and Reports 
Clinical investigators of St. Jude Medical investigational products are required to 
maintain records, prepare and submit reports , and permit FDA Bioresearch 
Monitoring Inspections relating to the investigator’s participation in and conduct of 
the study, as described in 21 CFR §812.150. St. Jude Medical will provide 
demographic and safety data to the FDA on an annual basis.   
17.1 Custody 
An investigator may withdraw from the responsibility to maintain records for 
the period required and transfer custody of the records to any other person 
who will accept responsibility for them as described, including the 
requirements regarding FDA inspection. Notice of transfer shall be given to 
St. Jude Medical and FDA no later than ten working days after transfer 
occurs. 
17.2 Retention Period 
Clinical investigators of St. Jude Medical investigational products are required 
to maintain records during the investigation and for a period of two years after 
the latter of the following two dates: the date on which the investigation is 
terminated or completed, or the date that the records are no longer required for 
purposes of supporting a premarket approval application or a notice of 
completion of a product development protocol. 
 
 Publication 
This study will be posted on ClinicalTrials.gov and results will be posted on 
ClinicalTrials.gov as required.  The clinicaltrials.gov identifier is NCT01576016.

Investigational Plan 
MRI Study 
Page 77  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 Appendix A: MRI Screening Checklist 
Example of Pre-MRI Safety Screening form18,19 from the American College of Radiology 
Blue Ribbon Panel on MRI Safety.  
  
 
 
 

Investigational Plan 
MRI Study 
Page 78  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Safety Screening Form for  
Magnetic Resonance Imaging Procedure 
 
Site Name: ______________________________________________________________    
  
Patient ID: ______________________________________________________________    
 
check one: □ MRI Phase Screening   □ MRI Visit      □ MRI Phase Screening + MRI Visit on same day 
   
Questions to ask Patient 
 
YES  NO 
1. Why are you having this examination (medical problem)? – Participating in MRI Phase of MRI Study?....... 
 
____  ____ 
2. Have you ever had an MRI examination before and had a problem? …………………………………….….. 
 
____  ____ 
 
If YES, please describe__________________________________________________________________ 
 
 
  
3. Have you ever had a surgical operation or procedure of any kind? ……………...…………….………….…. 
 
____  ____ 
 
If YES, please list all prior surgeries and dates 
(any surgeries that resulted in the use of metallic material that is not MRI compatible at ≥4 W/kg or 
is not MRI safe that remains implanted in the patient disqualifies the patient for participation in the MRI Phase):  
 
 
 
 
_____________________________________________________________________________________ 
 
 
 
 
_____________________________________________________________________________________ 
  
  
 
4. Have you ever been injured by a metal object/foreign body (e.g., bullet, BB, shrapnel) or have metal in 
your eyes? ………………………………………………………………………………………..…………... 
 
____  ____ 
If YES, was the metal removed?........................................................................................................................   
____  ____ 
5. Do you have any drug allergies that would prevent you from getting the study MRI scan? ............................ 
 
____  ____ 
 
If YES, please list drugs _________________________________________________________________ 
 
  
 
6. Are you a female of child-bearing potential?  If “yes” complete questions 7-9……………………..……… 
 
____  ____ 
7. Are you pregnant or suspect you may be pregnant? .………………………………………….……...…….. 
 
____  ____ 
8. Are you breast-feeding?
 (Answering YES does not disqualify patient for participation in the MRI Phase.)…………………………………... 
 
____  ____ 
9. Date of last menstrual period____________________ 
 
  
 
 
 
 
 
 
 
The purpose of this form is to ensure the patient meets the criteria to undergo the study MRI scan(s). All 
information on this form should be verifiable against the patient’s medical records and/or study records. 
Complete this form for each patient enrolled into the MRI Phase.  A second form should be filled out at the time 
of the MRI Visit.  If screening for the MRI Phase was done on the same day as the MRI Visit, a second form is 
not required to be completed.   
 
YES may be answered for some of the questions above, but does not disqualify the patient for enrollment into 
the MRI Phase.  If YES has been answered to any of the questions above, has it been verified that the patient is 
currently eligible for an MRI scan per the protocol requirements? 

Investigational Plan 
MRI Study 
Page 79  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
□ Yes, the patient IS eligible for a study MRI 
scan(s). 
□ 
The patient is NOT eligible for a study MRI 
scan(s). 
 
Study Personnel Completing Form: 
 
Print Name:__________________________ Signature:________________________ Date:________________ 
 
 
 
 

Investigational Plan 
MRI Study 
Page 80  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Sample MRI Hazard Checklist 
 
THE FOLLOWING ITEMS MAY BE HARMFUL TO YOU DURING YOUR MRI SCAN OR MAY 
INTERFERE WITH THE MRI EXAMINATION 
Please mark on the drawings provided the location of any metal inside your body or site of surgical operation.  
 
You must provide a Yes or No for every item. Please indicate if you have or have had any of the following?  
 
 
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.  
YES   NO 
____ ____Any type of electronic, mechanical or magnetic implant (Type ________) 
____ ____Cardiac pacemaker (Accent MRI pacemaker is OK) 
____ ____Aneurysm clip(s) 
____ ____Implantable cardiac defibrillator 
____ ____Neurostimulator 
____ ____Biostimulator (Type______________) 
____ ____Any type of internal electrode(s) or wire(s) (Tendril MRI leads are 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) 
____ ____Any hair accessories (e.g., bobby pins, barrettes, clips) 
____ ____Jewelry 
____ ____Any other type of implanted item (Type____________________) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Investigational Plan 
MRI Study 
Page 81  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
I attest that the above information is correct to the best of my knowledge. I have read or have had the questions read to me, 
understand the entire contents of this form, and I have had the opportunity to ask questions regarding the information on this 
form. 
           Patient signature______________________________________________________________________________ 
 
 
This document is not a substitute for medical records or a source document and is intended as a checklist to ensure the 
patient is able to undergo a study scan.  The form that is dated closest to and on or before the MRI Visit will be used as 
the form of record for the MRI Phase of the study. Complete a form for each patient enrolled into the MRI Phase of the 
study. 
 
A YES to one or more of the questions above does not automatically disqualify the patient from participating in the MRI 
Phase.  If YES has been answered to any of the questions above, ensure that all removable items are removed, and that 
implanted materials or devices can be scanned according to the study protocol, i.e. per protocol inclusion/exclusion criteria 
and protocol procedures - the material or device(s) can undergo an MRI scan at a specific absorption rate (SAR) of 4 W/kg 
or higher in addition to any other conditions specified by the manufacturer of the material or device.   
Check one: □
 
The patient is eligible for the study MRI scans.          
 □
 
The patient is NOT eligible for the study MRI scan. 
 
Study Personnel Completing Form  
 
 Print Name:___________________________________________________  
 
 Signature:_____________________________________________________ Date__________________________ 
 
 
Hazard Checklist for Radiology Personnel 
 
For MRI Site Use Only  
□
 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 section. If one is used, provide a copy 
to Cardiology for maintenance in the study records. Include the patient ID and Date that form was completed. It is expected that the 
patient should not have any of the items below. 
 
YES NO  
YES NO  
___ ___ 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 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Is the patient cleared to undergo an MRI scan per your center’s standard of practice?  
□ 
Yes, the patient meets criteria to undergo an MRI scan per standard of practice. 
 
Radiology Personnel Completing Checklist (MRI Personnel Section) 
 
 
 Print Name:________________________________ Signature___________________________ Date:__________ 

Investigational Plan 
MRI Study 
Page 82  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 Appendix B: MRI Scan Sequences 
The following are instructions and guidelines for performing MR scans for the MRI 
study. Updated instructions and/or sequences for the non-clinical and clinical scans 
may be provided to study centers by St. Jude Medical under separate cover. 
 
 

Investigational Plan 
MRI Study 
Page 88  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
4 W/kg Whole Body SAR Non-Clinical Scan Sequence Instructions 
 
1. Introduction 
The purpose of having patients implanted with an Accent MRI system undergo an MRI scan 
is to demonstrate the MRI scan will not adversely affect the functionality of the Accent MRI 
system.  To do so, the Accent MRI system will be exposed to two worst case MRI scan 
scenarios, one involving an RF intensive MRI scan sequence at 4 W/kg whole body SAR 
level, and one involving a gradient intensive MRI scan sequence.  The goal is not to obtain 
images for diagnostic purposes, but to expose the implanted Accent MRI system to two 
severe testing scenarios. The parameters relevant for the MRI system selection and selected 
scan sequences will be discussed in detail.  
 
The MRI scans are not intended to be diagnostic in nature and therefore the administration of 
contrast agents or sedation, or the application of saturation bands or water and fat saturation 
techniques are not permitted. During the MRI scan sequences, if patient movement causes 
distortion on the MRI, do not repeat the MRI scan (the scan is not meant to be diagnostic). 
 
2. Patient Screening and Safety 
The patient presenting for this MRI scan has been pre-screened by the cardiology team to 
ensure the patient has met the criteria set by St. Jude Medical to undergo an MRI scan for the 
MRI Study.  This includes review and verification of the following: 
 
Pacemaker Device Requirements: 
• Bipolar capture thresholds are stable at  ≤2.5V@ 0.5 ms 
• Bipolar pacing lead impedance is within range, i.e.  ≥ 200 and ≤ 2000 ohms 
• Device and Leads are labeled for MRI 
• No additional hardware (adaptors, extenders, or abandoned leads) 
 
MRI Scan Equipment Requirements: 
In additon to the screening above, before proceeding with any MRI scans, ensure the patient 
is not contra-indicated for an MRI scan, and that the MRI scanner meets the criteria below.    
• Scanner Manufacturer: General Electric (GE), Siemens or Philips with the 
following operating characteristics:  
• Horizontal closed bore scanner working in  
• Normal Operating Mode or  
• First Level Controlled Operating Mode 
• with Whole Body Specific Absorption Rate (SAR) ≤ 4.0 W/kg 
• and Head SAR ≤ 3.2 W/kg 
• A static magnetic field strength of 1.5 Tesla  
• Maximum gradient slew rate of 200 T/m/s per axis 
• An RF excitation frequency in the range of 63.75 ± 0.5 MHz 
(corresponding to 1.5 Tesla scanners using hydrogen-based imaging) 
 

Investigational Plan 
MRI Study 
Page 90  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 
There are two sequences prescribed for each scanner (GE, Philips, Siemens) to achieve the 
required RF intensive exposure.  Only ONE (1) RF intensive sequence is required to be 
completed: 
 
1) TSE (Turbo Spin Echo)(Philips/Siemens scanners)/FSE (Fast Spin Echo)(GE 
scanners)  
2) TrueFISP(Siemens scanners)/FIESTA (GE scanners)/balanced FFE(Philips scanners)  
 
TSE/FSE Guidelines: 
The TSE/FSE sequence uses an excitation pulse followed by a train of refocusing pulses to 
accelerate the image acquisition. To achieve a 4 W/kg SAR with a high flip angle, the 
following guidelines should be used. 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
TrueFISP/FIESTA/balanced FFE Guidelines: 
The TrueFisp sequence is a gradient recalled echo sequence that applies a fixed flip angle RF 
pulse α to achieve steady state imaging. To achieve a 4 W/kg SAR with a high flip angle, the 
following guidelines should be used. 
 
 
 
 
     
 
 
 
 
 
 
 
 

Investigational Plan 
MRI Study 
Page 91  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Landmark: 
Position the patient table bed such that the patient’s heart is at iso-center; this will result in 
the highest RF field exposure of the implant. Follow your institution’s standard operating 
procedures for performing a thoracic region scan, making sure to prepare the patient for pulse 
oximetry and ECG monitoring.  
 
4. Gradient Exposure: Sequence and Landmark 
The purpose of the gradient exposure sequence is to expose the pacemaker system to the 
maximum time varying magnetic field (dB/dt) which is produced by the gradients coils 
during ramp up and ramp down time.  
 
 
 
 
 
 
 
 
 
 
  
 
The slice selection direction must be sagittal and the phase encoding direction must be in the 
Head-Foot direction to ensure that the readout is the Y-direction (AP), which will maximize 
the gradient in the Y-direction.  
 
 
 
 
 
 
 
 
 
  
 
Note: The maximum spatial gradient for which the Accent MRI system has been determined 
safe is 10 T/m.  
 

Investigational Plan 
MRI Study 
Page 92  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Landmark: 
Position the patient table bed such that the implanted pacemaker is at the edge of the 
superoinferior extent of the gradient coils of your system to ensure the device is exposed to 
the highest gradient field (dB/dt). Follow your institution’s standard operating procedures for 
performing a head scan, making sure to prepare the patient for pulse oximetry and ECG 
monitoring.  
 
5. Patient Monitoring and Safety: 
Before the start of the scan, instruct the patient to verbalize any discomfort or pain he/she 
may experience while in the MRI bore.  
 
During the entire MRI scan, the patient’s cardiac function must be monitored using pulse 
oximetry and an ECG by an Accent MRI study trained electrophysiologist, cardiologist, or 
Advanced Cardiac Life Support (ACLS) trained clinician who is capable of delivering 
external cardiac pacing defibrillation and advanced cardiac life support.  Verbal 
communication with the patient must also take place to assess and/or confirm any clinically 
significant changes noted in the patient’s oxygen saturation or heart rate, as well as any 
clinically significant complaints not obvious with pulse oximetry.  Record these changes and 
complaints. 
 
Life–threatening Ventricular Arrhythmia and Asystole Assessment: 
Monitoring of spontaneous ventricular arrhythmias and asystole must be conducted via an 
ECG during the MRI scans. Any sustained ventricular arrhythmias or asystole 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 one time) while the 
patient is actively being scanned, report the event on an Adverse Event form. 
 
Definitions: 
• Sustained Ventricular Arrhythmia: Heart Rate  >150bpm for > 30 seconds 
• Asystole: A standstill > 6 seconds in electrical activity of the heart (i.e., no heart 
rate for 6 seconds or more) 
 
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 patient’s hemodynamic 
function is compromised or the patient experiences a medical emergency during the MRI 
scan, stop the MRI scan and take proper measures to restore the patient’s hemodynamic 
function and/or the appropriate steps per your institution’s standard operating procedures to 
addressing the medical emergency.   
 
Handling of Patients Unable to Tolerate an MR Scan  
In cases where the scan cannot be tolerated by the patient, remove the patient from the 
scanner. Assess the patient for possible adverse events, and treat the patient’s reported 
symptoms according to your institution’s standard of practice.  Note the reason for the 

Investigational Plan 
MRI Study 
Page 93  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
intolerance. Information related to the sequence used to perform the scan, the length of time 
the patient 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. 
 
6. Image Sequence Parameter Summary 
The preceding Non-Clinical Sequences tables (Appendix B) show the imaging parameters for 
a 4 W/kg whole body SAR level scan RF and gradient intensive sequences.  The total 
imaging time should last approximately 30 minutes, with 25 minutes of cumulative RF 
intensive scanning and 5 minutes of gradient intensive scanning.   
 
If needed, and/or as requested by St. Jude Medical, additional clinically useful scans will be 
performed for the purposes of conducting analyses on MR image quality and artifact. These 
scans should be performed until a total of 20 analyzable study-wide scans have been 
collected. St. Jude Medical will notify your study center which patients need to undergo these 
additional scan sequences.  Supplemental instructions will be provided for these sequences 
prior to the first MRI scan to those centers with eligible patients scheduled for an MRI scan. 
 
If the need arises, updated instructions and/or sequence tables for the non-clinical and 
clinically useful scans will be provided to your study center by St. Jude Medical under 
separate cover. 
 
 

Investigational Plan 
MRI Study 
Page 99  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
2 W/kg Whole Body SAR Non-Clinical Scan Sequence Instructions 
 
1. Introduction 
The purpose of having patients implanted with an Accent MRI system undergo an MRI scan 
is to demonstrate the MRI scan will not adversely affect the functionality of the Accent MRI 
system.  To do so, the Accent MRI system will be exposed to two worst case MRI scan 
scenarios at a 2 W/kg whole body SAR level, one involving an RF intensive MRI scan 
sequence, and one involving a gradient intensive MRI scan sequence.  The goal is not to 
obtain images for diagnostic purposes, but to expose the implanted Accent MRI system to 
these two severe testing scenarios. The parameters relevant for the MRI system selection and 
selected scan sequences will be discussed in detail.  
 
The MRI scans are not intended to be diagnostic in nature and therefore the administration of 
contrast agents or sedation, or the application of saturation bands or water and fat saturation 
techniques are not permitted. During the MRI scan sequences, if patient movement causes 
distortion on the MRI, do not repeat the MRI scan (the scan is not meant to be diagnostic). 
 
2. Patient Screening and Safety 
The patient presenting for this MRI scan has been pre-screened by the cardiology team to 
ensure the patient has met the criteria set by St. Jude Medical to undergo an MRI scan for the 
MRI Study.  This includes review and verification of the following: 
 
Pacemaker Device Requirements: 
• Bipolar capture thresholds are stable at  ≤2.5V@ 0.5 ms 
• Bipolar pacing lead impedance is within range, i.e.  ≥ 200 and ≤ 2000 ohms 
• Device and Leads are labeled for MRI 
• No additional hardware (adaptors, extenders, or abandoned leads) 
 
MRI Scan Equipment Requirements: 
In additon to the screening above, before proceeding with any MRI scans, ensure the patient 
is not contra-indicated for an MRI scan, and that the MRI scanner meets the criteria below.    
• Scanner Manufacturer: General Electric (GE), Siemens or Philips with the 
following operating characteristics:  
• Horizontal closed bore scanner working in  
• Normal Operating Mode or  
• First Level Controlled Operating Mode 
• with Whole Body Specific Absorption Rate (SAR) ≤ 2.0 W/kg 
• and Head SAR ≤ 3.2 W/kg 
• A static magnetic field strength of 1.5 Tesla  
• Maximum gradient slew rate of 200 T/m/s per axis 
• An RF excitation frequency in the range of 63.75 ± 0.5 MHz 
(corresponding to 1.5 Tesla scanners using hydrogen-based imaging) 
 

Investigational Plan 
MRI Study 
Page 101  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
There are two possible sequences that can be prescribed to achieve the required RF intensive 
exposure. Only ONE (1) RF intensive sequence is required to be completed: 
 
1) TSE (Turbo Spin Echo)(Philips/Siemens scanners)/FSE (Fast Spin Echo)(GE 
scanners)  
2) TrueFISP(Siemens scanners)/FIESTA (GE scanners)/balanced FFE(Philips scanners)  
 
TSE/FSE Guidelines: 
The TSE/FSE sequence uses an excitation pulse followed by a train of refocusing pulses to 
accelerate the image acquisition. To achieve a 2 W/kg SAR with a high flip angle, the 
following guidelines should be used. The flip angle of the excitation pulse is fixed at 90°. 
The flip angle of the refocusing pulses must be set to 180°. This will achieve the highest 
possible flip angle for the TSE/FSE sequence. If you are not able to obtain to exact sequence 
parameters as prescribed in the Table specific to your scanner, and/or the sequence does not 
result in 2 W/kg, please refer to the guidelines below for ways to increase the SAR .     
 
Ways to Increase SAR: 
The prescribed sequence will result in a higher SAR when you use the shortest possible TR 
and TE.
 
 
 
 
 
 
TrueFisp/FIESTA/balanced FFE Guidelines: 
The TrueFisp sequence is a gradient recalled echo sequence that applies a fixed flip angle RF 
pulse α to achieve steady state imaging. To achieve a 2 W/kg SAR with a high flip angle, the 
following guidelines should be used. The flip angle should be set to the maximum allowed by 
the scanner to achieve the SAR limit of 2 W/kg. If you are not able to obtain to exact 
sequence parameters as prescribed in Table specific to your scanner, and/or the sequence 
does not result in 2 W/kg with a high flip angle, please refer to the guidelines below for ways 
to increase the SAR.     
 
Ways to Increase SAR: 
It is important to increase the TR in order to achieve the highest flip angle possible. Often the 
TR is not a user-adjusted variable for this type of pulse sequence. 
 
 
 
 

Investigational Plan 
MRI Study 
Page 102  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 
 
 
Landmark: 
Position the patient table bed such that the patient’s heart is at iso-center; this will result in 
the highest RF field exposure of the implant. Follow your institution’s standard operating 
procedures for performing a thoracic region scan, making sure to prepare the patient for pulse 
oximetry and ECG monitoring.  
 
4. Gradient Exposure: Sequence and Landmark 
The purpose of the gradient exposure sequence is to expose the pacemaker system to the 
maximum time varying magnetic field (dB/dt) which is produced by the gradients coils 
during ramp up and ramp down time.  
 
Select a diffusion weighted EPI sequence and refer to the parameters in the Non-Clinical 
Sequences Tables specific to your scanner and to the descriptions below to achieve a gradient 
intensive sequence. Select the appropriate table, e.g. if the MRI scanner is a GE scanner, 
refer to the GE table, and program the values as shown in the table. Store a copy of this 
sequence on the scanner if possible for future study scanning. 
 
The sequence parameters in the table have been shown to result a gradient intensive sequence 
however, if you are not able to prescribe the sequence parameters as given please follow the 
guidelines for ways to reach the proper gradients. The required scan duration is 5 minutes 
and should be easily achieved using a single sequence. If you are not able to obtain to exact 
sequence parameters as prescribed in the Table specific to your scanner, refer to the 
guidelines below to ensure the sequence has maximized the gradient exposure.  
 
The slice selection direction must be sagittal and the phase encoding direction must be in the 
Head-Foot direction to ensure that the readout is the Y-direction (AP), which will maximize 
the gradient in the Y-direction.  
 
Ensure the field of view is small while the gradient encoding matrix is as large as possible. 
The readout bandwidth should be as high as possible in order to increase the gradient slew 
rate in the Y-direction. The b-values of 1000, 1500, and 2000 were chosen to create large 
diffusion weighted gradients and should be maintained as high as possible. The gradient 
stimulation monitor may require you to reduce some of these parameters if the stimulation 
threshold has been exceeded. If the gradient stimulation threshold is reached, then the first 
choice should be to increase the slice thickness, and second choice should be to decrease the 
phase encoding matrix size.  
 
If the programming the values as outlined in the Gradient Intensive scan sequence results in a 
predicted whole body SAR that is > 2W/kg,   the RF exposure should be reduced to the 
extent that would allow the Gradient Intensive scan to be performed.  This can be achieved 
using low flip angle set to a minimum value that minimizes RF exposure.   
 

Investigational Plan 
MRI Study 
Page 103  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Note: The maximum spatial gradient for which the Accent MRI system has been determined 
safe is 10 T/m.  
 
Landmark: 
Position the patient table bed such that the implanted pacemaker is at the edge of the 
superoinferior extent of the gradient coils of your system to ensure the device is exposed to 
the highest gradient field (dB/dt). Follow your institution’s standard operating procedures for 
performing a head scan, making sure to prepare the patient for pulse oximetry and ECG 
monitoring.  
 
5. Patient Monitoring and Safety: 
Before the start of the scan, instruct the patient to verbalize any discomfort or pain he/she 
may experience while in the MRI bore.  
 
During the entire MRI scan, the patient’s cardiac function must be monitored using pulse 
oximetry and an ECG by an Accent MRI study trained electrophysiologist, cardiologist, or 
Advanced Cardiac Life Support (ACLS) trained clinician who is capable of delivering 
external cardiac pacing defibrillation and advanced cardiac life support.  Verbal 
communication with the patient must also take place to assess and/or confirm any clinically 
significant changes noted in the patient’s oxygen saturation or heart rate, as well as any 
clinically significant complaints not obvious with pulse oximetry.  Record these changes and 
complaints. 
 
Life–threatening Ventricular Arrhythmia and Asystole Assessment: 
Monitoring of spontaneous ventricular arrhythmias and asystole must be conducted via an 
ECG during the MRI scans. Any sustained ventricular arrhythmias or asystole 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 one time) while the 
patient is actively being scanned, report the event on an Adverse Event form. 
 
Definitions: 
• Sustained Ventricular Arrhythmia: Heart Rate  >150bpm for > 30 seconds 
• Asystole: A standstill > 6 seconds in electrical activity of the heart (i.e., no heart 
rate for 6 seconds or more) 
 
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 patient’s hemodynamic 
function is compromised or the patient experiences a medical emergency during the MRI 
scan, stop the MRI scan and take proper measures to restore the patient’s hemodynamic 
function and/or the appropriate steps per your institution’s standard operating procedures to 
addressing the medical emergency.   
 
Handling of Patients Unable to Tolerate an MR Scan  

Investigational Plan 
MRI Study 
Page 104  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
In cases where the scan cannot be tolerated by the patient, remove the patient from the 
scanner. Assess the patient for possible adverse events, and treat the patient’s reported 
symptoms according to your institution’s standard of practice.  Note the reason for the 
intolerance. Information related to the sequence used to perform the scan, the length of time 
the patient 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. 
 
6. Image Sequence Parameter Summary 
The preceding Non-Clinical Sequences tables (Appendix B) show the imaging parameters for 
the RF and gradient intensive sequences.  The total imaging time should last approximately 
30 minutes, with 25 minutes of RF intensive scanning and 5 minutes of gradient intensive 
scanning.   
 
If needed, and/or as requested by St. Jude Medical, additional clinically useful scans will be 
performed for the purposes of conducting analyses on MR image quality and artifact. These 
scans should be performed until a total of 20 analyzable study-wide scans have been 
collected. St. Jude Medical will notify your study center which patients need to undergo these 
additional scan sequences.  Supplemental instructions will be provided for these sequences 
prior to the first MRI scan to those centers with eligible patients scheduled for an MRI scan. 
 
If the need arises, updated instructions and/or sequence tables for the non-clinical and 
clinically useful scans will be provided to your study center by St. Jude Medical under 
separate cover. 

Investigational Plan 
MRI Study 
Page 105  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Image Quality and Artifact Clinical Scan Sequence Instructions 
 
 
The sequences provided are intended to be a reference sequence for a cardiac, thoracic spine, 
cervical spine, and shoulder joint scan, and are clinically relevant scan sequences.  St. Jude 
Medical will provide confirmation on which area should be scanned for up to the first 5 
patients to undergo an MRI scan at each study center. 
 
The goal of the clinical scan is to obtain scan images for the purposes of image quality and 
artifact analysis.  If needed, updated instructions or refinements to the sequences may be 
provided by St. Jude Medical under separate cover. 
 
The MRI scan should be reviewed for any obvious abnormalities by a radiologist within a 
reasonable timeframe.  Any obvious abnormalities that are noted must be reported to the 
patient’s physician (per standard of care by the facility performing the MRI scan).  A copy of 
the documentation of the abnormality discovered on the MRI scan should be kept in the 
patient’s file and/or study records.  The review of the MRI scan is not meant to be diagnostic.   
 
 
After receiving the clinical scan assignment confirmation from St. Jude Medical, refer to the 
specific scanner table, e.g. GE, Philips and Siemens.  Each table contains sequences for 
cardiac, thoracic spine, cervical spine, and shoulder joint scans. You may use the sequence 
parameters given in the tables to perform the scan for which the patient has been assigned to 
receive. Alternatively, you may use similar clinically relevant sequences that are available 
and used on the scanner at your center. 
 
The MRI scans are intended to generate clinically relevant images for the purpose of 
analyzing those images for quality and artifact.  However, the administration of contrast 
agents or sedation is not permitted. During the MRI scan sequences, if patient movement 
causes distortion on the MRI, it is acceptable to repeat the MRI scan.  
 
 
Save and export the scan images. Provide a copy of the images and programmed parameter 
values to St. Jude Medical.   
 
Refer to the instructions below to perform the scan.  
 
 
The patient presenting for this MRI scan has been pre-screened by the cardiology team to 
ensure the patient has met the criteria set by St. Jude Medical to undergo a clincally relevant 
MRI scan for the MRI Study.  This includes review and verification of the following: 
 
Pacemaker Device Requirements: 
•  Bipolar capture thresholds are stable at  ≤2.5V@ 0.5 ms 
• Bipolar pacing lead impedance is within range, i.e.  ≥ 200 and ≤ 2000 ohms 

Investigational Plan 
MRI Study 
Page 106  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
• Device and Leads are labeled for MRI 
• No additional hardware (adaptors, extenders, or abandoned leads) 
 
MRI Scan Equipment Requirements: 
In additon to the screening above, before proceeding with any MRI scans, ensure the patient 
is not contra-indicated for an MRI scan, and that the MRI scanner meets the criteria below.  
   
• Scanner Manufacturer: General Electric (GE), Siemens or Philips with the 
following operating characteristics:  
• Horizontal closed bore scanner working in  
• Normal Operating Mode or First Level Controlled Operating Mode 
• with Whole Body Specific Absorption Rate (SAR) ≤ 2.0 W/kg 
• and Head SAR ≤ 3.2 W/kg 
• A static magnetic field strength of 1.5 Tesla  
• Maximum gradient slew rate of 200 T/m/s per axis 
• An RF excitation frequency in the range of 63.75 ± 0.5 MHz (corresponding 
to 1.5 Tesla scanners using hydrogen-based imaging) 
 
Follow your institution’s standard guidelines and procedures to ensure it is safe for the 
patient to undergo an MRI scan, including verifying implanted MRI-compatible and/or MRI-
safe materials may be scanned according to the applicable manufacturer’s labeling. 
 
 
Position the patient table bed such that the area being scanned is at iso-center. Follow your 
institution’s standard operating procedures to perform a scan, making sure to prepare the 
patient for pulse oximetry and ECG monitoring.  
 
 
Before the start of the scan, instruct the patient to verbalize any discomfort or pain he/she 
may experience while in the MRI bore.  
 
During the entire MRI scan, the patient’s cardiac function must be monitored using pulse 
oximetry and an ECG by an Accent MRI study trained electrophysiologist, cardiologist, or 
Advanced Cardiac Life Support (ACLS) trained clinician who is capable of delivering 
external cardiac pacing defibrillation and advanced cardiac life support.  Verbal 
communication with the patient must also take place to assess and/or confirm any clinically 
significant changes noted in the patient’s oxygen saturation or heart rate, as well as any 
clinically significant complaints not obvious with pulse oximetry.  Record these changes and 
complaints. 
 
Life–threatening Ventricular Arrhythmia and Asystole Assessment: 
Monitoring of spontaneous ventricular arrhythmias and asystole must be conducted via an 
ECG during the MRI scans. Any sustained ventricular arrhythmias or asystole must be 

Investigational Plan 
MRI Study 
Page 107  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
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 one time) while the 
patient is actively being scanned, report the event on an Adverse Event form. 
 
Definitions: 
• Sustained Ventricular Arrhythmia: Heart Rate  >150bpm for > 30 seconds 
• Asystole: A standstill > 6 seconds in electrical activity of the heart (i.e., no heart 
rate for 6 seconds or more) 
 
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 patient’s hemodynamic 
function is compromised or the patient experiences a medical emergency during the MRI 
scan, stop the MRI scan and take proper measures to restore the patient’s hemodynamic 
function and/or the appropriate steps per your institution’s standard operating procedures to 
addressing the medical emergency.   
 
Handling of Patients Unable to Tolerate an MR Scan  
In cases where the scan cannot be tolerated by the patient, remove the patient from the 
scanner. Assess the patient for possible adverse events, and treat the patient’s reported 
symptoms according to your institution’s standard of practice.  Note the reason for the 
intolerance. Information related to the sequence used to perform the scan, the length of time 
the patient 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. 
 
 

Investigational Plan 
MRI Study 
Page 111  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 Appendix C: Patient Informed Consent 

Investigational Plan 
MRI Study 
Page 112  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Patient Informed Consent for the  
Accent MRI™ Pacemaker and Tendril MRI™ Lead IDE Study 
 
Introduction 
You are being asked to take part in this research study because your doctor has determined 
that you may qualify to take part in the Accent MRI™ (magnetic resonance image) 
Pacemaker and Tendril MRI™ Lead IDE (investigational device exemption) study.  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.  
 
Please read this form, and ask your study doctor any questions about the study so that you 
can have your questions 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, friend, or family 
doctor.   
 
This consent form may contain some words that you do not understand.  Please ask the study 
doctor or the study staff to explain any words or information that you do not understand. 
 
If you agree to be in the study, you will need to sign this form.  Taking part in this study is 
entirely voluntary. You may decide not to participate without penalty or loss of benefits to 
which you are otherwise entitled 
 
What is the purpose of this study? 
The purpose of this IDE study is to evaluate the short and long term safety of the Tendril 
MRI lead and the Accent MRI pacemaker, together known as the Accent MRI system.  There 
are two parts to this study. One part of the study will look at how the Accent MRI system 
performs independent of an MRI scan. This part of the study will be referred to as the lead 
part of the study. 
 
The second part of the study will look at how the Accent MRI system works after it has 
undergone an MRI scan. This part of the study will be referred to as the MRI part of the 
study.  Additionally, the MRI Activator Device (Model EX4000), a small hand-held device 
that will be used to change the settings in the Accent MRI pacemaker in preparation for an 
MRI scan, will also be evaluated in this study. You may be asked if you wish to participate in 
that part of the study in addition to your participation in the lead part of the study.  If you do, 
you will be asked to sign a separate consent form.   
 
In comparison to FDA approved St. Jude Medical™ pacemakers and leads, there are changes 
to the design of both the investigational Accent MRI pacemaker and the Tendril MRI lead. 
The MRI Activator is also investigational. These changes are listed below: 

Investigational Plan 
MRI Study 
Page 113  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 
• The Accent MR pacemaker has new hardware to prevent an MRI scanner from 
changing certain settings in your pacemaker. The shape and size of the device has 
been changed to hold this new hardware. The device has an X-ray marker built 
into it so that your doctor can identify that the device is MRI compatible. 
• The Tendril MRI lead has also been modified to prevent the MRI scanner from 
heating the lead. The lead has an X-ray identification marker built into it so that 
your doctor can identify the lead is MRI compatible. 
• The MRI Activator (portable handheld device) is used by the study staff to turn 
the MRI functions of the Accent MR pacemaker on or off before and after the 
MRI scan.  
 
What will happen if you take part in this research study? 
If you decide to take part in this study, you will be asked a series of questions about whether 
or not you’ve had any MRI scans in the past and other relevant information that will help 
your doctor determine if you qualify the study.  Based on your answers and your medical 
history, your doctor will decide if you qualify to take part in the Accent MRI™ Pacemaker 
and Tendril MRI™ Lead IDE study.   
 
If your doctor determines that you qualify, and you decide to take part in this study, the 
procedure(s) described below will be performed for the lead portion of the study.  
 
There may be a representative of 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. 
 
At each scheduled study visit, your study doctor or staff will ask you about the medications 
that you take every day.  
 
All patients will be implanted with the Accent MRI pacemaker and at least one Tendril MRI 
lead during a procedure in the Electrophysiology Laboratory (EP Lab) or in the Operating 
Room (OR). The total estimated time for a pacemaker procedure is approximately 1 hour. 
This implant procedure is similar to the implant procedure for any approved pacemaker 
system (pacemaker and pacing leads).  Your doctor will insert the pacing lead(s) into the 
vein, and gently guide the lead(s) through the vein into your heart.  Once the lead(s) are in 
your heart, your doctor will test the lead(s) to see if they are in a good place.  Your doctor 
will connect the lead(s) into the pacemaker, and place the pacemaker into a small pocket 
made just beneath the skin on your upper chest before closing the pocket with stitches. 
 
Part One:  Lead Evaluation   

Investigational Plan 
MRI Study 
Page 114  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
You will be required to return for follow-up study visits to have your implanted pacemaker 
and leads checked.  These visits will be done at the following times:  
  
 
• Pre-Discharge (following implant before you are sent home from the hospital)  
• 2 months after implant  
• 6 months after implant  
• 12 months after implant 
• Every 6 months after the 12 month visit until the study is finished  
 
You may also need to return for additional visits not listed above if your MRI lead(s) 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 following tests will be done at the follow-up study visits: 
 
1. Pre-Discharge  
• The study doctor or staff will ask you about the medications that you take every 
day 
• Your Pacemaker 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.   
• A chest x-ray will be performed to check the position of the leads (wire) in your 
heart.  An x-ray technician will ask you to hold your breath for 5 seconds when 
the x-ray is taken.  This procedure should take approximately 15 minutes. 
 
2. 2 Month Visit (after implant) 
• The study doctor or staff will ask you about the medications that you take every 
day 
• Your Pacemaker device will be tested using a programmer (a computer and a 
wand) in the same way as at a regular clinical check-up.  You should not feel any 
discomfort during this procedure.   
 
3. 6 months, 12 months, and every 6 months after implant until study 
completion Visits 
 
• The study doctor or staff will ask you about the medications that you take every 
day 
• Your Pacemaker 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.  A sponsor representative may also program your device or collect 
information from your device under a physician’s supervision.  
 
How long will the study last? 

Investigational Plan 
MRI Study 
Page 115  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
A minimum of 800 patients at up to 80 investigational centers in and outside of the United 
States will take part in this IDE study. This study will last for approximately 34 months.  You 
will take part in this study for about 34 months for active follow-up or less depending on 
when the last person is enrolled in the study.  
 
Additionally, you will be asked to participate in a post-approval study following the 
completion of the MRI IDE study. Your participation in the post-approval study may last for 
up to 5 years starting from the day you provide informed consent for the post-approval study. 
 
What are the possible discomforts and risks? 
Risks associated with a standard pacemaker system and surgery 
Your doctor will review the risks related to a standard pacemaker surgery.  The risks related 
to the use of a pacemaker system are expected to be similar to those related to any other FDA 
approved pacemaker system. These adverse events include, but are not limited to: 
 
Potential Pacing System Adverse Events: 
• Air embolism 
• Body rejection phenomena 
• Cardiac tamponade or perforation 
• Hematoma, bleeding hematoma, seroma 
• Formation of fibrotic tissue; local tissue reaction 
• Inability to interrogate or program due to programmer or device malfunction 
• Infection/erosion 
• Interruption of desired pulse generator function due to electrical interference 
either electromyogenic or electromagnetic 
• Loss of capture or sensing due to lead dislodgement or reaction at the 
electrode/tissue interface 
• Loss of desired pacing and/or sensing due to lead displacement, body reaction at 
electrode interface, or lead malfunction (fracture or damage to insulation) 
• Lead malfunction due to conductor fracture or insulation degradation 
• Loss of normal pacemaker function due to battery failure or component 
malfunction 
• Pacemaker migration, pocket erosion 
• Pectoral muscle stimulation 
• Phrenic nerve or diaphragmatic stimulation 
• Pneumothorax/hemothorax 
• Endocarditis 
• Excessive bleeding 
• Induced atrial or ventricular arrhythmias 
• Myocardial irritability 
• Pericardial effusion 
• Pericardial rub 
• Pulmonary edema 

Investigational Plan 
MRI Study 
Page 116  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
• Rise in threshold and exit block 
• Valve damage 
 
Potential lead related adverse events 
• Cardiac tamponade 
• Diaphragmatic/phrenic nerve stimulation 
• Embolism 
• Excessive bleeding 
• Induced ventricular ectopy 
• Infection 
• Loss of pacing and/or sensing due to dislodgement or mechanical malfunction of 
the pacing lead 
• Thrombosis 
 
Complications reported with direct subclavian venipuncture include pneumothorax, 
hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, 
thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, 
death. 
 
Study procedures may also involve risks that are currently unforeseeable.  
 
Risks for Women of Childbearing Age 
If you are pregnant or plan to become pregnant in the next 20 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 to others?   
If you decide to take part in this study, you may benefit from the ability to safely undergo 
MRI scans with an implanted pacemaker system, 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 slow heart rates who require MRI scans.  We expect patients 
implanted with an Accent MRI™ Pacemaker system to receive the same benefit as patients 
implanted with other St. Jude Medical pacemaker systems.    
 
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. 
 
If you do not want to take part in this study, what other options are 
available to you?   

Investigational Plan 
MRI Study 
Page 117  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Your doctor will discuss other options available to you, including the possibility of receiving 
another market approved pacemaker. 
 
How will your privacy and the confidentiality of your research records be 
protected? 
 
If you decide to take part in this study, your medical records and personal information will be 
kept private to the extent allowed by federal, state, and local law.  No personal information 
about you, your illness, or your treatment will be made public.  
 
Information (data) collected from the study will be sent to St. Jude Medical.  A special code 
(letter and number combination) will be used to identify your personal information.  
 
The data may be given to governmental agencies, for example: the Food and Drug 
Administration (FDA) or similar government agencies in other countries.  Only information 
about your medical condition as it relates to the Accent MRI™ system will be provided to St. 
Jude Medical.  In order to verify study data, monitors from governmental agencies (for 
example: FDA), St. Jude Medical, and the Institutional Review Board (IRB)/Ethics 
Committee (EC) will also have the right to review your medical records as they relate to this 
study.  In addition, publication(s) using data collected during the study will not include your 
name or any information that can identify you. 
 
A description of this 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 this web site at any time.  
 
St. Jude Medical may export data to countries where different data protection laws apply.  
  
If you receive medical care from a doctor other than your study doctor while taking part in 
this study, you agree that your medical records will be made available for the collection of 
data related to this study. 
 
If you choose to take part in this study, will it cost you anything?   
You and your insurance company are responsible for the costs of all standard of care tests, 
procedures, and devices.  There is no guarantee that your insurance company will cover 
100% of these costs.  You should check with your insurance company to verify coverage or 
payments of these procedures. 
 
Will you receive compensation (payment) for taking part in this study?   
You will not receive any compensation for your participation in part one of the study. 
 
What if the device needs to be removed? 

Investigational Plan 
MRI Study 
Page 118  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
In the event your Accent MRI™ 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 
Accent MRI™ system or any part of it removed, the cost will be your responsibility. 
 
In the event of your death, your implanted Accent MRI™ 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 the study?   
If you are injured as a direct result of taking part in this study, medical treatment will be 
available to you.  You, or your insurance company, will be responsible for all costs incurred 
as a result of that treatment.  No other arrangement has been made for financial payments or 
other forms of compensation (such as lost wages, lost time or discomfort) with respect to 
such injuries.  You do not waive any legal rights by signing this consent form. 
 
During the study, if you experience any medical problems or illnesses 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 ___-___-_____.  A decision to withdraw 
or to not take part in the study will not affect the quality of medical care that you receive.  
Your decision will not result in any penalty or loss of benefits to which you are otherwise 
entitled or affect your future medical care.  
 
Your doctor or the sponsor, St Jude Medical, may decide to withdraw you from the study at 
any time without your consent.  If it is felt to be in your best interest, or if the study is 
stopped, your doctor may withdraw you from this research.  If you have a problem as 
described in the risks section, or if you become ill during the research, you may have to stop 
participating in the study, even if you would like to continue.  Your study doctor will make 
this decision.  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. Early 
consequences include inability for another non-study site to interrogate the device. 
 
If important information is learned during the course of this study, your doctor will be 
notified by St. Jude Medical.  You will be told of any important new information that is 
learned during the course of this research study that may affect your condition or your 
willingness to continue to take part in this study. 
 
Who can you contact for study information? 

Investigational Plan 
MRI Study 
Page 119  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
If you have any questions about the study or taking part in this study, please contact Dr. 
______________ at ___-___-_____. 
 
In addition, if you have questions about your rights as a research patient, or if you have 
complaints, concerns, or questions about the research, please contact ______________ at -
___-___-_____. 
 
Signature 
You are making a decision on whether or not to take part in the study.  Your signature 
indicates that you have read the information in this form and have decided to take part in 
the Lead Safety Portion of the study.  You will be given a signed copy of this form to keep.   
 
___________________________________    
 
Printed Name of Patient  
 
___________________________________    
___________    
    
Signature of Patient     
  
          
Date 
 
___________________________________    
  
    
Print Name of Person Obtaining Consent    
 
 
___________________________________    
___________ 
Signature of Person Obtaining Consent   
 
Date   
 
 
 
 

Investigational Plan 
MRI Study 
Page 120  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 
 Appendix D: Patient Informed Consent Addendum: MRI 
Consent  
 
 

Investigational Plan 
MRI Study 
Page 121  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 
Patient Informed Consent Addendum: MRI consent 
 
ACCENT MRI™ PACEMAKER AND TENDRIL MRI™ LEAD IDE
 STUDY 
 
Introduction 
You were asked to and agreed to participate in the Accent MRI™ (magnetic resonance 
image) Pacemaker and Tendril MRI™ Lead IDE (investigational device exemption) research 
study because your doctor had determined that you qualified to take part in the lead portion 
of the study.  Because you have an Accent MRI system implanted, you may be eligible to 
participate in the MRI portion of the study.   
 
If you decide to take part in the MRI portion of this study, you will be asked a series of 
questions about whether or not you’ve had any MRI scans in the past and other relevant 
information that will help your doctor determine if you qualify for the MRI portion of the 
study.  Based on your answers and your medical history, your doctor will decide if you 
qualify to take part in the MRI portion of the study. 
 
When you agreed to take part in the lead portion of the study, FDA may not yet have granted 
permission for your study doctor to perform MRI scans for the study.  If that was the case, 
you were not allowed to undergo an MRI scan until now.  FDA is now allowing your study 
doctor to perform MRI Scans for the study; your Accent MRI system is now MR 
Conditional. This means you may undergo MRI scans with your implanted Accent MRI 
system.   
 
This consent addendum covers information related to the MRI scan, including what will 
happen during the MRI visits, the risks associated with an MRI scan and your implanted 
Accent MRI system.  It will also cover information related to and costs associated with the 
MRI Scan and MRI visits, along with other information related to the MRI and 1 Month Post 
MRI visits.  Please refer to your original consent form for other information such as your 
rights as a study participant.  
 
In order to participate in the MRI related visits, you must sign and date this consent form. 
 
Please read this form, and ask your study doctor any questions about the study so that you 
can have your questions answered before you decide if you want to take part in this portion 
of the study.  Please take your time and talk about this information with your family, 
friend, or family doctor.  Taking part in this portion of the study is entirely voluntary. 
 
Part Two: MRI Study Visits  
All patients who agree to complete the MRI and 1 Month Post MRI visits of the study will 
undergo the tests and procedures described below.   
 

Investigational Plan 
MRI Study 
Page 122  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
There may be a representative of 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. 
 
1. MRI Visit 
The section below describes the procedures that will occur. You may be asked to come back 
on a different day to complete your MRI visit depending on the outcome of the testing of 
your pacemaker device. 
 
Please note: There are two types of scans that may be performed for the MRI study. One is a 
non-clinical scan.  This MRI scan is being performed to demonstrate safety and MRI 
compatibility of the Accent MRI system for MRI scans for the purposes of this study. This 
MRI scan is not meant to be diagnostic in nature. You will receive this type of scan. 
 
The second type of scan that will be performed is a clinical scan.  This type of scan is being 
performed to collect information on the image quality of the MRI scan and to see if there is 
any artifact on the MR image.  This MRI scan is not meant to be diagnostic in nature.  This 
type of scan will be performed until at least 20 scans are collected that can be analyzed for 
image quality and artifact.  Your study doctor or study staff will inform you if you will 
receive the clinical scan.   
 
Before the MRI Scan: 
• The study doctor or staff will ask you about the medications that you take every day 
• A pregnancy test will be given (for women of child bearing age) 
• Before the actual MRI scan, your Pacemaker 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.   
• A member of your study doctor’s staff or the radiological team will ask you a series 
of questions (MRI Screening Assessment) to make sure you meet the safety 
requirement to receive the MRI scan. 
• Your device settings will be adjusted for the MRI scan. The MRI Activator will be 
used to turn on the MRI Setting in the pacemaker device.  The programmer will be 
used to double check that the MRI feature was turned on by the MRI Activator. 
   
During the MRI scan 
Once approved to have an MRI, 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 (a painless finger clip to 
measure the amount of oxygen in your body) will be put on your finger tip.  This allows 
the doctor to monitor the oxygen content in your blood during the MRI. During the exam, 
the MRI staff is able to see and hear you. You will be able to hear the MRI staff. 

Investigational Plan 
MRI Study 
Page 123  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 
Depending on the type of MRI you are having, a soft padded coil may be placed at the 
area where the pictures will be taken. 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. When MRI pictures are taken, radio signals and magnetic fields are used. 
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. 
 
When the MRI exam is finished, the pulse oximeter and ECG electrodes will be removed. 
 
After the MRI Scan 
After the MRI scan, the MRI Activator will be used to turn the MRI Setting off in the 
pacemaker. The programmer will be used to double check that the MRI Setting was 
turned off by the MRI Activator.  After you have your scan, your device will be checked   
(an external evaluation with a computer and “wand”) again, and reset to your regular 
settings. Your Pacemaker device will be tested using a programmer.  Your device settings 
may be adjusted if changes occurred during the MRI.  
 
 
2. 1 Month Post MRI Visit 
• The study doctor or staff will ask you about the medications that you take every 
day 
• Your Pacemaker 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.  A sponsor representative may also program your device or collect 
information from your device under a physician’s supervision.  
  
How long will the MRI part of study last? 
 Up to 363 patients (including patients randomized to the MRI Control Group under previous 
versions of the protocol) will be enrolled. Your participation in the MRI Phase of the study 
will last approximately one to two months, roughly the amount of time from when you come 
in for your MRI visit to when you return for your 1 month check after the MRI visit.  Your 
participation may last longer if you need to have your MRI lead repositioned or replaced 
before you complete an MRI visit.  
 
If you need to have your Accent MRI system, either the pacemaker or an MRI lead to be 
repositioned or replaced and your study doctor decides that the MRI lead will no longer be 
used, or if your study doctor plugs one of the ports on your device before you complete your 
MRI visit, you will no longer be able to participate in the MRI part of the study. You will be 
withdrawn from the MRI part of the study. You will, however, still continue to participate in 
Part One, the lead portion, of the study if you still have the Accent MRI pacemaker and at 
least one working Tendril MRI lead implanted.   

Investigational Plan 
MRI Study 
Page 124  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 
What are the possible discomforts and risks? 
Risks associated with MRI scans of patients with Cardiac Devices: 
The following risks have been associated with MRI scans of patients with implanted cardiac 
devices: 
 
a) Potential MRI Scan Adverse Events: 
• Claustrophobia (fear of enclosed spaces) 
• Mild diaphoresis (sweating)  
• Hearing impairment (difficulty hearing) 
• Sensation of bodily warmth 
• 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 MRI System Adverse Events: 
• Lead electrode heating and tissue (heart muscle) damage resulting in loss of 
sensing or capture or both 
• Device heating resulting in tissue damage in the implant pocket or patient 
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: 
• the system to fail to detect or treat irregular heartbeats 
• 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) 
• Competitive pacing and potential for VT/VF induction due to ambulatory 
asynchronous pacing in MRI mode  
 
These risks would also apply if you undergo a non-study MRI scan. 
 
There may be other risks to you that are not known at this time.  
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 
part of the study. 

Investigational Plan 
MRI Study 
Page 125  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 
If you choose to take part in this study, will it cost you anything?   
You and your insurance company are responsible for the costs of all standard of care tests, 
procedures, and devices.  There is no guarantee that your insurance company will cover 
100% of these costs.  You should check with your insurance company to verify coverage or 
payments of these procedures. 
 
The cost of the MRI scan performed at the MRI visit will be covered through the study.   
Will you receive compensation (payment) for taking part in this study?   
You will receive a payment of $60 to compensate you for your travel, time, meals, and 
parking related to your MRI visit.   
 
What are the possible benefits to you or to others?   
If you agree to participate in the study, you will be able to undergo an MRI if it were needed 
to help your doctor confirm a diagnosis.  The Accent MRI system was designed to be MRI 
compatible.  The information gathered in this study will add to the understanding of 
treatment options for patients with implanted pacemaker systems who need to have an MRI 
scan performed. 
 
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 the MRI Phase of the study.  
Your signature indicates that you have read the information in this form and have decided 
to take part in the MRI Phase of the study. You will be given a signed copy of this form to 
keep.   
 
If you previously consented to participate in the MRI Phase of the study, by signing this 
consent form, you are making a decision on whether or not to undergo the study MRI scan 
in the MRI Phase of the MRI Study.  Your signature indicates that you have read the 
information in this form and have decided to undergo the study MRI scan.  All the tests 
and procedures outlined in this consent form are the same as the tests and procedures in 
previous versions of the consent form for the MRI Phase of the study.  You will be given a 
signed copy of this form to keep.   
 
 Please check this box if the patient was previously enrolled in the MRI Phase under 
Revision J of the Protocol and was randomized to the MRI Control Group. 
 
___________________________________    
 

Investigational Plan 
MRI Study 
Page 126  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Printed Name of Patient  
 
___________________________________    
___________    
    
Signature of Patient     
  
          
Date   
 
___________________________________    
  
    
Print Name of Person Obtaining Consent    
 
 
___________________________________    
___________ 
Signature of Person Obtaining Consent   
 
Date   
 
 
 

Investigational Plan 
MRI Study 
Page 127  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
 Appendix E: MRI Conditional notification to Patients 

Investigational Plan 
MRI Study 
Page 128  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
Patient Notification of MRI Conditional status of Accent MRI 
System 
 
Accent MRI™ Pacemaker and Tendril MRI™ Lead IDE Study 
 
 
 
Dear <insert patient name and/or study ID>: 
 
 
You are receiving this notice because you are participating in the Accent MRI™ Pacemaker 
and Tendril MRI™ Lead IDE Study at <insert study center name>.  At the time of your 
enrollment into the study, your implanted pacemaker system was not MR conditional.  This 
meant that you were not allowed to have an MRI scan. 
 
The Food and Drug Administration, FDA, has now granted permission for your study doctor 
to perform MRI scans on your pacemaker system for the study.  What this means is you are 
now allowed to undergo an MRI scan, if you need one.  If you need to have an MRI scan not 
related to the study, you should speak with and ask your doctor about the risks associated 
with MRI scans of patients with implanted cardiac devices.  A list of the risks is provided 
below for your reference. These are the same risks that could occur during a study MRI scan. 
There may be other risks that could occur. 
 
1. Risks associated with MRI Scans of Patients with Implanted Cardiac Devices: 
The following risks have been associated with MRI scans of patients with implanted cardiac 
devices: 
 
a) Potential MRI Scan Adverse Events: 
• Claustrophobia (fear of enclosed spaces) 
• Mild diaphoresis (sweating)  
• Hearing impairment (difficulty hearing) 
• Sensation of bodily warmth 
• Body stiffness related to immobility 
 
b) Potential MRI System Adverse Events: 
• Lead electrode heating and tissue (heart muscle) damage resulting in loss of 
sensing or capture or both 
• Device heating resulting in tissue damage in the implant pocket or patient 
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: 

Investigational Plan 
MRI Study 
Page 129  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
• the system to fail to detect or treat irregular heartbeats 
• 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) 
• Competitive pacing and potential for VT/VF induction due to ambulatory 
asynchronous pacing in MRI mode  
 
 
You may be asked by your study doctor if you want to participate in the MRI part of the 
study.  Your study doctor or his staff may ask you this question at your next study visit, or 
he/she may call you or contact you by other means to determine if you are interested.  Please 
contact Dr. <insert investigator name> or his study staff at <insert phone number> if you 
have any questions about the content of this letter. 
 
 
Sincerely, 
 
 
<insert name of site> 
 
 

Investigational Plan 
MRI Study 
Page 130  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
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 A Primer on Medical Device Interactions with MRI Systems;      
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m107721.htm#overview], 9-Feb-10 
8 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. 
9 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. 
10 Levine P. Industry viewpoint: St. Jude medical: Pacemakers, ICDs and MRI. PACE 
2005;28(4):266-267. 
11 Shellock F G, et al.  Cardiac pacemaker: In vitro assessment at 1.5 T.  American Heart 
Journal.  2006 Feb; 151(2): 436-443. 
12 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. 
13 Valhaus C, Sommer T, Lewalter T. et al. Inteference with cardiac pacemakers by magnetic 
resonance imaging : Are there irreversible changes at 0.5 Tesla? PACE 2001; 24: 489-495.   
14 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. 
15 Loewy J, Loewy A, and Kendall EJ. Reconsiderations of pacemakers and MR imaging. 
RadioGraphics 2004; 24:1257-1268. 
16 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. 
17 Gimbel J R and Kanal E.  Can patients with implantable pacemakers safely undergo 
magnetic resonance imaging?  Journal of the American College of Cardiology.  2004 April; 
43(7): 1325-1327. 
 

Investigational Plan 
MRI Study 
Page 131  
 July 10, 2014 
 
CONFIDENTIAL 
60028820/K  
 
                                                                                                                                                       
18 Faris O, Shein M. Government viewpoint: US Food & Drug Administration: Pacemakers, 
ICDs   and MRI. PACE 2005; 28(4) 268-269. 
19 Wilkoff B L, Bello D, Taborsky M, Vymazal J, Kanal E, Heuer H, et al. EnRhythm MRI 
SureScan Pacing System Study Investigators, Magnetic Resonance Imaging in Patients with 
a Pacemaker System Designed for the MR Environment, Heart Rhythm (2009), doi: 
10.1016/j.hrthm.2010.10.002..