Optisure Lead Post Approval Study
Conditions: Heart Failure, Tachycardia, Ventricular
Sponsor: Abbott Medical Devices

Post Approval Study Plan  
 
Optisure Lead Study 
 
December 12, 2013 
 
CONFIDENTIAL 
60045220 /G 
 
 
 
 
 
 
STUDY PLAN  
FOR THE 
 
 
 
 OPTISURE STUDY 
OPTISURE LEAD POST APPROVAL STUDY 
 
 
 
 
 
 
 
 
December 12, 2013 
 
 
 
 
 
 

Post Approval Study Plan  
 
 Optisure Lead Study 
Page 1 of 45 
December 12, 2013 
 
CONFIDENTIAL 
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Table of Contents 
1.0 
Introduction ..................................................................................................... 3 
2.0 
Purpose............................................................................................................. 3 
3.0 
Description of Device ...................................................................................... 4 
4.0 
Clinical Protocol .............................................................................................. 5 
4.1 
Study Design and Scope ................................................................................... 5 
4.2 
Definitions......................................................................................................... 5 
4.3 
Sub-Study Design and Scope ............................................................................ 7 
4.4 
Study Flow Diagram ......................................................................................... 9 
4.5 
Optisure Projected Study Timeline ................................................................. 10 
5.0 
Study Outcome Measures............................................................................. 11 
5.1 
Primary Outcome Measure ............................................................................. 11 
5.1.1 
Freedom from RV Lead Related Complications ...................................... 11 
5.2 
Secondary Outcome Measures ........................................................................ 12 
5.2.1 
Optisure Lead-Related Complication Rates.............................................. 12 
5.2.2 
Optisure Lead Related Events ................................................................... 14 
5.3 
Sub-study - Outcome Measures ...................................................................... 14 
5.3.1 
The annual hazard rate of lead electrical dysfunction .............................. 14 
5.3.2 
The annual hazard rate of externalized conductors (from enrollment) ..... 14 
5.3.3 
The annual hazard rate of other visual lead anomalies by each subcategory 
(from enrollment) .................................................................................. 15 
5.3.4 
Prevalence of “other insulation anomalies” in “returned leads” (as defined 
in section 2.0) ........................................................................................ 15 
5.3.5 
Time from externalized conductors to electrical dysfunction ................... 15 
5.3.6 
Time from other visual lead anomalies by each subcategory to electrical 
dysfunction ............................................................................................ 16 
5.3.7 
Adverse Event rate through 30 days post-intervention for lead (e.g. 
extraction, abandonment, revision, other) ............................................. 16 
5.3.8 
Time from externalized conductors to clinical intervention ..................... 16 
5.3.9 
Time from other visual lead anomalies by each subcategory to clinical 
intervention ............................................................................................ 17 
5.3.10 
Comparison of patients with lead compromise as evidenced by imaging 
(includes externalized conductors and other visual lead anomalies) to 
those without lead compromise ............................................................. 17 
5.3.11 
Comparison of patients with electrical dysfunction to those without 
electrical dysfunction. ........................................................................... 17 
6.0 
Analysis and Reporting ................................................................................ 18 
6.1 
Interim Reports and Trend Analysis ............................................................... 18 
6.2 
Final Study Report .......................................................................................... 20 
7.0 
Site Selection .................................................................................................. 20 
8.0 
Patient Selection ............................................................................................ 20 
8.1 
Inclusion Criteria ............................................................................................ 20 
8.2 
Exclusion Criteria ........................................................................................... 20 
8.3 
Sub-study Enrollment Criteria ........................................................................ 21 

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 Optisure Lead Study 
Page 2 of 45 
December 12, 2013 
 
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9.0 
Study Procedures .......................................................................................... 21 
9.1 
Data Entry ....................................................................................................... 21 
9.2 
Enrollment Requirements ............................................................................... 22 
9.2.1 
Enrollment................................................................................................. 22 
9.2.2 
Unsuccessful Implant– if applicable ......................................................... 23 
9.3 
System Revisions – if applicable .................................................................... 24 
9.4 
Follow-Up Requirements ................................................................................ 24 
10.0 
Protocol Deviations ....................................................................................... 25 
11.0 
Adverse Events .............................................................................................. 26 
12.0 
Other Reported Events ................................................................................. 28 
13.0 
Health Care Utilization/Hospitalization Visits ........................................... 28 
14.0 
Deaths ............................................................................................................. 28 
15.0 
Patient Relocation ......................................................................................... 29 
16.0 
Withdrawals .................................................................................................. 29 
17.0 
Returning Devices and Leads to St. Jude Medical..................................... 30 
18.0 
Risk Analysis ................................................................................................. 30 
19.0 
Committees .................................................................................................... 30 
19.1 
Cinefluoroscopy Adjudication Committee ..................................................... 30 
19.2 
Electrical Data Adjudication Committee ........................................................ 31 
20.0 
Investigator Information .............................................................................. 31 
21.0 
Monitoring Procedures ................................................................................. 32 
22.0 
FDA Inspections ............................................................................................ 33 
23.0 
Labeling ......................................................................................................... 33 
24.0 
Consent Materials ......................................................................................... 33 
25.0 
IRB/MEC Information ................................................................................. 33 
26.0 
Other Institutions .......................................................................................... 33 
26.1 
Records and Reports ....................................................................................... 34 
26.2 
Custody ........................................................................................................... 34 
26.3 
Retention Period.............................................................................................. 34 
27.0 
Publications ................................................................................................... 34 
Appendix A: Lead Compromise Details ............................................................................. 35 
Appendix B: Study Consent Form ...................................................................................... 36 
Appendix C: Sub-Study Consent Form .............................................................................. 42 
Appendix D: Detailed Sample Size Calculations for Complication Free Survival 
Endpoint..................................................................................................................... 47 
 
 
Table of Tables 
 
 
Table 1: Summary of RV Lead Related Complications ......................................................... 13 
Table 2: Complications or Observations That Are Unrelated To the RV Lead ...................... 19 
Table 3: Schedule of Evaluations Summary ........................................................................... 21 
Table 4: Study Interval Time Windows .................................................................................. 24 
 

Post Approval Study Plan  
 
 Optisure Lead Study 
Page 3 of 45 
December 12, 2013 
 
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1.0 Introduction 
The Optisure™ Lead Post Approval Study (Optisure Lead Study) is a multi-center post-
approval study of the Optisure family of high voltage (HV) leads.   
 
The product under study is a St. Jude Medical lead available with a DF1 or DF4 connector, 
active or passive fixation method and single or dual shocking coils. The goal of this post 
approval study is to characterize the chronic performance of the St Jude Medical (SJM) 
Optisure family of right ventricular (RV) HV leads. 
 
2.0 Purpose 
The purpose of this post approval study is to characterize the chronic performance of the 
SJM Optisure family of HV leads in patients that have an approved indication, as per 
ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment 
of heart failure or life-threatening ventricular tachyarrhythmia, and who meet all the 
inclusion/exclusion criteria. The Optisure lead study will be performed in compliance with 
the Conditions for Approval as agreed upon with the FDA. If during the course of the study a 
future generation of the Optisure RV lead is approved, these devices may be included in the 
study upon agreement with the FDA. 
 
The following objectives will be evaluated in the post approval study: 
1. To determine the Optisure lead related complication free rate at 5 years 
2. To document all Optisure lead related adverse events 
 
Additionally, the following objectives will be evaluated in a subset of patients in the Optisure 
lead study who agree to participate in a sub-study: 
1.  To determine the incidence of externalized conductors after enrollment 
2.  To determine the incidence of other visual lead anomalies by each subcategory 
per Appendix A after enrollment 
3.  To determine the incidence of electrical dysfunction§ after enrollment 
4.  To evaluate the 30-day adverse event rate associated with lead revision 
procedures (include lead extractions or abandonments with or without lead 
replacement) 
5.  To determine the prevalence of “other insulation anomalies” in returned 
Optisure leads: 
o  Internal abrasion short under RV shock coil 
o  Internal abrasion short under SVC shock coil 
o  Exposed conductors defined as a breach of the outer insulation and/or 
breach of the internal silicone lumen tubing, but the conductor cable is 
contained within the lead body diameter.  
§”Electrical dysfunction” is determined to be present after adjudication of the 
following cases of potential electrical failures that led to the lead being either 
surgically capped/extracted or electrically abandoned. Potential electrical failures 
include the following: 

Post Approval Study Plan  
 
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December 12, 2013 
 
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o Presence of non-physiologic noise not due to external interference 
o Rise in pace/sense (p/s) conductor impedance to > 2000 Ω or increase of 
more than 200 Ω over previous 6 months or increase of 400 Ω over any 
period of time 
o Decrease of more than 200 Ω over previous 6 months or to impedance < 
200 Ω from baseline impedance > 300 Ω or decrease of 400 Ω over any 
period of time 
o Change in any high voltage coil impedance of > 25 Ω or to > 125 Ω or < 
20 Ω 
o Capture threshold > 5 V or an increase of > 2 V from baseline (all 
measurements) of < 1 V 
NOTE: In all cases, external sources of “noise” and other header-
connector causes would be excluded. Functional abnormalities, including 
exit block and physiologic oversensing in the presence of an electrically 
intact lead are not electrical failures.  
3.0 Description of Device 
The Optisure HV lead is an 8 French, transvenous, steroid eluting, bipolar lead intended for 
the permanent sensing and pacing of the right ventricle, and the delivery of 
cardioversion/defibrillation therapy when used with a compatible SJM ICD or CRT-D 
device. 
 
Optisure 
Model Number 
Connector 
Type 
Fixation Single/Dual 
Coil 
LDA220 
DF-1/IS-1 
Active 
Dual 
LDA220Q 
DF4 
LDA230 
DF-1/IS-1 
Active 
Dual 
LDA230Q 
DF4 
LDA210 
DF-1/IS-1 
Active 
Single 
LDA210Q 
DF4 
LDP220 
DF-1/IS-1 
Passive 
Dual 
LDP220Q 
DF4 
LDP230 
DF-1/IS-1 
Passive 
Dual 
LDP230Q 
DF4 
 
As compared to the Durata leads, the Optisure HV dual coil leads have an increased Optim 
sheath thickness of 0.0070” (from 0.0035”) between the connector boot and the SVC 
defibrillation coil.  In order to accommodate the increase in the thickness of the Optim 
sheath, minor modifications have been made to increase the inner dimensions of the suture 
sleeve.  The Optisure HV dual coil leads also have an Optim sheath underneath the SVC 
defibrillation coil. In order to accommodate the Optim sheath underneath the SVC 
defibrillation coil, the SVC defibrillation coil has an increased diameter of 0.100” (from 
0.092”).  

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 Optisure Lead Study 
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December 12, 2013 
 
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As compared to the Durata leads, the Optim sheath thickness in the Optisure family of HV 
single coil leads has been increased by 0.0035” between the connector boot and the proximal 
portion of the lead body, which is 9.85” from the distal tip of the lead.  
4.0 Clinical Protocol 
4.1 
Study Design and Scope 
The Optisure lead study is a multi-center, post-approval study that will be performed 
in compliance with the Conditions for Approval, as agreed upon with the FDA.  
Patients will be permitted to enroll in the study up to 30 days post-implant of the 
Optisure lead.  Following a successful implant, patients will be followed every 6 
months until 60 months (5 years).  After patients complete 60 months of follow-up, 
their participation in the study will end. Patients who are consented prior to implant 
and for whom an implant is unsuccessful will be followed for 30 days for any 
adverse events and then withdrawn from the study, or may have an implant 
reattempted if the physician and patient choose to do so. 
 
Patients who meet inclusion/exclusion criteria, sign an IRB/MEC approved informed 
consent, and have an implanted Optisure RV lead or attempted implant of the 
Optisure RV lead will be considered to be enrolled in the study.  A total of 1725 
patients will be enrolled at a maximum of 60 centers.  Enrollment is expected to be 
completed between 20 and 24 months depending on the rate of enrollment. 
 
Enrollment will be proportional to actual sales, and enrollment duration will not 
exceed 24 months. If implantation at the study sites is higher than the projected 
estimates (see section 4.5), then the study enrollment period will be decreased 
proportionately. Reporting will occur per section 6.0 of the protocol.  In order to 
accomplish this, the study will be conducted at a maximum of 60 study centers.  
4.2 
Definitions  
The following definitions will be used in the Optisure lead study. 
 
 Abnormal Lead Defibrillation Impedance:  Measured high voltage 
impedances with values ≤ 20 Ω or ≥ 100 Ω 
 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. 
 Cardiac Tamponade:  Confirmed or suspected accumulation of fluid in the 
pericardial space leading to hemodynamic compromise. 

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 Cardiac Perforation:  An excursion of the lead through themyocardium.  
Signs and symptoms of perforation by an intra-cardiac lead 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..   
 Complication:  An adverse event that requires invasive intervention to 
resolve (e.g., lead fracture) 
 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:  Voltage thresholds > 3.0V at implant or 2-
fold increase between visits (after lead maturation) leading to a threshold 
greater than 3.5V at follow up. This definition is intended to serve as a 
guideline and it is understood that individual patients may have unique 
situations. 
 Externalized Conductor: The appearance on x-ray or fluoroscopy of 
conductors outside of the lead body due to an abrasion-related breach of the 
outer insulation. 
 Generator Malfunction: A confirmed failure of the device to perform as 
indicated.  
 Lead Dislodgement:  The movement of a pacing lead from its originally 
implanted position; often associated with changes in pacing and/or sensing 
thresholds including loss of sensing and/or capture. Dislodgement can often 
be confirmed by radiographic studies.  
 Lead Fracture:  A break in a conduction cable or 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 rarely, by 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 cable(s) or coil observed visually, 
electrically, or radiographically.  An insulation break may be indicated by a 
drop in impedance, and can cause loss of capture or high voltage therapy 
delivery 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, some anti-arrhythmic medications 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 (applicable to RA and RV leads). 

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December 12, 2013 
 
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 Observation:  Adverse events that can be managed without invasive 
intervention (e.g., oversensing or loss of pacing capture, which is remedied 
by reprogramming of the pulse generator). 
 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 (applicable to RA and RV leads).  
 Pneumothorax:  An accumulation of air in the pleural cavity due to a 
disruption of the pleural lining.  
 Re-Attempted Implant: Implant is being re-attempted in a new procedure 
due to previous failed implant of the Optisure lead 
 Re-Implant: Implant is being attempted in a new procedure because of a 
previous removal of the Optisure lead implanted at enrollment, e.g. due to 
infection.  
 Successful implant:  An Optisure lead is implanted. 
 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 (mV) value. 
(Applicable to RA and RV leads).   
 Unsuccessful implant:  An attempted implant that does not result in a 
successful Optisure lead implant. 
 
4.3 
Sub-Study Design and Scope 
This sub-study will determine the incidence of externalized conductors and other 
visual lead anomalies (as evidenced by imaging) and the risk of progression to 
electrical dysfunction in patients implanted with an Optisure HV lead.  A minimum 
of 200 subjects who consent to participate in this sub-study will undergo 
cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° or the best 
possible RAO view) at the 24, 36, 48 and 60 month follow-up visits.  
 
Expected Attrition in patients with high voltage leads 
Withdrawals due to death  
Assuming an annual mortality of 7% in the ICD patient population, the 
mortality at 5 years is 30% [1 – (1-0.07)^5]  In the recent RHYTHM 
ICD/QuickSite 1056K left heart lead study using CRT-D devices, the annual 
mortality was 12.8%, which would result in a mortality of 49% [1 – (1-
0.128)^5] at 5 years.  If the ICD:CRT-D device mix is 60%:40% then the 
expected 
overall 
mortality 
in 
this 
study 
at 
5 
years 
is 
38% 
(=0.6×0.30+0.4×0.49). 
 
Withdrawals due to reasons other than death  

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In an ongoing St. Jude Medical post-approval study consisting of CRT devices 
and LV leads, 102 patients have been withdrawn for reasons other than death 
during an average of 22 months of follow-up.  This translates to an attrition of 
22% over 5 years.  
 
Assuming that deaths and withdrawals are independent events, the total 
attrition is expected to be approximately 52% (= 1-(1-0.38)×(1-0.22)) over 5 
years. With an expected attrition at 5 years to be 52%, a total of 417 subjects 
who consent to participate in this sub-study will be enrolled in order to have at 
least 200 subjects with fluoroscopy data available at the 60 month follow-up 
visit.  
 
 
 
 

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4.4 
 Study Flow Diagram 
 
 
 
Informed 
Consent 
Enrollment/ 
Implant 
Re-Attempted 
Implant 
Follow Up Every 6 Months 
Sub-Study 
In addition, a subset of patients 
participating in the sub-study will 
undergo cinefluoroscopy at 24, 36, 
48 and 60 month follow-up visits 
Withdraw 
Patient 
Implant  
Successful? 
Yes 
Re-Attempt Planned 
within 30 days? 
No 
Yes 
No 
Follow the patients 
for 30 days and 
report any 
applicable adverse 
events 
Was patient 
already implanted 
with an Optisure 
lead less than 30 
days ago? 
Enrollment 
Yes 
No 

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4.5 
 Optisure Projected Study Timeline 
A timeline for the Optisure Lead Post Approval study is provided below. This timeline may change the actual enrollment rate. 
 
Time = 0; 
month 1 
FDA Approval 
Time = 
month 2 
Time = 
month 3  
 
Time = 
month 4 
 
Time = 
month 5 
 
Time = 
month 6 
Time = 
month 7 
Time = 
month 8  
 
Time = 
month 9 
 
Time = 
month 10 
Time = 
month 11 
Time = 
month 12 
 
 Study 
Initiation 
 
 
 
 10 sites 
with IRB 
approval 
 First 
enrollment  
 Enrollment 
& follow-up 
 
 
 
 60 sites 
with IRB 
approval 
 
 
 
 
 
 
 Estimated 
enrollment 
=  20  
 Estimated 
enrollment 
= 30  
 Estimated 
enrollment 
= 40  
 Estimated 
enrollment 
= 50  
 Estimated 
enrollment 
= 60  
 Estimated 
enrollment 
= 70 
 Estimated 
enrollment 
= 80 
 Estimated 
enrollment 
= 90 
 Estimated 
enrollment 
= 100 
 
 
Cumulative 
enrollment 
 20 
 50 
 90 
 140 
 200 
 270 
 350 
 440 
 540 
 
Time = 
month 13 
Time = 
month 14 
Time = 
month 15 
Time = 
month 16 
Time = 
month 17 
Time = 
month 18 
Time = 
month 19 
Time = 
month 20 
Time = 
month 21 
Time = 
month 22 
Time = 
month 23 
Time = 
month 24 
 Anticipated 
enrollment 
of 100/mo 
after month 
12 
 
 
 
 
 
 
 
 
 
 
 Enrollment 
completed 
Cumulative 
enrollment 
 740 
 840 
 940 
 1040 
 1140 
 1240 
 1340 
 1440 
 1540 
 1640 
 1725 
 
Time = 
month 25 
Time = 
month 26 
Time = 
month 27 
Time = 
month 28 
Time = 
month 29 
Time = 
month 30 
Time = 
month 31 
Time = 
month 32 
Time = 
month 33 
Time = 
month 34 
Time = 
month 35 
Time = 
month 36 
 Patient 
follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
Time = 
month 37 
Time = 
month 38 
Time = 
month 39 
Time = 
month 40 
Time = 
month 41 
Time = 
month 42 
/ / 
Elapsed time of 42 months 
Time = 
month 84 
 
Time = 
month 85 
 
Time = 
month 86 
 
Time = 
month 87 
 Patient 
follow-up 
 
 
 
 
 
/ / 
 Follow-up 
completed 
 Complete 
Monitoring 
 Data 
Analysis 
 Final report 
submission 
Enrollment for the sub-study (target sample size = 417) is expected to be completed by month 14 assuming that approximately 55% patients will provide consent 
to participate in the sub-study. Final follow-up visit (60 month visit) in the sub-study is expected to be done in month 84. Results from the sub-study will be 
included in the progress reports submitted to FDA.  

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5.0 Study Outcome Measures 
5.1 
Primary Outcome Measure  
5.1.1 Freedom from RV Lead Related Complications 
The primary outcome measure for the Optisure Lead Post Approval study is 
the complication free survival rate at 5 years for complications related to the 
Optisure RV leads. 
 
The hypothesis is as follows: 
 
H0:  Complication free survival at 5 years ≤ 92.5% 
H1:  Complication free survival at 5 years > 92.5% 
 
The desired outcome is to reject the null hypothesis.  The null hypothesis will 
be rejected at the 5% significance level if the 95% Lower Confidence Bound 
(LCB) for the freedom from complications is greater than 92.5%. 
 
Sample Size 
Assuming that the time to first complication follows an exponential 
distribution and the complication-free survival at 5 years is 95%, a sample 
size of 645 patients provides 80% power to reject the null hypothesis of 92.5% 
complication-free survival years at the 5% significance level (See Appendix D 
for detailed sample size calculations). 
 
Patient Group 
All patients who had an attempted implant of the Optisure RV lead will be 
included in the analysis of this endpoint.  
 
Analysis 
All complications will be classified as related to the Optisure RV lead or 
unrelated. 
 
The following complications will be included in this analysis: 
 
 Cardiac perforation 
 Lead dislodgement that occurred greater than 30 days after implant  
 Lead insulation damage 
 Lead fracture 
 Abnormal RV lead performance (abnormal lead defibrillation 
impedance, abnormal lead pacing impedance, elevated pacing 
thresholds, loss of capture, failure to deliver therapy, loss of sensing, 
oversensing, undersensing) 

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 Other unexpected complications that are considered related to the RV 
lead  
 
The survival time for all patients will be calculated as the number of days 
from implant or attempted implant to the date the complication was first 
discovered.  For patients who do not experience a complication related to the 
Optisure RV lead at the time of their withdrawal, the survival time will be 
censored on the date of their withdrawal.  For patients who have not 
experienced any complication related to the Optisure RV lead at the time of 
analysis, the survival time will be censored on the date of analysis.  The 
endpoint will be evaluated using the Kaplan-Meier method and the 95% lower 
confidence bound (LCB) will be obtained by transformation from its log scale, 
based on Peto et al1.  The null hypothesis will be rejected if the 95% LCB is 
greater than 92.5%.   
 
Kaplan-Meier curves will also be presented for each adverse event category of 
complication listed above. 
5.2 
Secondary Outcome Measures 
5.2.1 Optisure Lead-Related Complication Rates 
The objective is to characterize the complication rate of the Optisure lead, and 
to perform a trend analysis of all complications. All complications will be 
evaluated for their relationship to the RV lead, reported and summarized.  
 
The following complications will be reported as related to the RV lead: 
 
 Cardiac perforation 
 Lead dislodgement that occurred greater than 30 days after implant  
 Lead insulation damage 
 Lead fracture 
 Abnormal RV lead performance (abnormal lead defibrillation 
impedance, abnormal lead pacing impedance, elevated pacing 
thresholds, loss of capture, failure to deliver therapy, loss of sensing, 
oversensing, undersensing) 
 Other unexpected complications that are considered related to the RV 
lead  
 
 

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Table 1: Summary of RV Lead Related Complications 
  
 
 
Description of Complication 
 
Number of  
Patients with 
Comp 
(No. of pts = 
X) 
% of  
Patients with 
Comp 
Number of  
Comps 
# Comps/pt-
years 
(Total pt- 
years =  ) 
Cardiac perforation 
X 
X% 
X 
X 
Lead dislodgement that 
occurred greater than 30 days 
after implant  
X 
X% 
X 
X 
Lead insulation damage 
X 
X% 
X 
X 
Lead fracture 
X 
X% 
X 
X 
Abnormal RV lead 
performance 
X 
X% 
X 
X 
Other unexpected 
complications that are 
considered related to the RV 
lead  
X 
X% 
X 
X 
Total 
X 
X% 
X 
X 
 
Sample Size  
The sample size required to obtain a two-sided 95% upper confidence limit for 
the complication rate of no more than 5%, based on the Clopper-Pearson exact 
Binomial method2, assuming an expected complication rate of 3.5%, is 828 
patients (See Appendix D for detailed sample size calculations). 
 
Sample size accounting for patient attrition 
The following categories are included to account for patient attrition. 
 
1. Unsuccessful Implant  
 
A small proportion of the patients are expected to have an unsuccessful 
implant of the Optisure lead (less than 1%).  
 
2. Mortality 
 
The expected distribution of ICDs to CRT-Ds in this post-market 
surveillance study is 3:23.  The annual mortality in the ICD patient 
population varies between 5.6% and 7%, which are calculated from the 
published results of the SCD-HeFT and MADIT II trials4,5. Assuming an 
annual mortality of 7% in the ICD patient population, the mortality at 5 
years is 30%.  In the recent RHYTHM ICD/QuickSite 1056K left heart 
lead study6, the annual mortality was 12.8%, which gives a mortality of 
49% at 5 years.  Hence the expected overall mortality in this post-approval 
study at 5 years is 38% (=0.6×0.30+0.4×0.49).   

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3. Withdrawal due to Lost-to-follow-up, system explant due to heart 
transplant/infection, patient/physician request 
 
In the ongoing St. Jude Medical post-approval study consisting of CRT 
devices and LV leads7, out of a total of 1127 enrollments, 102 patients 
have been withdrawn for reasons other than death during an average of 22 
months of follow-up.  This translates to an attrition of 22% over 5 years.  
It is assumed that attrition in the study over 5 years is 22%.  This is a 
conservative assumption since the CRT Device System Post Approval 
Surveillance study solely enrolled patients indicated for CRT, while this 
study is expected to enroll patients receiving either a CRT-D or an ICD. 
 
Assuming that deaths and withdrawals are independent events, the total 
attrition is thus expected to be approximately 52% (= 1-(1-0.38)×(1-0.22)) 
over 5 years. Thus, a minimum of 1725 patients will be enrolled in the 
post-approval study.  
 
Patient Group 
All patients who give consent for the study and undergo an attempted implant 
of the Optisure lead or had an Optisure lead implanted within 30 days of 
enrollment will be included in this analysis.   
5.2.2 Optisure Lead Related Events 
Adverse Events related to the Optisure lead will be classified and reported as 
complications or observations.  RV lead related complications or observation 
are defined in section 5.2.1 
 
5.3 
Sub-study - Outcome Measures 
5.3.1 The annual hazard rate of lead electrical dysfunction  
 
Lead Population  
 
All enrolled Optisure leads being followed in this sub-study. 
 
 
Analysis: 
The annual hazard rate will be assessed.  
 
5.3.2 The annual hazard rate of externalized conductors (from 
enrollment) 
 
 
Lead Population  
 
All enrolled Optisure leads being followed in this sub-study. 

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 Analysis: 
The annual hazard rate will be assessed.   
 
5.3.3 The annual hazard rate of other visual lead anomalies by each 
subcategory (from enrollment) 
 
 Lead Population  
 
All enrolled Optisure leads being followed in this sub-study. 
 
 
 Analysis: 
The annual hazard rate will be assessed.   
 
5.3.4 Prevalence of “other insulation anomalies” in “returned leads” (as 
defined in section 2.0) 
 
Lead Population  
 
Any enrolled lead in the sub-study that is returned to St. Jude 
Medical for analysis. 
 
 
Analysis: 
The prevalence of “other insulation anomalies” will be 
calculated as the number of returned leads that have “other 
insulation anomalies” divided by the total number of returned 
leads in enrolled sub-study patients. The one-sided 95% UCB 
for prevalence will be calculated using Clopper-Pearson exact 
method. 
 
5.3.5 Time from externalized conductors to electrical dysfunction 
 
Lead Population  
 
All Optisure leads with externalized conductors but without 
electrical dysfunction. 
 
 
 
Analysis: 
Time to electrical dysfunction will be analyzed using the 
Kaplan-Meier method. The zero time will be the date at which 
externalized conductor was detected.  Those patients who 
experience an externalized conductor after enrollment, but do 
not experience an electrical dysfunction will be censored 3 
years after enrollment in this trial. 
 

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5.3.6 Time from other visual lead anomalies by each subcategory to 
electrical dysfunction 
 
Lead Population  
 
All Optisure leads with other visual lead anomalies (by each 
subcategory) but without electrical dysfunction. 
 
 
 
Analysis: 
Time to electrical dysfunction will be analyzed using the 
Kaplan-Meier method. The zero time will be the date at which 
other visual lead anomaly (by each subcategory) was detected.  
Those patients who experience other visual lead anomaly (by 
each subcategory) after enrollment, but do not experience an 
electrical dysfunction will be censored 3 years after enrollment 
in this trial.   
 
5.3.7 Adverse Event rate through 30 days post-intervention for lead 
(e.g. extraction, abandonment, revision, other) 
Lead Population 
All Optisure leads that require an intervention/revision (e.g. 
extraction, abandonment, other).  
 
Analysis 
The 30-day adverse event rate will be calculated as the number 
of adverse events within 30 days associated with lead related 
interventions divided by total lead related interventions.  
 
5.3.8 Time from externalized conductors to clinical intervention 
 
 Lead Population  
 
All Optisure leads with externalized conductors. 
 
 
 
Analysis: 
Time to clinical intervention will be analyzed using the 
Kaplan-Meier method. The zero time will be the date at which 
externalized conductor was detected.  Those patients who 
experience externalized conductor after enrollment but do not 
experience clinical intervention will be censored 3 years after 
enrollment in this trial.   
 
 

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5.3.9 Time from other visual lead anomalies by each subcategory to 
clinical intervention 
 
 Lead Population  
 
All Optisure leads with other visual lead anomalies (by each 
sub category). 
 
 
 
Analysis: 
Time to clinical intervention will be analyzed using the 
Kaplan-Meier method. The zero time will be the date at which 
other visual lead anomaly (by each subcategory) was detected.  
Those patients who experience other visual lead anomaly (by 
each subcategory) after enrollment but do not experience 
clinical intervention will be censored 3 years after enrollment 
in this trial.   
5.3.10 Comparison of patients with lead compromise as evidenced by 
imaging (includes externalized conductors and other visual lead 
anomalies) to those without lead compromise  
Patient Population 
All the patients implanted with Optisure leads. 
 
Analysis 
Demographic and clinical parameters will be compared 
between patients who experience lead compromise as 
evidenced by imaging and those who do not experience lead 
compromise.  Specifically, the variables age, gender, body 
mass index, lead size, lead model, and implant factors such as 
venous access site, number of other leads in the vasculature, 
fixation location in the right ventricle, level of activity (based 
on functional NYHA class scale I, II, III, IV), level of therapy 
that patient received (no ATP/shock, ATP or shock) and slack 
(grades 0, 1, 2, 3, 4 based on the scale described by Ha et al., 
20108) in the lead will be used for the comparison.  Continuous 
variables such as age or body mass index will be compared 
using Student’s T-tests while categorical variables such as 
gender or lead models will be compared using Pearson’s Chi-
square statistic.  Point estimates and p-values will be provided 
from these analyses. 
 
5.3.11 Comparison of patients with electrical dysfunction to those 
without electrical dysfunction. 
Patient Population 
All the patients implanted with Optisure leads. 

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Analysis 
Demographic and clinical parameters will be compared 
between patients who experience electrical dysfunction and 
those who do not experience electrical dysfunction.  
Specifically, the variables age, gender body mass index, lead 
size, lead model, and implant factors such as venous access 
site, number of other leads in the vasculature, fixation location 
in the right ventricle, level of activity (based on functional 
NYHA class scale I, II, III, IV), level of therapy that patient 
received (no ATP/shock, ATP or shock)  and slack in the lead 
(grades 0, 1, 2, 3, 4 based on the scale described by Ha et al, 
20108) will be used for the comparison.  Continuous variables 
such as age or body mass index will be compared using 
Student’s T-tests while categorical variables such as gender or 
lead models will be compared using Pearson’s Chi-square 
statistic.  Point estimates and p-values will be provided from 
these analyses. 
 
6.0 Analysis and Reporting 
6.1 
Interim Reports and Trend Analysis  
Interim reports will be submitted to FDA every 6 months for the first 2 years and 
yearly thereafter.  
 
The observed number of enrollments in the study and the sub-study at participating 
centers, number of implants at participating centers and number of overall US 
implants will be included in the progress reports until enrollment is completed.   
 
Other data summarized in the progress reports will include: 
 Demographic data including gender, age, NYHA functional classification, 
left ventricular ejection fraction, and indication for device. Continuous 
variables will be summarized by average and standard deviation. Categorical 
variables will be summarized by frequency and percentage 
 Complications and observations related to the Optisure RV lead will be 
summarized and reported 
 Complications or observations that are unrelated to the RV lead (shown in 
Table 2) will be summarized and reported 
  Signal amplitude measurements for Optisure leads at implant/enrollment, as 
appropriate, and at each follow-up visit (if available) will be summarized and 
reported. 
  Capture thresholds for Optisure leads at implant/enrollment, as appropriate, 
and at each follow-up visit will be summarized and reported. 

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  Pacing lead impedance for Optisure leads at implant/enrollment, as 
appropriate, and at each follow-up will be summarized and reported. 
 High voltage lead impedance for Optisure leads at implant/enrollment, as 
appropriate, and at each follow-up will be summarized and reported. 
 The rate of successful Optisure RV lead implants will be reported (only 
applicable to patients enrolled at or before implant) 
  Total implant procedure time (skin to skin) – the average and standard 
deviation for successful Optisure lead implants will be reported (only 
applicable to patients enrolled at or before implant) 
 Implant approach (site of venous access) (only applicable to patients enrolled 
at or before implant) 
 Percentage of leads with externalized conductors, other visual lead anomalies 
at different time points (24, 36, 48 and 60 months) 
 Type, location and extent of externalized conductors and other visual lead 
anomalies 
 Percentage of leads with electrical dysfunction in the sub-study 
 Prevalence of “other insulation anomalies” in returned Optisure leads 
 
 
Table 2: Complications or Observations That Are Unrelated To the RV Lead 
 
Pneumothorax 
Lead dislodgement occurring in the peri-operative period (within 30 days 
of implant) 
Elevated pacing thresholds due to patient physiology  
Loss of capture unrelated to lead fracture or dislodgement 
Loss of sensing unrelated to lead fracture or dislodgement 
Oversensing due to a change in patient physiology 
Undersensing due to a change in patient physiology 
Generator malfunction 
Abnormal lead pacing impedance (≤ 200 Ω or ≥ 2000 Ω) unrelated to lead 
fracture or dislodgement 
Abnormal lead defibrillation impedance (≤ 20 Ω or ≥ 100 Ω) unrelated to 
lead fracture or dislodgement 
Failure to detect VT/VF due to a cause unrelated to the Optisure RV lead 
Complications related to other implanted leads (right atrial or left 
ventricular) 
 
A trend analysis for the complications listed in Table 1 will be summarized by 
quarter with the first analysis carried out after 100 patients have been enrolled and 
followed for a minimum of 6 months. Each interim report will include a plot of 
quarterly trend analyses of % of Patients with Complications and # of 
Complications/patient-year from all preceding analyses.   

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6.2 
Final Study Report 
In addition to the summaries described in section 6.1, the following will also be 
included in the final report: The number and proportion of patients who experience 
each type of complication in Table 1 at 5 years will be presented along with the 95% 
confidence intervals for the proportion based on the Clopper-Pearson exact Binomial 
method. A Kaplan-Meier analysis will be performed for all-cause death for the final 
report. 
 
7.0 Site Selection 
Centers will be selected for participation in the study and sub-study based on their 
ability to screen and enroll eligible patients, and perform the required study 
procedures outlined in section 9.0. SJM will attempt to have a diversified group of 
centers participating in the study, including academic and non-academic institutions, 
and anticipates participation to be in the order of approximately 25-30 percent from 
academic institutions.  To ensure a widespread distribution of data and minimize site 
bias, a maximum of approximately 15% of the total enrollment will be allowed at a 
single site.  
8.0 Patient Selection 
8.1 
Inclusion Criteria 
Eligible patients will meet all of the following: 
 
1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for 
implantation of an ICD or CRT-D system for treatment of heart failure or 
life-threatening ventricular tachyarrhythmia(s).  
2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 
days or are scheduled for an Optisure lead implant. 
3. Have the ability to provide informed consent for study participation and be 
willing and able to comply with the prescribed follow-up tests and schedule 
of evaluations.  
4. Are 18 years or above, or of legal age to give informed consent specific to 
state and national law. 
8.2 
Exclusion Criteria  
Patients will be excluded if they meet any of the following: 
 
1. Enrolled or intend to participate in a clinical drug and/or device study, which 
could confound the results of this trial as determined by SJM, during the 
course of this clinical study. 
2. Have a life expectancy of less than 5 years due to any condition. 

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8.3 
Sub-study Enrollment Criteria 
Patients enrolled in the main study who provide their consent to participate in the 
sub-study will be enrolled until 417 patients are enrolled.  
 
9.0 Study Procedures 
All required study procedures at each specified interval are outlined in the sections below.  
 
Table 3: Schedule of Evaluations Summary 
Evaluation 
Enrollment* 
Every 6 
months 
thereafter 
until 5 years 
24, 36, 48 
and 60 month 
follow-up 
visits 
Inclusion/Exclusion 
Criteria Evaluation 
 
 
 
Record capture threshold, 
signal amplitude, pacing 
lead impedance and high 
voltage lead impedance 
measurements on Optisure 
lead 
 
 
 
RV Lead Handling 
Characteristics (only 
applicable to patients 
enrolled at or before 
implant) 
 
 
 
Cinefluoroscopy (AP, 
LAO 45° or the best 
possible LAO view, RAO 
45° or the best possible 
RAO view) 
 
 
** 
* Enrollment can occur up to 30 days post implant 
**Only applies to patients participating in the sub-study 
 
9.1 
Data Entry   
Each study center will capture all study-related data and submit via an Electronic 
Data Capture (EDC) system.  All study data will be entered and submitted through 
this system, including device data.  The device session record data will be submitted 
through the SJM EDC system using the device data upload portal. The SJM EDC 
system complies with regulatory requirements to protect patient privacy and 
maintain data integrity.    
 

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Patient-specific device print-outs may be placed in the provided Patient Binders.  
Alternatively, print-outs may be stored electronically on the thumb drive provided to 
the centers specifically for the purpose of data collection and retention. The thumb 
drives will be stored in a secure location and made available to the sponsor 
representatives as required. The thumb drives will be returned or destroyed at 
sponsor request at the end of the study. All other study training material will be 
placed in the provided study Regulatory Binder.   
 
Training for the EDC system will be provided by SJM.  
9.2 
Enrollment Requirements 
9.2.1 Enrollment 
Patients 
will 
undergo 
screening 
evaluations 
as 
outlined 
by 
the 
inclusion/exclusion criteria.  To ensure enrollment of a diverse patient 
population into the Optisure lead study, centers will be instructed to approach 
and invite all patients who meet all of the inclusion and none of the exclusion 
criteria for participation in the study.  
 
Data will be collected on the patient’s gender, age, indication for device 
implantation, NYHA functional classification, and left ventricular ejection 
fraction. 
 
Patients who meet inclusion/exclusion criteria, sign an IRB/MEC approved 
informed consent, and have an Optisure lead implant or attempted implant of 
the Optisure lead will be considered enrolled in the study. Enrolled patients 
who provide consent to participate in the sub-study will be included in the 
sub-study. 
 
The following electrical measurements* must be performed: capture threshold 
testing for all implanted leads, signal amplitude measurements for the RV and 
RA leads, pacing lead impedance for all implanted leads and high voltage lead 
impedance for all implanted leads.  
 
*Notes 
1. If the patient is in atrial fibrillation or atrial flutter, RA electrical 
measurements are not required.  
2. If the patient is pacemaker dependent, RV sensing amplitude is not 
required.  
3. As referenced under the Definitions in section 4.2, abnormal pacing 
lead impedances are defined as measured pacing impedances with 
values ≤ 200 Ω or ≥ 2000 Ω. RV lead pacing impedances have been 
observed in typical clinical settings to be in the range of 200-1200 
Ω for the majority of patients. However, lead pacing impedances 
measured up to 1999 Ω are considered to be within the normal bounds 
of the performance of the RV lead because characteristics such as non-

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viable myocardium, lead-to-tissue contact, etc., specific to each patient 
have been known to produce measured pacing impedances that are 
higher than the observed 1200 Ω noted above.  
 
Device diagnostics and archives of RV lead impedance values may also be 
used to diagnose potential lead failures. Alternatively, investigators should 
consult the respective device and lead user manuals, St. Jude Medical 
technical support or other St. Jude Medical clinical support personnel to 
diagnose potential lead failures. 
 
The enrollment date for patients in the study will be the date when all protocol 
defined enrollment procedures (consent, implant and lead measurements) are 
completed.   
 
Complete an Enrollment, Implant and Lead Measurements Case Report Forms 
and record all results. Complete an Adverse Event Case Report Form (if 
applicable) for all adverse events which occurred since the implant of the 
Optisure lead.  Submit the forms to St. Jude Medical using the EDC system. 
Complete an Out of Service Form for any product used but not implanted (e.g. 
contaminated, dropped or opened in error). 
 
Upload the device session record including all stored IEGMs to St. Jude 
Medical using the SJM EDC Portal device data upload utility. If the patient is 
enrolled after implant, provide the session record from the enrollment visit. 
9.2.2 Unsuccessful Implant– if applicable 
Enrolled patients who have an unsuccessful implantation of a St. Jude Medical 
Optisure lead (see definition for successful Optisure lead implant in section 
4.2) will be followed for a period of 30 days for adverse events and then 
withdrawn from the study unless the implant will be re-attempted within 30 
days of the unsuccessful implant. The physician may re-attempt the 
implantation of a St. Jude Medical Optisure lead at his/her discretion. 
 
In addition to the Forms identified in section 9.2.1 complete the Out of 
Service for any product used but not implanted (e.g. contaminated, dropped or 
opened in error) and record all results. After 30 days, if the patient has not had 
an implant re-attempted, complete a Withdrawal Case Report Form and record 
all results. Submit the forms to St. Jude Medical using the EDC system.  
 
If the physician chooses to re-attempt the implantation of a St. Jude Medical 
Optisure lead within 30 days, complete Implant and Lead Measurements Case 
Report Forms, an Adverse Event Case Report Form (if applicable) and Out of 
Service Case Report Form (if applicable) and record all results. Submit the 
forms to St. Jude Medical using the EDC system.  
 

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9.3 
System Revisions – if applicable 
If the system revision procedure occurs more than 3 months after implant then obtain 
cinefluoroscopy views of the entire length of the implanted leads before 
repositioning or explanting the Optisure lead.  Cinefluoroscopy should be performed 
in three views (AP, LAO 45° or the best possible LAO view, RAO 45° or the best 
possible RAO view) and submitted to St. Jude Medical.  If the patient is unwilling 
then the imaging is not required.   
 
For all lead revisions (e.g. replacement or repositioning of the lead) complete the 
applicable testing as outlined in section 9.2.1.  Any explanted pulse generator or 
leads (including damaged leads, lead segments and lead fragments) should be 
returned to St. Jude Medical for analysis promptly.   
 
Any changes to the status of a lead (i.e., capped, removed) will be documented on 
the Product Out of Service Case Report Form.  Complete an Adverse Event (if 
applicable), System Revision, Imaging (if applicable), and Out of Service for any 
product used but not implanted (e.g. contaminated, dropped or opened in error) Case 
Report Form. Submit the forms to St. Jude Medical using the EDC system.  
9.4 
Follow-Up Requirements 
Lead measurements and adverse events (if applicable) will be obtained every 6 
months from patients who have a successfully implanted Optisure lead until they 
reach the 5 year follow-up.   
The schedule of follow-ups is based on the date of a successful Optisure lead 
implant. Table 4 outlines the time window that is permitted for each of the study 
interval visits.  
 
Table 4: Study Interval Time Windows 
  
Every 6 months 
thereafter until 5 
years 
±  90 days 
  
The following electrical measurements* will be obtained at each follow up: capture 
thresholds for all implanted leads, signal amplitude measurements for the RV and 
RA leads, pacing lead impedance for all implanted leads and high voltage lead 
impedance for all implanted leads.  
 
*Notes  
1. If patient is in atrial fibrillation or atrial flutter or RA lead is turned 
off, RA electrical measurements are not required. 
2. If patient is pacemaker dependent, RV sensing amplitude is not 
required. 

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3. As referenced under the Definitions in section 4.2, abnormal pacing 
lead impedances are defined as measured pacing impedances with 
values ≤ 200 Ω or ≥ 2000 Ω. RV lead pacing impedances have been 
observed in typical clinical settings to be in the range of 200-1200 
Ω for the majority of patients. However, lead pacing impedances 
measured up to 1999 Ω are considered to be within the normal bounds 
of the performance of the RV lead because characteristics such as non-
viable myocardium, lead-to-tissue contact, etc., specific to each patient 
have been known to produce measured pacing impedances that are 
higher than the observed 1200 Ω noted above.  
 
Device diagnostics and archives of RV lead impedance values may also be used to 
diagnose potential lead failures. Alternatively, investigators should consult the 
respective device and lead user manuals, St. Jude Medical technical support or other 
St. Jude Medical clinical support personnel to diagnose potential lead failures. 
 
In the subset of patients participating in the sub-study, cinefluoroscopy (AP, LAO 
45° or the best possible LAO view, RAO 45° or the best possible RAO view) of the 
entire lead length and the pocket area will be performed at the 24, 36, 48 and 60 
month visits.  Additionally, query the patient to determine whether the patient has 
had any chest x-rays or fluoroscopy of the implanted leads since the last visit.  
Whenever possible, obtain copies of any imaging done (x-ray or fluoroscopy).  
Review those images for signs of lead conductor externalization.  Report those 
events, as applicable, on an adverse event form.  Also, query the patient regarding 
any adverse events occurring between routine visits.  Complete a Follow-up Case 
Report Form and record all results.  Should any adverse event occur, complete an 
Adverse Event Case Report Form.  If any images were obtained (especially for 
patients participating in the sub-study at the 24, 36, 48 and 60 month visits), 
complete an Imaging Case Report Form.  Submit the forms to St. Jude Medical using 
the EDC system.  
 
Upload the device session record including all stored IEGMs to St. Jude Medical 
using the SJM EDC Portal device data upload utility.  
10.0 Protocol Deviations 
Investigators are required to adhere to the protocol, 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 protocol must be reported to St. Jude Medical per 21 CFR 
§812.150.  In addition, all deviations must be reported to the reviewing IRB/MEC per the 
IRB/MEC’s reporting requirements.  
 

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The investigator must notify St. Jude Medical and the reviewing IRB/MEC of any deviation 
from the protocol plan to protect the life or physical well-being of a subject 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.  
 
Should a deviation occur, complete a Deviation Case Report Form and submit to St. Jude 
Medical using the EDC system. If a deviation occurs between scheduled visits, the event 
should be reported at the next scheduled visit. Visits will be considered missed if they are 
outside of the visit window. 
11.0 Adverse Events 
Adverse events 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 complication or observations.  
 
Complications: Adverse events that require invasive intervention (e.g., lead fracture) with 
the exception of RV lead perforations.  All adverse events reported as RV lead perforations 
(managed with or without an invasive intervention) will be considered a complication.  Each 
complication will be reported in one of the following categories for analysis purposes: 
 
 RV lead related complication: A complication that is related to the RV lead.  
 Device related: A complication related to the device  
 Other lead related complication:  A complication that is related to the LV or RA lead. 
 Procedure related complication: A complication related to an implant or system 
revision procedure. 
 Other complication: Any complication that does not fall into one of the categories 
listed above. 
 
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 pulse 
generator). Observations will be reported in one of the following categories: 
 
 RV lead observation: An observation that is related to the RV lead. 
 Device related: An observation that is related to the device. 
 Other lead related observation:  An observation that is related to the LV or RA lead. 
 Procedure related observation: An observation that is related to an implant or system 
revision procedure. 
 Other observation: Any observation that does not fall into one of the categories listed 
above. 
 
Should an adverse event occur at any time between implant and withdrawal, complete an 
Adverse Event form and submit to St. Jude Medical using the EDC system as soon as 
possible or within 10 days from the date the site became aware of an event. If an adverse 
event occurs between scheduled visits, the event should be reported at the next scheduled 

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visit. 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.  
 
Possible adverse events (in alphabetical order) associated with leads, devices or implant 
and/or system revision procedure may include, but are not limited to the following: 
 Abnormal lead defibrillation impedance 
 Abnormal lead pacing impedance 
 Acceleration of arrhythmias (caused by the device) 
 Air embolism 
 Allergic reaction 
 Bleeding 
 Cardiac perforation  
 Cardiac tamponade 
 Chronic nerve damage 
 Decompensated heart failure 
 Elevated pacing thresholds  
 Erosion 
 Exacerbation of heart failure 
 Excessive fibrotic tissue growth 
 Extracardiac stimulation (phrenic nerve, diaphragm, chest wall) 
 Failure to detect VT/VF 
 Fluid accumulation 
 Formation of hematomas or cysts 
 Generator malfunction 
 Hemothorax 
 Inappropriate shocks 
 Infection 
 Lead/port damage 
 Lead fracture 
 Lead insulation damage 
 Lead migration/dislodgement 
 Lead Noise 
 Loss of capture 
 Failure to deliver therapy 
 Loss of sensing 
 Myocardial Infarction (MI) 
 Oversensing 
 Pectoral Stimulation 
 Pericardial Effusion 
 Pneumothorax 
 Thromboemboli 
 Undersensing 
 Venous occlusion 
 

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Patients susceptible to frequent shocks despite antiarrhythmic medical management may 
develop psychological intolerance to an ICD or CRT-D system that may include the 
following: 
 Dependency 
 Depression 
 Fear of premature battery depletion 
 Fear of shocking while conscious 
 Fear that shocking capability may be lost 
 Imagined shocking (phantom shock) 
 
For unexpected failure modes or unexpected adverse events, the site should follow their 
standard reporting practices for medical device reporting (MDR). As defined in 21 CFR 803, 
a MDR reportable event (or reportable event) means: An event that device user facilities 
become aware of that reasonably suggests that a device has or may have caused or 
contributed to a death or serious injury.  A device user facility must report deaths and serious 
injuries that a device has or may have caused or contributed to, establish and maintain 
adverse event files, and submit summary annual reports to FDA. 
12.0 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 11.0.  
13.0 Health Care Utilization/Hospitalization Visits  
All inpatient, urgent care, ER, observational or outpatient visits for cardiac or suspected heart 
failure reasons which occur after a successful implant of the Optisure RV lead must be 
reported using the Health Care Utilization Case Report Form. 
 
A Health Care Utilization/Hospitalization Case Report Form must be completed and 
submitted along with supporting documentation (i.e. Admission/Discharge Summary) to St. 
Jude Medical using the EDC system. 
14.0 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 
(Death form, Withdrawal form, and Product Out of Service form). A Mortality Committee 
will review and classify all patient deaths.  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 

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 Place death occurred (e.g., hospital, nursing home, patients 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 
 
Provide clinical notes and witness statements. If possible, interrogate the pulse generator. 
Retrieve and print all episode diagnostics, IEGMs, and programmed parameters. If 
applicable, the pulse generator should then be programmed OFF.  
 
Every attempt should be made to explant the pulse generator and/or leads intact. Any 
explanted devices or leads (including damaged leads, lead segments and lead fragments) 
should be returned to St. Jude Medical for analysis promptly. In the event that the device is 
not explanted, the above procedure must be followed to retrieve the data. The reason the 
pulse generator and/or lead(s) are not being returned to St. Jude Medical must be stated 
clearly on the case report form. 
15.0 Patient Relocation 
If a patient moves from the geographic catchment area of their investigator, then St. Jude 
Medical (SJM) will first attempt to place the patient with another Optisure investigator.  If it 
is not possible to place the patient with another Optisure investigator, then SJM will request 
that the patient’s new physician forward the patient’s study information to the investigator.  
If patient follow up information is not forwarded to the investigator the patient will be 
considered lost to follow up per the lost to follow up definition in section 16.0. 
16.0 Withdrawals 
Withdrawal is defined as termination of participation of a patient from a clinical study. All 
reasonable efforts should be made to retain the subject in the clinical study until completion 
of the clinical study. Reasons for withdrawal include, but are not limited to the following: 
 
 Patient Death  
 Patient and/or Family Request 
 Patient Lost to Follow-Up - Defined as the following: Patient will be considered “lost 
to follow-up” after a minimum of two documented phone calls were made by 
personnel at the study center to the patient or emergency contact, a certified letter was 
sent to the last known address, and two consecutive visits pass without an investigator 
receiving data 
 Patient Non-compliance 

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 Patient Participation terminated by Investigator 
 Sponsor Request 
 Unsuccessful Implant 
 Heart transplant 
  Optisure lead removed or capped without a Optisure lead replacement   
 
A Withdrawal Case Report Form should be completed and submitted to St. Jude Medical 
using the EDC system. If there is a potential withdrawal in the study, please contact a 
member of the study team to see if there is anything that can be done to keep the patient 
in the study. 
 
17.0 Returning Devices and Leads to St. Jude Medical 
St. Jude Medical strongly encourages physicians to notify our Patient Records department 
(888-SJM-2763) each time a device or lead is removed from service for any reason. 
Additionally, all explanted products are requested to be returned to St. Jude Medical for 
laboratory evaluation whether or not a malfunction is suspected. To facilitate the return of 
explanted devices and leads, St. Jude Medical offers a no-cost Returned Products Kit 
comprised of a postage paid explant box with a shipping address label, a removed device 
information form, a biohazard bag, and biohazard labels to seal the explant box. This kit, 
#N0004, can be ordered free of charge by contacting St. Jude Medical Customer Service 
(888-SJM-2763). 
 
18.0 Risk Analysis 
The risks associated with the use of the Optisure lead are anticipated to be comparable to 
those associated with the use of other currently available ICD leads.  Patients participating in 
this study are indicated for an ICD or CRT-D system as part of their standard medical 
management and are subject to the risks associated with these devices (refer to Section 11.0). 
There are no expected additional risks associated with this study beyond those found with 
testing at standard implant and follow up visits.  
 
19.0 Committees 
19.1 Cinefluoroscopy Adjudication Committee 
Cinefluoroscopy Adjudication Committee (CAC) will be comprised of at least 
three Electrophysiologists or Cardiologists specially trained in using 
Cinefluoroscopy in this patient population. The role of the CAC is to 
adjudicate the cinefluoroscopy videos/images to determine the presence of 
lead compromise in the sub-study patient population. Committee members 
will be reviewing the cinefluoroscopy videos/images for the 24, 36, 48 and 60 
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received during the course of the study. Data will be sent either electronically 
or on a disk to the committee members. Once the adjudication is complete, a 
cinefluoroscopy adjudication form will be collected per patient per study visit. 
If the presence of externalized conductors is deemed to be ‘indeterminate’ 
then the cinefluoroscopy will be further reviewed by two other CAC 
members. Sample pictures/fluoros/x-rays and other examples of “other visual 
lead anomalies” will be provided to the adjudication committee to aid the 
committee members in identifying these “other visual lead anomalies” on the 
cinefluoroscopy videos/images received from the site. 
 
Only the adjudicated imaging data will be included in the progress reports. 
Percentage of leads with compromise, evidenced by imaging, will be 
presented in the report. The type, extent and location of lead compromise, as 
described in Appendix A, will also be included. As detailed in Appendix A, 
the HV lead is divided into different regions. Both the proximal as well as 
distal ends of externalization will be recorded by the cinefluoroscopy 
adjudication committee. The distribution of externalization (both absolute 
number and percentage) by each region of the lead will be presented for both 
proximal and distal ends of externalization. The distribution of “other visual 
lead anomalies” (both absolute number and percentage) by each region of the 
lead and each individual subcategory of “other visual lead anomalies” will be 
presented.  The frequency (both absolute number as well as percentage) of 
individual subcategories will be reported for “other visual lead anomalies”.  
 
19.2 Electrical Data Adjudication Committee 
Electrical Data Adjudication Committee (EDAC) will be comprised of at least 
three Electrophysiologists or Cardiologists experienced in analyzing and 
interpreting device data. The role of the EDAC is to adjudicate the device 
session records to determine the presence of electrical dysfunction in the 
Optisure lead sub-study patient population. Committee members will be 
reviewing device session records for all leads taken out of service during the 
course of the sub-study. Data will be sent either electronically or in a paper 
binder to the committee members. Once the adjudication is complete, an 
electrical data adjudication form will be collected per patient.  
 
Only the adjudicated cases of electrical dysfunction will be included in the 
progress reports. Percentage of leads with electrical dysfunction (based on the 
definition in section 2.0) will be part of the reports.  
 
20.0 Investigator Information 
This post approval study will be conducted by investigators with experience and/or 
willingness to be trained in the use of ICD or CRT-D devices. A principal investigator should 
have experience in and/or will be responsible for: 

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 Conducting the clinical investigation in accordance with the signed agreement with 
St. Jude Medical, the protocol, all applicable FDA regulations (21 CFR Parts 50, 54, 
56), 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 protocol 
during the course of the study and after the study has been completed 
 Strict adherence to the post approval study testing requirements  
 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 post approval study and 
collecting all required data.  
21.0 Monitoring Procedures 
St. Jude Medical will serve as the “sponsor” of the Optisure lead study.  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 protocol 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 ensure 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) or, if developed, the 
study specific Monitoring Plan.  
 
Responsibility for overall study management will be held by the Vice President of Clinical 
Affairs, St. Jude Medical.   
 
Clinical Affairs 
St. Jude Medical 
15900 Valley View Court 
Sylmar, CA 91342 
TEL: (800) 423-5611 ext. 2739 or 2872 
FAX: (800) 254-6411 
 

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22.0 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. 
 
An investigator shall permit authorized FDA employees, at reasonable times and in a 
reasonable manner, to enter and inspect any establishment where post approval study devices 
are used and to inspect and copy all records relating to the study. 
 
An investigator shall permit authorized FDA employees to inspect and copy records that 
identify subjects, 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/MEC have not been submitted or are incomplete, inaccurate, false, or misleading. 
23.0 Labeling 
Please see the respective device and lead user manuals for appropriate handling and implant 
technique of the Optisure lead.  
24.0 Consent Materials 
See attached consent forms in Appendices B and 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/MEC 
consistent with the IRB/MEC’s reporting requirements. 
25.0 IRB/MEC Information 
IRB/MEC approval for the study and informed consent will be required prior to beginning 
the study. A copy of the IRB/MEC 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/MEC approval should be reported to St. Jude Medical within 5 
working days of the withdrawal of approval. 
 
Institutional Review Board (IRB/MEC) for participating Institutions 
A list of IRB/MEC’s for Institutions participating in the Clinical Investigation will be 
provided upon request. 
26.0 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/MEC information, will be provided upon 
request. 

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26.1 Records and Reports 
Clinical investigators of post approval studies performed as a condition of FDA approval 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. 
26.2 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. 
26.3 Retention Period 
Clinical investigators in the Optisure lead study are required to maintain records during the 
investigation and for a period of at least two years after the date on which the post approval 
study is terminated or completed.  
27.0 Publications 
This study will be posted on ClinicalTrials.gov and results will be posted on 
ClinicalTrials.gov as required.   

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Appendix A: Lead Compromise Details 
 
Lead Compromise as evidenced by imaging includes externalized conductors or other visual 
lead anomalies. The types, extent and location of these anomalies in high voltage (HV) leads 
are listed below: 
 
Type 
Extent  
Location on the lead  
(see figure below) 
Externalized Conductors 
-  Apparent width and 
length of externalized 
conductors on 
fluoroscopy   
- Region 1 
- Region 2 
- Region 3 
- Region 4 
Other Visual Lead 
Anomalies  
-  Fracture 
-  Subclavian crush 
-  Kink 
-  Other irregularities 
 
- Region 1 
- Region 2 
- Region 3 
- Region 4 
- RV coil 
- SVC coil 
- Distal to RV coil 
- Proximal to region 1 
 
 
 
 
 
 
 
Single Coil ICD Lead 
Dual Coil ICD Lead 

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Appendix B: Study Consent Form  
Statement of Informed Consent 
 
Study Title: Optisure Lead Study 
  
Introduction  
You are being asked to participate in a post approval study involving research. This informed 
consent form explains why this study is being performed and what your role will be if you 
decide to participate. This form also describes the possible risks associated with being in this 
study. This study is sponsored by St. Jude Medical, Inc., a company that currently 
manufactures Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Implantable 
Cardiac Defibrillators (ICDs), pacemakers, lead systems, heart valves and catheters.  
 
Please read this form and feel free to ask your doctor any questions you may have about 
the information provided. You will be given the opportunity to ask questions and have your 
questions answered before making a decision whether to take part in the study. Please take 
your time and discuss this information with your family, friends or family physician.  
 
If you agree to be in the study, you will need to sign this consent form. You will be given a 
copy to keep. Your participation is entirely voluntary and you can refuse to participate 
without penalty or loss of benefits to which you are otherwise entitled.  
 
What is the purpose of this study?  
This study is called the Optisure TM Lead study.  You are being asked to participate because 
you either have been implanted with one of St. Jude Medical’s family of high voltage right 
ventricular leads within the past 30-days or are having one of St. Jude Medical’s family of 
high voltage right ventricular leads implanted.  These products are already approved by the 
FDA and we are studying their long term performance. 
 
These leads are currently being implanted in other patients not participating in this research 
study.  The leads will be referred to as “the RV lead” (right ventricular lead).  The implanted 
lead along with the CRT-D or ICD will be referred to as “the device system.”     
 
Even though your device system has been approved by the FDA, this study will allow St. 
Jude Medical to continue to monitor it for a period of up to five years from the date of your 
implant.  You are being asked to take part in this study because your doctor (Dr. 
______________) has determined that you are a suitable candidate. Your participation in this 
study is voluntary.  
 
Up to 1725 patients will be enrolled in this study. Patients will be enrolled at a maximum of 
60 study centers.  
 
What will happen if I take part in this post approval study?  

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Your doctor has determined that you are a suitable candidate to participate in the Optisure 
Lead Study because you will be or have already been implanted with a St. Jude Medical 
(SJM) Optisure lead within the past 30-days. Your device system will be tested using a 
programmer (computer) that will be used to communicate with your device system. You 
should not feel any discomfort during this procedure. It should take no longer than 15 
minutes to gather information on your device.  
 
If you decide to take part in this study prior to your implant procedure, the following 
describes what will happen. If you have already been implanted with the Optisure lead then 
this section does not apply to you and you may skip to the Follow-up requirements section 
below. The implant procedure will be the same as if you were receiving a device system and 
not participating in a study. The device system will be implanted during a procedure in the 
Electrophysiology Laboratory (EP Lab) or in the Operating Room (OR). The total estimated 
time for you to have the device put in is approximately 2 hours.  
 
Prior to the procedure, the doctor will give you medicine to make you sleepy. This could 
involve general anesthesia or a local anesthesia and sedation, depending on your doctor’s 
preference. The doctor will discuss this with you before surgery.  
 
The device system will have one (1), two (2) or three (3) wires depending on the device that 
your doctor decides is right for you. The leads are inserted through your veins, positioned in 
your heart and, after testing, are connected to the ICD or CRT-D device. These wires allow 
information to travel between your heart and the device, and help the device monitor your 
heart. The study doctor will use x-rays to be sure that the wires are positioned correctly. The 
lead placement procedure and the location of the implanted leads will be the same as if you 
were receiving a device system and not participating in a study.  
 
It is common practice for testing to be performed during the placement of your device. This 
is to confirm that the wires are placed in the position that would be most effective in pacing 
your heart and detecting and treating your heart rhythm problem(s). Testing of the device 
may cause your heart to beat very fast similar to what happens when you are having an 
arrhythmia. Your doctor will then use your device to return your heart to its regular rhythm. 
Throughout the procedure, there are back-up defibrillators readily available, if they should 
become necessary. After testing is finished, a pocket for the device will be made under the 
skin in the left or right upper-chest near the shoulder and the incision will be closed after the 
device is placed in the pocket. The St. Jude Medical CRT-D or ICD device and wires that 
will be used in the study are all legally marketed.  This procedure and testing are the same 
regardless of whether you participate in this study or not.    
 
Follow-up Requirements  
If you decide to take part in this study, you will be required to return for follow-up visits.  
The function of your device system will be checked at each of these visits. The follow-up 
visits required for this study will occur every 6 months after you leave the hospital until you 
have completed 5 years of visits.  After your 5 year visit, your participation in the study is 
complete.   
 

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These 6 month follow-ups will occur in-clinic. 
 
 
At each in-clinic follow-up visit, you will have the following testing done by the research 
staff. 
  
• Your device system will be tested using a programmer (computer) that will be used to 
communicate with your device system. You should not feel any discomfort during this 
procedure. It should take no longer than 15 minutes to gather information on your device.  
 
• Your study doctor or nurse will ask you questions regarding your health. 
 
The testing and information collected at these follow up visits is no different than if you were 
not participating in this study.    
 
You will be required to carry an identification card indicating that you have a St. Jude 
Medical device system. If you are hospitalized during your participation in this study, please 
inform the treating doctor that you are enrolled in this post approval study and show the 
doctor your identification card. If you have any changes in your address or telephone number 
over the length of this study, please report those changes to your study doctor and to St. Jude 
Medical Patient Tracking at 1-800-423-5611.  
 
What are the possible discomforts, side effects, and risks?  
Since your RV lead is already approved by the FDA, the risks associated with your 
participation will not be different than if you chose not to participate in this study.  If any 
significant new findings are identified during the study that would affect your willingness to 
participate, your doctor will inform you of this new information. Any risks that may occur 
because you are having a device system implanted will be explained in a separate consent. 
 
What are the possible benefits to you or to others?  
The information obtained through this study will add to the overall knowledge of the long 
term performance of the lead. We cannot and do not guarantee that you will receive any 
benefits from taking part in this study.  
 
 
If you do not want to take part in this study, what other options are 
available to you?  
Your participation in this study is voluntary. You are free to refuse to be in the study, and 
your refusal will not influence your current or future relationship with your doctor. If you 
choose not to be in the study, your doctor will still follow your progress in a similar manner.  
However, no data will be submitted to SJM. 
 
How will your privacy and the confidentiality of your research records be 
protected?  

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If you choose to take part in this study, your medical records will be kept confidential to the 
extent provided by federal, state and local law. Nothing about you, your illness or your 
treatment will be made public. The information obtained from the study will be submitted to 
St. Jude Medical. The data will then be presented in a report to the applicable governmental 
agencies (for example: the Food and Drug Administration). Your personal information will 
be kept confidential. Any publications using the information collected during the study will 
not include your name or any information that can identify you. Your name will not be 
included in mailing lists or used for marketing purposes. Only information about your 
medical condition as it pertains to the study will be provided to St. Jude Medical. Information 
from this study may be exported to countries where different data protection laws apply. 
Professional standards of confidentiality and data protection will be maintained. In order to 
verify study data, monitors from governmental agencies (for example: the Food and Drug 
Administration), St. Jude Medical, and the hospital’s Institutional Review Board will have 
the right to review your medical records as they pertain to this study.  
 
If you receive medical care at another location while still being followed in this study, you 
agree to allow copies of your medical records from the location to be made available for 
collection of data related to the study.  
 
If you choose to take part in this study, will it cost you anything?  
All test and procedures, as well as the cost of your device implantation will be the 
responsibility of you and your insurance company. There is no guarantee that your insurance 
company will cover 100% of the expenses. You are encouraged to check with your insurance 
company to verify coverage or payments of these procedures. The testing procedures listed in 
the follow-up requirements section of this consent form are all considered standard of care.  
 
What if the device needs to be removed?  
In the event your device system or any part has to be removed, you agree to have the 
removed device system components returned to St. Jude Medical for analysis. In the event of 
your death, you agree that your implanted device system may be removed and returned to St. 
Jude Medical for analysis. Should you withdraw from this study and choose to have your 
device system or any part of it removed, the cost will be your responsibility.  
 
Who can you contact for study information?  
If you have any questions regarding your participation 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 ______________ the 
Institutional Review Board Administrator at ___-___-_____.  
 
What if you are injured because of the study?  
In the event of injury to you resulting directly from your participation in this study, medical 
treatment shall be available to you. You or your insurance company shall be responsible for 
all costs 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 

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respect to such injuries. However, you do not waive any legal rights by signing this consent 
form.  
 
During the study, if you experience any medical problems or illnesses, please contact Dr. 
______________ at ___-___-_____.  
 
What are your rights if you decide to participate in this study?  
Your signature on this consent form means that you have received information about this 
study and that you agree to be a part of the study. If you decide to participate, you are free to 
discontinue participation at any time without penalty or loss of benefits to which you are 
otherwise entitled. If you wish to stop your participation in this post approval 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 certain circumstances arise and it is felt to be in your best 
interest, or if the study is discontinued, your doctor may withdraw you from this research. If 
you experience side effects as described in the risks section or if you become ill during the 
research, you may have to be withdrawn from the study, even if you would like to continue. 
Your study doctor will make this decision.  
 
Participation in the study is strictly voluntary. Your decision whether or not to participate 
will not affect the quality of medical care that you receive or your future relations with your 
doctor.  
 
If significant new findings are developed during the course of this study, your doctor will be 
notified immediately by St. Jude Medical and will advise you of such developments that may 
affect your willingness to continue your participation in this study.  
You will be a given a copy of this form to keep.  
 
A description of this clinical trial will be available on http://www.Clinical Trials.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. 
 
 
 
 
 
 
 
 
 

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You are making a decision as to whether or not to participate in the study. Your signature 
indicates that you have read the information provided above and have decided to 
participate in the study. You may withdraw at any time after signing this form should you 
no longer want to participate in this study.  
 
Printed Name of Subject:__________________________________    
 
Signature of Subject:____________________________________     
 
Date (must be written in by Subject):_________________________    
 
 
 
_____________________________________________ 
Name of Person Obtaining Consent   
 
Date of Consent:_________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix C: Sub-Study Consent Form  
 
Statement of Informed Consent 
 
Study Title: Optisure Lead Sub-Study 
  
Introduction  
You are being asked to participate in a sub-study involving research. This informed consent 
form explains why this sub-study is being performed and what your role will be if you decide 
to participate. This form also describes the possible risks associated with being in this sub-
study. This sub-study is sponsored by St. Jude Medical, Inc., a company that currently 
manufactures Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Implantable 
Cardiac Defibrillators (ICDs), pacemakers, lead systems, heart valves and catheters.  
 
Please read this form and feel free to ask your doctor any questions you may have about 
the information provided. You will be given the opportunity to ask questions and have your 
questions answered before making a decision whether to take part in the study. Please take 
your time and discuss this information with your family, friends or family physician.  
 
If you agree to be in the sub-study, you will need to sign this consent form. You will be given 
a copy to keep. Your participation is entirely voluntary and you can refuse to participate 
without penalty or loss of benefits to which you are otherwise entitled.  You may also refuse 
to participate in this sub-study and still participate in the Optisure TM Lead Post Approval 
Study. 
 
What is the purpose of this sub-study?  
This sub-study is called the Optisure TM Lead sub-study.  You are being asked to participate 
because you have agreed to participate in the Optisure TM Lead Post Approval Study.   
 
You are being asked to take part in this sub-study because your doctor (Dr. 
______________) has determined that you are a suitable candidate. Your participation in this 
sub-study is voluntary.  
 
Up to 318 patients will be enrolled in this sub-study. Patients will be enrolled at a maximum 
of 60 study centers.  
 
The purpose of this sub-study is to determine the incidence of wires being visible outside the 
lead insulation body (externalized conductors) or other forms of visual compromise in the 
Optisure ICD leads.  In order to evaluate the incidence of externalized conductors or other 
forms of visual compromise in the Optisure ICD leads, cinefluoroscopy (i.e. video or x-ray) 
will be taken to determine the incidence of externalized conductors or other forms of visual 
compromise of the lead.   
 

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What will happen if I take part in this sub-study?  
Your doctor has determined that you are a suitable candidate to participate in the Optisure 
Lead Sub-Study because you are participating in the Optisure TM Lead Post Approval Study. 
You will be screened for evidence of externalized conductors, forms of visual compromise of 
the lead through cinefluoroscopy (i.e. X-ray, video, etc.), demographics (gender, age, 
medical history, history of electrical malfunctions in the past, etc.) and lead electrical 
performance will also be evaluated. 
 
There may be a representative of the sponsor at your study visits and the representative and 
the sponsor’s representative will work under the direction of your study doctor or other care 
provider. 
 
 
Follow-up Requirements  
 
You will be screened for evidence of externalized conductors or other forms of visual 
compromise of the lead through cinefluoroscopy (i.e. X-ray, video, etc.) every 12 months 
starting 24 months post lead implant up to 60 months post lead implant.  None of the test 
required in this sub-study are experimental in nature. 
 
You will be required to carry an identification card indicating that you have a St. Jude 
Medical device system. If you are hospitalized during your participation in this study, please 
inform the treating doctor that you are enrolled in this sub-study and show the doctor your 
identification card. If you have any changes in your address or telephone number over the 
length of this study, please report those changes to your study doctor and to St. Jude Medical 
Patient Tracking at 1-800-423-5611.  
 
What are the possible discomforts, side effects, and risks?  
Since your RV lead is already approved by the FDA, the risks associated with your 
participation will not be different than if you chose not to participate in this sub-study.  If any 
significant new findings are identified during the sub-study that would affect your 
willingness to participate, your doctor will inform you of this new information.  
 
There may be risks that are unforeseeable.  In addition, there may be risks associated with (a 
small amount of radiation) exposure to cinefluoroscopy (required in the sub-study) which 
may increase your risk of cancer. The estimated fluoroscopy time required is approximately 
45 seconds per visit. 
 
What are the possible benefits to you or to others?  
If you decide to take part in the sub-study, you may encounter an additional benefit if the 
incidence of externalized conductors is identified. You may also be more closely monitored 
by your physician. 
 

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If you do not want to take part in this sub-study, what other options are 
available to you?  
Your participation in this sub-study is voluntary. You are free to refuse to be in this sub-
study, and your refusal will not influence your current or future relationship with your doctor 
nor will it influence your participation in the Optisure TM Lead Post Approval Study. If you 
choose not to be in the study, your doctor will still follow your progress in a similar manner 
and your decision will not result in any penalty or loss of benefits to which you are otherwise 
entitled or affect your future medical care.  However, no data will be submitted to SJM.  
Should you choose not to participate in this sub-study, you may discuss alternatives with 
your physician that may include no screening or screening at intervals other than what is 
required by the sub-study. 
 
How will your privacy and the confidentiality of your research records be 
protected?  
If you choose to take part in this sub-study, your medical records will be kept confidential to 
the extent provided by federal, state and local law. Nothing about you, your illness or your 
treatment will be made public. The information obtained from the sub-study will be 
submitted to St. Jude Medical. The data will then be presented in a report to the applicable 
governmental agencies (for example: the Food and Drug Administration). Your personal 
information will be kept confidential. Any publications using the information collected 
during the sub-study will not include your name or any information that can identify you. 
Your name will not be included in mailing lists or used for marketing purposes. Only 
information about your medical condition as it pertains to the sub-study will be provided to 
St. Jude Medical. Information from this sub-study may be exported to countries where 
different data protection laws apply. Professional standards of confidentiality and data 
protection will be maintained. In order to verify sub-study data, monitors from governmental 
agencies (for example: the Food and Drug Administration), St. Jude Medical, and the 
hospital’s Institutional Review Board will have the right to review your medical records as 
they pertain to this sub-study.  
 
If you receive medical care at another location while still being followed in this sub-study, 
you agree to allow copies of your medical records from the location to be made available for 
collection of data related to the sub-study.  
 
If you choose to take part in this sub-study, will it cost you anything?  
All the tests for this sub-study will be paid by the sponsor.  
 
What if the device needs to be removed?  
In the event your device system or any part has to be removed, you agree to have the 
removed device system components returned to St. Jude Medical for analysis. In the event of 
your death, you agree that your implanted device system may be removed and returned to St. 
Jude Medical for analysis. Should you withdraw from this sub-study and choose to have your 
device system or any part of it removed, the cost will be your responsibility.  

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Who can you contact for study information?  
If you have any questions regarding your participation in this sub-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 ______________ the 
Institutional Review Board Administrator at ___-___-_____.  
 
What if you are injured because of the sub-study?  
In the event of injury to you resulting directly from your participation in this sub-study, 
medical treatment shall be available to you. You or your insurance company shall be 
responsible for all costs 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. However, you do not waive any legal rights by 
signing this consent form.  
 
During the sub-study, if you experience any medical problems or illnesses, please contact Dr. 
______________ at ___-___-_____.  
 
What are your rights if you decide to participate in this sub-study?  
Your signature on this consent form means that you have received information about this 
sub-study and that you agree to be a part of the sub-study. If you decide to participate, you 
are free to discontinue participation at any time without penalty or loss of benefits to which 
you are otherwise entitled. If you wish to stop your participation in this sub- study for any 
reason, you should contact Dr. ______________ at ___-___-_____. A decision to withdraw 
or to not take part in the sub-study will not affect the quality of medical care that you receive 
or your ability to continue your participation in the Optisure TM Lead Post Approval Study. 
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 sub-study 
at any time without your consent. If certain circumstances arise and it is felt to be in your 
best interest, or if the sub-study is discontinued, your doctor may withdraw you from this 
research. If you experience side effects as described in the risks section or if you become ill 
during the research, you may have to be withdrawn from the sub-study, even if you would 
like to continue. Your sub-study doctor will make this decision.  
 
Participation in the sub-study is strictly voluntary. Your decision whether or not to participate 
will not affect the quality of medical care that you receive or your future relations with your 
doctor.  
 
If significant new findings are developed during the course of this sub-study, your doctor will 
be notified immediately by St. Jude Medical and will advise you of such developments that 
may affect your willingness to continue your participation in this sub-study.  
You will be a given a copy of this form to keep.  
 

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A description of this clinical trial will be available on http://www.Clinical Trials.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. 
 
You are making a decision as to whether or not to participate in the sub-study. Your 
signature indicates that you have read the information provided above and have decided to 
participate in the sub-study. You may withdraw at any time after signing this form should 
you no longer want to participate in this sub-study.  
 
Printed Name of Subject:__________________________________    
 
Signature of Subject:____________________________________     
 
Date (must be written in by Subject):_________________________    
 
 
 
_____________________________________________ 
Name of Person Obtaining Consent   
 
Date of Consent:_________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix D: Detailed Sample Size Calculations for Complication Free 
Survival Endpoint 
 
The sample size is calculated assuming that the time to first complication follows an 
exponential distribution.  For a given sample size (N), N samples of time to first 
complication are generated from an exponential distribution with rate of (-log(0.95)/5 = 
0.0103).  The 95% lower confidence bound for the survival probability at 5 years is 
calculated by transformation from its log-survival scale based on Peto et al.  For each sample 
size N, this is repeated 10,000 times and the power is estimated as the number of times the 
95% lower confidence bound is greater than 0.925.  This process is repeated and the power is 
estimated for different values of N, and the sample size is chosen as the smallest N for which 
the estimated power is > 80%.  Simulations were carried out in R version 2.7.1 and the code 
is provided below: 
 
# Power calculation for exponential assumption 
p.nul <- 0.925 
p.exp <- 0.95 
l.exp <- -log(p.exp)/5 
 
N <- seq(630,660,5) 
P <- numeric(length(N)) 
 
for (i in 1:length(N)){ 
 
n <- N[i] 
 
l <- NULL  
 
for (j in 1:10000) { 
 
 
print(j) 
 
 
x <- data.frame(time=rexp(n, l.exp), event=1) 
 
 
s.fit <- summary(survfit(Surv(time, event)~1, data=x, conf.int=0.9, 
conf.lower="peto", conf.type="log-log")) 
 
 
idx <- sum(s.fit$time<=5) 
 
 
l <- c(l, ifelse(idx==0, 1, s.fit$lower[idx]))  
 
 
} 
 
P[i] <- mean(l>p.nul,na.rm=T) 
} 
res <- cbind(N, P) 
dimnames(res)[[2]] <- c("N", "Power") 
 
Output: 
 
> cbind(N, Power) 
[1,] 630 0.8257 
[2,] 635 0.8046 
[3,] 640 0.7909 
[4,] 645 0.8324 
[5,] 650 0.8132 
[6,] 655 0.8067 
[7,] 660 0.8399

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Detailed Sample Size Calculations for Complication rate  
 
The 95% confidence interval for the Binomial proportion is calculated based on the Clopper-
Pearson exact Binomial method.  For a given observed value x, of the random variable X, 
which has a Binomial(n,p) distribution, the 100(1-α)% confidence interval for p is given by 
(L,U), where 1:  
   
 
Simulations for safety endpoint: 
For a particular sample size (n), generate 10,000 random binomial samples with p = 0.4%. 
Calculate the 95% Clopper-Pearson confidence interval for each sample. 
The mean of the 95% Upper Confidence Limit is estimated by the average UCL from the 
10,000 samples. 
 
The above process was repeated for different values of n, and the sample size was chosen as 
the smallest n such that the mean 95% UCL is no more than 1% for any sample size larger 
than n. 
Simulations were carried out in R version 2.5.1 and the code is provided below: 
 
# Clopper-Pearson interval 
intcp <- function(x, n, alpha) { 
       fl <- rep(1, length(x)) 
       fu <- rep(1, length(x)) 
 
       fl[x>0] <- qf(1-alpha/2, 2*(n-x[x>0]+1), 2*x[x>0]) 
       l <- x/(x+(n-x+1)*fl) 
       fu[x<n] <- qf(1-alpha/2, 2*(x[x<n]+1), 2*(n-x[x<n])) 
       u <- (x+1)*fu/(n-x+(x+1)*fu) 
 
       l[x==n] <- (alpha/2)^(1/n) 
       u[x==0] <- 1 - (alpha/2)^(1/n) 
       return(u) 
} 
 
N <- seq(800, 900, by=1) 
W <- numeric(length(N)) 
p.exp <- 0.035 
alpha <- 0.05 

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for (i in 1:length(N)){ 
       n <- N[i] 
       x <- rbinom(10000, n, p.exp) 
       W[i] <- mean(intcp(x,n,alpha)) 
} 
 
res <- cbind(N, W) 
dimnames(res)[[2]] <- c("N", "UCL_CP") 
 
Output: 
 
        N     UCL_CP 
  [1,] 800 0.05017309 
  [2,] 801 0.05024370 
  [3,] 802 0.05012932 
  [4,] 803 0.05018507 
  [5,] 804 0.05014391 
  [6,] 805 0.04987072 
  [7,] 806 0.04995208 
  [8,] 807 0.05000009 
  [9,] 808 0.05003701 
 [10,] 809 0.04995956 
 [11,] 810 0.05008931 
 [12,] 811 0.04996120 
 [13,] 812 0.04996724 
 [14,] 813 0.04991788 
 [15,] 814 0.04996942 
 [16,] 815 0.04987241 
 [17,] 816 0.04994953 
 [18,] 817 0.04987100 
 [19,] 818 0.05001757 
 [20,] 819 0.04988905 
 [21,] 820 0.04999551 
 [22,] 821 0.04991874 
 [23,] 822 0.04984346 
 [24,] 823 0.04982024 
 [25,] 824 0.04987433 
 [26,] 825 0.04984522 
 [27,] 826 0.04986564 
 [28,] 827 0.05003381 
 [29,] 828 0.04979808 
 [30,] 829 0.04988435 
 [31,] 830 0.04986327 
 [32,] 831 0.04984702 
 [33,] 832 0.04976303 
 [34,] 833 0.04985150 
 [35,] 834 0.04983886 
 [36,] 835 0.04980120 
 [37,] 836 0.04974487 
 [38,] 837 0.04983173 
 [39,] 838 0.04974888 
 [40,] 839 0.04968908 
 [41,] 840 0.04959278 
 [42,] 841 0.04955788 
 [43,] 842 0.04969887 
 [44,] 843 0.04967408 
 [45,] 844 0.04966207 

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References 
                                                 
1 Peto R, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each 
patient: II. Analysis and examples. British Journal Cancer 1977, 35:1-39 
 
2 Hahn, G.J. and Meeker, W.Q. Statistical Intervals: A Guide for Practitioners. Wiley Series in Probability and 
Mathematical Statistics. 1991. 
 
3 Stephen CH et al. Heart Rhythm (2007), 4:1260-1263. 
 
4 Bardy GH et al NEJM (2005), Amiodarone or an Implantable Defibrillator-Cardioverter for Congestive Heart 
Failure, 352: 225-237.  
 
5 Moss AJ et al NEJM (2002), Prophylactic Implantation of a Defibrillator in Patients with Myocardial 
Infarction and Reduced Ejection Fraction, 346: 877-883. 
 
6 RHYTHM ICD/QuickSite 1056K left heart lead study final report (IDE G020114). 
 
7 Biventricular Cardiac Pacing System and Cardiac Resynchronization Therapy Defibrillator System post-
approval study approved under P030035/S002 and P030054/S002. 
 
8 Ha A, Vezi BZ, Keren A, et al. Predictors of Fracture Risk of a Small Caliber Implantable Cardioverter 
Defibrillator Lead. PACE, 2010;33(4):437-443.