St.Jude Medical Cardiac Lead Assessment Study
Conditions: Externalized Conductors, Visual Lead Anomalies, Electrical Dysfunction
Sponsor: Abbott Medical Devices

 
2015, St. Jude Medical.  All rights reserved.  No portion of this work may be reproduced in whole or in part without the express 
written permission of St. Jude Medical. 
 
 
 
 
 
STUDY PROTOCOL 
FOR THE 
 
 
ST. JUDE MEDICAL CARDIAC LEAD ASSESSMENT 
STUDY  
 
 
 
 
 
September 18, 2015 
 
 
 
 
 
60039775/K-CLINICAL 
NCT01507987 
 
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page i 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                             Table of Contents 
 
 
 
1.0 
INTRODUCTION ............................................................................................................................... 1 
2.0 
PURPOSE ......................................................................................................................................... 2 
3.0 
CLINICAL PROTOCOL ....................................................................................................................... 3 
3.1 
STUDY DESIGN AND SCOPE .................................................................................................................. 3 
3.1.1 Projected Study Timeline ......................................................................................................... 8 
3.2 
STUDY OUTCOME MEASURES .............................................................................................................. 9 
3.2.1 Primary Outcome Measures .................................................................................................... 9 
3.2.2 Secondary Outcome Measures .............................................................................................. 12 
3.2.3 Additional Data ...................................................................................................................... 18 
3.3 
PATIENT SELECTION ......................................................................................................................... 18 
3.3.1 Inclusion Criteria .................................................................................................................... 18 
3.3.2 Exclusion Criteria ................................................................................................................... 18 
3.4 
STUDY PROCEDURES ........................................................................................................................ 19 
3.4.1 Enrollment ............................................................................................................................. 19 
3.4.2 Follow-up Requirements ........................................................................................................ 21 
3.4.3 System Revision ..................................................................................................................... 23 
3.4.4 Unscheduled Follow-up .......................................................................................................... 23 
3.4.5 Extended Follow-up (Eligible QuickSite/QuickFlex patients only) .......................................... 24 
4.0 
PROTOCOL DEVIATIONS ................................................................................................................ 25 
5.0 
HOSPITALIZATION ......................................................................................................................... 25 
6.0 
ADVERSE EVENTS .......................................................................................................................... 25 
7.0 
OTHER REPORTED EVENTS ............................................................................................................ 26 
8.0 
DEATHS ......................................................................................................................................... 26 
9.0 
WITHDRAWALS ............................................................................................................................. 27 
10.0 
RISKS AND BENEFITS ................................................................................................................. 27 
11.0 COMMITTEES ............................................................................................................................... 28 
11.1 
CLINICAL EVENTS COMMITTEE ........................................................................................................... 28 
11.2 
CINEFLUOROSCOPY ADJUDICATION COMMITTEE .................................................................................... 28 
11.3 
ELECTRICAL DATA ADJUDICATION COMMITTEE ...................................................................................... 29 
12.0 
INVESTIGATOR INFORMATION ................................................................................................. 29 
13.0 
MONITORING PROCEDURES ..................................................................................................... 30 
14.0 
CONSENT MATERIALS ............................................................................................................... 31 
15.0 
IRB INFORMATION ................................................................................................................... 31 
16.0 
OTHER INSTITUTIONS ............................................................................................................... 31 
17.0 
RECORDS AND REPORTS ........................................................................................................... 32 
18.0 
REFERENCES ............................................................................................................................. 33 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 1 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
1.0 
Introduction 
Lead durability and integrity depend on several factors, such as lead design, lead 
material, and mechanical stress. More than half of all lead complications are 
insulation defects, most frequently due to subclavian crush syndrome, abrasion of 
the lead by direct contact to the pulse generator  (i.e. pacemaker, ICD, or CRT-D), 
or abrasion of the lead against adjacent leads. Often these present clinically with 
evidence of impedance changes or inappropriate ventricular sensing and 
defibrillation1. 
 
St. Jude Medical Riata® and Riata® ST family of leads are high voltage 
implantable cardioverter defibrillator (ICD) endocardial leads with Silicone 
insulation.  QuickSite® and QuickFlex® left ventricular leads also utilize silicone 
rubber for insulation. Silicone rubber, while representing the industry’s most 
commonly used defibrillation lead insulation material over the past 20 years, has 
been observed to be vulnerable to abrasion2,3,4. Abrasion of silicone defibrillation 
leads is acknowledged within the clinical community as a well known clinical risk 
and is well documented in the literature as the number one cause of lead failure 
across the industry with reported failure rates ranging from 3 to 10 %5,6,7.  
 
A more recently reported manifestation of Riata lead insulation and 
QuickSite/QuickFlex lead abrasion involves conductors that are outside the lead 
body as detected by x-ray, fluoroscopy, or post-explant physical examination.  
This phenomenon, known as inside-out abrasion with externalized conductors, 
occurs when internal abrasion processes produce an outer insulation breach 
significant enough to allow the conductor to separate from the lead body in 
isolated regions.  Such a separation does not guarantee an electrical abnormality 
because the conductors themselves are insulated with a robust layer of 
ethylenetetrafluoroethylene (ETFE) polymer. 
 
The prevalence of externalized conductors proximal to the RV coil in Riata/Riata 
ST leads has been reported to vary from 0.5% to 33.3% depending on the lead 
model8-11. Some of these cases of externalized conductors have been accompanied 
with inappropriate shocks, oversensing, increased pacing impedance/ threshold 
and lead noise.  It remains unclear whether externalized conductors caused these 
electrical problems, as approximately 85% of the returned leads with externalized 
conductors do not have their ETFE insulation compromised and therefore should 
not be the cause of any reported electrical problem. 
 
The Durata® family of ICD leads utilizes a silicone polyurethane co-polymer 
insulation known as Optim which has been associated with a significant reduction 
in abrasion when compared to Riata and Riata ST silicone insulated leads. 
Although the incidence of these insulation abrasion issues is extremely low in 
Durata leads, the Durata leads are being included in this study for comprehensive 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 2 
September 18, 2015 
60039775/K-Clinical 
Confidential 
analysis across all St. Jude Medical ICD lead types. This study aims to 
prospectively determine the prevalence and incidence of lead compromise 
evidenced by imaging (includes externalized conductors and other visual lead 
anomalies, by each subcategory, as listed in Appendix A) and electrical 
dysfunction in patients with Riata, Riata ST silicone ICD, QuickSite/QuickFlex 
CRT and Durata ICD leads. Prevalence as well as incidence of externalized 
conductors and other visual lead anomalies will be separately analyzed and 
reported.  In addition, this study will provide information to the physicians 
regarding the possibility that an observation of externalized conductors with 
normal electrical function may progress to an electrical malfunction.  The SJM 
Cardiac Lead Assessment Study is sponsored by St. Jude Medical (SJM) and 
constitutes the modification of the “Riata Lead Evaluation Study”. 
2.0 
Purpose 
The objectives of the study are: 
1. To determine the prevalence of externalized conductors at enrollment in 
Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and  Durata® leads 
2. To determine the prevalence of other visual lead anomalies by each 
subcategory per Appendix A at enrollment in Riata®, Riata® ST Silicone, 
QuickSite®/QuickFlex® and  Durata® leads 
3. To determine the prevalence of electrical dysfunction§ at enrollment in 
Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and  Durata® leads 
4. To determine the incidence of externalized conductors after enrollment in 
Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and  Durata® leads 
5. To determine the incidence of other visual lead anomalies by each 
subcategory per Appendix A after enrollment in Riata®, Riata® ST Silicone, 
QuickSite®/QuickFlex® and  Durata® leads 
6. To determine the incidence of electrical dysfunction§ after enrollment in 
Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and  Durata® leads. 
7. To evaluate the 30-day adverse event rate associated with lead revision 
procedures (include lead extractions or abandonments with or without lead 
replacement) in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and  
Durata® families of leads 
8. To determine the prevalence of “other insulation anomalies” in “returned 
leads” for Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and  Durata® 
families of leads. “Other insulation anomalies” include any of the following: 
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  
o 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 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 3 
September 18, 2015 
60039775/K-Clinical 
Confidential 
surgically capped/extracted or electrically abandoned. Potential electrical failures 
include the following: 
▪ Presence of non-physiologic noise not due to external interference 
▪ 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 
▪ 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 
▪ Change in any high voltage coil impedance of > 25 Ω or to > 125 Ω or < 
20 Ω 
▪ 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 
Clinical Protocol 
3.1 
Study Design and Scope 
This study is a prospective, non-randomized, multi-center, international post market 
study that will determine the prevalence and incidence of externalized conductors and 
other visual lead anomalies (as evidenced by imaging) and the risk of progression to 
electrical dysfunction in a large series of ICD/ CRT-D/CRT-P devices containing one or 
more of the following SJM leads: Riata leads, Riata ST silicone leads, Durata leads, 
QuickSite/QuickFlex CRT leads. A patient that has at least one market released lead 
implanted in time period indicated in Table 1 is eligible for enrollment in the study. Each 
lead group will be considered separately for independent analysis.  
 
Table 1:  Leads Eligible for Enrollment 
Lead Group 
Model Numbers 
Lead 
Implant Date 
Riata 
1560, 1561, 1562, 1570, 1571, 1572, 1580, 
1581, 1582, 1590, 1591, 1592  
2002-2009 
Riata ST Silicone 
7000, 7001, 7002, 7010, 7011, 7040, 7041, 
7042 
2006-2009 
QuickSite/QuickFlex 
1056T, 1058T, 1156T, 1158T 
2006-2010 
Durata 
7120, 7121, 7122, 7130, 7131, 7120Q, 7121Q, 
7122Q, 7170Q, 7171Q, 7172Q 
2008-2010 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 4 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
In order to determine the prevalence and incidence of externalized 
conductors, other visual lead anomalies as well as electrical dysfunction in 
the population of leads being evaluated, a minimum of 1500 leads listed 
above will be enrolled at up to 60 sites. This will comprise a minimum of 
300 leads in the Riata lead group and a minimum of 200 leads in the Riata 
ST lead group to make a combined total of at least 500 Riata and Riata ST 
silicone leads. The study will also include at least 500 leads in the 
QuickSite/QuickFlex and Durata lead groups. All patients will be followed 
every six months for three years. 
 
Adequate representation across the different ages of the leads is also 
needed to understand the lead population being studied.  Therefore, the 
leads from each group of leads will be compromised of subgroups based 
on the age of lead (at enrollment) being studied. The required minimum 
enrollment for each subgroup per lead group is indicated in Table 2. Even 
if the minimum enrollments indicated in Table 2 are met, extra 
enrollments may be required to ensure a minimum of 500 leads in each 
lead group. 
 
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 3 years is 20% [1 – (1-0.07)^3]  In the recent RHYTHM 
ICD/QuickSite 1056K left heart lead study, the annual mortality was 
12.8%, which would result in a mortality of 33.7 % [1 – (1-0.128)^3] at 3 
years.  If the ICD:CRT-D device mix is 60%:40% then the expected 
overall mortality in this study at 3 years is 25.5% (=0.6×0.20+0.4×0.337). 
  
Withdrawals due to reasons other than death  
 
In an ongoing St. Jude Medical post-approval study (SJ4 PAS), the 
attrition rate due to reasons other than death at 22 months of follow-up is 
9%.  Thus, it is anticipated that the attrition rate at 3 years for reasons 
other than death will be 15%.    
   
Assuming that deaths and withdrawals are independent events, the total 
attrition is expected to be approximately 37% (= 1-(1-0.255)×(1-0.15)) 
over 3 years.  
  
Since the Riata/Riata ST leads are recalled, it is more likely that some 
physicians will explant them, even when electrical function is normal. For 
this reason, an additional 10% of the patients are expected to be 
prematurely withdrawn. This leads to a total attrition of approximately 
43% (= 1-(1-0.255)×(1-0.15)×(1-0.10)) over 3 years. 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 5 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
Expected Attrition in patients with left ventricular leads 
Withdrawals due to deaths  
 
In the RHYTHM ICD/QuickSite 1056K left heart lead study, the annual 
mortality was 12.8%, providing an estimated mortality rate of 33.7 % [1 – 
(1-0.128)^3] at 3 years.  
  
Withdrawals for reasons other than death  
 
In the ongoing St. Jude Medical post-approval study, the attrition rate due 
to reasons other than death at 22 months of follow-up is 9%.  Thus, it is 
anticipated that the attrition rate at 3 years for reasons other than death will 
be 15%.   
 
Assuming that deaths and withdrawals are independent events, the total 
attrition is expected to be approximately 43.6% (= 1-(1-0.337)×(1-0.15)) 
over 3 years.  
 
Table 2:  Enrollment in Lead Subgroups 
 
Lead Group 
Age of 
Lead at 
Enrollment 
(Years) 
Min 
Enrollm
-ent 
Expected 
Attrition 
at 3 years* 
Target 
Enrollment 
Riata Silicone 
≥ 7 
100 
47% 
195 
≥ 6 and < 7 
100 
45% 
185 
< 6 
100 
43% 
180 
Riata ST 
≥ 5.5 
100 
45% 
185 
< 5.5 
100 
43% 
180 
QuickSite 
1056T/1058 and 
QuickFlex 
1156T/1158T 
 ≥ 6 
115 
46% 
225 
≥ 5 and < 6 
115 
46% 
225 
< 5 
170 
44% 
300 
Durata 
 ≥ 5 
167 
37% 
275 
 ≥ 4 and < 5 
167 
37% 
275 
 < 4 
167 
37% 
275 
*Expected attrition in each of the lead groups is based on the rationale 
provided above the table as well as larger attrition expected in older leads. 
 
At enrollment, medical history, demographic data and lead measurement 
data will be collected. Additionally, cinefluoroscopy (AP, LAO 45° or the 
best possible LAO view, RAO 45° or the best possible RAO view) will be 
performed to determine the prevalence of lead compromise. A copy of 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 6 
September 18, 2015 
60039775/K-Clinical 
Confidential 
cinefluoroscopy performed as part of separate screening can be used to 
determine the prevalence of lead compromise as long as all three views 
(AP, LAO 45° or the best possible LAO view, RAO 45° or the best 
possible RAO view) are available.  In patients with evidence of 
externalized conductors or other visual lead anomalies (fracture, 
subclavian crush, kink, broken filars on a shocking coil and other 
irregularities) the following chest x-rays or other available imaging studies 
will be collected (if available): a) earliest imaging study showing evidence 
of externalized conductors or other visual lead anomaly and b) latest 
imaging study that does not show any evidence of externalized conductors 
or other visual lead anomaly 
 
Data will be collected at 6, 12, 18, 24, 30, and 36 months post enrollment 
and during any unscheduled follow-up visits due to patient symptoms 
suggestive of or with evidence of lead electrical problems. Additionally, 
cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° 
or the best possible RAO view) will be performed in all patients to 
determine the incidence and mechanical progression of externalized 
conductors at the 12, 24, and 36 month visits. 
 
During any follow-up visits, device data and stored electrograms will be 
collected. All clinical events such as hospitalizations, emergency room 
visits, and adverse events will also be collected. All study data, including 
device data and stored electrograms will be sent to SJM electronically. If 
any lead being followed in this study develops a significant electrical 
abnormality suggestive of lead malfunction and x-ray or cinefluoroscopy 
would be performed as per the site standard of care then copies of x-ray or 
cinefluoroscopy should be submitted to SJM. 
 
During the course of the study, any explanted leads should be returned to Returned 
Goods, St Jude Medical, Sylmar, CA, for analysis. 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 7 
September 18, 2015 
60039775/K-Clinical 
Confidential 
             Study Flow Diagram  
 
Patient Enrolled in the Study
- Cinefluoroscopy (AP, LAO 45º or best possible LAO view, 
RAO 45º or best possible RAO view)
- Lead Measurements
- Demographics
- Medical History
Evidence of 
Externalized 
Conductors or other 
visual 
lead anomaly
Collect chest X-ray or any other imaging study (if available)
- Earliest imaging study with evidence of externalized conductors or 
other visual lead anomaly
- Latest imaging study with no evidence of externalized conductors or 
other visual lead anomaly
Follow Up Visits (6, 18, 30 months)
- In-office follow-up
- Lead measurements
Follow Up Visits (12, 24, 36 months)
- In-office follow-up
- Lead measurements
- Cinefluoroscopy (AP, LAO 45º or best possible LAO view, RAO 
45º or best possible RAO view))
Y
N
Follow Up Visit (42 month)
- In-office follow-up
- Lead measurements
Follow Up Visit (48 month)
- In-office follow-up
- Lead measurements
- Cinefluoroscopy (AP, LAO 45º or best possible LAO view, RAO 
45º or best possible RAO view))
Eligible QuickSite/QuickFlex Patients 
consent for extended follow-up
  
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 8 
September 18, 2015 
60039775/K-Clinical 
Confidential 
3.1.1 Projected Study Timeline 
A projected timeline for the SJM Cardiac Lead Assessment Study is provided below. Since patients implanted 
with Riata and Riata ST silicone leads enrolled in the Riata Lead Evaluation Study will be rolled over to this 
protocol, the timeline takes into the account the initiation of the Riata Lead Evaluation Study done in the 4th 
quarter of 2011; dates will change based on the date enrollment begins again, and/or the actual enrollment rate.  
Time = 0; month 1 
September 2011 
Time = 
month 2 
Time = 
month 3  
 
Time = 
month 4 
December 2011 
Time = 
month 5 
 
Time = 
month 6 
February 2012 
Time = 
month 7 
Time = 
month 8  
 
Time = 
month 9 
 
Time = 
month 10 
June 2012 
Time = 
month 11 
Time = 
month 12 
August 2012 
Study Initiation 
 
 
 
 
4 site with IRB 
approval 
  
9 sites with IRB 
approval 
 
11 sites with IRB 
approval 
 
17 sites with IRB 
approval 
 
22 sites with IRB 
approval 
 
24 sites with IRB 
approval 
 
24 sites with IRB 
approval 
 
Enrollment 
Closed for Riata 
Silicone Leads 
Received FDA 
522 Order 
 
 
 
Enrollment =  5 
Enrollment = 36 
Enrollment = 72  Enrollment = 216 Enrollment = 329 Enrollment = 77 
Enrollment = 47  
 
 
 
Cumulative 
enrollment 
5 
41 
113 
329 
658 
735 
782 
Patient follow-up  
Time = month 13 
September 2012 
 
 
 
 
Time =  
FDA approval 
of Initial 
Protocol Rev F 
February 2013 
Time = FDA 
approval + 1 
month 
Time = FDA 
approval + 2 
months 
Time = FDA 
approval + 3 
months 
Time = FDA 
approval + 4 
months 
Time = FDA 
approval + 5 
months 
Time = FDA 
approval + 6 
months 
Protocol Submitted to 
FDA based on 522 order
/ / 
 
/ / 
 
/ / 
 
/ / 
 
 
 
Enrollments for 
522 Order 
Eligible Leads 
 
 
 
29 sites with 
IRB approval 
 
/ / 
 
/ / 
 
/ / 
 
/ / 
 
522 Order 
eligible 
enrollments= 
720 
Enrollment = 4 
Enrollment = 56 
Enrollment 
= 
66 
Enrollment 
= 
77 
Enrollment = 
126 
Enrollment = 128 
Patient  
follow-up 
 
 
 
 
 
Cumulative 
enrollment= 724 
780 
846 
923 
1049 
1177 
Time = FDA 
approval + 7 
months 
Time = FDA 
approval + 8 
months 
Time = FDA 
approval + 9 
months 
Time = FDA 
approval + 
10 months 
 
Time = FDA 
approval + 
11 months 
Time = FDA 
approval + 
12 months 
Feb. 2014 
 
Time = FDA 
approval + 
18 months 
 
Time = FDA 
approval + 
24 months 
Feb. 2015 
 
 
 
Enrollment = 168 
Enrollment = 80 Enrollment = 58 Enrollment = 36 
Enrollment = 16 
35 sites with IRB 
approval 
Enrollment = 77 
 
43 sites with IRB 
approval 
Enrollment = 217 
 
44 sites with IRB 
approval 
Enrollment = 135 
 
 
Cumulative enrollment = 
1345 
1425 
1483 
1519 
1535 
1612 
 
1829 
 
1964 
 
 
Time = Orig. FDA 
approval +  
32 months 
October 2015 
Anticipate FDA approval 
of protocol revision K 
 
Time = Orig. 
FDA 
approval +  
37 months 
Durata and Riata 
enrollment 
completed 
 
Time = Orig. 
FDA 
approval +  
42 months 
QuickSite/ 
QuickFlex 
enrollment 
completed 
 
 
 
 
Time =  Orig. 
FDA approval  
+ 78 months 
Time = Orig. 
FDA 
approval           
+ 79 months 
Time =  Orig. 
FDA approval  
+ 80 months 
Time =  Orig. 
FDA approval  
+ 81 months 
Time =  Orig. 
FDA approval  
+ 82 months 
 
 
55 sites with IRB 
approval 
 
Patient follow-up 
/ / 
/ / 
Follow-up 
completed 
 
Complete 
Monitoring 
Data Analysis 
Final report 
submission 
Projected Cumulative 
enrollment  = 2025 
 
2060 
 
2110 
 
 
 
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 9 
September 18, 2015 
60039775/K-Clinical 
Confidential 
3.2 
Study Outcome Measures 
3.2.1 Primary Outcome Measures 
3.2.1.1 The prevalence of electrical dysfunction in the Riata, 
Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 
1158) and Durata leads. 
 
 
Lead Population  
 
All enrolled leads within the Riata, Riata ST, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 
Durata lead groups. 
 
 
Analysis: 
The prevalence of electrical dysfunction will be calculated 
as the number of leads that have electrical dysfunction at 
the time of enrollment in each of the 4 lead groups divided 
by total number of leads in enrolled patients in each of the 
4 lead groups. The one-sided 95% UCB for prevalence will 
be calculated using Clopper-Pearson exact method. 
 
 
3.2.1.2 The prevalence of externalized conductors in the Riata, 
Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 
1158) and Durata leads. 
 
 
Lead Population  
 
All enrolled leads within the Riata, Riata ST, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 
Durata lead groups. 
 
 
Analysis: 
The prevalence of externalized conductors will be 
calculated as the number of leads that have been shown to 
have externalized conductors by imaging at the time of 
enrollment in each of the 4 lead groups divided by total 
number of leads in enrolled patients in each of the 4 lead 
groups. The one-sided 95% UCB for prevalence will be 
calculated using Clopper-Pearson exact method. 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 10 
September 18, 2015 
60039775/K-Clinical 
Confidential 
3.2.1.3 The prevalence of other visual lead anomalies by each 
subcategory (fracture, kink, subclavian crush, other 
irregularities) in the Riata, Riata ST, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 
Durata leads. 
 
 
Lead Population  
 
All enrolled leads within the Riata, Riata ST, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 
Durata lead groups. 
 
 
Analysis: 
The prevalence of other visual lead anomalies (by each 
subcategory) will be calculated as the number of leads that 
have been shown to have other visual anomaly (by each 
subcategory) at the time of enrollment in each of the 4 lead 
groups divided by total number of leads in enrolled patients 
in each of the 4 lead groups. The one-sided 95% UCB for 
prevalence will be calculated using Clopper-Pearson exact 
method. 
 
3.2.1.4 The annual hazard rate of lead electrical dysfunction 
(from enrollment) by lead subgroups in the Riata, Riata 
ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) 
and Durata leads. 
 
 
Lead Population  
 
All enrolled leads being followed in this study within the 
Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 
1156T, 1158) and Durata lead groups. 
 
 
Analysis: 
The annual hazard rate will be assessed separately in each 
of the 4 lead groups along with the subgroups listed in 
Table 2.   
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
3.2.1.5 The annual hazard rate of new cases of externalized 
conductors (from enrollment), by lead subgroups in the 
Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 
1156T, 1158) and Durata leads. 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 11 
September 18, 2015 
60039775/K-Clinical 
Confidential 
Lead Population  
 
All enrolled leads being followed in this study within the 
Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 
1156T, 1158) and Durata lead groups. 
 
 
 
 
Analysis: 
The annual hazard rate will be assessed separately in each 
of the 4 lead groups along with the subgroups listed in 
Table 2.  
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
 
3.2.1.6 The annual hazard rate of new cases of other visual lead 
anomalies by each subcategory (from enrollment), by 
lead subgroups in the Riata, Riata ST, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 
Durata leads. 
 
 
Lead Population  
 
All enrolled leads being followed in this study within the 
Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 
1156T, 1158) and Durata lead groups. 
 
 
Analysis: 
The annual hazard rate will be assessed separately in each 
of the 4 lead groups along with the subgroups listed in 
Table 2. 
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
 
3.2.1.7 Prevalence of “other insulation anomalies” in “returned 
leads” (as defined in section 2.0), by lead subgroups in 
the Riata, Riata ST, QuickSite/QuickFlex (1056T, 
1058T, 1156T, 1158) and Durata leads. 
 
 
Lead Population  
 
Any enrolled lead in the study that gets returned to St. Jude 
Medical for analysis. 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 12 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
Analysis: 
The prevalence of “other insulation anomalies” will be 
calculated as the number of returned leads that have “other 
insulation anomalies” in each of the 4 lead groups divided 
by the total number of returned leads in enrolled patients in 
each of the 4 lead groups. The one-sided 95% UCB for 
prevalence will be calculated using Clopper-Pearson exact 
method. 
 
 
 
3.2.2 Secondary Outcome Measures 
3.2.2.1 Time from enrollment to externalized conductors by 
lead subgroups 
 
 
 
Lead Population  
 
All the leads without externalized conductors at enrollment 
within the Riata, Riata ST silicone, QuickSite/QuickFlex 
(1056T, 1058T, 1156T, 1158) and Durata lead groups 
 
 
Analysis: 
 
Time to externalized conductors will be analyzed using the 
Kaplan-Meier method.  Those patients who do not 
experience externalized conductors will be censored 3 years 
after enrollment in this trial.  A separate Kaplan-Meier 
curve will be calculated for each of the lead subgroups 
outlined in Table 2. 
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
 
3.2.2.2 Time from enrollment to other visual lead anomalies 
(evidenced by imaging) by lead subgroups and each 
subcategory 
 
 
 
Lead Population  
 
All the leads without other visual lead anomalies at 
enrollment (by each subcategory) within the Riata, Riata 
ST silicone, QuickSite/QuickFlex (1056T, 1058T, 1156T, 
1158) and Durata lead groups 
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 13 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
Analysis: 
 
Time to other visual lead anomalies (by each subcategory) 
will be analyzed using the Kaplan-Meier method.  Those 
patients who do not experience other visual lead anomalies 
(by each subcategory) will be censored 3 years after 
enrollment in this trial.  A separate Kaplan-Meier curve 
will be calculated for each of the lead subgroups outlined in 
Table 2. 
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
 
3.2.2.3 Time from enrollment to electrical dysfunction, by lead 
subgroups 
 
 
 
Lead Population  
 
All the leads without electrical dysfunction at enrollment 
within the Riata, Riata ST silicone, QuickSite/QuickFlex 
(1056T, 1058T, 1156T, 1158) and Durata lead groups 
 
 
 
 
Analysis: 
Time to electrical dysfunction will be analyzed using the 
Kaplan-Meier method.  Those patients who do not 
experience an electrical dysfunction will be censored 3 
years after enrollment in this trial.  A separate Kaplan-
Meier curve will be calculated for each of the lead 
subgroups outlined in Table 2. 
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
 
3.2.2.4 Time from externalized conductors to electrical 
dysfunction, by lead subgroups 
 
 
Lead Population  
 
All the leads with externalized conductors but without 
electrical dysfunction within the Riata, Riata ST silicone, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 
Durata lead groups 
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 14 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
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.  A separate 
Kaplan-Meier curve will be calculated for each of the lead 
subgroups outlined in Table 2. 
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
 
3.2.2.5 Time from other visual lead anomalies by each lead 
subcategory to electrical dysfunction, by lead subgroups 
 
 
Lead Population  
 
All the leads with other visual lead anomalies (by each 
subcategory) but without electrical dysfunction within the 
Riata, Riata ST silicone, QuickSite/QuickFlex (1056T, 
1058T, 1156T, 1158) and Durata lead groups 
 
 
 
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.  A separate Kaplan-
Meier curve will be calculated for each of the lead 
subgroups outlined in Table 2. 
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
3.2.2.6 Adverse Event rate through 30 days post-intervention 
for lead (e.g. extraction, abandonment, revision, other) 
 
Lead Population 
All the leads within the Riata, Riata ST silicone, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 15 
September 18, 2015 
60039775/K-Clinical 
Confidential 
Durata lead subgroups 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 
study lead related interventions in each of the 4 lead groups 
divided by total study lead related interventions in each of 
the 4 lead groups.  
 
3.2.2.7 Time from externalized conductors to clinical 
intervention 
 
 
 
Lead Population  
 
All the leads with externalized conductors within the Riata, 
Riata ST silicone, QuickSite/QuickFlex (1056T, 1058T, 
1156T, 1158), and Durata lead groups 
 
 
 
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.  A separate Kaplan-
Meier curve will be calculated for each of the lead 
subgroups outlined in Table 2. 
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
 
 
3.2.2.8 Time from other visual lead anomalies by each 
subcategory to clinical intervention 
 
 
 
Lead Population  
 
All the leads with other visual lead anomalies (by each sub 
category) within the Riata, Riata ST silicone, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158), and 
Durata lead groups 
 
 
 
Analysis: 
Time to clinical intervention will be analyzed using the 
Kaplan-Meier method. The zero time will be the date at 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 16 
September 18, 2015 
60039775/K-Clinical 
Confidential 
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.  A separate Kaplan-Meier 
curve will be calculated for each of the lead subgroups 
outlined in Table 2. 
 
For QuickSite/QuickFlex leads only, data from patients 
with an additional 1 year of follow-up will contribute to 2 
separate lead subgroups (See Section 3.4.5). 
 
 
3.2.2.9 Comparison of patients with lead compromise as 
evidenced by imaging (includes externalized conductors 
and other visual lead anomalies by each subcategory) to 
those without lead compromise  
 
Patient Population 
All the patients within the Riata, Riata ST silicone, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 
Durata lead subgroups. 
 
Analysis 
Demographic and clinical parameters will be compared 
between patients who experience a lead compromise as 
evidenced by imaging and those who do not experience a 
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., 201012) 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. 
 
3.2.2.10 Comparison of patients with electrical dysfunction to 
those without electrical dysfunction. 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 17 
September 18, 2015 
60039775/K-Clinical 
Confidential 
Patient Population 
All the patients within the Riata, Riata ST silicone, 
QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158) and 
Durata lead subgroups. 
 
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, 201012) 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. 
 
In addition, the two patient groups will be compared for the 
following endpoints: 
 
1. Frequency of externalized conductors. This will be 
done using a Pearson’s Chi-square analysis. 
2. Frequency of other visual lead anomalies. This will be 
done using a Pearson’s Chi-square analysis. 
3. Time to detection of externalized conductors.  A 
Kaplan-Meier analysis will be used for this comparison. 
4. Time to detection of other visual lead anomalies.  A 
Kaplan-Meier analysis will be used for this comparison. 
5. The extent of externalization will be compared using 
Pearson’s Chi-square analysis.  
6. Number of zones with externalization within one lead 
will be compared using a Student’s T-test. 
7. Location of externalization will be compared using 
Pearson’s Chi-square analysis.  
8. Amount of slack in the lead (based on the scale 
described by Ha et al, 2010)12 will be compared using 
Pearson’s Chi-square analysis. 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 18 
September 18, 2015 
60039775/K-Clinical 
Confidential 
3.2.3 Additional Data  
▪ Adverse events 
▪ Lead Electrical Measurements: capture threshold, signal 
amplitude and impedance 
▪ Types of clinical interventions following externalized 
conductors 
▪ Types of clinical interventions following other visual lead 
anomalies 
▪ Types of events leading to detection of externalized conductors 
▪ Types of events leading to detection of other visual lead 
anomalies by each subcategory 
▪ Types of events leading to detection of electrical dysfunction 
3.3 
Patient Selection 
3.3.1 Inclusion Criteria 
Eligible patients will meet all of the following: 
1. Patient has a market released SJM ICD, CRT-D or CRT-P 
already implanted. 
2. Patient has at least one market released Riata/ Riata 
ST/QuickSite/QuickFlex/Durata already implanted in which 
the lead model number and lead implant date is indicated in 
Table 1.*  
3. Have the ability to provide informed consent for study 
participation and be willing to comply with the prescribed 
evaluations as detailed in this study plan. 
4. Are 18 years or above. 
 
*As different subgroups reach the minimum number of patients 
required for analysis, St. Jude Medical may notify the sites in 
writing that enrollment for a specific age of lead within a lead 
group are no longer eligible for enrollment.  This will ensure a 
more even distribution of lead ages and lead types across the study 
population. 
 
3.3.2 Exclusion Criteria  
Patients will be excluded if they meet any of the following: 
1. Patient is currently pregnant. 
2. *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. 
 
*NOTE: Patients enrolled in St. Jude Medical SJ4 post approval 
study, OPTIMUM and SCORE registries can be enrolled in this 
study. 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 19 
September 18, 2015 
60039775/K-Clinical 
Confidential 
3.4 
Study Procedures 
Study procedures are described in the sections below. Refer to Table 3 for an overview of 
the required study procedures.  St. Jude Medical will provide supplemental step by step 
instructions for obtaining required study data.  
 
 
Table 3:  Study Procedures 
  
Enrollment 
6, 18, and 30 
month visit 
12, 24, and 
36 month 
visit 
Unscheduled 
visit 
Extended 42 
month visit c 
Extended 48 
month visit c 
Informed Consent 
✓    
  
  
  
 
 
Demographics 
✓    
  
  
  
 
 
Medical History 
✓    
  
  
  
 
 
Electrical 
Malfunction History 
✓    
  
  
  
 
 
Cinefluoroscopy (AP, 
LAO 45° or the best 
possible LAO view, 
RAO 45° or the best 
possible RAO view) 
✓a    
  
✓    
 
 
✓ c 
Chest X-ray or Any 
Imaging Study 
✓ b 
  
  
  
  
 
Lead Measurements 
✓     
✓    
✓    
✓     
✓ c    
✓ c 
 
a - Patients who underwent cinefluoroscopy at enrollment as part of the “Riata Lead 
Evaluation Study” will not be required to undergo another baseline cinefluoroscopy. 
b - In patients with evidence of externalized conductors under cinefluoroscopy at 
enrollment, the following chest x-ray or imaging study will be collected, if available: a) 
earliest chest x-ray or imaging study with evidence of externalized conductors and b) 
latest chest x-ray or imaging study with no evidence of externalized conductors. 
c – For only eligible patients with QuickSite/QuickFlex leads that consent for an 
additional year of follow-up (42 and 48 Month Visits).   
 
3.4.1 Enrollment  
Upon determination of study eligibility, informed consent will be 
obtained from eligible patients by the principal investigator or 
designee prior to initiation of any study related screening activities.  
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 20 
September 18, 2015 
60039775/K-Clinical 
Confidential 
Patients with Riata, Riata ST, QuickSite (1056T or 1058T), 
QuickFlex (1156T or 1158T), and Durata leads with model 
numbers and lead implant dates indicated in Table 1 will be 
screened for evidence of externalized conductors or other visual 
lead anomalies through cinefluoroscopy that will include three 
videos/cines of the entire lead length as well as the pocket area 
(AP, LAO 45º or best possible LAO, RAO 45º or best possible 
RAO). A copy of Cinefluoroscopy performed as part of separate 
screening can be used to determine the incidence of externalization 
as long as all three views (AP, LAO 45° or the best possible LAO 
view, RAO 45° or the best possible RAO view) are available. 
Patients who underwent cinefluoroscopy at enrollment as part of 
the “Riata Lead Evaluation Study” will not be required undergo 
another baseline cinefluoroscopy. In patients with evidence of 
externalized conductors, the following chest x-rays will be 
collected, if available: a) earliest chest x-ray or imaging study 
showing an evidence of externalized conductors or other visual 
lead anomalies and b) latest chest x-ray or imaging study that does 
not show any evidence of externalized conductors or other visual 
lead anomalies. 
 
Data will be collected on the patient demographics (gender, age, 
medical history, history of electrical dysfunctions in the past, etc).  
Lead electrical performance will also be evaluated. 
 
For the purposes of this study, a patient is considered enrolled 
upon signing of the consent form and collection of data at 
enrollment visit. Data previously collected from patients enrolled 
in other ongoing SJM registries may be used for this study.  
 
Data to be captured at enrollment includes: 
• RV lead capture threshold, lead pacing impedance and 
signal amplitude (only required if RV lead model and 
implant date is listed in Table 1)* 
• LV lead capture threshold, lead pacing impedance in a 
bipolar configuration (only required if LV lead model and 
implant date is listed in Table 1) 
• High Voltage Lead impedance (HVLI) testing – mandatory 
for Current/ Promote or later ICD and CRT-D, optional for 
devices before Current/Promote ICD and CRT-D, and not 
applicable to CRT-P 
• It is recommended that the Stored EGM Configuration be 
programmed to the following in patients with 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 21 
September 18, 2015 
60039775/K-Clinical 
Confidential 
Current/Promote or newer devices ICDs and CRT-Ds: 
o RV Bipolar 
o RV Unipolar Tip 
o Custom: RV Coil to Can (optional) 
* Note: If patient is pacer dependent or R-wave is not 
available then RV signal amplitude is not required. 
 
Upon completion of the enrollment visit, complete the enrollment 
case report form (CRF) using the EDC system and submit the 
supportive data listed below to St. Jude Medical. Contact and 
address information are available on the last page of the CRF 
worksheet. 
Enrollment CRF 
Electronic device session records 
Cinefluoroscopy (AP, LAO 45º or best possible LAO view,  RAO 
45º or best possible RAO view) 
Earliest Chest X-ray or imaging study with evidence of 
externalized conductors or other visual lead anomalies, if available 
Latest Chest X-ray or imaging study with no evidence of 
externalized conductors or other visual lead anomalies, if available 
 
All eligible patients will be required to undergo the protocol 
specified follow-up visits. Patient participation in the study will be 
terminated once the 36 month visit is completed or after all leads 
being followed by the study are extracted and/or abandoned and 
the patient is monitored for 30 days. 
 
3.4.2 Follow-up Requirements 
The schedule of follow-up visits is based on the date of enrollment. 
Table 4 outlines the time window that is permitted for each of the 
study interval visits. 
 
Table 4: Study Interval Time Windows 
Visit Type 
6*, 12, 18, 24, 30, and 36 
months 
42** and 48** 
Months 
Window 
±  60 days* 
±  60 days** 
*In order to accommodate many patients with Riata/Riata ST silicone leads who 
were previously enrolled in the “Riata Lead Evaluation Study” in last 10 
months, the window for the 6 month visit will be -60 days to + 120 days.  
**For only those eligible QuickSite/Quickflex patients that consent to extended 
follow-up. 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 22 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
Cinefluoroscopy (AP, LAO 45° or the best possible LAO view, 
RAO 45° or the best possible RAO view) will be taken to 
determine the incidence/ mechanical progression of externalized 
conductors at the 12, 24, and 36 month visits for all patients and at 
the 48 month visit for only those eligible QuickSite/QuickFlex 
patients that consent for extended follow-up. 
 
If the Riata, Riata ST, QuickSite (1056T/1058T), QuickFlex 
(1156T/1158T), or Durata lead develops a significant electrical 
abnormality suggestive of lead malfunction and x-ray or 
cinefluoroscopy would be performed as per the site’s standard of 
care.  The x-ray or cinefluoroscopy should be submitted to SJM. 
 
All patients will be required to attend the in-clinic follow-up visits 
at 6, 12, 18, 24, 30, and 36 months.  Only those eligible 
QuickSite/QuickFlex patients that consent for extended follow-up 
will be required to attend the 42 month in-clinic follow-up visit.  
Data to be captured includes the following: 
 
• RV lead capture threshold, lead pacing impedance and signal 
amplitude (only required if RV lead model and implant date is 
listed in Table 1) * 
• LV lead capture threshold, lead pacing impedance in a bipolar 
configuration (only required if LV lead model and implant date 
is listed in Table 1) 
• High Voltage Lead impedance (HVLI) testing – mandatory for 
Current/ Promote or later ICD and CRT-D, optional for devices 
before Current/Promote ICD and CRT-D, and not applicable to 
CRT-P 
 
* Note: If patient is pacer dependent or R-wave is not available 
then RV signal amplitude is not required. 
 
Upon completion of the follow-up above visits, complete the 
applicable CRFs using the EDC system and submit the supportive 
data listed below to St. Jude Medical. 
• Follow-up CRF 
• Product Out of service ( if applicable) 
• Electronic device session records 
• Cinefluoroscopy (AP, LAO 45º or best possible LAO view,  
RAO 45º or best possible RAO view) 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 23 
September 18, 2015 
60039775/K-Clinical 
Confidential 
• System Revision (if applicable) 
 
If an adverse event, hospitalization, death, or deviation occurs during 
the course of study testing and data collection, as applicable, also fill 
out and submit the following: 
 
• Adverse Event CRF 
• Hospitalization CRF 
• Deviation CRF 
• Death CRF 
• Withdrawal CRF 
• Supporting documentation of adverse events, deviation(s) from 
the protocol, and/or death 
 
3.4.3 System Revision  
All pulse generator and lead related system revisions should be 
reported. If a patient’s existing Riata, Riata ST, QuickSite 
(1056T/1058T), QuickFlex (1156T/1158T), or Durata lead is 
extracted or capped, and no other of the above mentioned leads are 
still implanted then the patient will be followed for 30 days and 
withdrawn from the study.  It is recommended to provide 
fluoroscopy data, RV (if applicable) and LV (if applicable) capture 
threshold, pacing impedance and signal amplitude measurements, 
and session records at system revision. 
 
Upon completion of system revision, complete the following case 
report forms using the EDC system and submit the supportive data 
listed below: 
 
• System Revision 
• Product Out of service (if applicable) 
• Device session records 
• Fluoroscopy/ CXR images (if applicable) 
• Adverse Event CRF 
• Withdrawal CRF (if applicable) 
• Supporting documentation of adverse events, deviation(s) from 
the protocol, and/or death 
 
3.4.4 Unscheduled Follow-up 
Unscheduled follow-up visit data will be captured if patients 
present in the clinic with any symptoms suggestive of or with 
evidence of lead related electrical problems for non protocol 
specified visits. It is recommended to do all the applicable RV and 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 24 
September 18, 2015 
60039775/K-Clinical 
Confidential 
LV (if applicable) lead measurements at that time. A follow-up 
CRF must be submitted for these unscheduled visits. 
 
3.4.5 Extended Follow-up (Eligible QuickSite/QuickFlex 
patients only) 
The purpose of extending follow-up for eligible  
patients with QuickSite/QuickFlex leads is to address challenges  
with fulfilling the minimum number of leads to enroll for the  
QuickSite/QuickFlex lead group/subgroups as shown in Table 2.   
 
The extended follow-up will help address this issue since the data  
from patients with extended follow-up will contribute to 2 separate  
sub-group cohorts for the primary and secondary outcome measure  
analyses. 
 
For example, a patient who was enrolled with a  
QuickSite/QuickFlex lead that was implanted for 5 years at the  
time of enrollment will contribute to the ≥ 5 to <6 year age of lead  
subgroup cohort (data from lead 5, 6, 7, and 8 years implanted).    
After this patient provides consent and completes the additional  
year of follow-up, this patient will also contribute to the ≥ 6 year  
age of lead subgroup cohort (data from lead 6, 7, 8, and 9 years  
implanted) as shown in Table 5 below. 
 
Table 5:  Extended Follow-Up Example 
 
QS/QF 
Subgroup cohort 
Age of Lead  
@ Enrollment 
Primary and Secondary Outcome Measure 
Data Analyses Timepoints 
Extended 
Follow-up 
Enrollment 
/Baseline  
12 Mo. 
Visit  
24 Mo. 
Visit 
36 Mo. 
Visit 
48 Mo. 
Visit 
≥ 5 and < 6 year 
5 yr. lead 
data 
6 yr. lead 
data 
7 yr. lead 
data 
8 yr.lead 
data 
9 yr. lead 
data 
≥ 6 year 
6 yr. lead 
data 
7 yr. lead 
data 
8 yr. lead 
data 
9 yr. lead 
data 
 
 
Patients eligible for extended follow-up are those already enrolled 
with QuickSite/QuickFlex leads that have not previously 
withdrawn and have a QuickSite/QuickFlex lead that will 
contribute to a second subgroup cohort with an additional year of 
follow-up.   
 
In order to maintain an unbiased study design, all eligible patients 
will be approached to provide consent for extended follow-up.  
SJM will provide study sites with a list of all eligible patients upon 
approval of this protocol.  After eligible patients have been 
approached to consent for extended follow-up, complete the 
Extended Follow-Up Consent CRF using the EDC system. 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 25 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
Eligible patients must provide consent for extended follow-up prior 
to completing the 42 and 48 month follow-up visits (See Section 
14.0).  Refer to Table 3 and Section 3.4.2 for the requirements for 
these additional follow-up visits. 
 
4.0 
Protocol Deviations 
Investigators are required to adhere to the investigational plan, signed 
Investigator’s Agreement, applicable federal (national) or state/local, laws and 
regulations, and any conditions required by the IRB/MEC or applicable regulatory 
authorities. 
 
A protocol deviation is used to describe situations in which the study protocol was 
not followed.  All deviations from the study protocol must be reported to St. Jude 
Medical as soon as possible but no later than 10 working days of notification of 
event.  In addition, all deviations must be reported to the reviewing IRB per the 
IRB’s reporting requirements.   
5.0 
Hospitalization 
Hospitalization for any reason other than a system revision must be reported to St. 
Jude Medical via the Hospitalization Case Report Form using the EDC system 
within 10 working days of the center becoming aware of the patient’s admission 
to the hospital.  
6.0 
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 
dislodgment requiring repositioning). 
 
Observations: Adverse events that can be managed without invasive intervention 
(e.g., oversensing or loss of pacing capture, which is remedied by reprogramming 
of the pulse generator).  
 
HV and CRT lead related adverse events along with other adverse events like 
cardiac tamponade, hematoma, high DFTs, infection and therapy for non-
ventricular rhythm will be collected in the study 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 26 
September 18, 2015 
60039775/K-Clinical 
Confidential 
If the patients with no evidence of externalized conductors by imaging at 
enrollment show evidence of externalization later in the study, please submit an 
adverse event form for lead insulation damage (i.e. externalized conductors).  
 
Should an adverse event occur, an Adverse Event Form must be completed and 
submitted to St. Jude Medical. Report the adverse event to the IRB/MEC per the 
IRB/MEC policy. Any explanted devices or leads should be returned to St. Jude 
Medical for analysis.  
7.0 
Other Reported Events 
Other Reported Events is any other clinical event that is submitted by the 
investigator which is not caused by or associated with the study device and/or 
system component(s) and/or defined as an Adverse Event in section 6.0.  
8.0 
Deaths 
All patient deaths that occur during this study must be reported to St. Jude 
Medical within 10 working days of the center being notified. Notification of death 
should include a detailed statement of the pertinent events and be signed by the 
investigator in addition to the appropriate case report forms (Patient Death form, 
Withdrawal form, and Product Out of Service form). It is the investigator’s 
responsibility to notify the IRB/MEC per the IRB/MEC policy. The CEC will 
review and classify all patient deaths. 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 of death 
• 
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  
• 
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.  
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 27 
September 18, 2015 
60039775/K-Clinical 
Confidential 
Every attempt should be made to explant the pulse generator and/or leads intact. 
Any explanted devices or leads should be returned to St. Jude Medical for 
analysis promptly. In the event that the device is not explanted, the above 
procedure must be followed to retrieve the data. The reason the pulse generator 
and/or lead(s) are not being returned to St. Jude Medical must be stated clearly on 
the case report form. 
9.0 
Withdrawals 
Withdrawal is defined as termination of participation of a patient from a clinical 
trial. All reasonable efforts should be made to retain the subject in the clinical trial 
until completion of the clinical trial. Reasons for withdrawal include, but are not 
limited to the following: 
 
• 
Patient Lost to Follow-up - must be documented by two documented phone 
calls and one certified letter 
• 
Death 
• 
Patient had an explanted or abandoned Riata/ Riata ST RV lead and no other 
lead under investigation is currently implanted 
• 
Patient had an explanted or abandoned Durata RV lead and no other lead 
under investigation is currently implanted  
• 
Patient had an explanted or abandoned QuickSite/QuickFlex 1056T, 1058T, 
1156T, or 1158T lead and no other lead under investigation is currently 
implanted 
• 
Patient/Family request 
• 
Participation terminated by Physician 
 
Patient Relocation: If a patient moves from the geographic area of the 
investigator, then SJM will first attempt to place the patient with another St. Jude 
Medical Cardiac Lead Assessment Study investigator.  If it is not possible to place 
the patient with another St. Jude Medical Cardiac Lead Assessment study 
investigator, SJM will request that the patient’s new physician forward the 
patient’s study information to the investigator.   
 
Complete and submit a copy of the Withdrawal form to St. Jude Medical using 
the EDC system. Contact and address information is available on the Withdrawal 
form. 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. 
 
10.0 Risks and Benefits 
The risks involved with this study are similar to those associated with other 
commercially available ICD or CRT-D systems.   

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 28 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
In addition, patients in this study will receive a minimum of 4 fluoroscopic 
procedures where each procedure is taken in 3 different views.  Although these 
fluoroscopic procedures are short in duration (approximately 45 seconds) they do 
provide a minimum dose of radiation to the patient which may increase their risk 
of cancer. 
 
Patients who enroll in this study may encounter an additional benefit if the 
incidence of externalized conductors is identified. All patients may also be more 
closely monitored by their physician. 
11.0 Committees 
11.1 Clinical Events Committee 
The Clinical Events Committee (CEC) will be comprised of at least three 
Electrophysiologists or Cardiologists. The CEC will review and adjudicate 
all Adverse Events and Deaths.  The CEC will base their final adjudication 
on the information provided on the case report forms, medical records, and 
their clinical knowledge and experience. 
11.2 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 SJM Cardiac Lead Assessment study patient 
population. Committee members will be reviewing the cinefluoroscopy 
videos/images for the enrollment, 12, 24, and 36 month follow-up visits 
and any additional cinefluoroscopy videos/images 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 post market 
surveillance reports. Percentage of leads with compromise, evidenced by 
imaging, will be presented in the report. The type, extent and location of 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 29 
September 18, 2015 
60039775/K-Clinical 
Confidential 
lead compromise, as described in Appendix A, will also be included. As 
detailed in Appendix A, each region of the HV as well as CRT leads 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”.  
 
11.3 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 SJM Cardiac Lead Assessment study patient population. Committee 
members will be reviewing device session records for all leads taken out 
of service during the course of the 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 
post market surveillance reports. Percentage of leads with electrical 
dysfunction (based on the definition in section 2.0) will be part of the 
reports.  
12.0 Investigator Information 
This clinical investigation will be conducted by investigators with experience 
and/or willingness to be trained in the use of the device therapy for the treatment 
of these patients.  A principal investigator should have experience in and/or will 
be responsible for: 
 
• 
Conducting the clinical investigation in accordance with the signed agreement 
with St. Jude Medical, the investigational plan, all applicable, GCP guidelines, 
and any conditions of approval imposed by the IRB/MEC 
• 
Providing signed Investigator/Co-Investigator(s) Agreement  
• 
Providing IRB/MEC Approved Informed Consent  

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 30 
September 18, 2015 
60039775/K-Clinical 
Confidential 
• 
Collection and archiving of data obtained pursuant to the requirements of the 
investigational plan during the course of the study and after the study has been 
completed 
• 
Screening and selecting appropriate patients 
 
It is acceptable for the principal investigator to delegate one or more of the above 
functions to an associate or co-investigator, however, the principal investigator 
remains responsible for the proper conduct of the clinical investigation, 
complying with the investigational plan and collecting all required data. 
13.0 Monitoring Procedures 
St. Jude Medical will serve as the “sponsor” of the Cardiac Lead Assessment 
Trial.  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. 
 
A St. Jude Medical monitor may visit the investigator or designee periodically 
during the study to monitor progress, assist in gathering the required data, verify 
study endpoints, clarify data discrepancies and answer any questions. During 
these visits, the clinical monitor will review the patient’s records to verify that all 
records and files are up to date, and to assure compliance with all requirements of 
the protocol,local IRB procedures and applicable FDA regulations. A monitoring 
report following the on-site visit will be provided to the site to document 
monitoring findings. 
 
The investigator will make patient and study records available to the clinical 
monitor for periodic inspection. Clinical monitoring will be conducted as defined 
in the St. Jude Medical Monitoring Plan for this study.  
 
Responsibility for overall study management will be held by the Director of 
Clinical Studies, St. Jude Medical.  
 
Clinical Studies Organization 
St Jude Medical  
15900 Valley View Court 
Sylmar, CA 91342 
Tel: 800-933-9956 
Fax: 866-632-8191  
 
FDA Inspections 
 
The investigator and/or designee should contact St. Jude Medical 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. 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 31 
September 18, 2015 
60039775/K-Clinical 
Confidential 
 
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 have not been submitted or 
are incomplete, inaccurate, false, or misleading. 
 
14.0 Consent Materials 
Please refer to the attached Statement of Informed Consent in Appendix B to be 
used for enrolling patients into this study.   
 
Failure to obtain informed consent from a patient prior to study screening and 
enrollment should be reported to St. Jude Medical within 5 working days and to 
the reviewing IRB consistent with the IRB’s reporting requirements. 
 
Please refer to the attached Informed Consent Addendum for Extended Follow-
Up in Appendix C to be used for obtaining consent for only those enrolled 
patients with QuickSite/QuickFlex leads eligible for extended follow-up (see 
Section 3.4.5).   
 
Failure to obtain consent from eligible patients prior to conducting extended 
follow-up visits (42 and 48 month visits) should be reported to St. Jude Medical 
within 5 working days and to the reviewing IRB consistent with the IRB’s 
reporting requirements. 
 
15.0 IRB 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 approval should be 
reported to St. Jude Medical within 5 working days of the withdrawal of approval. 
 
A list of IRBs for Institutions participating in the Clinical Investigation will be 
provided upon request. 
 
16.0 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 information, will be 
provided upon request. 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 32 
September 18, 2015 
60039775/K-Clinical 
Confidential 
17.0 Records and Reports 
Clinical investigators of St. Jude Medical investigational products are required to 
maintain records during the investigation and for a period of two years after the 
latter of the following two dates: the date on which the investigation is terminated 
or completed, or the date that the records are no longer required for purposes of 
supporting a premarket approval application or a notice of completion of a 
product development protocol. 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 33 
September 18, 2015 
60039775/K-Clinical 
Confidential 
18.0 References 
                                                 
1 Duray GZ, Isreal CW, Schmitt J, Hohnloser SH. Implantable cardioverter-defibrillator lead disintegration 
at the level of the tricuspid valve. Heart Rhythm 2008; 5:1224-1225. 
 
2 Mehta D, Nayak H, Singson M, Chao S, Jorge E, Camunas L, Gomes J. Late Complications in Patients 
with Pectoral Defibrillator Implants with Transvenous Defibrillator Lead Systems: High Incidence of 
Insulation Breakdown. PACE,1998; 21:1893-1900. 
 
3 De Lurgio D, Sathavorn C, Mera F, Leon A, Walter P, Langberg J. Incidence and Implications of 
Abrasion of Implantable Cardioverter-Defibrillator Leads. American Journal of Cardiology,1997, 79:1409-
1411. 
 
4 Pavia S, Saliba W, Wilkoff B. Lead System Dysfunction, Diagnosis, and Therapy. In: Pacifico A. ed-in-
chief. Implantable Defibrillator Therapy: A Clinical Guide. Norwell, Ma. Kluwer Academic Publishers 
2002:259-278. 
 
5 Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, Saggau W, Weisse U, Seidl K. 
Annual Rate of Transvenous Defibrillation Lead Defects in Implantable Cardioverter-Defibrillators over a 
Period > 10 years. Circulation. 2007;115:2474-2480. 
 
6 Blommaert D, Louagie Y, Eucher P, Collet B, Mancini I, Govarets G, Leclercq C, De Roy L. Are 
Cardioverter-Defibrillator Leads Reliable Over time? NASPE Abstracts, 2003, 26:1123. 
 
7 Degeratu F, Khalighi K, Peters R, Shorofsky S, Gold M. Sensing Lead Failure in Implantable 
Defibrillators: A Comparison of Two Commonly Used Leads. J Cardiovasc Electrophysiol, 2000, 11:21-
24. 
 
8 Liu J, Rattan R, Adelstein E, et al. Fluoroscopic screening of asymptomatic patients implanted with the 
recalled Riata lead family.  Circ Arrhythm Electrophysiol. 2012 Aug 1;5(4):809-14.  
 
9 Shen S, Bhave P, Giedrimas E, et al. Prevalence and Predictors of Cable Extrusion and Loss of Electrical 
Integrity with the Riata Defibrillator Lead. J Cardiovasc Electrophysiol. 2012 May 15.  
 
10 Parvathaneni SV, Ellis CR, Rottman JN. High prevalence of insulation failure with externalized cables in 
St. Jude Medical Riata family ICD leads: Fluoroscopic grading scale and correlation to extracted leads. 
Heart Rhythm. 2012 Aug;9(8):1218-24. Epub 2012 Mar 23. 
 
11Corbisiero R, Armbruster R. Incidence of Externalized Conductors in ICD Leads Using PA and Lateral 
Chest X-Ray Imaging. Heart Rhythm 2012;9(5):S236.  
 
12Ha 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. 
 
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 34 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
Appendix A: Details About Lead Compromise 
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 
- Broken filars on a 
shocking coil 
- Other irregularities 
 
- Region 1 
- Region 2 
- Region 3 
- Region 4 
- RV coil 
- SVC coil 
- Distal to RV coil 
- Proximal to region 1 
 
 
 
 
 
 
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 35 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
Similarly, the type, extent and location of these anomalies in CRT 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 a 
- Region b 
- Region c 
- Region d 
Other Visual Lead 
Anomalies 
- Fracture 
- Kink 
- Subclavian crush 
- Other irregularities 
- Region a 
- Region b 
- Region c 
- Region d 
 
 
. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 36 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
Appendix B: Statement of Informed Consent 
 
Statement of Informed Consent 
 
Study Title: ST. JUDE MEDICAL CARDIAC LEAD ASSESSMENT STUDY  
 
Introduction 
You are being asked to take part in this research study because your doctor has 
determined that you may qualify to take part in the St. Jude Medical (SJM) Cardiac Lead 
Assessment Study. The SJM Cardiac Lead Assessment Study is sponsored by SJM and 
constitutes the modification of the “Riata Lead Evaluation Study”.  This form explains 
why this research is being done and what your role will be if you decide to participate.  
This form also talks about the possible risks that may happen if you take part in this 
study.  This study is sponsored by St. Jude Medical. 
 
Please read this form, and ask your study doctor any questions about the study so that you 
can have your questions answered before you decide if you want to take part in the study.  
Please take your time and talk about this information with your family, friend, or family 
doctor. 
 
This consent form may contain some words that you do not understand.  Please ask the 
study doctor or the study staff to explain any words or information that you do not 
understand. 
 
If you agree to be in the study, you will need to sign this form.  Taking part in this study 
is entirely voluntary.  You may decide not to participate without penalty or loss of 
benefits to which you are otherwise entitled. 
 
What is the purpose of the study?  
The purpose of this study is to determine the prevalence of wires being visible outside the 
lead insulation body (externalized conductors) or other forms of visual compromise in the 
Riata®, Riata® ST silicone ICD, QuickSite®/QuickFlex® CRT and Durata® ICD leads.  In 
order to evaluate the prevalence of externalized conductors or other forms of visual 
compromise in the Riata, Riata ST silicone ICD, QuickSite/QuickFlex CRT and Durata 
ICD leads, cinefluoroscopy (i.e. video or x-ray) will be taken to determine the prevalence 
of externalized conductors or other forms of visual compromise of the lead.  This study 
does not involve any investigational product (medical device) or procedures. 
 
Approximately 1500 patients (500 with Riata or Riata ST leads, 500 with 
QuickSite/QuickFlex leads and 500 with Durata leads) will be enrolled in this non-
randomized, multi-center, international post market study at up to 60 sites. 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 37 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
 
In order to determine the risk that externalized conductors will result in an electrical 
malfunction, all patients will be followed every 6 months for a three-year period (36 
months) in the study.  
 
What will happen if you take part in the research study?  
If you decide to take part in this study, some tests will be done to help your doctor 
determine if you qualify. You must have a market released SJM ICD or CRT-D already 
implanted and also have a market released Riata ICD, Riata ST silicone ICD, 
QuickSite/QuickFlex CRT or Durata ICD lead.  Once all of the tests have been 
completed, your doctor will decide if you qualify to take part in the SJM Cardiac Lead 
Assessment Study.  If you do not qualify for the study, your participation will end. 
 
If your doctor determines that you qualify, and you decide to take part in this study, the 
following procedure(s) will be performed.  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 
may carry out some of the study procedures. The study doctor may direct a representative 
from the sponsor to collect the signal information.  At the study doctor’s direction, the 
sponsor representative may also program your device or run tests to see if your device is 
working as expected.  The sponsor’s representative will work under the direction of your 
study doctor or other care provider. 
How long will study last? 
You will be followed for a period of three years. Data will be collected at 6, 12, 18, 24, 
30 and 36 months post enrollment.  
 
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  
including the final study visit at 36 months. 
What are possible discomforts or risks?  
There may be risks associated with (a small amount of radiation) exposure to 
cinefluoroscopy which may increase your risk of cancer. The estimated fluoroscopy time 
required is approximately 45 seconds per visit. 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 38 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
Risk for women of childbearing age? 
If you are pregnant or plan to become pregnant in the next 6 months, you should discuss 
your participation with your study doctor.  Patients who become pregnant while taking 
part in the study should contact the study doctor right away. 
What are the possible benefits to you or to others? 
If you decide to take part in this study, you may encounter an additional benefit if the 
incidence of externalized conductors is identified. You may also be more closely 
monitored by your physician. 
 
The sponsor of this study is paying for cost of data capture and items that are not deemed 
standard of care/routine care in the study. St. Jude Medical will pay the study center 
where the study is being conducted. 
If you do not want to take part in this study, what other options are 
available to you?   
Your doctor will discuss other options available to you.  
How will your privacy and the confidentiality of your research records be 
protected? 
If you decide to take part in this study, your medical records and personal information 
will be kept private to the extent allowed by federal, state, and local law.  No personal 
information about you, your illness, or your treatment will be made public.  
 
Information (data) collected from the study will be sent to St. Jude Medical.  A special 
code (letter and number combination) will be used to identify your personal information.  
 
The data may be given to governmental agencies, for example: the Food and Drug 
Administration (FDA) or similar government agencies in other countries.  Only 
information about your medical condition as it relates to the Riata®/ Riata® ST Silicone 
Leads, Quicksite/Quickflex or Durata lead will be provided to St. Jude Medical.  In order 
to verify study data, monitors from governmental agencies (for example: FDA), St. Jude 
Medical, and the Institutional Review Board (IRB)/Ethics Committee (EC) will also have 
the right to review your medical records as they relate to this study.  In addition, 
publication(s) using data collected during the study will not include your name or any 
information that can identify you. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law.  This web site will not include information that can identify you.  
At most, the web site will include a summary of the results.  You can search this web site 
at any time. 
 
St. Jude Medical may export data to countries where different data protection laws apply.   

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 39 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
 If you receive medical care from a doctor other than your study doctor while taking part 
in this study, you agree that your medical records will be made available for the 
collection of data related to this study. 
If you choose to take part in this study, will it cost you anything?   
You and your insurance company are responsible for the costs of all standard of care 
tests, procedures, and devices.  There is no guarantee that your insurance company will 
cover 100% of these costs.  You should check with your insurance company to verify 
coverage or payments of these procedures. 
Will you receive compensation (payment) for taking part in this study?   
No payment will be made to you for taking part in this study. 
What if the device needs to be removed? 
In the event your Riata®, Riata® ST Silicone lead, Durata lead or QuickSite/QuickFlex 
bipolar silicone CRT lead or any part has to be removed, it will be returned to St. Jude 
Medical for analysis.  Should you withdraw from this study and choose to have your 
RiataICD, Riata ST silicone ICD, QuickSite/QuickFlex CRT or Durata ICD lead or any 
part of it removed, the cost will be your responsibility. 
 
In the event of your death, your implanted Riata ICD, Riata ST silicone ICD, 
QuickSite/QuickFlex CRT or Durata ICD leadmay be removed and returned to St. Jude 
Medical for analysis.  The study doctor will get your family’s approval prior to removing 
the device.   
What if you are injured because of the study?   
If you are injured as a direct result of taking part in this study, medical treatment will be 
available to you.  You, or your insurance company, will be responsible for all costs 
incurred as a result of that treatment.  No other arrangement has been made for financial 
payments or other forms of compensation (such as lost wages, lost time or discomfort) with 
respect to such injuries.  You do not waive any legal rights by signing this consent form. 
 
During the study, if you experience any medical problems or illnesses from taking part in 
this study, please contact Dr. ______________ at ___-___-_____. 
What are your rights if you decide to take part in this study? 
Your signature on this consent form means that you have received information about this 
research study and that you agree to be a part of the study.  
You may stop taking part in the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.  If you wish to stop taking part in this research study for 
any reason, you should contact Dr. ______________ at ___-___-_____.  A decision to 
withdraw or to not take part in the study will not affect the quality of medical care that 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 40 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
you receive.  Your decision will not result in any penalty or loss of benefits to which you 
are otherwise entitled or affect your future medical care.  
 
Your doctor or the sponsor, St Jude Medical, may decide to withdraw you from the study 
at any time without your consent.  If it is felt to be in your best interest, or if the study is 
stopped, your doctor may withdraw you from this research.  If you have a problem as 
described in the risks section, or if you become ill during the research, you may have to 
stop participating in the study, even if you would like to continue.  Your study doctor will 
make this decision.  Your study doctor or designee will discuss with you what follow-up is 
required if you decide to withdraw, or are withdrawn from the study before the study is 
finished. 
 
If important information is learned during the course of this study, your doctor will be 
notified by St. Jude Medical.  You will be told of any important new information that is 
learned during the course of this research study that may affect your condition or your 
willingness to continue to take part in this study. 
Who can you contact for study information? 
If you have any questions about the study or taking part in this study, please contact Dr. 
______________ at ___-___-_____. 
 
In addition, if you have questions about your rights as a research patient, or if you have 
complaints, concerns, or questions about the research, please contact ______________ at 
___-___-_____. 
 
You are making a decision on whether or not to take part in the study.  Your signature 
indicates that you have read the information in this form and have decided to take part 
in the study.  You will be given a signed copy of this form to keep.   
 
 
___________________________________  
 
Printed Name of Patient  
 
 
___________________________________  
___________  
     
Signature of Patient  
 
 
 
Date  
 
 
___________________________________  
___________  
     
Signature of Person Obtaining Consent  
Date 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 41 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
Appendix C: Informed Consent Addendum for Extended Follow-
up 
 
Informed Consent Addendum for Extended Follow-up 
 
Study Title: ST. JUDE MEDICAL CARDIAC LEAD ASSESSMENT STUDY  
 
Introduction 
This Addendum contains important information regarding your participation in this 
research study, the St. Jude Medical (SJM) Cardiac Lead Assessment Study.  Due to a 
shortage of enrollments of patients implanted with certain QuickSite/QuickFlex leads, 
only those patients already enrolled with these specific leads will be asked to extend their 
follow-up duration for one (1) additional year in order to have enough data to meet the 
study objectives.   
 
You are being asked to extend participation in this study because your study doctor has 
determined that you have a qualifying QuickSite/QuickFlex lead.  If you agree to extend 
your participation in the study, you will need to sign this form.  Extending your 
participation in this study is entirely voluntary.  You may decide not to extend your 
participation without penalty or loss of benefits to which you are otherwise entitled and 
continue to participate according to the original follow-up duration. 
 
Please read this form, and ask your study doctor any questions about the study so that you 
can have your questions answered before you decide if you want to extend your 
participation in the study.  Please take your time and talk about this information with your 
family, friend, or family doctor. 
 
This form may contain some words that you do not understand.  Please ask the study 
doctor or the study staff to explain any words or information that you do not understand.   
 
The language in this Addendum may replace statements made in the existing 
Informed Consent Form that you previously signed. 
 
Extended Follow-Up 
If you extend your participation in this study for one (1) additional year, data will also be 
collected at 42 and 48 months post enrollment.  At the 42 and 48 month visits, lead 
electrical performance will be evaluated.  At the final 48 month visit, you will also be 
screened for evidence of externalized conductors or other forms of visual compromise of 
the lead through cinefluoroscopy (i.e. X-ray, video, etc.). 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 42 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
Who can you contact for study information? 
If you have any questions about the study or taking part in this study, please contact Dr. 
______________ at ___-___-_____. 
 
In addition, if you have questions about your rights as a research patient, or if you have 
complaints, concerns, or questions about the research, please contact ______________ at 
___-___-_____. 
 
 
Agreement of Decision to Extend Participation  
 
Taking part in this extended follow-up is entirely voluntary.  You are making a 
decision on whether or not to take part in the extended follow-up for this study.  Your 
signature indicates that you have read the information in this form and have decided to 
extend your participation for this study.  You will be given a signed copy of this form to 
keep.   
 
 
___________________________________  
 
Printed Name of Patient  
 
 
___________________________________  
___________  
     
Signature of Patient  
 
 
 
Date  
 
 
___________________________________  
___________  
     
Signature of Person Obtaining Consent  
Date 
 
 
 
 
 
 
 
 
 

 
 
Study Protocol 
St. Jude Medical Cardiac Lead Assessment 
 
Page 43 
September 18, 2015 
60039775/K-Clinical 
Confidential 
                                                                                                                                                 
Appendix D: Revision History 
Revision History 
Amendment 
Number 
Version 
Date 
Rationale 
Details 
2 
K 
18Sept2015 
• Change lead subgroup cohort 
defined by lead implant date to 
age of lead at enrollment (in 
years) and added Riata leads 
implanted in 2002 and 2003 to 
the eligible leads for 
enrollment in order to 
complete enrollments in a 
timely manner while adhering 
to the original 522 order study 
design (analyses of  lead 
subgroups by age of lead). 
   
• Increased number of sites 
from 50 to 60 to increase 
enrollment rate 
 
• Added extended follow-up for 
eligible patients already 
enrolled with 
QuickSite/QuickFlex leads in 
order to address challenges 
with completing enrollments 
with this lead group/sub-
groups. 
Updates: 
• Table 1 and 2  
• Enrollment Timeline 
• Sections 3.2.1, 3.3.1 
 
 
 
 
 
 
 
 
 
• Sections 3.1, 
Appendix B. 
 
 
• Sections  3.2.1, 3.2.2, 
3.4, 3.4.5, 14.0, 
Appendix C 
• Tables 3 and 5