Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Conditions: Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
Sponsor: Boston Scientific Corporation

Boston Scientific Corporation
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The Longitudinal Surveillance Study of the 
4-SITE Lead/Header System 
(The LSS of 4-SITE Study) 
CLINICAL PROTOCOL
[ 90884085 ] 
[ Approved: 02-Nov-2012 ] 
Sponsored By
Boston Scientific, CRM
4100 Hamline Avenue North
Saint Paul, MN 55112 USA
NOTE: This protocol contains confidential information for use by the Investigators and 
their designated representatives participating in this clinical investigation. It must be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation.

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3. Table of Contents
1. TITLE PAGE ........................................................................................................... 1 
2.
PROTOCOL SYNOPSIS .......................................................................................................... 6 
3.
TABLE OF CONTENTS ........................................................................................................ 11 
3.1.
Table of Figures ...................................................................................................... 15 
3.2.
Table of Tables ....................................................................................................... 15 
4.
INTRODUCTION ................................................................................................................. 16 
4.1.
QUADRIPOLAR Technology ............................................................................... 16 
4.1.1. 
ISO Standard (ISO 27186) For Quadripolar Connectors and 4-SITE ....... 16 
4.2.
Background ............................................................................................................. 16 
4.3.
Study Purpose ......................................................................................................... 17 
5.
DESCRIPTION OF DEVICES UNDER SURVEILLANCE ......................................................... 17 
5.1.
4-SITE ENDOTAK RELIANCE Leads ............................................................... 17 
5.2.
4-SITE Compatible Header ................................................................................... 17 
5.3.
4-SITE Lead Accessories ....................................................................................... 18 
6.
STUDY OBJECTIVE ............................................................................................................ 18 
7.
STUDY ENDPOINTS ............................................................................................................ 18 
8.
STUDY DESIGN .................................................................................................................. 18 
8.1.
Scale and Duration ................................................................................................. 19 
8.2.
Anticipated Study Timeline ................................................................................... 20 
8.3.
Treatment Assignment .......................................................................................... 21 
8.4.
Justification for the Study Design ......................................................................... 21 
9.
SUBJECT SELECTION ......................................................................................................... 21 
9.1.
Study Population and Eligibility ........................................................................... 21 
9.2.
Inclusion Criteria ................................................................................................... 22 
9.3.
Exclusion Criteria .................................................................................................. 23 
10. SUBJECT ACCOUNTABILITY .............................................................................................. 24 

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10.1. Point of Enrollment ................................................................................................ 24 
10.2. Point of Study Exit ................................................................................................. 25 
10.3. Subject Status and Classification .......................................................................... 25 
10.4. Enrollment Controls .............................................................................................. 25 
11. STUDY METHODS/PROCEDURES ....................................................................................... 26 
11.1. Enrollment in Study ............................................................................................... 26 
11.1.1. Subjects Consented Prior to Device System Implant ................................ 26 
11.1.2. Subjects Consented Within 14 Calendar Days After Device Implant ....... 27 
11.2. Device System Implantation Visit ......................................................................... 28 
11.2.1. 4-SITE Lead/Header Connection Integrity ................................................ 28 
11.2.2. Additional Implant Data Collection and Final Subject Status ................... 29 
11.2.3. Source Documents ..................................................................................... 29 
11.3. Pre-Discharge Visit ................................................................................................ 30 
11.4. One-Month Follow-up Visit .................................................................................. 31 
11.5. Bi-Annual Study Subject Follow-up Visits .......................................................... 31 
11.5.1. Missed Bi-Annual Study Subject Follow-Up Visits .................................. 32 
11.6. Unscheduled Follow-Up Visits .............................................................................. 32 
11.7. Study Completion ................................................................................................... 33 
12. STATISTICAL CONSIDERATIONS ....................................................................................... 33 
12.1. Primary Study Endpoint ....................................................................................... 33 
12.1.1. Description and Rationale for Endpoint Selection .................................... 33 
12.1.2. Endpoint-related Adverse Events .............................................................. 33 
12.1.3. Hypotheses ................................................................................................. 35 
12.1.4. Study Subject Sample Size ........................................................................ 35 
12.2. Number of Subjects per Investigative Site ........................................................... 36 
12.3. Data Analyses ......................................................................................................... 36 
12.3.1. Primary Study Endpoint Analysis ............................................................. 36 
12.3.2. Additional Analyses/Changes to Planned Analyses .................................. 37 
12.3.3. Subgroup Analyses .................................................................................... 37 
12.3.4. Center Pooling Analysis ............................................................................ 37 
12.3.5. Trend Analysis ........................................................................................... 37 
12.3.6. Progress Reporting Analysis ...................................................................... 38 
12.3.7. Product Performance Reporting ................................................................ 38 

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13. DATA MANAGEMENT ........................................................................................................ 38 
13.1. Data Collection, Processing and Review .............................................................. 38 
13.2. Data Retention ........................................................................................................ 39 
13.3. Case Report Forms ................................................................................................ 39 
13.3.1. Enrollment Case Report Form ................................................................... 39 
13.3.2. Implant Case Report Form ......................................................................... 40 
13.3.3. Pre-Discharge Case Report Form .............................................................. 40 
13.3.4. One-Month Follow-up Case Report Form ................................................. 40 
13.3.5. Bi-Annual Follow-up Case Report Form .................................................. 40 
13.3.6. Unscheduled Visit Case Report Form ....................................................... 40 
13.3.7. Adverse Event Case Report Form ............................................................. 40 
13.3.7.1. Additional Information Collected at Device System 
Revision/Replacement or Upgrade ........................................... 40 
13.3.8. Device Deficiency Case Report Form ....................................................... 41 
13.3.9. End of Study Case Report Form ................................................................ 41 
13.3.10. Explanted and Out-of-Service Device Case Report Form ......................... 41 
13.3.11. Deviations Case Report Form – Definition & Major Reasons .................. 41 
13.4. Additional Information Collected at Suspected Lead Failure ........................... 41 
13.5. Additional Information Collected at Study Subject’s Death ............................. 42 
13.6. Study Subject Data Confidentiality ...................................................................... 43 
13.7. US Health Insurance Portability and Accountability Act (HIPAA) ................. 43 
14. STUDY PROTOCOL AMENDMENTS .................................................................................... 44 
15. STUDY PROTOCOL DEVIATIONS ....................................................................................... 44 
16. COMPLIANCE ..................................................................................................................... 44 
16.1. Statement of Compliance ....................................................................................... 44 
16.2. Investigator Responsibilities ................................................................................. 44 
16.3. Delegation of Responsibility .................................................................................. 47 
16.4. Institutional Review Board / Ethics Committee .................................................. 47 
16.5. Sponsor Responsibilities ........................................................................................ 47 
16.6. Role of Boston Scientific Representatives ............................................................ 48 
16.7. Insurance Coverage ............................................................................................... 49 
17. STUDY MONITORING ......................................................................................................... 49 

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18. POTENTIAL RISKS AND BENEFITS .................................................................................... 50 
18.1. Adverse Event Reporting ...................................................................................... 50 
18.2. Adverse Event Definitions ..................................................................................... 50 
18.3. Potential Lead Implantation Adverse Events ...................................................... 50 
18.4. Risks Associated with Participation in the Clinical Study ................................. 52 
18.5. Risk Minimization Actions .................................................................................... 53 
18.6. Anticipated Study Subject Benefits ...................................................................... 53 
18.7. Risk to Benefit Rationale ....................................................................................... 53 
19. STUDY SUBJECT INFORMED CONSENT ............................................................................. 53 
20. SAFETY REPORTING .......................................................................................................... 55 
20.1. Definitions and Classification ............................................................................... 55 
20.2. Relationship to Study Device ................................................................................ 56 
20.3. Investigator Reporting Requirements .................................................................. 57 
20.4. Boston Scientific Device Deficiencies .................................................................... 58 
20.5. Reporting to Regulatory Authorities / IRBs / ECs / Investigators .................... 59 
21. COMMITTEES .................................................................................................................... 59 
21.1. BSC Global Safety Office – Safety Monitoring Program ................................... 59 
21.2. Clinical Events Committee .................................................................................... 59 
22. STUDY TERMINATION AND CENTER/SITE SUSPENSION ................................................... 59 
22.1. Premature Termination of the Study ................................................................... 59 
22.2. Criteria for Premature Termination of the Study .............................................. 60 
22.3. Termination of Study Participation by the Investigator or Withdrawal of 
IRB/EC Approval ................................................................................................... 60 
22.4. Requirements for Documentation and Study Subject Follow-up ...................... 60 
22.5. Criteria for Suspending/Terminating a Study Center ........................................ 60 
23. PUBLICATION POLICY ....................................................................................................... 61 
24. BIBLIOGRAPHY .................................................................................................................. 61 
25. PROTOCOL ABBREVIATIONS/ACRONYMS AND STUDY DEFINITIONS .............................. 61 
25.1. Protocol Abbreviations/Acronyms ....................................................................... 61 

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25.2. Study Protocol Definitions ..................................................................................... 67 
26. APPENDICES ...................................................................................................................... 68 
26.1. Investigator/Center Selection Criteria ................................................................. 68 
26.2. Glossary of Definitions ........................................................................................... 69 
3.1.
Table of Figures
Figure 8.1-1:  LSS of 4-SITE Study Design .......................................................................20
3.2.
Table of Tables
Table 9.2-1: Inclusion Criteria............................................................................................23
Table 9.3-1: Exclusion Criteria...........................................................................................24
Table 11.1-1: Study Procedures, Timelines and Data Collection ...................................26
Table 11.2.3-1: Disposition of Required Source Documentation ...................................29
Table 12.1.4-1:  Sample Size Parameters and Justification ............................................35
Table 18.2-1:  Some Examples of Possible Causes for Reportable Adverse Events ...51
Table 18.2-2:  Supporting Adverse Event Information ….………………………….………52 
Table 20.1-1: Adverse Event Definitions.........................................................................556
Table 20.2-1: Criteria for Assessing Relationship of Device to Adverse Event .…..….56
Table 20.3-1: Investigator Reporting Requirements .……...………...…….….....……….. 57
Table 25.1-1: Study Abbreviations/Acronyms..................................................................62
Table 25.2-1: Study Protocol Definitions ..........................................................................67

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4. Introduction
Boston Scientific CRM intends to complete a Post-Approval/Condition of Approval study as 
required by the US 21 CFR 814.82(a)(2) and in accordance with the regulatory process in 
several other countries.  Post-approval studies of implanted leads provide an opportunity to 
observe and assess patient outcomes and technology performance in a real-world setting.  
The goal of the study referred to in this document as the Longitudinal Surveillance Study of 
4-SITE (i.e., LSS of 4-SITE) is to evaluate, document and report on the appropriate clinical 
performance, long term reliability and the functional integrity of the Boston Scientific 
ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header (i.e., the 
4-SITE Lead/Header System that incorporates four conductors into a quadpole DF-4 
connection) that is found in market released ICD and CRT-D PGs.  The study protocol takes 
into consideration existing guidance from the FDA on Post Approval Studies as well as 
applicable elements of Post Approval Studies currently being conducted.
4.1. QUADRIPOLAR Technology
The Boston Scientific 4-SITE Lead/Header System was designed and developed in parallel 
with, and with the intent of meeting, the approved quadripolar ‘IS-4/DF-4’ connector 
standard.  The four-pole connector standard is designed to provide interchangeability 
between implantable leads and pulse generators from compliant manufacturers of these 
devices. 
Given the intent of the connector standard to substantially supplant the IS-1/DF-1 versions of 
high voltage devices and leads, it is anticipated that this technology will be incorporated into 
other future medical device products.  The 4-SITE technology will not affect current ICD and 
lead functionalities, such as sensing, pacing and defibrillation.
4.1.1. ISO Standard (ISO 27186) For Quadripolar Connectors and 4-SITE
The quadripolar connector standard was developed under the auspices of the Association for 
the Advancement of Medical Instrumentation (AAMI) CRM-Device Connector Task Force 
(Work Item PC 73).  The International Standards Organization (ISO 27186) provides the 
dimensional and functional requirements for the new standard connector.  
Boston Scientific CRM 4-SITE leads and devices are designed to be compatible with the 
International Standard ISO/DIS 27186 for quadripolar connectors, but they are currently 
labeled only for use with a compatible Boston Scientific 4-SITE device.
4.2.
Background 
Boston Scientific CRM (BSC) continuously strives to improve the performance of its 
products.  To do so, a complete understanding of device performance is necessary through 
bench testing and real-world monitoring.  While bench testing provides predictions as to 

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safety and performance, real-world monitoring aids in understanding in vivo failure 
mechanisms that require monitoring of large sample sizes over extended periods of time.  
The LSS of 4-SITE Study will monitor the chronic performance of the 4-SITE Lead/Header 
System to assess time-dependent failure modes. 
4.3.
Study Purpose
The primary purpose of this study is to evaluate, document and report on the appropriate 
clinical performance, the long-term reliability and the functional integrity of the 4-SITE 
Lead/Header System.  This 4-SITE Lead/Header System consists of a 4-SITE ENDOTAK® 
RELIANCE defibrillation lead connected to a 4-SITE Header (which is the only PG 
component under study) of a single or dual chamber (VR and DR) implantable cardioverter 
defibrillator (ICD) or a cardiac resynchronization therapy ICD (CRT-D) pulse generator.  
Additionally, system-related diagnostic information and implant data will be collected during 
the conduct of this study. 
5. Description of Devices Under Surveillance
4-SITE leads and pulse generators with a 4-SITE Header as well as other components of the 
implanted system are included in this study.  The initial products incorporating the 4-SITE 
quadripolar connector technology which are being evaluated are:
Commercially available 4-SITE ENDOTAK® RELIANCE family of leads; and 
Commercially available 4-SITE Header (which in the only component under study of 
an implanted pulse generator). 
5.1.
4-SITE ENDOTAK RELIANCE Leads 
The 4-SITE ENDOTAK RELIANCE® G, SG and non-Gore coated leads are integrated 
bipolar endocardial cardioversion/defibrillation, pace/sense, steroid-eluting, active/passive 
fixation leads with a 4-SITE terminal connector.  The following BSC lead model numbers 
are the only leads that will be investigated in the LSS of 4-SITE Study:  0265,  0266,  0275,
0276,  0282,  0283,  0285,  0286,  0292,  0293,  0295  and  0296.  The abbreviation for these 
leads is “4-SITE”.
5.2.
4-SITE Compatible Header
Pulse generator (PG) models with headers compatible with the 4-SITE ENDOTAK® 
RELIANCE family of cardiac leads vary in different geographies.  The only model PGs that 
will be utilized in this study are those commercially available from Boston Scientific that 
incorporate headers which are compatible with the 4-SITE lead. The general abbreviation for 
these devices is “4-SITE PGs”.  The other functionalities of an implanted PG are not 
included within the scope of this study and will not be included in the endpoint analysis.   
Thus, adverse events, other than those directly related to the lead/header system, will be 
recorded separately, but excluded from the endpoint analysis. 

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5.3.
4-SITE Lead Accessories
There are several 4-SITE Lead Accessories: (1) Model 7001 – EZ-4™ Terminal Connector 
Tool; (2) Model 7006 – Lead Pulling Tip; (3) Model 7007 – Lead Cap Kit; and (4) Model 
6888 – Lead Tunneler Kit.  The EZ-4 Terminal Connector Tool protects the lead terminal 
during the implant procedure, provides a safe and secure connection between pacing system 
analyzer (PSA) patient cables and the lead terminal, guides the stylet into the lead through 
the stylet funnel, and rotates the terminal pin to extend or retract the helix (for leads with a 
helix).  The 4-SITE connector fits into one end of the Lead Pulling Tip which is a stainless 
steel bullet shaped slug that can be used subcutaneously to move the lead from the venous 
access site to the PG pocket if needed.  The platinum cure silicon rubber Lead Cap is used to 
isolate and cover the quadripolar lead connector when it is not inserted in an ICD or CRT-D.  
The Lead Tunneler Kit includes a lead tunneling handle and two rods and tips for IS-1 and 
DF-1 connectors. 
6. Study Objective
The objective of the LSS of 4-SITE Study is to prospectively determine the chronic 
complication-free rate of the 4-SITE Lead/Header System in order to verify its long-term 
functional integrity. 
7. Study Endpoints
The 4-SITE Lead/Header System will be evaluated based on the “chronic 4-SITE 
Lead/Header System-related complication-free rate” for the five (5) year follow-up period 
after the index implantation.  The primary endpoint analysis will include confirmed chronic 
4-SITE Lead/Header System-related complications that result in study subject permanent loss 
of therapy, invasive intervention, injury or death.  Investigator and study subject induced 
device dysfunctions (e.g., Twiddler’s Syndrome and inadvertent cutting of lead insulation
during the implantation procedure) will be recorded, but will not be included in the study 
endpoint analysis. 
8. Study Design
The LSS of 4-SITE Study is a prospective, non-randomized, multi-center, global clinical 
investigation of subjects implanted with the 4-SITE Lead/Header System.  The LSS of 4-
SITE Study is designed to collect product performance information, any reportable adverse 
events and withdrawal data.  Study subjects who are enrolled prior to implantation of the 
device system will have an enrollment visit during which informed consent is obtained, 
followed by device system implantation (i.e., day 0) and a pre-discharge visit (0 to 3 days)
after implantation, during which a full device system interrogation will be performed. Study 
subjects who are enrolled after device system implantation (up to 14 days post implant) will 
undergo an enrollment visit during which informed consent is obtained, followed by 
information gathered from their implant.  Regarding the pre-discharge visit (0 to 3 days post 

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implant) for subjects enrolled post implant, information from a full device system 
interrogation is optional and will be provided to Boston Scientific only if it is available. 
All study subjects will then have another full device system evaluation performed at the 
investigational site facility at 30 (+/- 7) days post implant. Thereafter, subjects are required to 
participate in a follow-up visit (to be performed at the investigational site facility) for a full 
device system (i.e., pulse generator and lead) evaluation at least once every six (6) months 
(+/- 30 days).  A deviation must be reported if the evaluation is not done within the required 
follow-up visit window timeframe.  Study subjects will be followed for at least five (5) years 
from the time of implant or until death, withdrawal from the study, or termination/closure of 
the study.  The study design is presented below in Figure 8.1-1. 
Subjects may be followed on the LATITUDE system (which may include weight scale and 
blood pressure sensors) from the time they are implanted. However, required LSS of 4-SITE 
Study follow-ups cannot be substituted with a LATITUDE remote follow-up. 
8.1.
Scale and Duration
The study will be conducted at a maximum of 200 global centers.  A maximum of 125 will 
be located in the US, with the remainder in Canada, Europe, Asia Pacific, Australia and New 
Zealand.  At least 1,780 subjects will be enrolled and successfully implanted with the 4-SITE 
Lead/Header System.  However, any one individual center may not enroll more than twenty 
percent (20%) of this ceiling without prior approval from Boston Scientific CRM.
Investigational centers may continue to enroll patients until the enrollment ceiling is reached
or until notified by the Sponsor that study enrollment has been completed.   
The entire study will be conducted for approximately eight (8) years; that is, three (3) years 
for enrollment and five (5) years for follow-up visits.  All subjects enrolled in this study must 
be followed in strict accordance to the investigational plan unless BSC notifies the 
Investigator to the contrary or BSC has officially terminated/closed the study.   Boston 
Scientific will seek FDA’s concurrence to terminate/close the study if both parties determine 
the circumstances are appropriate for study termination/closure.  Study subjects should 
expect data collection to last five (5) years from implantation. After a subject has completed 
five (5) years of follow-up, their participation in the study is complete. 

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Approximate Final Report Submission: The final study report submission will 
occur within approximately six (6) months following the final study subject follow-
up visit. 
8.3.
Treatment Assignment
The LSS of 4-SITE Study is a post-approval clinical study and as such study subjects will 
essentially include “all-comers” who meet enrollment criteria.  Study Investigators are 
expected to approach all potentially eligible study subjects who have been (within 14 
calendar days post-implant window), or will be, implanted with the 4-SITE Lead/Header 
System at the investigational center for enrollment into this study until the enrollment ceiling 
is reached.  
8.4.
Justification for the Study Design 
The 4-SITE Lead/Header System will be evaluated based on the “chronic 4-SITE 
Lead/Header System-related complication-free rate” for the five (5) year follow-up period 
after the device system implant.  Thus, the LSS of 4-SITE Study is designed to collect 
product performance information, any reportable adverse events and withdrawal data. 
Study subjects who are enrolled prior to implantation of the device system will have an 
enrollment visit during which informed consent is obtained, followed by device system 
implantation (i.e., day 0) and a pre-discharge visit (0 to 3 days) after implantation, during 
which a full device system interrogation will be performed. Study subjects will then have 
another full device system evaluation performed at 30 (+/- 7) days post implant.  Thereafter, 
subjects are required to participate in a follow-up visit for a full device system (i.e., pulse 
generator and lead) evaluation at least once every six (6) months (+/- 30 days).  Study 
subjects will be followed for at least five (5) years from the time of implant or until death, 
withdrawal from the study, or termination/closure of the study. 
Study subjects who are enrolled after device system implantation (up to 14 days post 
implant) will undergo an enrollment visit during which informed consent is obtained, 
followed by information gathered from their implant.  Regarding the pre-discharge visit (0 to 
3 days post implant) for subjects enrolled post implant, information from a full device system 
interrogation is optional and will be provided to Boston Scientific only if it is available.    
If such is not provided, the investigational site will not be considered to have deviated from 
this protocol.
9. Subject Selection 
9.1.
Study Population and Eligibility 
Investigators are expected to approach all potentially eligible study subjects who have been
(within 14 calendar days post implant window), or will be, implanted with the 4-SITE 
Lead/Header System at the investigational center for enrollment into this study until the 

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enrollment ceiling is reached.  All study subjects must meet all the inclusion criteria and none 
of the exclusion criteria (listed hereinafter in Sub-sections 9.2 and 9.3, respectively).  
Investigational centers are encouraged to enroll subjects in the LSS of 4-SITE Study prior to 
the implantation of the 4-SITE Lead/Header System.  However, a maximum of fifty percent 
(50%) of the study subjects may be enrolled up to 14 calendar days post device system 
implant as long as the required data are available from/since the implant.  The required data 
for a post-implant enrollment must include the following implant information and data: 
Right ventricle (RV) lead and pulse generator (PG) date of implant;
RV lead and PG model and serial numbers;
RV lead implant attempts/repositioning (whether more than one lead or lead 
position was attempted to achieve a successful lead implant);
RV lead electrical measurements for final lead configuration (i.e., sensing, 
pacing threshold and impedance values from the implanted PG device);
Assessment and documentation of the absence/presence of adverse events by 
reviewing available patient medical records including, but not limited to, the 
following:
o Progress notes;
o Laboratory reports;
o Operations reports; and
o Discharge summary.
For study subjects enrolled after device system implant (within 14 calendar days), the 
required One-Month Post-Implant Follow-up Visit is still required.  Study subjects will then 
continue to have a complete device system interrogation at least once every six (6) months 
from the date of their device system implant for a five (5) year term.  A deviation must be 
reported if a study subject is not seen within the follow-up visit window (i.e., 6 months +/- 30 
days). 
Participation in another clinical study and/or registry is generally permitted for subjects 
enrolled in the LSS of 4-SITE Study unless its requirements conflict with the conduct of the 
LSS of 4-SITE Study.  Enrollment in any concurrent clinical study and/or registry requires 
prior written approval from Boston Scientific CRM.  However, governmental mandated 
clinical registries do not require prior approval.
9.2.
Inclusion Criteria
Subjects who meet all of the following criteria (see Table 9.2-1 below) may be given 
consideration for inclusion in this clinical investigation, provided no exclusion criterion (see 
Section 9.3 below) is met.

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Table 9.2-1: Inclusion Criteria
Clinical 
Inclusion 
Criteria
CI-1. Subject is medically indicated for implantation of an ICD/CRT-D
device system in their respective geography; and 
CI-2. Has been or will be implanted with the 4-SITE Lead; and 
CI-3. Has been or will be implanted with a BSC commercially available 4-
SITE compatible pulse generator; and
CI-4. Plans to remain in the long-term care of his/her enrolling Investigator
for the full five (5) year follow-up visit schedule; and 
CI-5. Is willing and capable (or appropriate legal representative is willing 
and capable) of authorizing access to and use of health information as 
required by an institution’s Institutional Review Board (IRB), 
Research ethics Board (REB) or Ethics Committee (EC); and 
CI-6. Is willing and capable (or appropriate legal representative is willing 
and capable) of providing authorization/consent for participation in the 
study. 
9.3.
Exclusion Criteria
Subjects who meet any one of the following criteria (see Table 9.3-1) will be excluded from 
participation in this clinical study. 

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Table 9.3-1: Exclusion Criteria
Clinical 
Exclusion 
Criteria
CE-1. More than 14 calendar days have passed since device system implant;
or 
CE-2. For subjects enrolled within 14 calendar days post implant, they are 
excluded if any of the required implant data listed below is missing; 
or 
Right ventricle (RV) lead and pulse generator (PG) date of implant; 
RV lead and PG model and serial numbers; 
RV lead implant attempts/repositioning (whether more than one lead 
or lead position was attempted to achieve a successful lead implant); 
RV lead electrical measurements for final lead configuration (i.e.,
sensing, pacing threshold and impedance); or 
Documented assessment of adverse event status since implant.
CE-3. Subject is unable or unwilling to comply with the study protocol 
requirements; or 
CE-4. Subject is under the legal age for signing study consent in accordance 
with state or national law.
10. Subject Accountability
10.1. Point of Enrollment
At enrollment, the Informed Consent form must be completed and signed/dated by the 
subject (or signed/dated by a legally authorized representative).  Subjects who meet all of the 
inclusion criteria and none of the exclusion criteria, and who have signed an Informed 
Consent form, are considered enrolled in the study and will count toward the study 
enrollment ceiling.  Patients may be consented only one time for this protocol and can only 
be enrolled with their initial implant of a 4-SITE lead.  Even if an enrolled study subject is 
subsequently determined to be an attempt or intent with respect to the implantation of a 
device system (see Sub-section 11.5.2), he/she will be counted toward the study enrollment 
ceiling.  Attempt subjects shall be withdrawn from participation in the study after collection 
of any potential 4-SITE Lead/Header System related adverse events.  The original Informed 
Consent form and any screening documentation for intent subjects should be maintained in 
the center’s administrative study files.

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10.2. Point of Study Exit
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented.  Study subjects can exit the 
study for the following reasons: study completion (subject completed 5 years of follow-up), 
death, or withdrawal. If a subject withdraws from the clinical investigation, the reason(s) 
shall be reported.
Reasons for withdrawal include, but are not limited to: adverse event, Investigator 
discretion, Lost to follow-up, RV lead no longer in service, transplant or removal of target 
organ, or subject withdrew from participation in study.  While study withdrawal is 
discouraged, subjects may withdraw from the study at any time, with or without reason, and 
without prejudice to further treatment.  All applicable case report forms up to the point of 
subject withdrawal and an “End of Study” form must be completed.  Subjects who are “lost-
to-follow-up” should have documented attempts to contact them prior to completion of the 
“End of Study” form.
Additional data may no longer be collected after the point at which a subject has been 
withdrawn from the study or withdraws his/her consent, for whatever reason.  All open 
adverse events should be closed or documented as chronic.  Data collected up to the point of 
study subject withdrawal may be used. 
10.3. Subject Status and Classification
Final study subject status is defined as being one of the following:  an implant subject, an
attempt subject or an intent subject.  The detailed definitions of these classifications are 
presented within Sub-section 11.2.2. 
10.4. Enrollment Controls
Investigational centers will be notified to cease enrolling patients for this study when the 
enrollment target is reached, or at the Sponsor’s discretion in consultation with the FDA.  
This notification is expected to happen when at least 1,780 study subjects have been enrolled 
and successfully implanted with the 4-SITE Lead/Header System.  In order to ensure 
geographical dispersion of investigational sites, individual study sites may not enroll more 
than twenty percent (20%) of the anticipated enrollment ceiling of 1,780 subjects (i.e., not 
more than 356 subjects at any single site).  For the study overall, no more than 50% of 
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11.2. Device System Implantation Visit
The Device System Implantation Visit is considered as day zero (0) for all visits going 
forward.  The following information must be collected at device system implant or during the 
post-implant enrollment visit:
Right ventricle (RV) lead and pulse generator (PG) date of implant; 
RV lead and PG serial numbers;
RV lead implant attempts/repositioning (i.e., whether more than one lead or lead 
position was attempted to achieve a successful lead implant); 
RV lead electrical measurements for final lead placement and configuration (i.e.,
sensing, pacing threshold and impedance values from the implanted PG device);
Documented assessment of adverse event status since implant; 
Documented assessment of  device deficiency; and
Defibrillation test information (if available). 
In addition, the following study subject data should be collected at implant: 
Medical history (e.g., arrhythmia history, selected prescribed medications, non-
cardiac disease history, etc.); 
PG implant pocket location (i.e., right/left side as well as sub-pectoral or 
subcutaneous location); 
Lead implant technique (e.g., subclavian stick, axillary stick or cut-down); and
Handling experience using the Terminal Tool (per labeling) during pacing system 
analyzer (PSA) testing. 
Study subject data collected during the Device System Implantation Visit must be promptly 
entered into the BSC electronic data capture system.  
Additionally, at any point during the study, information regarding any newly implanted leads 
(RA or LV) or pulse generators should be recorded.  Also, at device system revision, check 
for lead fixation in the header, check for set screw tightness, and check for incomplete lead 
insertion. 
11.2.1. 
4-SITE Lead/Header Connection Integrity
Lead and Pulse Generator Physician Technical Manuals describe lead impedance testing 
protocols that may be performed at the discretion of the Investigator.  Upon device system 
implant, a low-energy impedance test may be performed to verify the 4-SITE Lead/Header 
connection integrity.  A commanded low-energy impedance test is a more robust tool for 
identifying and verifying a potential open shocking lead condition.  Also, Investigators, at 
their discretion, may perform a high- or maximum-energy ventricular tachyarrhythmia 
conversion test in accordance with RELIANCE 4-SITE Lead labeling.  A high- or maximum-
energy shock is a more robust test for identifying and verifying a potential shorted shocking 
lead condition and assessing sensing of ventricular fibrillation (VF). If defibrillation testing 

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Documentation Regarding: 
Study Subject Demographics 
Cardiovascular Medication
Arrhythmia History
Cardiac Disease History
Device System Implant Procedure 
Retain at Investigational Site/Center
Printout of Implanted Pulse Generator 
Measurements and Threshold Results
Retain at Investigational Site/Center
In the Event of Study Subject Death: 
Death Narrative
Pertinent Medical Record 
Information
Copy of Death Certificate
Copy of Autopsy Report 
Submit One (1) Copy of All Documents 
to Boston Scientific CRM
– and – 
Retain a Copy of All Documents in the 
Study File at Investigational Site/Center
11.3. Pre-Discharge Visit
Study subject pre-discharge data is usually collected between 0 to 3 days post device system 
implant.  A full device system evaluation must be performed during this visit as well as a 
check for adverse events since implant.  The following study subject data must be collected 
during the Pre-Discharge Visit for all pre-implant enrolled subjects and, if available, for all 
post-implant enrolled subjects: 
Measurements regarding the 4-SITE Lead/Header System; and, for the RV lead, the 
following: 
o
Amplitude (sensing);
o
Impedance (shock and pacing); and 
o
Voltage pacing threshold (record pulse width used). 
4-SITE Lead/Header System-related Adverse Events.
The presence/absence of adverse events identified during active study subject medical 
record review.
Upon device interrogation, if observed values show evidence of suspected 
lead/device malfunction, a chest radiograph(s) to determine lead position is 
strongly recommended, but at the discretion of the Investigator.  If noise is 
detected in the intracardiac electrogram (EGM) storage, techniques such as pocket 
manipulation, arm maneuvers, valsalva maneuver, coughing and/or exploration of 
potential sources of external magnetic interference (EMI) may be used to detect 
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Source documentation must be maintained by the center personnel in the study files.  Where 
copies of original source documents as well as printouts of original electronic source 
documents are retained, these shall be signed and dated by a member of the investigational 
site/center team as confirmation that they are a true reproduction of the original source 
documents.  Any prolonged hospitalization should be considered as a serious adverse event 
and reported appropriately.  Prolonged hospitalization for anticoagulation will be adjudicated 
by the Clinical Events Committee. Study subject data collected during the Pre-Discharge 
Visit must be promptly entered into the BSC electronic data capture system.   
11.4. One-Month Follow-up Visit
At thirty (30) +/- 7 days following device system implant, study subjects must participate in 
an in office One-Month Follow-up Visit.  A full device system evaluation must be performed 
during this visit as well as a check for adverse events since implant.  The following study 
subject data must be collected during the One-Month Follow-up Visit: 
Measurements regarding the 4-SITE Lead/Header System; and, for the RV lead, the 
following: 
o
Amplitude (sensing); 
o
Impedance (shock and pacing); and 
o
Voltage pacing threshold (record pulse width used). 
4-SITE Lead/Header System-related Adverse Events; and
The presence/absence of adverse events identified during active study subject medical 
record review.
Upon device interrogation, if observed values show evidence of suspected 
lead/device malfunction, a chest radiograph(s) to determine lead position is 
strongly recommended, but at the discretion of the Investigator.  If noise is 
detected in the intracardiac electrogram (EGM) storage, techniques such as pocket 
manipulation, arm maneuvers, valsalva maneuver, coughing and/or exploration of 
potential sources of external magnetic interference (EMI) may be used to detect 
system abnormalities, at the discretion of the Investigator. 
Study subject data collected during the One-Month Follow-up Visit must be promptly 
entered into the BSC electronic data capture system.  Source documentation must be 
maintained by the center in the study files.  Where copies of original source documents as
well as printouts of original electronic source documents are retained, these shall be signed 
and dated by a member of the investigational site/center team with a statement that they are a
true reproduction of the original source documents. 
11.5. Bi-Annual Study Subject Follow-up Visits
The study subject’s implanted device system must be evaluated on a regular basis at the 
investigational site’s facility.  An implanted device system interrogation must take place bi-
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of five (5) years.  All study follow-up visit dates are based on days from the device system 
implant.  The dates for the follow-up visits are listed in Table 11-1 above. 
A full device system evaluation must be performed during this visit at the investigational 
site’s facility as well as a check for any adverse events occurring since implant.  The 
following study subject data must be collected during all Bi-Annual Study Subject Follow-up 
Visits:
Measurements regarding the 4-SITE Lead/Header System; and 
o
Amplitude (sensing); 
o
Impedance (shock and pacing); 
o
Voltage pacing threshold (record pulse width used); and 
o
4-SITE Lead/Header System-related adverse events. 
The presence/absence of adverse events identified during active study subject medical 
record review.
Follow-up visit data must be promptly entered into the BSC electronic data capture system.  
Source documentation must be maintained by the investigational site/center personnel in the 
study files.  Where copies of original source documents as well as printouts of original 
electronic source documents are retained, these shall be signed and dated by a member of the 
investigational site/center team as confirmation that they are a true reproduction of the 
original source documents. 
11.5.1.
Missed Bi-Annual Study Subject Follow-Up Visits  
In the event that a Bi-Annual Study Subject Follow-Up Visit is missed, investigational 
site/center personnel are expected to make every effort to contact the study subject (e.g., via 
certified mail, telephone calls, Email messages, etc.) in order to determine the subject’s 
status.  Study subjects are considered “lost-to-follow-up” after three (3) documented contact 
attempts and should be immediately withdrawn from the study if investigational site/center 
personnel have not had any contact with a study subject after three attempts.  The date of the 
study subject’s last in-clinic follow-up visit (scheduled or unscheduled) will be used as the 
date that he/she was “lost-to-follow-up” and therefore ended their participation in the study.  
Study subjects will be withdrawn at any time if they express their desire to cease their 
participation in the study.
11.6. Unscheduled Follow-Up Visits
Unscheduled Follow-up Visits occurring between regularly scheduled study visits are 
intended to collect information on adverse events, or in response to a sponsor-requested visit. 
NOTE: For visits where device reprogramming is completed, or other regular interim visits 
not required by the study (i.e. optimization of programmed settings); this information is not 
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11.7. Study Completion
Study subjects should expect data collection to last five (5) years from the index device 
system implant or if BSC has officially terminated/closed the study.  After a subject has 
completed his/her last scheduled bi-annual visit (at five years post implant) or the study has 
been terminated, their participation in the study is complete.  Subsequent to the completion of 
this last visit and the recording of any adverse events, the subject will no longer be 
considered enrolled in the study and all parameters regarding the implanted device system 
may be managed at the discretion of a qualified investigator. An “End of Study Form” is 
required to be completed, whenever a study subject exits the study (regardless of timing). 
12. Statistical Considerations
12.1. Primary Study Endpoint
The primary LSS of 4-SITE Study endpoint is the “chronic 4-SITE Lead/Header System-
related complication-free rate”.
12.1.1.
Description and Rationale for Endpoint Selection
The 4-SITE Lead/Header System will be evaluated based on the “chronic 4-SITE 
Lead/Header System-related complication-free rate” for the five (5) year follow-up period 
after the index implantation.  The primary endpoint analysis will include confirmed 4-SITE 
Lead/Header System-related complications that result in permanent loss of therapy, invasive 
intervention, injury or death.  
12.1.2.
Endpoint-related Adverse Events
Inclusion of adverse events in the endpoint is based on the adjudication of the adverse event 
by the independent Clinical Events Committee (CEC), and on the time of occurrence of the 
adverse event.
The following adverse events will all be reported, and those adverse events that result in 
permanent loss of therapy, invasive intervention, injury or death will be included in the 
endpoint analysis regardless of cause or time of occurrence: 
Pneumothorax; 
Perforation; and
Cardiac tamponade.
The following adverse events, occurring at 30 days or less from lead-related surgery, will all 
be reported, and those adverse events that result in permanent loss of therapy, invasive 
intervention, injury or death and that are also determined to be attributable to a structural 
lead/header failure by the Clinical Events Committee (CEC) will included in the endpoint 
analysis: 
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Extra-cardiac (diaphragmatic/pectoral) stimulation caused by the RV lead;
Inability to place or position the right ventricle (RV) lead;
Implant procedure-related complications such as arrhythmias and hematoma 
formations; 
Infection; 
In-patient damage to RV lead (e.g., accidental cut to lead body during pocket 
revision, device replacement, etc.); 
Other procedure-related adverse events identified at implantation; 
Lead under-insertion identified at implant; and 
Loose header set screws identified at implant.
The following adverse events, occurring more than 30 days after lead-related surgery, will all 
be reported, and those adverse events that result in permanent loss of therapy, invasive 
intervention, injury or death will be included in the endpoint analysis for the 4-SITE 
Lead/Header System: 
Right ventricular lead dislodgment; 
Extra-cardiac (diaphragmatic/pectoral) stimulation caused by the RV lead; 
Low/High impedance values; and 
High right ventricle (RV) pacing threshold with sudden change (>2 volts),
intermittent RV capture and non-capture of the RV lead.
The following adverse events, occurring more than 30 days after lead-related surgery, will all 
be reported, and those adverse events that result in permanent loss of therapy, invasive 
intervention, injury or death and that are determined to be attributable to a structural 4-SITE 
Lead/Header System failure by the Clinical Events Committee will be included in the 
endpoint analysis.  Examples of events which will be sent to the Clinical Events Committee 
are listed below.  Many of these may be adjudicated by the Clinical Events Committee to be 
unrelated to malfunction of the 4-SITE Lead/Header System,
Lead/Header connection-related adverse events in systems not tested using a 
high- or maximum-energy ventricular tachyarrhythmia conversion test; 
RV lead-related thrombosis;
Twiddler’s syndrome (i.e., permanent malfunction of a pacemaker due to the 
patient's manipulation of the pulse generator in the implant pocket) leading to 
RV lead dislodgment; 
Infection;  
Atrial lead, CRT lead or generator adverse events requiring additional 
interventions; 
RV lead-related hospitalizations;
Death;
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above, acute adverse events associated with attempted lead implants will not be included in 
this analysis.  These events fall within the 30 days of an invasive cardiac surgery and do not 
meet the criteria outlined in Sub-section 12.1.2 above. 
12.3.2.
Additional Analyses/Changes to Planned Analyses
In addition to the primary endpoint analysis, the adverse events contributing to the endpoint 
will be analyzed.   The individual adverse event rates and 95% upper confidence bounds will 
be provided. 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan approved prior to performing the 
analyses.  Changes from the planned statistical methods after performing the analyses will be 
documented in the clinical study report along with a reason for the deviation. 
12.3.3.
Subgroup Analyses
An analysis will be performed for the primary endpoint to determine whether significant 
differences exist in endpoint results between subgroups.  The list of baseline covariates (with 
applicable subgroups in parentheses) includes, but is not necessarily limited to, the following:
Sex (Female vs. Male);
Geography (International vs. United States);  
Enrollment Timing (Pre-Implant versus Post-implant).
The baseline covariate will be added to a univariate logistic regression model and a test for 
significance at the 5% level will be performed.  For each baseline covariate in which a 
significant difference exists between subgroups, the results for each subgroup will be 
presented separately.
12.3.4.
Center Pooling Analysis
Center-to-center heterogeneity will be assessed for the primary endpoint by performing a 
random effects logistic regression analysis.  Centers will be deemed to be heterogeneous if 
the variance of the random center effect is found to significantly differ from zero.  A 
significance level of 10% will be used for this test.
12.3.5.
Trend Analysis
BSC trend management procedures provide criteria for initiating trend analysis and will be 
utilized in conjunction with data collected in this study. Device performance information is 
received from many sources through various channels including clinical studies and device 
registries. BSC also monitors product performance information from many sources including 
suppliers, testing, manufacturing, clinicians, physicians, patients and field-based personnel to 
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laboratory technicians and engineers assess overall device function and perform analyses
using specific tests related to the clinical observation(s).  Test results are compared to the 
original manufacturing records and design intent.  Clinical observations are added to 
laboratory findings to help determine the root cause of the clinical observation(s). Each 
discrete event is then compared to other similar-appearing events. If a pattern is detected, 
actions are taken to identify a common root cause, and device enhancements that are focused 
on improving product reliability may be implemented.  Improvements, when implemented,
may include design changes to the existing products or to subsequent generations, 
manufacturing and supplier process modifications, software updates, educational 
communications and/or labeling changes, for example. 
12.3.6.
Progress Reporting Analysis
Progress reports to the FDA will be provided by the Sponsor every six (6) months.  These 
reports will generally include: 
A summary of enrollment and lead status; 
A Kaplan-Meier plot of time to first endpoint-defined chronic 4-SITE 
Lead/Header System-related complication;
A summary of trend analysis; and 
A summary of RV lead and header-related adverse events. 
12.3.7.
Product Performance Reporting
In order to share information learned from this study with practitioners on an on-going basis, 
data will be published in a BSC Product Performance Report.  However, this will occur no
sooner than one (1) year post study initiation when at least 200 subjects are participating in 
the study and who have implanted with the 4-SITE Lead/Header System and when at least 50 
subjects having reached a reporting interval in the United States.
13. Data Management
13.1. Data Collection, Processing and Review
Study subject data will be recorded in a limited access secure electronic data capture (EDC) 
system provided by the Sponsor.  
The clinical database will reside on a production server hosted by Medidata Solutions (New 
York, NY). All changes made to the clinical data will be captured in an electronic audit trail 
and available for review by Boston Scientific Corporation (BSC) or its representative. The 
associated RAVE software application and database have been designed to meet regulatory 
compliance for deployment as part of a validated system compliant with laws and regulations 
applicable to the conduct of clinical studies pertaining to the use of electronic records and 
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For the LSS of 4-SITE Study, all data will be entered into electronic case report forms 
(eCRFs) that are located on BSC’s study electronic data capture system (EDC).  Study 
subjects’ medical records/charts serve as source documentation for electronically entered 
data.
Center personnel are required to conduct an active study subject review of medical 
records/charts (e.g., involving implantation, subject discharge and any subsequent in office 
follow-up visits) to ensure the capture of all possible adverse events during and between 
study subject follow-up visits.  Following thorough review of each study subject’s medical 
records/charts, site/center research personnel are asked whether adverse events were
identified by answering a designated questionnaire on the corresponding case report form.   
Site/center research personnel verify whether any of the reportable adverse events as 
described in Sub-section 12.1.2 and Section 18 have occurred. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation.  Changes to data 
previously submitted to the Sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data discrep-
ancies. Manual and/or automatic queries will be created in the EDC system and will be 
issued to the site for appropriate response.  Investigational site staff will be responsible for 
resolving all queries in the database.
13.2. Data Retention
The Investigator will maintain, at the investigative site, in original format all essential study 
documents and source documentation that support the data collected on the study subjects in 
compliance with ICH/GCP guidelines.  Documents must be retained for at least two (2) years 
after the last approval of a marketing application or until at least two (2) years have elapsed 
since the formal discontinuation of the clinical investigation of the product.  These 
documents will be retained for a longer period of time by agreement with BSC or in 
compliance with other local regulations. It is BSC’s responsibility to inform the Investigator 
when these documents no longer need to be maintained.  The Investigator will take measures 
to ensure that these essential documents are not accidentally damaged or destroyed.  If for 
any reason the Investigator withdraws responsibility for maintaining these essential 
documents, custody must be transferred to an individual who will assume responsibility and 
BSC must receive written notification of this custodial change.  
13.3. Case Report Forms
13.3.1.
Enrollment Case Report Form
An Enrollment Case Report Form is completed when a study subject has completed their 
enrollment visit and all required data collection is complete.

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13.3.2.
Implant Case Report Form
An Implant Case Report Form is completed at the device system implant of a study subject or 
at post-implant enrollment, as applicable.  All required data collection must be completed.  
13.3.3.
Pre-Discharge Case Report Form
A Pre-Discharge Case Report Form will be completed to record all lead measurements 
collected at the time of hospital/center discharge. For study subjects enrolled post-implant, 
this data is requested, but not required.  An active medical records/charts review will be 
conducted to identify all adverse events, as defined in Sub-section 12.1.2 and Section 18.
13.3.4.
One-Month Follow-up Case Report Form
A One-Month Follow-up Case Report Form will be completed to record all lead 
measurements collected during this study subject follow-up visit.  An active medical 
records/charts review will be conducted to identify all adverse events, as defined in Sub-
section 12.1.2 and Section 18. 
13.3.5.
Bi-Annual Follow-up Case Report Form
The Bi-Annual Follow-up Case Report Form will be completed every six (6) months (+/- 30 
days) to record all lead measurements collected during this study subject follow-up visit.  
These forms are labeled by visit within the EDC system (e.g., 6-Month Follow-up, 12-Month 
Follow-up, etc.).  An active medical records/charts review will be conducted to identify all 
adverse events, as defined in Sub-section 12.1.2 and Section 18.
13.3.6.
Unscheduled Visit Case Report Form
In the event of an unscheduled study subject visit, an Unscheduled Visit Case Report Form 
will be completed to provide the reason for the visit and record any adverse events, as 
defined in Sub-section 12.1.2 and Section 18. 
13.3.7.
Adverse Event Case Report Form
Upon discovery of an adverse event with a study subject, an Adverse Event Case Report 
Form must be completed to record any adverse events, as defined in Sub-section 12.1.2 and 
Section 18. 
13.3.7.1.
Additional Information Collected at Device System Revision/Replacement or 
Upgrade 
Should study subjects undergo surgical intervention for lead or pocket revision/reposition, 
this information is captured on the Adverse Event Case Report form. In the event of a 4-SITE 
RV lead revision, a detailed assessment of the proximal end of the lead and the header at lead 
revision/reposition should be completed. The investigator should also document any lead 
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13.3.8.
Device Deficiency Case Report Form
In the event a device deficiency (as defined in the protocol (Table 20.1-1)) is identified, a
Device Deficiency Case Report Form will be completed. 
13.3.9.
End of Study Case Report Form
An End of Study Case Report Form will be completed when a study subject is no longer 
active in the LSS of 4-SITE Study.  Reasons for a change in study subject status include
study completion, death and withdrawal. 
The status of the 4-SITE lead must be reported at the time of subject withdrawal from the 
study. 
13.3.10.
Explanted and Out-of-Service Device Case Report Form
For any implanted devices which are explanted and/or taken out of service (whether capped 
or removed), the Explanted and Out-of-Service Case Report Form must be completed.  
NOTE : If the 4-SITE RV lead is explanted and/or taken out of service, the study subject 
must be withdrawn from the study.   
13.3.11.
Deviations Case Report Form – Definition & Major Reasons
Protocol deviations are defined as any divergence from the study protocol.  Reasons for a 
deviation include, but are not limited to, the following: study subject consent not obtained, 
testing incomplete/not performed, and/or follow-up outside the scheduled protocol required 
follow-up visit window.  Study protocol deviations are further clarified in Section 15 
13.4. Additional Information Collected at Suspected Lead Failure
If the reason for study subject withdrawal is lead failure, supporting objective evidence is 
required.  Objective evidence includes, but is not necessarily limited to, the following: Pacing 
System Analyzer (PSA) measurements demonstrating lead performance (thresholds, 
impedance, and/or sensing), stored EGMs, cine recordings and/or radiographic evidence.
Techniques such as pocket manipulation, arm maneuvers, valsalva maneuver, coughing 
and/or exploration of potential sources of external magnetic interference (EMI) may be used 
to detect system abnormalities, at the discretion of the Investigator.  Please refer to Sub-
section 26.2 hereinafter for suggested suitable confirmation information depending on the 
lead failure mode.
A detailed assessment and report by the explanting Investigator/ Physician of the proximal 
end of the lead and the header at device change-outs is required.  Data collected during 
explant of a lead will also be required, including extraction method and tools/instruments

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used.   
NOTE: For US and Canadian site personnel, please make every 
attempt to return explanted product to the manufacturer. Boston 
Scientific provides a Returned Products Kit (Model #6499) that can 
be requested through BSC’s Customer Service Department at 1-
800-CARDIAC (1-800-227-3422), by phoning 1-651-582-2698 or 
by submitting an online request at: www.bostonscientific.com/ppr.
Site representatives from Other Countries should please contact 
the local Boston Scientific office and/or affiliate for assistance 
(contact information may be found at the BSC website: 
www.bostonscientific.com/home.bsci). 
13.5. Additional Information Collected at Study Subject’s Death
Additional data must be collected and recorded upon a study subject’s death as follows:
Was the pulse generator explanted (Yes, No, or Unknown)?  Please attempt to 
return pulse generator to BSC upon the death of a study subject. 
Was an autopsy performed (Yes, No, or Unknown)? 
Was the pulse generator interrogated “in situ” after death (Yes, No, or Unknown)? 
Pulse generator interrogated data and status at time of death: monitor + therapy, 
monitor only, off, not functioning, or unknown? 
Primary organ cause of death: cardiac: arrhythmic, pump function, ischemic, 
other cardiac, or unknown; non-cardiac; or unknown? 
If cardiac ischemia, was it: acute, myocardial infarction (MI), non-acute MI or 
unknown? 
Temporal course of death: sudden, non-sudden or unknown / presumed sudden, or 
unknown? 
Antecedent worsening heart failure (Yes, No or Unknown)? 
Operative relationship: pre-operative, peri-operative or post-operative? 
Death witnessed (Yes, No or Unknown)? 
Death monitored (Yes, No or Unknown)? 
If death was monitored, were any of these observed: VT, brady-arrhythmia, 
pulseless electrical activity, unknown or other? 
If brady-arrhythmia was observed, was it: sinus brady-arrhythmia, high-degree 
AV Block with slow ventricular response or asystole?
What was the cause of death: procedure-related, pulse generator-related, 
lead/catheter-related, unknown or other? 
If a death is considered 4-SITE Lead/Header System-related, it will be 
adjudicated by medical review.*

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________________________
Post mortem assessment is strongly encouraged. Whenever possible, the device should be interrogated and
deactivated with the device information saved prior to being disconnected from the lead(s).  Lead extraction and 
return are also strongly encouraged.
13.6. Study Subject Data Confidentiality
All information sent to Boston Scientific (BSC) or entered in the electronic data capture 
website concerning subjects or their participation in the study will be considered and treated 
as confidential information.  Authorized BSC and the FDA personnel, as well as repre-
sentatives of other regulatory agencies, have the right to inspect and/or copy all records 
pertinent to the LSS of 4-SITE Study.  Data from the study that are used in reporting will be 
without identifiable reference to an individual study subject. 
For questions regarding any matter, BSC may be contacted as follows: 
 
 
Boston Scientific Corporation 
CRM Clinical Department
4100 Hamline Avenue North, 
Saint Paul, Minnesota  55112-5798 
Telephone:  1-800-CARDIAC (1-800-227-3422) 
Fax:  651-582-4982 
13.7. US Health Insurance Portability and Accountability Act (HIPAA)
The HIPAA requirements affect clinical trials1 in three key areas as described below:
Accounting of Disclosures: Data collected during the conduction of prescreening activities 
for this study are subject to the HIPAA accounting of disclosures’ regulations.  It is the 
responsibility of the investigative center personnel to tell all study subjects whose records 
were screened for eligibility in the study that their records were used in this manner if he or 
she requests an accounting of when his or her data were disclosed.  
Consent: All subjects participating in the study will be made aware that their participation 
in the study will involve disclosure of certain protected health information to BSC and for 
what purpose.  The Subject Informed Consent Form will contain a listing of the type of 
information that will be disclosed during the course of the clinical study. 
Withdrawal of Consent: HIPAA specifically allows companies such as BSC that are 
subject to the jurisdiction of the FDA access to protected health information for activities 
related to the quality, safety or effectiveness of devices. This means that BSC can use data 
from this study even if the individual withdraws his or her authorization.

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14. Study Protocol Amendments 
If a LSS of 4-SITE Study protocol revision is necessary which affects the rights, safety or 
welfare of the subjects or scientific integrity of the data, an amendment is required. 
Appropriate approvals (e.g., IRB/EC/FDA/CA) of the revised protocol must be obtained 
prior to implementation of amendments. 
15. Study Protocol Deviations
An Investigator must not make any changes or deviate from this study protocol, except to 
protect the life and physical well-being of a subject in an emergency.  An Investigator shall 
notify the Sponsor and the reviewing IRB/EC of any deviation from the investigational plan 
to protect the life or physical well-being of a study subject in an emergency, and those 
deviations which affect the scientific integrity of the clinical investigation.  Such notice shall 
be given as soon as possible, but no later than five (5) regular work days after the emergency 
occurred, or in accordance with prevailing local requirements, if such requires notification 
sooner than five (5) regular work days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the Sponsor via Email, CRF and/or EDC.  
Sites may also be required to report deviations to the IRB/EC, in accordance with local 
guidelines and government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis during the conduct of the 
LSS of 4-SITE Study and, as necessary, appropriate corrective and preventive actions 
(including notification, center re-training and/or participation discontinuation) will be 
instituted by the Sponsor. 
16. Compliance
16.1. Statement of Compliance
This study will be conducted in accordance with FDA regulations, ISO 14155 (Clinical 
Investigation of Medical Devices for Human Subjects – Good Clinical Practice), the relevant 
parts of the ICH Guidelines for Good Clinical Practices, ethical principles that have their 
origins in the Declaration of Helsinki, and pertinent individual country laws and regulations. 
The study shall not begin until the required approval/favorable opinion from the IRB/EC 
and/or regulatory authority has been obtained, if appropriate.  Any additional requirements 
imposed by the IRB/EC or regulatory authority shall be followed, if appropriate.
16.2. Investigator Responsibilities
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with the Clinical Study Agreement, the investigational 
plan/protocol, ISO 14155, ethical principles that have their origins in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing IRB/EC, and prevailing local 

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and/or country laws and/or regulations, whichever affords the greater protection to the study 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following:  
Prior to beginning the study, sign the Investigator Agreement and Protocol 
Signature page documenting his/her agreement to conduct the study in accordance 
with the protocol; 
Provide his/her qualifications and professional experience to assume 
responsibility for the proper conduct of the study and that of key members of the 
center team through up-to-date curriculum vitae or other relevant documentation, 
and disclose potential conflicts of interest, including financial conflicts of interest,
that may interfere with the conduct of the clinical study or interpretation of its 
results;
Make no changes in or deviate from this study protocol, except to protect the life 
and physical well-being of a subject in an emergency – document and explain any 
deviation from the approved protocol that occurred during the course of the 
clinical investigation;
Create and maintain source documents throughout the conduct of the clinical 
study and ensure their availability with direct access during monitoring visits or 
audits – ensure that all clinical-investigation-related records are retained in 
accordance with requirements;
Ensure the accuracy, completeness, legibility and timeliness of the data reported 
to the Sponsor in the case reports forms (CRFs) and in all required reports; 
Record, report and assess (seriousness and relationship to the device
system/procedure) every adverse event and observed device system deficiency;
Report to BSC, per the protocol requirements, all serious adverse events (SAEs) 
and device system deficiencies that could have led to a serious adverse device 
event (SADE);
Report to the IRB/EC and regulatory authorities any SAEs and device system 
deficiencies that could have led to a SADE, if required by the national regulations 
or this protocol or by the IRB/EC, and supply BSC with any additional requested 
information related to the safety reporting of a particular event;
Maintain the device accountability records and control of the device, ensuring that 
the investigational device is used only by authorized/designated users and in 
accordance with this protocol and instructions/directions for use;
Allow the Sponsor to perform monitoring and auditing activities, and be 
accessible to the monitor and respond to questions during and regarding 
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Allow and support regulatory authorities and the IRB/EC when performing 
auditing activities; 
Ensure that informed consent is obtained in accordance with this protocol and
local IRB/EC requirements;
Provide adequate medical care to a study subject during and after a subject’s 
participation in a clinical study in the case of adverse events, as described in the 
Informed Consent Form (ICF);
Inform the study subject of the nature and possible cause of any adverse events 
experienced;
As applicable, provide the study subject with necessary instructions on proper 
use, handling, storage and return of the investigational device when it is 
used/operated by the subject; 
Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required;
Provide the study subject with well-defined procedures for possible emergency 
situations related to the clinical study, and make the necessary arrangements for 
emergency treatment, including decoding procedures for blinded/masked clinical 
investigations, as needed; 
Ensure that clinical medical records are clearly marked to indicate that the subject 
is enrolled in this clinical study;
Ensure that, if appropriate, subjects enrolled in the clinical investigation are 
provided with some means of showing their participation in the clinical 
investigation, together with identification and compliance information for 
concomitant treatment measures (contact address and telephone numbers shall be 
provided); 
Inform, with the study subject’s approval or when required by national 
regulations, the subject’s personal physician about the subject’s participation in 
the clinical investigation;
Make all reasonable efforts to ascertain the reason(s) for a study subject’s 
premature withdrawal from the clinical investigation while fully respecting the 
subject’s rights;
Ensure that an adequate investigational site team and facilities exist, and are 
maintained and documented during the conduct of the clinical investigation; and 
Ensure that maintenance and calibration of the equipment relevant for the 
assessment of the clinical investigation is appropriately performed and 
documented, where applicable.

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16.3. Delegation of Responsibility
When specific tasks are delegated by an Investigator, including but not limited to conducting 
the informed consent process, the Investigator is responsible for providing appropriate 
training and adequate supervision of those to whom tasks are delegated.  The Investigator is 
accountable for regulatory violations resulting from failure to adequately supervise the 
conduct of the clinical study.  
16.4. Institutional Review Board / Ethics Committee
Prior to achieving approval-to-enroll subject status, the investigational center will provide to 
the Sponsor documentation verifying that their IRB/EC is registered or that registration has 
been submitted to the appropriate agency, as applicable, according to national/regulatory 
requirements.   
A copy of the written IRB/EC and/or competent authority approval of the study protocol (or 
permission to conduct the study) and Informed Consent Form, must be received by the 
Sponsor before recruitment of subjects into the study.  Investigators must provide IRB 
approval of revisions to the study subject Informed Consent Form or amendments to the 
protocol.  Prior approval must also be obtained for other materials related to subject
recruitment or which will be provided to study subjects. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the study 
as required by local/country or IRB/EC requirements.  Copies of the Investigator’s reports 
and the IRB/EC continuance of approval must be provided to the Sponsor in a timely
manner.  
16.5. Sponsor Responsibilities
Boston Scientific (BSC) will serve as the Sponsor of this clinical investigation. A Sponsor is 
defined as a person or organization that initiates, but does not actually conduct, the clinical 
investigation.  It is the responsibility of BSC as the Sponsor to ensure proper monitoring of 
the investigation and to see that all clinical requirements are met.  In addition, BSC 
representatives may participate in the conduct of the trial to the extent described in the 
following section that describes the role of BSC representatives.  BSC personnel may or may 
not be blinded to the study results.  Participation in the study’s conduct will be limited to 
BSC personnel who are appropriately qualified and trained such as those personnel with an 
engineering, technical or nursing degree or equivalent training, or who have significant 
experience in cardiology, electrophysiology or the implantable cardiovascular device 
industry.  All personnel will be aware of general clinical study regulations and guidelines for 
medical device trials.
All information and data sent to BSC concerning study subjects or their participation in this 
clinical study will be considered confidential by BSC. Only authorized BSC personnel or a 
BSC representative will have access to these confidential records.  Authorized regulatory 
personnel have the right to inspect and copy all records pertinent to this clinical study.  Study 
data collected during this study may be used by BSC for the purposes of this study, for 

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publication purposes, and to support future research and/or other business purposes.  All data 
used in the analysis and reporting of this study will be without identifiable reference to 
specific subject name.
Boston Scientific will keep subjects’ health information confidential in accordance with all 
applicable laws and regulations.  Boston Scientific may use subjects’ health information to 
conduct this research, as well as for additional purposes, such as overseeing and improving 
the performance of its device, new medical research and proposals for developing new 
medical products or procedures, and other business purposes.  Information received during 
the clinical study will not be used to market to subjects; subject names will not be placed on 
any mailing lists or sold to anyone for marketing purposes.  
16.6. Role of Boston Scientific Representatives
Boston Scientific personnel may provide technical support to the Investigator and other 
health care personnel (collectively HCP) as needed during implant, testing required by the 
protocol and follow-up visits.  Support may include HCP training, addressing HCP questions 
and/or providing clarification to HCPs concerning the operation of BSC equipment/device 
systems (including programmers, analyzers and other support equipment).
At the request of the Investigator and while under his/her supervision, BSC personnel may 
operate equipment during implantation or subject follow-up visits, assist with the conduct of 
testing specified in the protocol, and interact with the study subject to accomplish requested 
activities.  Typical tasks may include the following: 
Interrogating the device system or programming device parameters to the 
Investigator’s requested settings; 
Performing lead diagnostic testing using a Pacing System Analyzer (PSA) or 
programmer to obtain pacing and sensing thresholds and impedance 
measurements; 
Clarifying device system behavior, operation or diagnostic output as requested by 
the Investigator or other health care personnel; and
Assisting with the collection of study data from Pacing System Analyzers, 
programmers and/or other equipment. 
In addition, BSC personnel may perform certain activities to ensure study quality.  These 
activities may include the following: 
Observing testing or medical procedures to provide information relevant to 
study protocol compliance; and 
Reviewing collected data and study documentation for completeness and 
accuracy. 
Boston Scientific personnel will not perform the following: 
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Provide medical diagnosis or treatment to subjects;
Discuss a subject’s condition or treatment with a subject without the approval 
and presence of the HCP; 
Independently collect critical study data (defined as primary or secondary 
endpoint data); or 
Enter data in electronic data capture systems or on paper case report forms. 
16.7. Insurance Coverage
When required by local and/or country regulation, the type and proof of insurance coverage 
secured by Boston Scientific for subjects in the study will be provided. 
17. Study Monitoring
A monitor and/or BSC representative may visit an Investigator during the clinical study to 
assess the following criteria:
Adherence to the study protocol and applicable regulations regarding the 
obligations of the Investigator; and/or
Maintenance of adequate records; and/or 
Accurate clinical study data entry. 
In the event of noncompliance (e.g., repeated failure to transfer data, multiple study protocol 
deviations), as determined by BSC study management, a monitor and/or BSC representative 
may attempt to secure compliance by one or more actions such as the following:
Corresponding with the Investigator; and/or 
Telephoning the Investigator to have discussion(s); and/or 
Visiting the Investigator at the investigational site/center; and/or
Implementing a Corrective Action Plan for the site/center.
If an Investigator is found to be repeatedly noncompliant with the terms and conditions in the 
signed agreement, with the requirements specified in the protocol or with any other 
conditions of the study, then BSC will either secure compliance or, at its sole discretion, 
terminate the Investigator’s participation in the study.
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations.  In addition, the monitor verifies that study records are 
adequately maintained, that data are reported in a satisfactory manner with respect to 
timeliness, adequacy and accuracy, and that the Investigator continues to have sufficient staff 
and facilities to conduct the study safely and effectively.  The Investigator/institution 
guarantees direct access to original source documents by BSC personnel, their designees and 
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The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities.  It is important that the Investigator and 
relevant clinical study personnel are available during on-site monitoring visits and/or audits 
and that sufficient time is devoted to the process.
18. Potential Risks and Benefits
18.1. Adverse Event Reporting
The Investigator must report all adverse events occurring at or after device system implant
to BSC in a timely manner following the occurrence or discovery of such an event.  Specific 
event reporting requirements and timeframes are presented in Sub-section 20.3 and Table 
20.3-1.  Adverse events must be reviewed and classified by the Investigator for the study 
using the definitions outlined below. 
18.2. Adverse Event Definitions 
 
An adverse event is defined as any untoward medical occurrence, unintended disease or 
injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, 
users or other persons, whether or not related to the investigational medical device.  Adverse 
events may be a result of inappropriate performance of the 4-SITE Lead/Header System (i.e.,
a 4-SITE Lead and/or just the 4-SITE Header component of a PG) which results in an 
undesirable or unanticipated procedure or clinical occurrence.  Investigators are responsible 
for providing a description of the event, classifying each reported adverse event as being 
either related or unrelated to a 4-SITE Lead/Header System malfunction, describing the 
corrective action taken, explaining the method used to confirm the adverse event, reporting 
the clinical outcome, and determining the root cause of the adverse event based on available 
information.  All adverse events must be reported on the Adverse Event Form and reported in 
accordance with Medical Device Regulations.
The list of possible causes for reportable adverse events is presented in Table 18.2-1 below 
and the supporting adverse event information is presented in Table 18.2-2 below.  This 
tabular information is intended to be complete, but additional adverse events may be 
identified as more is learned about the device system’s performance.
18.3. Potential Lead Implantation Adverse Events 
 
Potential adverse events from implantation of a lead system include, but are not limited to, 
the following:  allergic/physical/physiologic reaction; death; erosion or migration; fibrillation 
or other arrhythmias; lead or accessory breakage (fracture/insulation/lead tip); hematoma or 
seroma; inappropriate or inability to provide therapy (shocks/pacing/sensing); infection; 
procedure related; and component failure.  In rare cases severe complications or device 
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18.5. Risk Minimization Actions
Additional study risks may exist.  Risks can be minimized through strict compliance with this 
protocol, by performing study procedures in the appropriate hospital environment, by 
adherence to study subject selection and enrollment criteria, by close monitoring of the 
subject's physiologic status during study procedures and in office follow-up visits, and by 
promptly supplying BSC with all pertinent information as required by this protocol. 
18.6. Anticipated Study Subject Benefits
Subjects enrolled in this clinical study may not receive any direct medical benefit from their 
participation.  However, the field of medical science and future study subjects who require 
implantation with a 4-SITE Header/Lead System may derive a benefit from the results of this 
clinical investigation. 
18.7. Risk to Benefit Rationale
The implantable device systems and accessories used for this clinical study are all 
commercially available and are considered to be “the standard of care” for study subjects 
indicated for such implants.  The risks involved with subject participation in this study are 
essentially the same as those for study subjects not participating in the study.  There are no 
additional risks from the implantation of the device system for a study subject compared to 
study subjects not participating in this study. 
Thus, even though there may be no direct clinical benefit for an individual study subject, 
study participants will not be exposed to any additional risks than they would encounter in 
the normal course of treatment for their malady.  Further, the study protocol required follow-
up visitation schedule and procedures may exceed the standard of care and thereby offer 
enhanced clinical observation for the five (5) years following the implant procedure. 
19. Study Subject Informed Consent
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
all study subjects or their legally authorized representative.  The Investigator is responsible 
for ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any national regulations and local 
Ethics Committee (EC) and/or regulatory authority body, as applicable. The Informed 
Consent Form (ICF) must be approved by the center’s IRB/EC, or central Institutional 
Review Board (IRB), if applicable.
Boston Scientific (BSC) will provide a study-specific template of the ICF to Investigators 
participating in this study.  The ICF template may be modified to meet the requirements of 
the investigative center’s IRB/EC.  However, any modification requires approval from BSC
prior to use of the form.  The ICF must be in a language understandable to the study subject 

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and if needed, BSC will assist the center in obtaining a written informed consent translation. 
Translated consent forms must also have IRB/EC approval prior to their use.  Privacy 
language shall be included in the body of the form or as a separate form, as applicable.  
The process of obtaining Informed Consent shall consist of the following: 
To be conducted by the Principal Investigator or designee authorized to conduct the 
process;
Must include a description of all aspects of the clinical study that are relevant to the 
subject’s decision to participate throughout the clinical study; 
Must avoid any coercion of or undue influence of subjects to participate in the study; 
Cannot waive or appear to waive study subject’s legal rights; 
Must use native language that is non-technical and understandable to the study 
subject or to his/her legal representative;
Shall provide ample time for the subject to consider study participation and ask 
questions, if necessary; and
Must ensure that important new information is provided to new and existing study 
subjects throughout the conduct of the clinical study.
The ICF must always be signed and personally dated by the study subject or by his/her legal 
representative, and by the Investigator or an authorized designee responsible for conducting 
the informed consent process.  If a legal representative signs the ICF, then the study subject 
shall be asked to provide informed consent for continued participation as soon as his/her 
medical condition allows.  The original signed ICF will be retained by the investigational 
center and a copy of the signed and dated document and any other written information must 
be given to the person signing the form.  
Failure to obtain study subject consent will be reported by BSC to the applicable regulatory 
body according to their requirements (e.g., FDA’s requirement is within 5 working days of 
learning of such an event).  Any violations of the informed consent process must be reported 
as study protocol deviations to the Sponsor and to local regulatory authorities (e.g., IRB/EC),
as appropriate. 
If new information becomes available that can significantly affect a study subject's future 
health and medical care, that information shall be provided to the affected subject(s) in 
written form via a revised ICF or, in some situations, enrolled study subjects may be 
requested to sign and date an addendum to the ICF.  In addition to new significant 
information during the course of a study, other situations may necessitate revision of the ICF, 
such as if there are amendments to the protocol, a change in Principal Investigator, 
administrative changes and/or following annual review by the IRB/EC.  The new version of 
the ICF must be approved by the IRB/EC.  Boston Scientific approval is required if changes 
to the revised ICF are requested by the center’s IRB/EC. The IRB/EC will determine the 
study subject population to be re-consented.

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20.5. Reporting to Regulatory Authorities / IRBs / ECs / Investigators
BSC is responsible for reporting adverse event information to all participating Investigators 
and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC and regulatory authorities 
of USADE and SAE as required by local/regional regulations.
21. Committees
21.1. BSC Global Safety Office – Safety Monitoring Program
In order to promote early detection of safety issues, the Boston Scientific Safety Trial 
Operations staff will provide evaluations of study safety events. Success of this program 
requires dynamic collection of unmonitored data as soon as an event is reported.  This
process is expedited through BSC’s Global Safety Office which is responsible for 
coordinating the collection of information for the subject dossier from the investigational 
centers and core laboratories.  During regularly scheduled monitoring visits, clinical research 
monitors will support the dynamic reporting process through their review of source document 
information.
21.2. Clinical Events Committee
A Clinical Events Committee (CEC) is an independent group of individuals with pertinent 
expertise that reviews and adjudicates study endpoints and relevant adverse events reported 
by study Investigators. The CEC will review a safety event dossier, which may include 
copies of subject source documents provided by study sites, for all reported cases of serious 
adverse events, serious adverse device events and the death of a study subject. 
Committee membership will include practitioners with professional expertise in cardiology 
or electrophysiology who are engaged in device system implantation as well as other experts 
with the necessary therapeutic and subject matter expertise to adjudicate the event categories 
mentioned above.  CEC responsibilities, qualifications, membership and committee 
procedures are outlined in the CEC charter.  The CEC ensures consistency of adverse event 
classification thereby providing enhanced compliance with accepted classification and 
accuracy.
22. Study Termination and Center/Site Suspension
22.1. Premature Termination of the Study
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of study subjects.  Investigators, associated IRBs/ECs and regulatory 
authorities, as applicable, will be notified in writing in the event of the termination of the 
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22.2. Criteria for Premature Termination of the Study
Possible reasons for premature study termination include, but are not limited to, the 
following: 
The occurrence of unanticipated adverse device effects that present a significant 
or unreasonable risk to subjects enrolled in the study; 
An enrollment rate far below expectation that prejudices the conclusion of the 
study; or 
A decision on the part of Boston Scientific as study Sponsor to suspend or 
discontinue development of the device. 
22.3. Termination of Study Participation by the Investigator or 
Withdrawal of IRB/EC Approval
Any Investigator or an IRB/EC engaged with the LSS of 4-SITE Study may discontinue 
participation in the study or withdraw approval of the study, respectively, with suitable 
written notice to Boston Scientific. Investigators, associated IRBs/ECs and regulatory 
authorities, as applicable, will be notified in writing in the event of such an occurrence. 
22.4. Requirements for Documentation and Study Subject Follow-up
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating centers by Boston Scientific.
The IRB/EC and regulatory authorities, as applicable, will also be notified.  Detailed 
information on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB or EC terminates participation in the study, participating Investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by Boston Scientific. 
In the event an Investigator terminates participation in the study, study responsibility will be 
transferred to a co-investigator, if possible.  In the event there are no opportunities to transfer 
investigator responsibility; detailed information on how enrolled subjects will be managed 
thereafter will be provided by Boston Scientific. 
The Investigator must return all documents and investigational product to Boston Scientific, 
unless this action would jeopardize the rights, safety, or welfare of the study subjects.
22.5. Criteria for Suspending/Terminating a Study Center
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
center/investigational site at any time after the study initiation visit if no subjects have been 
enrolled for a period beyond six (6) months, or if the center has multiple or severe protocol 
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In the event of termination of Investigator participation, all study devices and testing 
equipment, as applicable, will be returned to BSC unless this action would jeopardize the 
rights, safety or well-being of the study subjects.  The IRB/EC and regulatory authorities, as 
applicable, should be notified.  All subjects enrolled in the study at the center will continue to 
be followed for the full five (5) year post implant follow-up, if possible.  The Principal 
Investigator at the center/site must make provision for these follow-up visits unless BSC
notifies the investigational center/site otherwise. 
23. Publication Policy
In accordance with the Corporate Policy on the Conduct of Human Subject Research, BSC 
requires disclosure of its involvement as a Sponsor or financial supporter in any publication 
or presentation relating to a BSC study or its results. In accordance with the Corporate 
Policy for the Conduct of Human Subject Research, BSC will submit study results for 
publication (regardless of study outcome) following the conclusion or termination of the 
study.  Boston Scientific Corporation adheres to the Contributor-ship Criteria set forth in the 
Uniform Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org).  In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and Investigators regarding publication preparation provided the following 
guidelines are adhered to: 
All authorship and contributor-ship requirements as described above must be 
followed; 
BSC involvement in the publication preparation and the BSC Publication Policy 
should be discussed with the Coordinating Principal Investigator(s) and/or 
Executive Study Steering Committee (if one is convened) at the onset of the 
project; and
The First and Senior authors are the primary drivers of decisions regarding 
manuscript content, review, approval and submission.  
24. Bibliography
1. Muhlbaier, L.H. “HIPAA - A Training Handbook for Researchers.”  Marblehead, 
MA:  Opus Communications, Inc; 2002. 
25. Protocol Abbreviations/Acronyms and Study Definitions 
25.1. Protocol Abbreviations/Acronyms
Abbreviations are shown in Table 25.1-1.  This table is in alphabetical order based on the 
letters of the abbreviation/acronym. 

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26.2. Glossary of Definitions  
Cardiac Perforation  – Penetration of the lead tip through the myocardium to the 
pericardium or beyond (including micro-perforation) or associated venous anatomy, either 
clinically suspected or confirmed by chest x-ray, fluoroscopy, echocardiogram, intra-cardiac 
electrogram and/or visually. 
Cardiac Tamponade - also known as pericardial tamponade, is an acute type of pericardial 
effusion in which fluid accumulates in the pericardium.  Cardiac tamponade will be 
considered as a serious adverse event if invasive intervention is required for treatment.
Conductor Fracture/Lead Fracture  –  A mechanical break within the lead conductor 
(includes connectors, coils and/or electrodes) observed visually, electrically or 
radiographically.  . 
Elevated Pacing Thresholds  – At implant, pacing thresholds for the permanently 
programmed electrode that are greater than 3.0 volts and at follow-up pacing thresholds for 
the permanently programmed electrode that are either: (1) An observed increase of 2-fold 
over the first chronic threshold; or (2) An observed threshold greater than 3.5 volts.  Please 
note that these elevations in pacing threshold values may be physiologic, pathologic or 
device-related.
Extracardiac Stimulation (e.g., phrenic, diaphragm) – Clinical observation of inadvertent 
muscle/nerve stimulation other than cardiac muscle.
Hematoma – if a hematoma requires invasive intervention to evacuate the hematoma, it will 
be considered a serious adverse event.
High Pacing Impedance – Pacing impedance is considered abnormal based on lead model 
and measurement range of the device..
High Shock Impedance – Shock impedance is considered abnormal based on lead model 
and measurement range of the device. . 
High Shock Impedance when attempting to deliver a shock  – High shock impedance is 
considered abnormal based on lead model and measurement range of the device when 
attempting to deliver a shock. 
Inappropriate shock due to over-sensing  –  Shock delivered due to over-sensing resulting 
from either physiologic or non-physiologic causes. 
Inappropriate shock – shock delivered by the device which is  not appropriate 
therapy/treatment per the device programming.

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Infection – If oral/topical antibiotics are prescribed for treatment of an infection, it will be 
considered as an adverse event.  If Intravenous (IV) antibiotics are required for treatment of 
the infection (with associated increase in white blood cells), then it will be considered a 
serious adverse event.
Intermittent Sensing – Intermittent loss of sensing or failure to detect intended intrinsic 
cardiac signals (atrial or ventricular) during non-refractory periods at programmed sensitivity 
settings.
Lead Abrasion – Upon returned product analysis, leads are analyzed for abrasion.  Known 
examples of lead abrasion occur 1) proximal abrasions associated with lead-on-lead or lead-
on-PG contact in the pocket; 2) mid-lead insulation damage caused by clavicle flex-fatigue or  
crush, suture or suture sleeve, insulation wear in the area of vein insertion and 3) distal region 
wear due to lead-on-lead (intracardiac), lead-on-heart valve or lead-on-another anatomy 
contact 
Lead Insulation Breach – A disruption or break in lead insulation observed visually, 
electrically or radiographically.
Lead Migration/Dislodgment – Radiographic and electrical evidence of electrode 
displacement from the original implant site or electrode displacement that adversely affects 
pacing and/or lead performance.
Micro-dislodgement is not included. 
Loss-of-Capture – Intermittent or complete failure to stimulate cardiac stimulation (atrial or 
ventricular) at programmed output delivered outside of the cardiac refractory period.  .
Low Pacing Impedance – Pacing impedance is considered abnormal based on lead model 
and measurement range of the device. 
Low Shock Impedance   –   Shock impedance is considered abnormal based on lead model 
and measurement range of the device. 
Low shock impedance when attempting to deliver a shock  –  Low shock impedance is 
considered abnormal based on lead model and measurement range of the device) when 
attempting to deliver a shock.
    
 
Normal Battery Depletion  - For pulse generators, the condition when a) a device is 
returned with no associated complaint and the device has reached its elective replacement 
indicator (s)  with implant time that meets or exceeds the nominal (50 percentile)  predicted 
longevity at default (labeled) settings, or b) the device is returned and the device has reached 
it elective replacement indicator(s)  with implant time exceeding 75% of the expected 
longevity using the longevity calculation tool available at the time of product introduction, 
calculated using  the device’s actual use conditions and settings.

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Other, Lead related – Specific proprietary attributes of a lead, such as sensors which affect 
a leads ability to perform as designed and remain in service.
Other, Pulse Generator/Header related – Specific proprietary attributes of a pulse 
generator/header, which affect a device’s ability to perform as designed and remain in service.
Oversensing– The occurrence of cardiac or non-cardiac events being misinterpreted as 
cardiac depolarization, (e.g., T waves, multiple counting, skeletal muscle potentials and 
extra-cardiac electromagnetic interference (EMI)).
Pacing Impedance Changes – Pacing impedance changes are considered clinically 
significant if the value changes by more than a 2:1 ratio from the previous value. 
Pain - Pain requiring oral medications is not considered serious.  Pain requiring Intravenous 
analgesics or results in prolonged hospitalization will be considered a complication.
Pneumothorax - Is a collection of air or gas in the pleural space of the lung, causing the lung 
to collapse.  It will be considered a serious adverse event if invasive intervention is needed 
for treatment.
Possible Malfunction - May be considered if neither of the two listed below occurred. 
a) Malfunction with compromised therapy, PG – The condition when a device is 
found to have “malfunctioned” in a manner that compromised pacing or 
defibrillation therapy (including complete loss or partial degradation) while 
implanted and in service.  Therapy is considered to have been compromised if no 
therapy is available or critical patient protective pacing or defibrillation therapy is 
not available
b) Malfunction without compromised therapy, PG - The condition when a device 
is found to have “malfunctioned” in a manner that did not compromise pacing or 
defibrillation therapy while implanted and in service.  Therapy is not 
compromised as long as critical patient protective pacing or defibrillation 
therapies are available.  Changes in device setting that occur as intended by 
design (i.e. Power-on-reset (POR)) that do not result in loss of critical patient 
protective therapies but are reported as reasons for explant, shall be classified as 
malfunctions without compromised therapy.
Shock Impedance Changes – Shock impedance changes are considered clinically 
significant if the value changes by more than a 2:1 ratio from the previous value. 
Significant r-wave amplitude decrease over 2 weeks or less – A decrease in r-wave value 
is considered clinically significant if the value changes by more than a 2:1 ratio over the 
course of two (2) weeks or less.

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Suspected Lead Fracture – May be manifested by abnormal device measurements (i.e. RV
lead impedance, thresholds, inappropriate shocks) which may be caused as a result of 
conductor/lead fracture.  Investigator are requested to complete a through lead assessment (as 
defined in section 13.4); confirm through visual, radiographic and electrical analysis,  and are 
strongly recommended to return the lead to for analysis.  
Suspected Lead Abrasion – May be manifested by abnormal device measurements (i.e. RV 
lead impedance, thresholds) which may be as a result of unknown lead abrasion type (which 
are not already defined above).  Investigators are requested to complete a through lead 
assessment (as defined in section 13.4); and strongly recommended to return the lead to for 
analysis.
Twiddler’s Syndrome - A well-known complication of pacemaker treatment, it involves a 
patient manipulating and rotating the pulse generator in the pocket so many turns that it 
results in lead dislodgment, diaphragmatic stimulation and/or loss of capture.
Undersensing – Complete or intermittent loss of sensing or failure to detect the intended 
intrinsic cardiac signals (atrial or ventricular) during non-refractory periods at programmed 
sensitivity. 
________________________
Definition based on AdvaMed’s May 2009 Industry Guidance for Uniform Reporting of 
Clinical Performance of Cardiac Rhythm Management Pulse Generators and Leads.