Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
Phase: NA
Conditions: Tachycardia, Ventricular, Arrhythmia, Ventricular
Sponsor: Boston Scientific Corporation

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   MODULAR ATP, 92272548, Version I 
Page 1 of 148 
 
MODULAR ATP Clinical Study 
Effectiveness of the EMPOWER™ Modular Pacing System and 
EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing 
 
C1907 
CLINICAL INVESTIGATION PLAN 
 
MODULAR ATP IDE#: G200319 
NCT#: NCT04798768 
Sponsored By 
 
Boston Scientific Corporation 
4100 Hamline Avenue North 
St. Paul, MN 55112, USA 
And  
Boston Scientific International SA 
 
 
Le Val Saint-Quentin, 
2 rue René Caudron, 78960 
Voisins le Bretonneux, France 
And 
Guidant Europe NV  
Lambroekstraat 5D 
1831 Diegem, Belgium 
  
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 

          Confidential 
 
    
 
         MODULAR ATP, 92272548, Version I 
 
 
 
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Contact Information 
Role 
Contact  
Clinical Contact 
United States and Canada Contact: 
Julie West, MA 
Sr. Clinical Trial Manager 
Rhythm Management 
Boston Scientific Corporation 
St. Paul, MN 55112 
Tel: 651.261.5200 
julie.west@bsci.com 
 
Europe Contact:  
Ursula Appl 
Sr. Clinical Trial Manager 
Rhythm Management 
Boston Scientific Corporation 
Diegem, Belgium 
Tel: +32 (0) 477319218 
ursula.appl@bsci.com 
 
US and Canada Technical Services: 
Tel: 1.800.CARDIAC/ 1.800.227.3422 
Europe and United Kingdom Technical Services: 
Tel: +32 (2) 4167222 
Coordinating 
Principal Investigators 
US 
Europe 
Daniel Cantillon, MD, FACC, FHRS 
Cardiac Electrophysiology and 
Pacing 
Medical Director, Central 
Monitoring Unit 
Cleveland Clinic Foundation 
9500 Euclid Ave, Suite 122 
Cleveland, OH 44195 
CANTILD@ccf.org 
Reinoud Knops, MD, PhD 
Electrophysiologist, Academic 
Medical Centre 
Amsterdam University Medical 
Center 
r.e.knops@amsterdamumc.nl 
 +31 (2) 05669111 

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Vivek Y. Reddy, MD  
Professor of Medicine in Cardiac 
Electrophysiology 
Director of Cardiac Arrhythmia 
Services  
The Mount Sinai Hospital  
One Gustave L. Levy Place 
New York, NY 10029 
USA 
Prof. Lluís Mont, MD, PhD, 
FESC 
Associate Professor of Medicine  
Head of the Arrhythmia Section, 
Thorax Institute 
Department of Cardiology, 
Hospital Clínic, 
Villarroel 170 
Barcelona 08036, Catalonia  
Spain 
 
 
 

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Page 4 of 148 
  
 
Original Version: A, 26 June 2018 
Current Version:  I, 29 April 2022 
 
 
Revision History 
Revision 
Version 
Protocol 
Date 
Template 
number 
and version 
Protocol Section 
Modified 
Existing 
Text as 
Written in 
Protocol, 
Version  
Revised/N
ew Text as 
Written in 
Protocol, 
Version  
Justification 
for 
Modification 
I 
29 April 
2022 
90702637 
Ver AQ 
-Exclusion 
criterion related to 
femoral vein access 
updated to allow 
for other 
compatible 
introducer(s) 
-Added statement 
regarding remote 
case support 
Updates as 
applicable* 
 
Updates as 
applicable* 
 
-Allowance for 
use of other 
compatible 
introducer 
sheath(s) 
-Updated based 
on BSC internal 
requirements 
H 
21 
February 
2022 
90702637 
Ver AP 
Statement added 
regarding 
secondary endpoint 
multiplicity 
Updates as 
applicable* 
Updates as 
applicable* 
Request by 
FDA 
G** 
12 
January 
2022 
90702637 
Ver AP 
- Significance level 
for the Secondary 
Safety Endpoint 
sample size 
calculation from 
5% one sided to 
2.5% one sided 
- Safety Endpoint 1 
final analysis alpha 
level updated from 
1.3% to 1.9% 
Updates as 
applicable* 
 
Updates as 
applicable* 
 
Request by 
FDA; 
Correction of 
erroneous alpha 
level;  

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Page 5 of 148 
  
 
 
Revision History 
Revision 
Version 
Protocol 
Date 
Template 
number 
and version 
Protocol Section 
Modified 
Existing 
Text as 
Written in 
Protocol, 
Version  
Revised/N
ew Text as 
Written in 
Protocol, 
Version  
Justification 
for 
Modification 
- MEDDEV 2.7/3 
references to MDR 
2017/745  
F** 
1 
November 
2021 
90702637 
Ver AM 
-Removal of Study 
phases 
-Addition of 
Secondary Safety 
Endpoint 
-small 
clarifications 
Updates as 
applicable* 
Updates as 
applicable* 
Center for 
Medicare 
Services (CMS) 
Requirements; 
small changes 
for clarity 
E 
16 March 
2021 
90702637 
Ver AM 
N/A 
N/A 
Addition of 
NCT#; 
small fixes 
for clarity 
Release for 
study use 
D 
20 
January 
2021 
90702637 
Ver AM 
N/A 
N/A 
N/A 
Updates made 
in response to 
FDA feedback 
C 
26 
October 
2020 
90702637 
Ver AM 
N/A 
N/A 
N/A 
Version 
submitted in 
IDE to FDA 
B.1 
25 July 
2020 
90702637 
Ver AJ 
N/A 
N/A 
N/A 
BSC internal 
development 
A 
26 June 
2018 
90702637 
Ver AJ 
N/A 
N/A 
N/A 
 BSC internal 
development 
* 
Details of changes made since the first released version of the protocol (Version E), are included in 
Appendix H.  
** Note: Version F and Version G were not released for study use.  

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2 Protocol Synopsis 
MODULAR ATP Clinical Study 
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous 
ICD to Communicate Antitachycardia Pacing 
Study Objectives 
To demonstrate the safety, performance and effectiveness of the 
EMPOWER™ Modular Pacing System (MPS), as well as the EMPOWER and 
EMBLEM™ Subcutaneous ICD Coordinated System. Additionally, data 
from this study may be used to support pre-market and post-market 
approval requirements for the EMPOWER MPS. 
Planned 
Indication(s) for 
Use  
The mCRM Modular Therapy System is intended to provide: 
• 
Defibrillation (tachyarrhythmia) therapy from the S-ICD, which is used 
to treat rhythms associated with sudden cardiac death (SCD), such as 
VT and VF 
• 
Anti-tachycardia pacing (ATP) therapy, commanded from the S-ICD 
and provided from the EMPOWER System for the treatment of MVT 
• 
Anti-bradycardia pacing from the EMPOWER System to detect and 
treat bradyarrhythmias and to provide pacing support after 
defibrillation therapy 
Test Device  
The implantable portion of the investigational system comprises three 
component devices that are collectively referred to as the mCRM Modular 
Therapy System. The three component devices of the mCRM Modular 
Therapy System are: 
• 
(EMBLEM/ EMBLEM MRI) S-ICD Pulse Generator, Models A209/A219 
or future BSC S-ICD, with mCRM clinical firmware,  
• 
(EMBLEM) S-ICD Electrode, Model 3400/ 3401, Model 3501 or future 
BSC S-ICD Electrode  
• 
EMPOWER MPS Pulse Generator and Delivery Catheter, Model B170 
Study Design 
A prospective, non-randomized, multi-site study, single-arm, global study 
utilizing performance goals to demonstrate safety, performance, and 
effectiveness of the EMPOWER System and mCRM Modular Therapy 
System.  
Planned Number 
of Subjects 
Enrollment of up to 300 patients at up to 60 sites will be allowed to 
ensure all necessary data are collected to support pre-market applications 
of EMPOWER MPS and the mCRM Modular Therapy System for the US, 
Canada, the United Kingdom, and Europe.  

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MODULAR ATP Clinical Study 
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous 
ICD to Communicate Antitachycardia Pacing 
Planned Number 
of Investigational 
Sites/ Countries 
Up to 60 sites in North America, the United Kingdom, and Europe. 
Safety Endpoint 1 Major EMPOWER MPS System- and Procedure-related Complication-Free 
Rate from Implant through 6 Months Post-Implant 
Safety Endpoint 2 Major EMPOWER MPS System- and Procedure-related Complication-Free 
Rate from Implant through 12 Months Post-Implant 
Secondary Safety 
Endpoint 
All-Cause Survival from Implant through 2 Years Post-Implant 
Primary 
Effectiveness 
Endpoint 1 
Communication Success between the S-ICD and EMPOWER PG at the 6 
Month Visit 
Primary 
Effectiveness 
Endpoint 2 
Proportion of subjects with adequate Pacing Capture Threshold (PCT) 
(defined as ≤ 2 V@0.4 ms) at the 6 Month Visit 
Secondary 
Effectiveness 
Endpoint 1 
Mean Metabolic-Chronotropic Relation (MCR) slope from the Kay-Wilkoff 
model at the 3 Month Visit 
Additional 
Objectives 
• 
Summary of the mCRM Therapy System implant procedure 
characteristics: 
o Initial implant success rate of the EMPOWER PG  
o Initial implant success rate of the S-ICD (de novo Implants) 
• 
Summary of pacing impedance and sensing amplitude at protocol-
required follow ups 
• 
Summary of ventricular tachycardia (VT)/ ventricular fibrillation (VF) 
conversion and sensing interaction testing  
• 
Summary of Communication Threshold Test at Implant, Pre-
Discharge, 1-Month Visit and available Semi-Annual visits 
• 
Summary of incidence and threshold for Communication Muscle 
Stimulation at Implant 

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MODULAR ATP Clinical Study 
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous 
ICD to Communicate Antitachycardia Pacing 
• 
Summary of EMPOWER PG Pacing Capture Thresholds (PCT) at 
protocol-required follow ups 
• 
Summary of spontaneous treated VT/VF episodes 
• 
Incidence of syncope related to treated and untreated spontaneous 
episodes of VT/VF above the lowest programmed rate cutoff 
• 
Incidence and appropriateness of post-shock demand pacing by the 
EMPOWER PG  
• 
Summary of Inappropriate Therapy 
• 
Summary of Major EMPOWER MPS System- and Procedure-related 
Complications through both 6 and 12 months after the implant 
procedure 
• 
Summary of mCRM Therapy System-related complications through 
both 6 and 12 months after the implant procedure* 
• 
Summary of EMPOWER PG performance from Holter Monitor 
recording 
• 
Summary of EMPOWER PG battery charge remaining to End of 
Service (EOS) at protocol-required follow ups 
• 
Summary of S-ICD PG remaining battery to Elective Replacement 
Indicator (ERI) per protocol-required follow ups (baseline adjusted to 
time of enrollment for S-ICD PGs implanted prior to enrollment in 
MODULAR ATP) 
*S-ICD PG replacement due to normal battery depletion will not be 
included in this analysis 
Follow-up 
Schedule 
Follow up will be required at the following time points: 
• 
Pre-Discharge,  
• 
1 month,  
• 
3 months (for subjects participating in the Rate Response Substudy 
only),  
• 
6 months,  
• 
12 months,  
• 
18 months, and  
• 
24 months after the mCRM Coordinated System is implanted.  
Subjects will continue to be followed every 6 months until the 
Coordinated System receives Health Canada and FDA pre-market 
approval, and CE Mark has been granted, all subjects have been followed 
for at least 24 months, and BSC communicates study closure. 

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MODULAR ATP Clinical Study 
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous 
ICD to Communicate Antitachycardia Pacing 
Evaluation of communication between S-ICD and EMPOWER will be 
required at Implant, Pre-Discharge, and all protocol-required follow-ups 
post mCRM Coordinated System implant, including any Additional Visits 
due to adverse events related to communication of the Coordinated 
System. Communication testing requires an in-clinic visit.  
Study Duration 
The MODULAR ATP Clinical Study is expected to start in Q4 2021 and last 
for approximately 5 years. 
Inclusion Criteria 
• 
Patient who meets Class I, IIa, or IIb guideline ICD indications1,2, or 
who has an existing TV-ICD* or S-ICD** 
• 
Patient who is deemed to be at risk for MVT based on at least ONE of 
the following: 
o History of Non-Sustained MVT with LVEF ≤ 50% 
o History of sustained VT/VF (secondary prevention) with LVEF 
≤ 50% or significant cardiac scar***  
o History of syncope deemed to be arrhythmic in origin 
o History of ischemic cardiomyopathy with LVEF ≤35% 
o History of non-ischemic cardiomyopathy with LVEF ≤35% and 
significant scar*** 
• 
Patient is willing and capable of providing informed consent (which is 
not to include the use of a legally authorized representative (LAR) for 
documentation of informed consent) and participating in all testing 
associated with this investigation at an approved study site and at the 
intervals defined by this protocol 
• 
Patient is age 18 years or above, or of legal age to give informed 
consent specific to state and national law  
 
1 Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular 
Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of 
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm 
Society. Circulation. (2018); 138:e272-e391. 
2 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of 
sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and 
the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart 
Journal (2015) 36, 2793–2867. 

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MODULAR ATP Clinical Study 
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous 
ICD to Communicate Antitachycardia Pacing 
*TV-ICD system is expected to be fully explanted during or prior to full Coordinated 
System implant   
**Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for 
MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD 
Pulse Generator 
**Patients with an existing S-ICD PG subject to the electrical overstress field action are 
only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219, or 
future BSC S-ICD Pulse Generator 
***Significant cardiac scar is defined as a scar involving at least one ventricular myocardial 
segment (i.e., basal infero-septum) as identified in the official findings of a cMRI, or 
nuclear viability study, or echo report by the interpreting radiologist/ cardiologist who is 
not affiliated with the study 
Exclusion Criteria • 
Patient with an ongoing complication due to Cardiac Implantable 
Electronic Device (CIED) infection or CIED explant 
• 
Transvenous lead remnants within the heart from a previously 
implanted CIED (Note: transvenous lead remnants outside the heart 
(e.g., in the SVC) are allowed) 
• 
Patient with a known LA thrombus 
• 
Patient with a ventricular arrhythmia due to a reversible cause 
• 
Patient indicated for implantation of a dual chamber pacemaker or 
cardiac resynchronization therapy (CRT) 
• 
Patient with another implanted medical device that could interfere 
with implant of the leadless pacemaker, such as an implanted inferior 
vena cava filter or mechanical tricuspid heart valve 
• 
Patient requires rate-responsive pacing therapy 
• 
Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 
30 bpm) 
• 
Patient with Acute Coronary Syndrome (i.e. Acute Myocardial 
Infarction, Unstable Angina) within 40 days 
• 
Inability to access femoral vein with a 21-French or larger inner 
diameter introducer sheath due to known anatomy condition, recent 
surgery, and/ or other relevant condition  
• 
Patient who has an active implanted electronic medical device 
intended for chronic use concomitantly with the study system, such 
as a left ventricular assist device (LVAD). Note that a temporary 
pacing wire is allowed. 
• 
Patient with known or suspected sensitivity to Dexamethasone 
Acetate (DXA) 
• 
Patient with a known cardiovascular anatomy that precludes implant 
in the right ventricle 
• 
Patient with a known allergy to any system components 

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MODULAR ATP Clinical Study 
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous 
ICD to Communicate Antitachycardia Pacing 
• 
Patient with a known or suspected intolerance to S-ICD conversion 
testing, based on physician discretion 
• 
Patient is not likely to have meaningful survival1 for at least 12 
months (documented or per investigator’s discretion) 
• 
Patient is enrolled in any other concurrent study. Co-enrollment into 
other studies such as observational studies/registries needs prior 
written approval by BSC. Local mandatory governmental registries are 
accepted for co-enrollment without approval by BSC 
• 
Patient who is a woman of childbearing potential who is known to be 
pregnant at the time of study enrollment (method of assessment 
upon investigator’s discretion) 
1 meaningful survival means that a patient has a reasonable quality of life and functional 
status. 
 
 

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Statistical Methods  
 
 
Assessment 
Expected Value 
Performance Goal 
Statistical Test 
 
Alpha Level 
Power Level 
Number of Subjects  
Assumed Attrition 
Number of Subjects 
with Assumed Attrition 
Safety 1 
Major 
EMPOWER 
MPS System- 
and Procedure-
related 
Complication-
Free Rate from 
Implant through 
6 Months Post-
Implant 
93% 
86% 
Kaplan-
Meier 
2.5% 
(Overall) 
1.2% 
(Interim) 
1.9% 
(Final) 
90% 
134 
(Interim) 
223 
(Final) 
25% 
179 
(Interim) 
298 
(Final) 
Safety 2 
Major 
EMPOWER 
System and 
Procedure-
related 
Complication-
free Rate from 
Implant through 
12 Months 
Post-Implant 
92% 
81% 
Kaplan-
Meier 
2.5% 
90% 
112 
30% 
160 
Primary 
Effectiveness 1 
Communication 
Success 
between the S-
ICD and 
EMPOWER 
PG at 6 Month 
Visit 
95%  
88% 
One-Sided 
Lower 
Pointwise 
Confidence 
Limit 
2.5% 
80% 
152 
tests/ 38 
subjects 
30% 
220 
tests/55 
subjects 
Primary 
Effectiveness 2 
The percent of 
subjects with 
an adequate 
EMPOWER 
pacemaker 
PCT 
measurement. 
95%  
80% 
One-Sided 
Lower 
Confidence 
Limit 
2.5% 
90% 
57 
30% 
82 
 
 
 

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3 Table of Contents 
1. 
TITLE PAGE  ................................................................................................................. 1 
2 
PROTOCOL SYNOPSIS ................................................................................................... 6 
3 
TABLE OF CONTENTS ................................................................................................. 13 
4 
INTRODUCTION........................................................................................................... 21 
4.1 
Background ...................................................................................................... 21 
5 
DEVICE DESCRIPTION ................................................................................................ 24 
5.1 
mCRM Coordinated System .......................................................................... 24 
5.2 
Implantable Study Devices ............................................................................. 24 
5.3 
Non-Implantable Study Devices..................................................................... 24 
5.3.1 
Non-Implantable Study Devices Associated with the EMPOWER 
System ................................................................................................. 24 
5.3.2 
Model 3870 Programmer Software Application and Associated 
Firmware ............................................................................................. 25 
5.3.3 
Non-implantable Study Devices Associated with the S-ICD System 26 
5.4 
Accessories ....................................................................................................... 26 
5.5 
Additional Equipment .................................................................................... 27 
6 
STUDY OBJECTIVES AND ENDPOINTS ........................................................................ 27 
6.1 
Study Objectives .............................................................................................. 28 
6.2 
Study Endpoints .............................................................................................. 28 
6.3 
Safety Endpoints.............................................................................................. 28 
6.4 
Effectiveness Endpoints .................................................................................. 28 
6.5 
Ancillary Objectives ........................................................................................ 29 
6.6 
Study Rationale ............................................................................................... 29 
7 
STUDY DESIGN ........................................................................................................... 30 
7.1 
Scale and Duration .......................................................................................... 31 
7.2 
Justification for the Study Design .................................................................. 32 
8 
SUBJECT SELECTION .................................................................................................. 33 
8.1 
Study Population and Eligibility .................................................................... 33 
8.2 
Inclusion Criteria ............................................................................................ 34 
8.3 
Exclusion Criteria ........................................................................................... 35 

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9 
SUBJECT ACCOUNTABILITY ....................................................................................... 36 
9.1 
Point of Enrollment ......................................................................................... 36 
9.2 
Subject Status and Classification ................................................................... 36 
9.2.1 
Intent ................................................................................................... 36 
9.2.2 
Attempt ............................................................................................... 36 
9.2.3 
Partial Implant .................................................................................... 36 
9.2.4 
Implant ................................................................................................ 37 
9.3 
Access to EMPOWER MPS Programmer Software and S-ICD System 
mCRM Programming ..................................................................................... 37 
9.4 
Strategies for Recruitment and Retention .................................................... 37 
9.5 
Withdrawal ...................................................................................................... 38 
9.6 
Lost-to-Follow-up ............................................................................................ 39 
9.7 
End-of-Study Definition.................................................................................. 39 
9.8 
End of Study Action Plan ............................................................................... 39 
10 STUDY METHODS ....................................................................................................... 40 
10.1 Data Collection ................................................................................................ 40 
10.2 Enrollment Visit .............................................................................................. 42 
10.2.1 
Informed Consent ............................................................................... 42 
10.2.2 
Enrollment Data .................................................................................. 42 
10.2.3 
Enrollment Visit Source Documentation Requirements ..................... 43 
10.3 Implant ............................................................................................................. 44 
10.3.1 
Implant of the EMPOWER PG ........................................................... 44 
10.3.2 
Implant of the S-ICD .......................................................................... 48 
10.3.3 
S-ICD Firmware Update ..................................................................... 50 
10.3.4 
mCRM Coordinated System Imaging and Testing ............................. 51 
10.3.5 
S-ICD Evaluation ................................................................................ 56 
10.3.6 
S-ICD System Programming Considerations ..................................... 56 
10.3.7 
mCRM Coordinated System Data and Source Documentation 
Requirements ...................................................................................... 56 
10.4 Pre-Discharge Visit ......................................................................................... 57 
10.4.1 
EMPOWER PG Evaluation ................................................................ 58 
10.4.2 
S-ICD Evaluation ................................................................................ 58 
10.4.3 
mCRM Coordinated System Testing .................................................. 58 

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10.4.4 
mCRM Coordinated System Programming ........................................ 59 
10.4.5 
Pre-Discharge Source Documentation Requirements ........................ 61 
10.5 1 Month Visit: (10 days – 42 days post-Coordinated System Implant) ...... 62 
10.5.1 
EMPOWER PG Evaluation ................................................................ 62 
10.5.2 
S-ICD Evaluation ................................................................................ 63 
10.5.3 
mCRM Coordinated System Testing .................................................. 63 
10.5.4 
mCRM Coordinated System Programming ........................................ 64 
10.5.5 
Holter Substudy .................................................................................. 64 
10.5.6 
1 Month Visit Source Documentation Requirements ......................... 66 
10.6 Rate Response Substudy (3 Month Visit (90±15 Days Post-implant)) ....... 67 
10.6.1 
Paced Morphology Sensing Test (PMST) .......................................... 67 
10.6.2 
Rate Response Substudy Source Documentation Requirements ........ 67 
10.7 6 Month Visit (180 days ± 30 days Post-system Implant) ............................ 69 
10.7.1 
EMPOWER PG Evaluation ................................................................ 69 
10.7.2 
S-ICD Evaluation ................................................................................ 69 
10.7.3 
mCRM Coordinated System Testing .................................................. 69 
10.7.4 
mCRM Coordinated System Programming ........................................ 70 
10.7.5 
6 Month Visit Source Documentation Requirements ......................... 70 
10.8 Semi-Annual Visits .......................................................................................... 71 
10.8.1 
EMPOWER PG Evaluation ................................................................ 72 
10.8.2 
S-ICD Evaluation ................................................................................ 72 
10.8.3 
Communication Test in One Posture .................................................. 72 
10.8.4 
mCRM Coordinated System Programming ........................................ 73 
10.8.5 
Semi-Annual Visit Source Documentation Requirements ................. 73 
10.9 Additional Visits .............................................................................................. 74 
10.9.1 
EMPOWER PG Evaluation ................................................................ 74 
10.9.2 
S-ICD Evaluation ................................................................................ 75 
10.9.3 
Additional Visit Source Documentation Requirements ..................... 75 
10.10 Medically Necessary MRI Scans .................................................................... 76 
10.10.1 Medically Necessary MRI Scan Source Documentation Requirements
 ............................................................................................................ 77 
10.11 LATITUDE Monitoring ................................................................................. 78 
10.12 Revisions, Replacements and Explants ......................................................... 79 

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10.12.1 EMPOWER PG Evaluation ................................................................ 79 
10.12.2 S-ICD Evaluation ................................................................................ 79 
10.12.3 mCRM Coordinated System Programming ........................................ 80 
10.12.4 Revisions, Replacements, and Explants Data and Source 
Documentation Requirements ............................................................ 80 
10.13 Study Completion ............................................................................................ 80 
10.14 Source Documents ........................................................................................... 81 
11 STATISTICAL CONSIDERATIONS ................................................................................ 81 
11.1 MODULAR ATP Clinical Study Endpoints ................................................. 81 
11.1.1 
Safety Endpoint 1: Major EMPOWER MPS System- and Procedure-
related Complication-Free Rate from Implant through 6 Months Post-
Implant ................................................................................................ 81 
11.1.2 
Safety Endpoint 2:  Major EMPOWER MPS System- and Procedure-
related Complication-free Rate from Implant through 12 Months Post-
Implant ................................................................................................ 83 
11.1.3 
Secondary Safety Endpoint: All-Cause Survival from Implant through 
2 Years Post-Implant .......................................................................... 85 
11.1.4 
Primary Effectiveness Endpoint 1: Communication Success between 
the S-ICD and EMPOWER PG at the 6 Month Visit ......................... 86 
11.1.5 
Primary Effectiveness Endpoint 2:  Proportion of Subjects with 
Adequate PCT at the 6 Month Visit ................................................... 88 
11.1.6 
Secondary Effectiveness Endpoint:  Mean Metabolic-Chronotropic 
Relation (MCR) Slope from the Kay-Wilkoff Model at the 3 Month 
Visit ..................................................................................................... 89 
11.2 Ancillary Objectives ........................................................................................ 90 
11.3 PMA Submission Cadence ............................................................................. 91 
11.4 Sample Size Summary .................................................................................... 91 
11.5 General Statistical Methods ........................................................................... 92 
11.5.1 
Study Success Criteria and Control of Type I Error ........................... 92 
11.5.2 
Control of Systematic Error/Bias ........................................................ 92 
11.6 Data Analyses .................................................................................................. 92 
11.6.1 
Interim Analyses ................................................................................. 92 
11.6.2 
Subgroup Analyses ............................................................................. 93 
11.6.3 
Pooling Analyses ................................................................................ 93 
11.6.4 
Multivariable Analyses ....................................................................... 94 

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11.7 Changes to Planned Analyses ......................................................................... 94 
12 HEALTH ECONOMICS OUTCOMES ............................................................................. 94 
13 DATA MANAGEMENT ................................................................................................. 94 
13.1 Data Collection, Processing, and Review ...................................................... 94 
13.2 Data Retention ................................................................................................. 95 
13.3 Technical Source Forms ................................................................................. 95 
13.4 Core Laboratory .............................................................................................. 95 
14 DEVIATIONS................................................................................................................ 95 
15 DEVICE ACCOUNTABILITY ........................................................................................ 96 
16 COMPLIANCE .............................................................................................................. 96 
16.1 Statement of Compliance ................................................................................ 96 
16.2 Investigator Responsibilities .......................................................................... 96 
16.3 Delegation of Responsibility ........................................................................... 98 
16.4 Institutional Review Board/ Ethics Committee/ Research Ethics Board ... 98 
16.5 Sponsor Responsibilities ................................................................................. 99 
16.6 Role of Boston Scientific Representatives ..................................................... 99 
16.7 Insurance ........................................................................................................ 100 
17 MONITORING ............................................................................................................ 100 
18 POTENTIAL RISKS AND BENEFITS ........................................................................... 101 
18.1 Risks Associated with the EMPOWER MPS ............................................. 101 
18.2 Risks Associated with the mCRM Coordinated System ............................ 103 
18.3 Risks Associated with MRI Scans ................................................................ 104 
18.3.1 
mCRM System Conditions of Use MET .......................................... 104 
18.3.2 
mCRM System Conditions of Use NOT MET ................................. 104 
18.3.3 
EMPOWER-only Conditions of Use MET ...................................... 105 
18.3.4 
EMPOWER-only Conditions of Use NOT MET ............................. 105 
18.4 Risks Associated with Retrieval of the EMPOWER PG ........................... 105 
18.5 Other Risks Associated with Participation in the Clinical Study ............. 107 
18.6 Risk Minimization Actions ........................................................................... 107 
18.7 Anticipated Benefits ...................................................................................... 108 

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18.8 Risk to Benefit Rationale .............................................................................. 108 
19 SAFETY REPORTING ................................................................................................. 109 
19.1 Reportable Events by Study Sites to Boston Scientific .............................. 109 
19.2 Reportable Adverse Events for this Study .................................................. 109 
19.3 Reportable Device Deficiencies .................................................................... 110 
19.4 Subject Death Reporting .............................................................................. 110 
19.5 Investigator Reporting Requirements ......................................................... 111 
19.6 Sponsor and CEC Definitions and Classification ....................................... 114 
20 INFORMED CONSENT ................................................................................................ 114 
21 COMMITTEES ........................................................................................................... 116 
21.1 Data Monitoring Committee ........................................................................ 116 
21.2 Clinical Events Committee ........................................................................... 116 
22 SUSPENSION OR TERMINATION................................................................................ 116 
22.1 Premature Termination of the Study .......................................................... 116 
22.2 Criteria for Premature Termination of the Study ..................................... 116 
22.3 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC/ REB Approval .............................................................................. 117 
22.4 Requirements for Documentation and Subject Follow-up ........................ 117 
22.5 Criteria for Suspending/ Terminating a Study Site ................................... 117 
23 STUDY REGISTRATION AND RESULTS ..................................................................... 117 
23.1 Study Registration ......................................................................................... 117 
23.2 Clinical Investigation Report ....................................................................... 118 
23.3 Publication Policy .......................................................................................... 118 
24 REIMBURSEMENT AND COMPENSATION FOR SUBJECTS ......................................... 118 
24.1 Subject Reimbursement ................................................................................ 118 
24.2 Compensation for Subject’s Health Injury................................................. 118 
25 ABBREVIATIONS AND DEFINITIONS ......................................................................... 119 
25.1 Abbreviations................................................................................................. 119 
25.2 Definitions ...................................................................................................... 121 
26 APPENDICES ............................................................................................................. 124 

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26.1 APPENDIX A: Detailed Implantable Device Descriptions ....................... 124 
26.1.1 
EMPOWER™ Modular Pacing System (MPS) ............................... 124 
26.1.2 
EMBLEM™ S-ICD and EMBLEM MRI S-ICD Pulse Generator .. 125 
26.1.3 
EMBLEM™ S-ICD Subcutaneous Electrode .................................. 125 
26.2 APPENDIX B: Detailed Non-implantable Device Descriptions ............... 126 
26.2.1 
EMPOWER MPS Delivery and Retrieval Accessories .................... 126 
26.2.2 
EMBLEM™ S-ICD Delivery Accessories ....................................... 129 
26.3 APPENDIX C: Communication Test S-ECG Report ................................ 130 
26.4 APPENDIX D: Paced Morphology Sensing Test Decision Tree ............... 131 
26.5 APPENDIX E: Conversion and Sensing Interaction Testing Decision Tree
 ......................................................................................................................... 132 
26.6 APPENDIX F: ISO 14155 Adverse Event Definitions ............................... 133 
26.7 APPENDIX G: Affect to Medicare Beneficiaries (US Only) .................... 138 
26.8 APPENDIX H: Protocol Revision History .................................................. 140 
Table of Figures 
Figure 7-1: MODULAR ATP Clinical Study Design ........................................................ 32 
Figure 10-1: Recommended Order of Postures for Four-Posture Communication 
Threshold Test ................................................................................................ 64 
Figure 10-2: Recommended Order of Postures for Four-Posture Communication Test ... 70 
Figure 11-1: PMA Submission Cadence for MODULAR ATP ........................................ 91 
Figure 26-1: EMPOWER PG ........................................................................................... 124 
Figure 26-2: EMPOWER Delivery Catheter ................................................................... 128 
Figure 26-3: Distal portion of the EMPOWER Delivery Catheter .................................. 128 
Figure 26-4: Retrieval System for the EMPOWER PG ................................................... 128 
Figure 26-5: Communication Test S-ECG Report ........................................................... 130 
 Table of Tables 
Table 6-1: Primary Objectives and Endpoints ................................................................... 27 
Table 6-2: Secondary Objectives and Endpoints ............................................................... 28 
Table 8-1: Inclusion Criteria .............................................................................................. 34 
Table 8-2: Exclusion Criteria ............................................................................................. 35 
Table 10-1: MODULAR ATP Clinical Study Data Collection Schedule ......................... 41 
Table 10-2: Enrollment Data and Source Documentation ................................................. 44 

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Table 10-3: Recommended Measures for Optimal EMPOWER PG Position ................... 46 
Table 10-4: EMPOWER MPS Implant Source Documentation ........................................ 48 
Table 10-5: S-ICD Implant Source Documentation .......................................................... 50 
Table 10-6: Communication Testing in the MODULAR ATP Clinical Study ................. 52 
Table 10-7: mCRM Coordinated System Implant Source Document Requirements ........ 57 
Table 10-8: EMPOWER PG Programming ....................................................................... 60 
Table 10-9: S-ICD Programming for Primary Prevention Subjects .................................. 60 
Table 10-10: S-ICD Programming for Secondary Prevention Subjects ............................ 61 
Table 10-11: Pre-Discharge Source Document Requirements .......................................... 62 
Table 10-12: 1 Month Visit Source Document Requirements ........................................... 66 
Table 10-13:  Rate Response Substudy Source Data ......................................................... 68 
Table 10-14: 6 Month Visit Data Collection Requirements .............................................. 71 
Table 10-15: Semi-Annual Visit Data Collection Requirements ...................................... 74 
Table 10-16: Additional Visit Data Collection Requirements ........................................... 76 
Table 10-17: Medically Necessary MRI Scan Visit Data Collection and Source 
Documentation Requirements ........................................................................ 78 
Table 10-18: Revisions, Replacements, and Explants Data and Source Documentation 
Requirements .................................................................................................. 80 
Table 19-1: Investigator Reporting Requirements ........................................................... 112 
Table 25-1: Abbreviations ............................................................................................... 119 
Table 25-2: Definitions .................................................................................................... 121 
Table 26-1: Recommended Introducer and Guidewire for EMPOWER PG Implant ..... 125 
Table 26-2: Study Device Status at Start of MODULAR ATP Clinical Study ............... 127 
Table 26-3: Safety Definitions ......................................................................................... 133 
Table 26-4: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event ............................................................................................................. 136 
Table 26-5: Changes Made to Protocol Version H to Create Version I .......................... 140 
Table 26-6: Changes Made to Protocol Version G (not released for study use) to Create 
Version H ...................................................................................................... 143 
Table 26-7: Changes Made to Protocol Version F (not released for study use) to Create 
Version G ...................................................................................................... 143 
Table 26-8: Changes Made to Protocol Version E to Create Version F (not released for 
study use) ...................................................................................................... 146 
 
 

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4 Introduction 
4.1 
Background 
Despite technological advances in pacing and defibrillation, the overwhelming majority 
of acute and chronic complications are related to incisional access for device pockets 
connected to indwelling transvenous leads. Over 600,000 patients implanted yearly 
worldwide are faced2 with adverse events due to the pulse generator (e.g., hematoma, skin 
erosion, pocket infections) or transvenous lead placement (e.g., pneumothorax, cardiac 
perforation, lead dislodgement)3. 
Advancements in electronic circuitry and battery technology enable manufacturers to 
develop pacemakers that can be completely implanted inside the right ventricle of the 
patient’s heart while keeping battery durability and longevity with communication to an 
entirely extravascular (subcutaneous) defibrillation system. 
The EMPOWER™ Modular Pacing System (EMPOWER MPS, comprised of the 
EMPOWER pacemaker and delivery catheter) and EMPOWER MPS accessories used for 
delivery and retrieval of the EMPOWER pacemaker build on Boston Scientific’s (BSC’s) 
decades of experience designing and manufacturing conventional transvenous 
pacemakers, as well as new key technologies within the rhythm management industry, 
such as circuit miniaturization, catheter technology, and new materials (e.g., innovative 
alloys). The EMPOWER pacemaker is placed directly into the right ventricle using a 
newly designed steerable, atraumatic delivery catheter system that enters the vasculature 
via the femoral vein. Leadless cardiac therapy eliminates the need for a transvenous 
pacing lead, as well as the subcutaneous pocket required for a conventional pulse 
generator; thereby, eliminating a larger proportion of complications common to 
transvenous pacemaker systems.  
The potential hazards and risks associated with the EMPOWER System throughout the 
product life cycle were identified by means of an exhaustive risk assessment. These risks 
were then compared to those of existing transvenous single-chamber pacemakers. The 
assessment and comparison identified many similarities between conventional 
transvenous single-chamber pacemakers and the EMPOWER pacemaker; however, the 
EMPOWER pacemaker decreases or eliminates several risks associated with transvenous 
pacemakers mainly due to the lack of a device pocket and/or use of a transvenous lead. 
While there are limited novel risks associated with the use of the EMPOWER System, the 
outcomes of the pre-clinical testing validate that the benefits of the EMPOWER System 
likely outweigh the possible risks. It is therefore considered safe and justified to continue 
evaluating the EMPOWER pacemaker by implanting it in human subjects. 
The subcutaneous implantable cardioverter defibrillator system (S-ICD System) was 
developed in part to address complications associated with traditional transvenous 
implantable cardioverter defibrillator (TV-ICD) leads. The nature of the transvenous 
system with the need for leads to be permanently dwelling in the venous circulation and 
cardiac chambers for very long term, increases the likelihood of certain types of lead 
failure like conductor fracture, insulation break and dislodgement that can compromise 
the system’s performance. Furthermore, when a system infection occurs, it usually 

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represents a severe complication and requires lead extraction with its own risks. Analyses 
of multiple large patient claims databases have evaluated transvenous device and lead 
complications.3,4,5 When TV-ICD leads are specifically considered, it is noted that the 
mechanical complication rate is 5% by 3 years post implant and continues to rise to 
23.9% for those patients who reach 10 years of follow-up7. Therefore, these 
complications have substantial implications for patient outcomes and health care system 
costs. According to an analysis of U.S. claims data6, these complications will affect 1 in 6 
patients by 3 years, which has substantial implications for patient outcomes and health 
care system costs.  
The S-ICD System does not require a lead to be placed either in (endocardium) or on 
(epicardium) the heart, which may be advantageous in reducing: 
• Implant-associated risks related to central venous access or endocardial lead 
positioning and fixation. 
• Exposure of the lead to stresses induced by repeated cardiac pulsations 
• Serious infections with a direct pathway to the blood stream and endocardium 
• Complications related to lead extraction 
Because the S-ICD System lacks a transvenous lead in the heart, it has no ability to 
provide bradycardia pacing or antitachycardia pacing (ATP). This limitation restricts the 
ICD-indicated patient population that can benefit from the S-ICD system. The approved 
indication for the S-ICD System reflects this restriction by specifically identifying S-ICD 
candidates as ICD-indicated patients who do not have symptomatic bradycardia, 
incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular 
tachycardia that is reliably terminated with anti-tachycardia pacing.6  
These restrictions limit the patients who receive an S-ICD based on their initial indication 
and the clinical likelihood of requiring the therapies not provided by this system in the 
future. However, some S-ICD candidates have or eventually develop symptomatic 
bradycardia or ventricular tachycardias that can be terminated with ATP. For S-ICD 
patients who develop bradycardia, published reports indicate that a concomitant 
 
3  Ranasinghe I, Parzynski CS, Freeman JV, et al. Long-Term Risk for Device-Related Complications and 
Reoperations After Implantable Cardioverter-Defibrillator Implantation: An Observational Study. Ann 
Intern Med. 2016 Jul 5; 165(1):20-29.  
4 Cantillon DJ, Exner DV, Badie N, et al. Complications and Health Care Costs Associated with 
Transvenous Cardiac Pacemakers in a Nationwide Assessment JACC: Clin Electrophysiology. 2017 Nov; 3 
(11) 1296-1305; DOI: 10.1016/j.jacep.2017.05.007 
5 Koneru JN, Jones PW, Hammill EF, et al. Risk Factors and Temporal Trends of Complications Associated 
With Transvenous Implantable Cardiac Defibrillator Leads. J Am Heart Assoc. 2018;7(10):e007691. 
Published 2018 May 10. 
6 EMBLEM S-ICD Pulse Generator Instructions for Use. 

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pacemaker may be implanted without adversely affecting the S-ICD function.7,8,9,10 
Unlike these S-ICD patients, those who need ATP do not currently have a concomitant 
device option as the implanted pacemaker and the S-ICD perform as individual systems 
and don’t communicate to one another. Options for patients who develop incessant or 
frequently recurring ventricular tachycardia (VT) include VT ablation or replacement of 
the S-ICD with a TV-ICD. 
The MODULAR ATP Clinical Study will evaluate another option for patients who may 
benefit from ATP: the investigational mCRM Modular Therapy System. The mCRM 
Modular Therapy System combines an S-ICD System with a specially designed leadless 
pacemaker (EMPOWER PG)) that can receive communication signals from the S-ICD 
System to provide ATP prior to (or as an alternative to) an S-ICD shock. The intended 
indication for the mCRM Modular Therapy System will be to provide defibrillation 
therapy and anti-tachycardia pacing (ATP) therapy for the treatment of life threatening 
ventricular tachyarrhythmias. The EMPOWER PG can also be programmed to provide 
bradycardia backup pacing when required. For the purpose of the MODULAR ATP 
Clinical Study, the devices included in the mCRM Modular Therapy System (S-ICD 
System and the EMPOWER PG) will be called the mCRM Coordinated System. 
Boston Scientific conducted extensive testing to determine that the EMPOWER MPS 
System and the coordination of the EMBLEM S-ICD System and EMPOWER MPS 
System elements of the mCRM System functions safely and effectively per the design 
intent. Boston Scientific performed safety risk management, nonclinical bench testing, 
and animal studies to support the project. These activities were performed in accordance 
with established national and international industry standards, Good Laboratory Practices 
(GLPs), product specifications, and internal Boston Scientific procedures. All testing 
demonstrated that the investigational EMPOWER MPS System and the coordination of 
the EMBLEM S-ICD System and EMPOWER MPS System elements of the mCRM 
System performed as intended and met all electrical and mechanical performance 
specifications.  
Note: Acronyms and terms used in this protocol are defined in Sections 25.1 and 25.2, 
respectively.  
 
7 Huang J, Patton KK, Prutkin JM. Concomitant Use of the Subcutaneous Implantable Cardioverter 
Defibrillator and a Permanent Pacemaker. PACE 2016 Nov; 38(11):1240-1245 
8 Ahmed FZ, Cunnington C, Motwani M, Zaidi AM.Totally Leadless Dual-Device Implantation for 
Combined Spontaneous Ventricular Tachycardia Defibrillation and Pacemaker Function: A First 
Report.Can J Cardiol 2017 Aug;33(8):1066 
9 Ljungstrom, E., Brandt, J., Mortsell, D., Borgquist, R., & Wang, L. (2019). Combination of a leadless 
pacemaker and subcutaneous defibrillator with nine effective shock treatments during follow-up of 
18months. Journal of Electrocardiology, 56, 1-3. doi:10.1016/j.jelectrocard.2019.06.001 
10 Ito R, Kondo Y, Winter J, et al. Combination of a leadless pacemaker and subcutaneous implantable 
cardioverter defibrillator therapy for a Japanese patient with prosthetic valve endocarditis. J Arrhythm. 
2019;35(2):311-313. Published 2019 Jan 16. doi:10.1002/joa3.12152 

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5 Device Description 
Detailed device descriptions are included in Appendix A and Appendix B.  
5.1 
mCRM Coordinated System 
The mCRM Coordinated System has both implantable and non-implantable components 
that are being evaluated in this study. A number of other market-released accessories are 
listed below that may be used with the system, but are neither investigational nor under 
direct study in the MODULAR ATP Clinical Study. 
5.2 
Implantable Study Devices 
The implantable portion of the system comprises three component devices that comprise 
the mCRM Coordinated System. The three component devices of the mCRM Coordinated 
System are: 
• (EMBLEM/ EMBLEM MRI) S-ICD Pulse Generator, Models A209/A219 or future 
BSC S-ICD Pulse Generator, with Coordinated System clinical firmware. (This, along 
with the S-ICD Electrode is referred to in this protocol as the “S-ICD System”) 
• S-ICD Electrode, Model 3400/3401, Model 3501 or future BSC S-ICD Electrode11  
• EMPOWER MPS Pulse Generator and Delivery Catheter12, Model B170 
Patients with an indication for rate-responsive pacing therapy are excluded from the 
MODULAR ATP Clinical Study. However, patients enrolled in the study may 
develop a need for this therapy during the course of the clinical study. Rate-
responsive pacing may be programmed ‘on’ based on Section 10.3.4.6.  
5.3 
Non-Implantable Study Devices 
The non-implantable portion of the mCRM Coordinated System includes accessories 
associated with both the EMPOWER MPS and the S-ICD System.13 
5.3.1 Non-Implantable Study Devices Associated with the EMPOWER System 
The EMPOWER MPS and associated retrieval accessories consist of both investigational 
and market-approved devices. The non-implantable EMPOWER System accessories that 
may be used during the implant and/or retrieval procedures at clinical sites include:   
• Delivery Catheter portion of the EMPOWER MPS, Model B170 (refer to Section 
26.2.1.1). 
• EMPOWER MPS Introducer Sheath, Model 8782  
Note: Another compatible introducer sheath may be used that is not part of the 
EMPOWER System accessories. Refer to Table 26-1 and the EMPOWER Modular 
Pacing System Physician’s Technical Manual and Label Supplement, as well as the 
 
11 Note that Cameron Health Q-Trak Electrode Model 3010 is the same as BSC Models 3400/3401, and is 
also allowable. 
12 Note that the Delivery Catheter is a non-implantable device; however, it is an integral part of Model 
B170. 
13 Subjects may be enrolled with an existing S-ICD System. In such subjects, information on the non-
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EMPOWER Retrieval System Physician’s Technical Manual and Label Supplement for 
more information.  
• Amplatz Super Stiff™ Guidewire Model M001465010, or equivalent stiff 0.035” 
(0.89mm) Guidewire  
o A 5-pack of Amplatz Super Stiff™ Guidewires carries Model Number 
M00146511, where each individual guidewire in that pack includes Model 
Number M00146510 
• EMPOWER MPS Retrieval System, (refer to Section 26.2.1.2): 
o Retrieval Catheter, Model 8780 
o Single-loop Snare, Model 8784 
o Tri-loop Snare, Model 8785 
• Surface ECG Cable, Model 3153 or equivalent 
• LATITUDE™ Programming System, Model 3300, using Programmer Software 
Application, Model 3870 and associated Firmware 
• Physical media containing the Programmer Software Application, such as a pen drive, 
Model 6226 (see Section 5.3.2) 
• LATITUDE Programming System – Feature Key, Model 6252 
• Sterile Tray Cable, Model 6157 
• Conducted Telemetry Cable (non-sterile and re-usable), Model 6396 
5.3.2 Model 3870 Programmer Software Application and Associated Firmware 
Investigational firmware for the Model 3300 LATITUDE Programming System is 
bundled with the Model 3870 Programmer Software Application installer. This firmware 
allows the use of the conducted telemetry hardware within the Model 3300 LATITUDE 
Programming System.  
The Model 3870 Programmer Software Application is used to support the communication 
with the EMPOWER PG. 
Note: the version of the 3870 software application may be updated during the study. If 
this occurs, study sites will be notified of the new software version(s) and a BSC 
representative will update the software on the PRM*. 
* A pen drive containing the investigational Model 3870 Programmer Software 
Application may be used to install the Programmer Software Application on the 
LATITUDE Programming System and is only available for use by a BSC 
representative. The Programmer Software Application may also be delivered to 
and installed on the programmer through the Software Distribution Network, 
which allows software downloads via the internet. Using the Software 
Distribution Network requires authorized site or BSC personnel to provide the 
serial number of the programmer(s) that will be used to support the study. Once 
the software is installed, the physical media and/or a connection to the Software 
Distribution Network are not required for device interrogation. 

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Interrogation of the Model B170 EMPOWER PG requires a programmer with 
Model 3870 Programmer Software, as well as Model 6396 Conducted Telemetry 
Cables, both investigational during all or part of the MODULAR ATP Clinical 
Study (note that commercially available ECG patches are also required for 
conductive communication). Model 6396 Conducted Telemetry Cables are only 
available for use by trained study personnel (ie, BSC personnel or trained site personnel). 
Therefore, trained study personnel will need to be present any time the investigational 
Model B170 EMPOWER PG is interrogated. This will continue to be a requirement 
during the MODULAR ATP Clinical Study in each study geography individually 
until the EMPOWER System is approved for commercial release in each study 
geography individually.  
5.3.3 Non-implantable Study Devices Associated with the S-ICD System 
The non-implantable S-ICD System accessories that may be used during the implant 
procedure at clinical sites include:   
• S-ICD Programmer, Model 3200, using Programmer Software Application, Model 
2877*  
• LATITUDE Programming System, Model 3300, using Programmer Software 
Application, Model 3877 (when available, per geography) 
• S-ICD Subcutaneous Electrode Insertion Tools (EIT), Model 4711 
• S-ICD Electrode Delivery System (EDS), Model 4712 
*The S-ICD Programmer, Model 3200 will be used in the MODULAR ATP Clinical 
Study until the LATITUDE Programming System, Model 3300 is available per 
geography 
A device-specific PIN is required only to access ATP parameters on the programmer 
during the study. These parameters are labeled as “mCRM” on the programmer 
screen. Interrogation and programming of all non-investigational S-ICD parameters 
will be available without the device-specific PIN. 
5.4 
Accessories 
Non-study accessories associated with the EMPOWER MPS include: 
• ECG patches for conductive communication (commercially available) 
Non-study accessories associated with the S-ICD System include: 
• EMBLEM S-ICD Patient Screening Tool, Model 4744 
• EMBLEM S-ICD Automatic Screening Tool (AST), Model 2889 (Used in 
conjunction with the ZOOM LATITUDE PRM, Model 3120 for ECG screening only; 
will not interrogate an S-ICD device) 
• EMBLEM S-ICD Automatic Screening Tool (AST), Model 3889 (Used in 
conjunction with the LATITUDE Programming System, Model 3300 for ECG 
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5.5 
Additional Equipment 
A commercially approved Holter monitor and its accessories will be provided to select 
study sites to conduct the 16-24 hour Holter Substudy. The equipment and monitoring 
service will be provided by an independent core lab. Refer to Section 10.5.5 for a 
description of the Holter Substudy. 
Equipment needed to perform required testing in subjects participating in the Rate 
Response Substudy (Section 10.6) include: 
• Treadmill (provided by the selected study site), 
• Laser Tachometer, Advent Model A2103/LSR/K 
• Tachometer-to-Programmer Cable, BSC equipment number E90017-100, 
• LATITUDE Programming System – Feature Key (Model 6252) 
6 Study Objectives and Endpoints 
Refer to Table 6-1 and Table 6-2 for a summary of the primary and secondary objectives 
and endpoints for the MODULAR ATP Clinical Study. Further justification for the study 
design is included in Section 7.2. 
Table 6-1: Primary Objectives and Endpoints 
Objective 
Endpoint 
Justification 
Assess safety of the 
EMPOWER Modular Pacing 
System (MPS) 
Safety Endpoint 1: Freedom from 
Major EMPOWER MPS System and 
Procedure-Related Complications 
through 6 months Post-Implant > 
86% 
Similar endpoints have been 
used for transvenous and 
leadless pacing system 
Safety Endpoint 2: Freedom from 
Major EMPOWER System- and 
Procedure-related Complications 
through 12 months Post-Implant > 
81% 
Similar endpoints have been 
used for historical pacing 
systems and similar market-
released devices 
Assess effective 
communication between the 
S-ICD and EMPOWER MPS 
Primary Effectiveness Endpoint 1: 
The proportion of communication 
attempts between the S-ICD and 
EMPOWER MPS that are 
successful at the 6 Month Visit > 
88% 
Communication between the 
devices was chosen as a 
measure of effectiveness as it 
is the novel part of the 
Coordinated System and ATP 
effectiveness has already been 
proven.  
Assess effectiveness of the 
EMPOWER MPS 
Primary Effectiveness Endpoint 2:  
Proportion of subjects with 
adequate PCT (defined as ≤ 2 
V@0.4 ms) collected at the 6 
Month Visit > 80% 
Similar endpoints have been 
used for historical pacing 
systems and similar market-
released devices12, 13 

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Table 6-2: Secondary Objectives and Endpoints 
Objective 
Endpoint 
Justification 
Assess safety of the 
EMPOWER Modular Pacing 
System (MPS) 
Secondary Safety Endpoint: All-
Cause Survival through 2 years 
Post-Implant > 85% 
Similar endpoints have been 
used for similar market 
release devices 
Assess the Rate Response 
function of the EMPOWER 
PG 
 
Secondary Effectiveness Endpoint 
1: Mean Metabolic-Chronotropic 
Relation (MCR) slope from the Kay-
Wilkoff model is between 0.65 and 
1.35 at the 3 Month Visit 
Similar endpoints have been 
used for historical pacing 
systems and similar market-
released devices14 
 
6.1 
Study Objectives 
The objective of the MODULAR ATP Clinical Study is to demonstrate the safety, 
performance and effectiveness of the EMPOWER™ Modular Pacing System (MPS), as 
well as the EMPOWER and EMBLEM™ Subcutaneous ICD Coordinated System. 
Additionally, data from this study may be used to support pre-market and post-market 
approval requirements for the EMPOWER MPS. 
6.2 
Study Endpoints 
The following endpoints will be evaluated to establish the safety, performance and 
effectiveness of the Coordinated System to satisfy global regulatory requirements. Refer 
to Section 11.1 for details on each endpoint. 
6.3 
Safety Endpoints 
• Safety Endpoint 1: Major EMPOWER MPS System- and Procedure-related 
Complication-Free Rate from Implant through 6 Months Post-Implant  
• Safety Endpoint 2: Major EMPOWER MPS System- and Procedure-related CFR from 
Implant through 12 Months Post-Implant 
• Secondary Safety Endpoint: All-Cause Survival from Implant through 2 Years Post-
Implant 
6.4 
Effectiveness Endpoints 
• Primary Effectiveness Endpoint 1: Communication Success between the S-ICD and 
EMPOWER PG at the 6 Month Visit 
• Primary Effectiveness Endpoint 2: Proportion of Subjects with Adequate Pacing 
Capture Threshold (defined as ≤2 V @ 0.4 ms) at the 6 Month Visit  
 
14 Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, Narasimhan C, Steinwender C, Brugada 
J, Lloyd M, Roberts PR, Sagi V, Hummel J, Bongiorni MG, Knops RE, Ellis CR, Gornick CC, Bernabei 
MA, Laager V, Stromberg K, Williams ER, Hudnall JH and Ritter P. A Leadless Intracardiac Transcatheter 
Pacing System. N Engl J Med. 2016;374:533-41. 
 

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• Secondary Effectiveness Endpoint: Mean Metabolic Chronotropic Relation (MCR) 
Slope from the Kay-Wilkoff Model at the 3 Month Visit 
6.5 
Ancillary Objectives 
Further data will be collected in the MODULAR ATP Clinical Study and summarized. 
Refer to Section 11.2 for more information. 
6.6 
Study Rationale 
Patients may benefit from ventricular arrhythmia termination with ATP because it can 
avoid a shock that is often painful and consumes battery energy. The effectiveness of 
ATP therapy in terminating VT is well established15 and recognized by international 
guideline recommendations for ICD programming.16,17 Therefore, ATP therapy 
effectiveness is not the primary focus of the study. Instead, the MODULAR ATP Clinical 
Study will focus on the novel aspects of the mCRM Coordinated System for the delivery 
of ATP.  
The MODULAR ATP Clinical Study evaluates the safety and effectiveness of the 
EMPOWER MPS and the unique aspect of the mCRM Coordinated System, which is the 
unidirectional transmission of conductive communication signals from the S-ICD System 
to the EMPOWER PG. The EMPOWER PG is designed to recognize communication 
signals sent from the S-ICD coil towards the S-ICD PG, creating a communicating vector. 
Because this communication can be affected by the orientation of the devices relative to 
each other, the primary effectiveness endpoint will demonstrate communication success 
in varied orientations by altering body postures of subjects. Communication is tested by 
commanding a communication signal from the S-ICD that results in EMPOWER pacing 
for 10 beats above the subject’s intrinsic rate.  
Additionally, communication success will be demonstrated during spontaneous 
ventricular tachyarrhythmia episodes.  
The effectiveness of the EMPOWER PG will be assessed by measuring adequate Pacing 
Capture Threshold (PCT) during follow-up visits post-implant. PCT has been shown to be 
affected by multiple factors, including the method and stability of fixation. The 
EMPOWER PG is designed to deploy using 4 active-fixation nitinol talons, as compared 
to the conventional active-fixation screw or passive-fixation tine engagement used in a 
transvenous lead system. The MICRA leadless pacemaker uses a similar mechanism 
consisting of 4 active-fixation nitinol tines, but the NANOSTIM leadless pacemaker uses 
a different mechanism consisting of an active-fixation fixed screw. Results from other 
 
15 Wathen M. Implantable cardioverter defibrillator shock reduction using new antitachycardia pacing 
therapies. Am Heart J. 2007 Apr;153(4 Suppl):44-52. 
16 Wilkoff BL, Fauchier L, Stiles MK, et al. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus 
statement on optimal implantable cardioverter-defibrillator programming and testing. Europace. 2016 
Feb;18(2):159-83. 
17 Martin K. Stiles, MBChB, PhD, FHRS (Chair), Laurent Fauchier, MD, PhD, Carlos A. Morillo, MD, 
FHRS, Bruce L. Wilkoff, MD, FHRS, CCDS. 2019 HRS/EHRA/APHRS/LAHRS focused update to 2015 
expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing. 
Heart Rhythm 2019;17:220–228.  

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leadless pacemaker clinical trials showed that dislodgment was higher for the 
NANOSTIM leadless pacemaker as compared to the MICRA leadless pacemaker. In the 
LEADLESS trial5 studying the NANOSTIM leadless pacemaker, no device 
dislodgements were identified. However, there were six device dislodgements in the 
LEADLESS II trial18. In comparison, there were no dislodgements in the MICRA IDE 
trial19 and only one occurred in the MICRA Post-Approval Study20. The difference in 
dislodgement rate could be related to the difference in the fixation mechanism design 
between the two leadless devices. The fixation mechanism of the EMPOWER devices 
warrants evaluation in the pre-market clinical study. 
The EMPOWER pacemaker uses a motion-based accelerometer to generate an electronic 
signal, which can be translated to a rate increase in proportion to the activity level of the 
patient. The rate response function will be evaluated during the trial due to the differences 
in the location of the accelerometer of an EMPOWER pacemaker, which resides inside of 
the heart chamber, compared to a transvenous pacemaker, which resides outside of the 
heart, usually in the infraclavicular or abdominal region.  
Modern VVI(R) transvenous pacemakers are proven to be reliable in providing adequate 
pacing support. The reliability of the EMPOWER leadless pacemaker in providing 
appropriate pacing must be demonstrated before using it in pacemaker-dependent 
patients. Therefore, the MODULAR ATP Clinical Study protocol is designed to obtain 
data using Holter monitoring to support use of the EMPOWER PG in future pacemaker 
dependent patients. 
Demonstration of the safety and effectiveness of the EMPOWER System in this study is 
required to obtain global market approval for commercial release. In addition, safety data 
collected may be used to support future post-market approval conditions mandated by 
global regulatory agencies.  
The data from this study will be used to support global regulatory approvals. 
7 Study Design 
The MODULAR ATP Clinical Study is a prospective, non-randomized, multi-site study, 
single-arm, global study utilizing performance goals to demonstrate safety, performance, 
and effectiveness of the EMPOWER MPS and mCRM Coordinated System.  
 
18 Reddy VY, Exner DV, Cantillon DJ, Doshi R, Bunch TJ, Tomassoni GF, Friedman PA, Estes NA, 3rd, 
Ip J, Niazi I, Plunkitt K, Banker R, Porterfield J, Ip JE and Dukkipati SR. Percutaneous Implantation of an 
Entirely Intracardiac Leadless Pacemaker. N Engl J Med. 2015;373:1125-35. 
19 Dwight Reynolds, M.D., Gabor Z. Duray, M.D., Ph.D., Razali Omar, M.D. A Leadless Intracardiac 
Transcatheter Pacing System. N Engl J Med 2016; 374:533-541. 
20 El-Chami et al. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A 
comparison to the investigational study and a transvenous historical control. Heart Rhythm 2018; 15:1800-
1807. 

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7.1 
Scale and Duration 
The MODULAR ATP Clinical Study will enroll up to 300 subjects at approximately 60 
sites in North America, the United Kingdom, and Europe. Other geographies may be 
added over the course of the study. This clinical study is designed to satisfy the regulatory 
requirements of multiple geographies. Therefore, subjects will continue to be followed 
every 6 months until the EMPOWER System and mCRM Coordinated System receives 
Health Canada and FDA pre-market approval, and CE Mark has been granted, all subjects 
have been followed for at least 24 months, and BSC communicates study closure.  
Figure 7-1 shows the follow-up plan for the MODULAR ATP Clinical Study. Subjects 
will be followed in the MODULAR ATP Clinical Study based on the date of their mCRM 
Coordinated System (both S-ICD and EMPOWER MPS) implant (i.e., the date on which 
the latter device was implanted.  
Follow up in the MODULAR ATP Clinical Study is required at Pre-Discharge, 1 month, 
3 months (only for subjects participating in the Rate Response Substudy), 6 months, 12 
months, 18 months, and 24 months after the full mCRM Coordinated System is 
implanted. Subjects will continue to be followed every 6 months until BSC notifies sites 
that follow up is complete. Please note S-ICD labeling suggests patients be followed 
every 3 months. Therefore, subjects may be seen more often than the follow ups required 
for this clinical study. Refer to Section 10.9 for reporting requirements of Additional 
Visits.  

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Figure 7-1: MODULAR ATP Clinical Study Design 
 
7.2 
Justification for the Study Design 
The MODULAR ATP Clinical Study is being conducted to collect data to support pre-
market regulatory submissions for the approval of the EMPOWER System in geographies 
where prospective clinical data are required.  
The EMPOWER PG was developed and built on historic experience of comparable 
devices. Therefore, the Safety Endpoint 1 of the MODULAR ATP Clinical Study aims to 
establish the clinical safety profile of the EMPOWER PG at 6 months post-implant. 
Subjects are also required to complete 12-month, 18-month, and 24-month follow-ups, 
serving as a longer-term assessment of the mCRM Coordinated System, including the 
EMPOWER PG within the scope of the pre-market clinical study. 
The effectiveness of the EMPOWER PG will be assessed by measuring adequate Pacing 
Capture Threshold (PCT) during follow-up visits post-implant. PCT has been shown to be 
impacted by multiple factors, including the method and stability of fixation. The 
EMPOWER PG is designed to deploy using 4 active fixation nitinol talons, as compared 
to the conventional active fixation screw and passive tine engagement used in a 
transvenous lead system. 
The EMPOWER PG uses a motion-based accelerometer to generate an electronic signal, 
which can be translated to a rate increase in proportion to the activity level of the patient. 

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The rate response function will be evaluated during the MODULAR ATP Clinical Study 
to gather data in support of the differences in the location of the accelerometer of an 
EMPOWER pacemaker, which resides inside of the heart chamber, compared to a 
transvenous pacemaker, which resides in the subcutaneous infraclavicular region of the 
patient.  
Modern VVI(R) transvenous pacemakers are proven to be reliable in providing adequate 
pacing support. The reliability of the EMPOWER leadless pacemaker in providing 
appropriate pacing must be demonstrated before using it in pacemaker-dependent 
patients. 
The mCRM System was designed as an evolution to the stand-alone EMBLEM S-ICD 
System such that it integrates wireless intrabody communication between an EMBLEM 
S-ICD and a co-implanted EMPOWER pacemaker; thereby, allowing the coordination of 
ATP therapy.   
As such, the mCRM System is intended to address the following patient needs, in 
addition to the therapy provided by the EMBLEM S-ICD alone: 
• ATP therapy to reduce shocks for patients who have or develop recurring 
monomorphic ventricular tachycardia (VT) 
• Ventricular bradycardia pacing therapy for EMBLEM S-ICD patients who could 
benefit from VVI(R) pacing 
The MODULAR ATP Clinical Study represents a scientifically and statistically-based 
study to evaluate the safety and effectiveness of both the EMPOWER System and mCRM 
System, while maintaining focus on a patient population with a unique and heretofore 
unmet clinical need:  patients with an existing EMBLEM S-ICD or patients deemed 
candidates for an EMBLEM S-ICD device who also have a need for ATP. 
Data gathered in the MODULAR ATP Clinical Study will also be used to support 
worldwide post-market requirements in certain geographies. 
8 Subject Selection  
8.1 
Study Population and Eligibility  
Subjects included in the MODULAR ATP Clinical Study should be selected among those 
with a standard ICD indication applying international practice guidelines, as well as those 
who already have an implanted S-ICD System and satisfy the inclusion criteria for this 
study, while not meeting any exclusion criteria. U.S.-based study sites shall also apply 
Centers for Medicare and Medicaid Services (CMS) requirements for Coverage with 
Evidence Development, Medicare National Coverage Determination 20.8.4 (Leadless 
Pacemakers); also refer to Appendix G.  
The investigator is responsible for screening all potential subjects and selecting those who 
meet the eligibility criteria for the study as described in Sections 8.2 and 8.3.   

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8.2 
Inclusion Criteria 
Subjects who meet all of the following criteria (Table 8-1) may be given consideration 
for inclusion in the MODULAR ATP Clinical Study, provided none of the exclusion 
criteria (refer to Section 8.3) are met.  
Table 8-1: Inclusion Criteria 
Inclusion 
Criteria 
• 
Patient who meets Class I, IIa, or IIb guideline ICD indications21,22, or who has 
an existing TV-ICD* or S-ICD** 
• 
Patient who is deemed to be at risk for MVT based on at least ONE of the 
following: 
o History of Non-Sustained MVT with LVEF ≤ 50% 
o History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% 
or significant cardiac scar***  
o History of syncope deemed to be arrhythmic in origin  
o History of ischemic cardiomyopathy with LVEF ≤35% 
o History of non-ischemic cardiomyopathy with LVEF ≤35% and 
significant scar*** 
• 
Patient who is willing and capable of providing informed consent (which is 
not to include the use of a legally authorized representative (LAR) for 
documentation of informed consent) and participating in all testing 
associated with this investigation at an approved study site and at the 
intervals defined by this protocol 
• 
Patient who is age 18 years or above, or of legal age to give informed 
consent specific to state and national law  
*TV-ICD system is expected to be fully explanted during or prior to full Coordinated System implant   
**Patients with a Model 1010 S-ICD Pulse Generator are only eligible for MODULAR ATP if they are getting upgraded 
to BSC Model A209 or A219, or future BSC S-ICD Pulse Generator 
**Patients with an existing S-ICD PG subject to the electrical overstress field action are only eligible for MODULAR ATP 
if they are getting a new BSC Model A209 or A219, or future BSC S-ICD Pulse Generator 
***Significant cardiac scar is defined as a scar involving at least one ventricular myocardial segment (i.e., basal infero-
septum) as identified in the official findings of a cMRI, or nuclear viability study, or Echo report by the interpreting 
radiologist/ cardiologist who is not affiliated with the study 
Abbreviations: ECG = Electrocardiogram; ICD = Implantable Cardioverter-Defibrillator; LAR = Legally Authorized 
Representative; MRI = Magnetic Resonance Imaging; cMRI = cardiac Magnetic Resonance Imaging; LVEF = Left 
Ventricular Ejection Fraction; MI = Myocardial Infarction; MVT = Monomorphic Ventricular Tachycardia; S-ICD = 
 
21 Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular 
Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of 
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm 
Society. Circulation. (2018); 138:e272-e391.  
22 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of 
sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and 
the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart 
Journal (2015) 36, 2793–2867. 

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Subcutaneous Implantable Cardioverter-Defibrillator; TV-ICD = Transvenous Implantable Cardioverter-Defibrillator; 
VF = Ventricular Fibrillation; VT = Ventricular Tachycardia   
8.3 
Exclusion Criteria 
Patients who meet any one of the following criteria (Table 8-2) will be excluded from 
this clinical study.  
Table 8-2: Exclusion Criteria 
Exclusion 
Criteria 
• 
Patient with an ongoing complication due to Cardiac Implantable Electronic 
Device (CIED) infection or CIED explant 
• 
Transvenous lead remnants within the heart from a previously implanted 
CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) 
are allowed) 
• 
Patient with a known LA thrombus 
• 
Patient with a ventricular arrhythmia due to a reversible cause 
• 
Patient indicated for implantation of a dual chamber pacemaker or cardiac 
resynchronization therapy (CRT) 
• 
Patient with another implanted medical device that could interfere with 
implant of the leadless pacemaker, such as an implanted inferior vena cava 
filter or mechanical tricuspid heart valve 
• 
Patient requires rate-responsive pacing therapy 
• 
Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 
bpm) 
• 
Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, 
Unstable Angina) within 40 days 
• 
Inability to access femoral vein with a 21-French or larger inner diameter 
introducer sheath due to known anatomy condition, recent surgery, and/ or 
other relevant condition 
• 
Patient who has an active implanted electronic medical device intended for 
chronic use concomitantly with the study system, such as a left ventricular 
assist device (LVAD). Note that a temporary pacing wire is allowed. 
• 
Patient with known or suspected sensitivity to Dexamethasone Acetate 
(DXA) 
• 
Patient with a known cardiovascular anatomy that precludes implant in the 
right ventricle 
• 
Patient with a known allergy to any system components 
• 
Patient with a known or suspected intolerance to S-ICD conversion testing, 
based on physician discretion 
• 
Patient is not likely to have meaningful survival1 for at least 12 months 
(documented or per investigator’s discretion) 
• 
Patient is enrolled in any other concurrent study. Co-enrollment into other 
studies such as observational studies/ registries needs prior written 
approval by BSC. Local mandatory governmental registries are accepted for 
co-enrollment without approval by BSC. 

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• 
Patient who is a woman of childbearing potential who is known to be 
pregnant at the time of study enrollment (method of assessment upon 
investigator’s discretion) 
1 meaningful survival means that a patient has a reasonable quality of life and functional status. 
 
9 Subject Accountability 
9.1 
Point of Enrollment 
Subjects will be considered enrolled into the MODULAR ATP Clinical Study at the time 
of Informed Consent Form (ICF) execution. All subject enrollments will be counted 
against the enrollment ceiling for the study.  
9.2 
Subject Status and Classification 
9.2.1 Intent 
Intent - refers to a subject who has been enrolled in the MODULAR ATP Clinical Study, 
but then does not have anesthesia administered in preparation for an EMPOWER PG and/ 
or S-ICD implant procedure. The original ICF and enrollment documentation for intent 
subjects should be maintained in the study site’s files and an End of Study Form 
completed in eDC. There are no follow-up requirements for intent subjects; intent 
subjects must be withdrawn from the study. 
9.2.2 Attempt 
Attempt - refers to a subject who 1) has been enrolled in the MODULAR ATP Clinical 
Study, 2) has had anesthesia administered in preparation for the surgical implant 
procedure of an EMPOWER PG and/or S-ICD, but 3) is not successfully implanted with 
the EMPOWER PG and/or S-ICD.  
Attempt subjects must be followed at least 30 days (either in-clinic or phone contact) 
post-attempted EMPOWER PG and/or S-ICD device implant to assure there are no 
associated adverse events or to assure the resolution of any adverse events associated with 
the attempted S-ICD and/or EMPOWER PG device implants. Attempt subjects will be 
included in the data analysis for the implant success rate. Attempt subjects must be 
withdrawn from the study after satisfying the follow-up of at least 30 days from attempted 
device implant.  
9.2.3 Partial Implant 
Partial Implant - refers to a subject who 1) has been enrolled in the MODULAR ATP 
Clinical Study, 2) has had either the S-ICD System introduced into their subcutaneous 
space or the EMPOWER MPS introduced into their vasculature, 3) is successfully 
implanted with either the S-ICD System or EMPOWER PG device, but not both, AND 
4) is unable to or for whom there is no intention to implant the full mCRM Coordinated 
System.  
Subjects classified as a Partial Implant that are implanted with an EMPOWER PG must 
be followed according to this protocol, with all relevant EMPOWER PG device data and 

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testing collected. Time 0 for the purpose of determining timing of follow ups for these 
subjects is the day it is determined the S-ICD will not be implanted.  
Note that subjects implanted with an S-ICD System (prior to upgrading with clinical 
firmware in the MODULAR ATP Clinical Study) who are not implanted with an 
EMPOWER PG may be withdrawn from the MODULAR ATP Clinical Study after 
satisfying the follow-up of at least 30 days from S-ICD device implant. 
9.2.4 Implant 
Implant - refers to a subject who has been enrolled in the MODULAR ATP Clinical 
Study and is successfully implanted with the S-ICD and EMPOWER PG device per the 
study protocol (this includes those subjects previously implanted with an S-ICD System). 
Implant subjects are followed in accordance with the follow-up schedule included in this 
protocol and included in analyses of safety, effectiveness, and performance based on 
provisions discussed in Section 11. 
9.3 
Access to EMPOWER MPS Programmer Software and S-ICD System mCRM 
Programming  
If a subject classified as either “Partial Implant” (those with the EMPOWER PG 
implanted, but not an S-ICD system) or “Implant” seeks routine or emergency care in a 
facility or from a physician who is not a study investigator, there may be a delay in: 
• accessing the EMPOWER PG’s data due to the need to secure access to the 
Programmer Software Application Model 3870, or 
• accessing programmable mCRM parameters of the S-ICD device due to the need to 
provide a device-specific PIN, which is only available to trained study personnel with 
authorized access as part of the MODULAR ATP Clinical Study  
o Note: Non-investigational S-ICD parameters continue to be accessible at all 
times. 
Trained study personnel (ie, BSC personnel or trained site personnel) are required to be 
present to access the Programmer Software Application Model 3870 and investigational 
features of the S-ICD (mCRM parameters) and report their use in these circumstances.   
9.4 
Strategies for Recruitment and Retention 
The MODULAR ATP Clinical Study will include subjects deemed at risk for 
monomorphic ventricular tachycardia (MVT), SCD, and who are indicated for an ICD 
(Section 8.2). The incidence of SCD increases markedly with age regardless of sex or 
race: Accordingly, the SCD rate is estimated to range from 1.40 per 100,000 person-years 
in women to 6.68 per 100,000 person-years in men. SCD in younger individuals has an 
estimated incidence of 0.46–3.7 events per 100,000 person-years, corresponding to a 
rough estimate of 1100–9000 deaths in Europe and 800–6200 deaths in the USA every 
year. The inclusion and exclusion criteria are not expected to have a negative effect 
on recruitment or retention of said populations. In the United States, the subjects eligible 
for inclusion in this study are likely to be a mixture of private payer and Medicare 
patients due to their expected age and the results of this study are likely to be 
generalizable to a Medicare population.  

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9.5 
Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn) shall be accounted 
for and documented. If a subject withdraws from the clinical study, the reason(s) shall be 
reported. The investigator should ask for the subject’s permission to follow his/her 
status/condition outside of the clinical study until the implanted investigational devices 
are approved by the FDA, Health Canada, and/or has received CE mark (per geography), 
or the device is explanted.   
Reasons for withdrawal include, but are not limited to: 
• Subject who does not receive either device for the purpose of supporting the study 
(EMPOWER PG or S-ICD). This includes subjects classified as “Intent”, and those 
classified as “Attempt”, according to the definitions in Section 9.2.  
• Subject found to be ineligible to participate in the study prior to implant of the S-ICD 
and/ or EMPOWER PG (refer to Section 9.2 for further information on follow up 
requirements) 
• Physician discretion 
• Subject choice to withdraw consent 
• Explant of the investigational device(s) (EMPOWER PG and/ or S-ICD converted 
with clinical firmware) *; subjects should be followed at least 30 days (either in-clinic 
or phone contact) post-explant of the mCRM Coordinated System to assure there are 
no associated adverse events or to assure the resolution of any adverse events 
associated with the explanted mCRM Coordinated System.  
o *Note: this provision includes explant of the EMPOWER PG in all subjects, and 
the S-ICD in the case where the device has had clinical firmware uploaded. 
• Lost to follow-up 
• Death 
While study withdrawal is discouraged, subjects may withdraw from the MODULAR 
ATP Clinical Study at any time, with or without reason, and without prejudice to further 
treatment. In cases of study withdrawal where the EMPOWER PG remains actively 
implanted, the subject should be informed that he/she will need to continue to have the 
EMPOWER PG evaluated per BSC’s recommended follow-up (1, 3, 6 months and every 
6 months) at a MODULAR ATP Clinical Study site where there is access to the 
investigational software (Model 3870) to interrogate the EMPOWER PG.  
If the subject seeks routine or emergency care from a physician who is not a study 
investigator, there may be a delay in accessing the EMPOWER PG’s data due to the need 
to secure access to the investigational software (Model 3870). Also, there may be a delay 
in accessing programmable mCRM parameters of the S-ICD device due to the need to 
provide a device-specific PIN, which is only available to trained study personnel with 
authorized access as part of the MODULAR ATP Clinical Study. Trained study personnel 
(ie, BSC personnel or trained site personnel) are required to be present to access the 
Programmer Software Application Model 3870 and investigational features of the S-ICD 
(mCRM parameters) and report their use in these circumstances.  

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All applicable case report forms up to the point of subject withdrawal and an End of 
Study Form must be completed in eDC.  
Additional study 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 subject withdrawal may be used. 
9.6 
Lost-to-Follow-up 
Subjects who are “lost-to-follow-up” should have three documented attempts to contact 
them prior to completion of the End of Study Form in eDC. Note: the end-of-study date 
should be on or after the last documented contact attempt.  
9.7 
End-of-Study Definition  
A clinical study is considered completed when participants are no longer being examined 
or the last participant’s final study visit has occurred.  
For the MODULAR ATP Clinical Study, subjects will be followed until the last subject is 
followed for at least 24 months, Health Canada and FDA pre-market approval has been 
granted, and CE Mark has been granted. In the event FDA approval, Health Canada 
approval, and/or CE Mark is not granted, the End of Study Action Plan will be followed 
(Section 9.8). Upon completion of participation in the study, subjects will be followed per 
the normal standard of care. 
 
9.8 
End of Study Action Plan 
BSC reserves the right to terminate the study, discontinue implanting the EMPOWER 
PG, or discontinue allowing conversion of the S-ICD with clinical firmware at any stage 
of the study. BSC intends to exercise this right only for valid scientific or administrative 
reasons and reasons related to protection of subjects. In the event of any of these 
occurrences, BSC will communicate to the investigators of the MODULAR ATP Clinical 
Study. The investigators will be responsible for communicating any information 
necessary to the subjects. BSC will support the investigators by providing 
recommendations for ensuring the safety of the subjects and the handling of the 
implantable investigational devices (EMPOWER PG and S-ICD converted with clinical 
firmware) which may include, but are not limited to: 
• Standard-of-care procedures 
• More frequent follow ups of the subject and the EMPOWER PG device and/or S-ICD 
converted with clinical firmware than per standard procedures 
• Longer-term follow-up (beyond length of initial consent) 
• Explant of EMPOWER PG and/or S-ICD converted with clinical firmware upon 
careful risk-benefit analysis 
• Other possible actions 
If it becomes apparent that the EMPOWER PG and/or mCRM Coordinated System will 
not be approved by Health Canada and/or FDA and/or will not receive CE Mark, a 

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communication and study action plan for the subjects with those unapproved devices will 
be implemented.  
10 Study Methods 
10.1 Data Collection 
Data will be collected from each subject at Enrollment, Implant, Pre-discharge, 1 Month, 
3 Months (only for subjects participating in the Rate Response Substudy), 6 Months, and 
follow-up visits every 6 months thereafter until BSC notifies study sites that follow up is 
complete, as defined in Section 9.7. Additional follow-up visits must be collected as 
defined in Section 10.9. All study-related visit windows are calculated from the date of 
both devices (EMPOWER PG and S-ICD converted with clinical firmware) being 
implanted (exceptions for those not implanted with both devices is included in Section 
9.2.3).  
The data collection schedule is shown in Table 10-1.   
 
 

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Table 10-1: MODULAR ATP Clinical Study Data Collection Schedule 
 
23 Only needed if de novo S-ICD 
Procedure/ 
Assessment 
Enrollment 
EMPOWER PG 
Implant 
S-ICD Implant 
mCRM Coordinated 
System 
Follow-up In-Office Visits 
Additional Visit 
System 
Testing 
Pre-
Discharge 
1 
Month 
3 
Month 
(treadmi
ll only) 
6 
Month 
Semi Annual 
Time Frame 
≤30 days prior to 
EMPOWER PG and/ 
or S-ICD implant 
-- 
-- 
Time 0 
Prior to hospital 
discharge with 
mCRM Coordinated 
System 
10d -42d 
90±15d 
180 ± 
30d 
12 Mo: 360 ± 45d 
18 Mo: 540 ± 45d 
24 Mo: 720 ± 45d 
30 Mo: 900 ± 45d 
36 Mo: 1080 ± 45d 
Etc.  
-- 
Informed consent 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Demographics 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Physical 
assessment 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Medical history 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Cardiac disease 
history 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Arrhythmia 
history 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Cardiovascular 
medications 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
S-ICD screening 
ECG 
X23 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Implant details  
-- 
X 
X23 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Product 
information 
-- 
X 
X 
-- 
-- 
-- 
-- 
-- 
-- 
-- 
Fluoro/ Cine 
image  
-- 
X 
-- 
X 
-- 
-- 
-- 
-- 
-- 
-- 
Chest X-Ray 
-- 
-- 
-- 
X (Either/ or) 
-- 
-- 
-- 
---- 
 
Pace Morphology 
Sensing Test 
(PMST) 
-- 
-- 
-- 
X 
X 
-- 
O 
-- 
-- 
O 
Communication 
Test/ 
Communication 
Threshold Test  
-- 
-- 
-- 
X** 
X** 
X** 
-- 
X** 
X** 
X** 
Muscle 
stimulation 
testing 
-- 
-- 
-- 
X 
-- 
-- 
-- 
-- 
-- 
-- 
S-ICD conversion 
and sensing 
interaction testing 
-- 
-- 
-- 
X (Either/ or) 
O 
O 
O 
O 
O 
EMPOWER MPS 
Evaluation 
-- 
X 
-- 
X 
X 
X 
-- 
X 
X 
X* 

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10.2 Enrollment Visit 
10.2.1 Informed Consent 
Subjects who meet all of the inclusion criteria and none of the exclusion criteria and agree 
to participate in the MODULAR ATP Clinical Study must give written informed consent 
approved by the regional regulatory body and the study site’s IRB, EC, or REB prior to 
study participation and use of any investigational device testing/ data collection. The 
Investigator is responsible for ensuring that informed consent is obtained prior to any 
study-required procedure and/or testing, or data collection. 
A subject is considered enrolled in the MODULAR ATP Clinical Study at the time the 
subject signs and dates the ICF.  
10.2.2 Enrollment Data 
All enrolled subjects must have a physical assessment for the study that includes height, 
weight, and vital signs. Also, women of child-bearing potential must have an assessment 
of pregnancy where the method of assessment is the investigator’s discretion. Other 
baseline data to be included at enrollment for all subjects includes: 
• Demographics 
• Medical History 
• Arrhythmia History 
• Cardiac Disease History, and 
• Cardiovascular Medications 
For enrolled subjects who are not already implanted with an S-ICD System, an S-ICD 
Screening ECG must be obtained. The screening assessment may be performed with 
either method described in the S-ICD User’s Manual, (i.e., Patient Screening Tool or S-
ICD Automated Screening Tool (AST)). The method and results of the S-ICD Screening 
ECG will be collected. As stated in the S-ICD User’s Manual, “Special circumstances 
may present in which the physician elects to proceed with the implantation of the S-ICD 
System despite failing the screening process. In this case, careful attention should be 
Procedure/ 
Assessment 
Enrollment 
EMPOWER PG 
Implant 
S-ICD Implant 
mCRM Coordinated 
System 
Follow-up In-Office Visits 
Additional Visit 
System 
Testing 
Pre-
Discharge 
1 
Month 
3 
Month 
(treadmi
ll only) 
6 
Month 
Semi Annual 
S-ICD Evaluation  
-- 
-- 
-- 
X 
X 
X 
-- 
X 
X 
X* 
Holter Monitor 
data recording 
(~ 50 subjects) 
-- 
-- 
-- 
-- 
-- 
X* 
-- 
-- 
-- 
-- 
Rate Response 
testing  
(~ 50 subjects) 
-- 
-- 
-- 
-- 
-- 
-- 
X* 
-- 
-- 
-- 
Adverse events 
assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
 
Legend: X = Required; X* = Required, if applicable; ** = See further information on Communication Threshold Test/ 
Communication Test in Table 10-6; O = Optional;  -- = Not required/ Not applicable; d = days; yr = years; add’l = additional 

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applied to the device setup process of the S-ICD System as the risk of poor sensing and/or 
inappropriate shock is increased. Rationale for proceeding with S-ICD implantation in the 
event of a failed screening will be collected.  
A subject deemed unsuitable for an S-ICD according to the discretion of the investigator, 
will be classified as an “Intent” subject and withdrawn from the study (refer to Section 
9.2). The screening assessment pertains only to S-ICD sensing of intrinsic rhythms and 
cannot predict whether the S-ICD will be able to appropriately sense paced rhythms. The 
Paced Morphology Sensing Test (PMST) described in Section 10.3.4.6 is used to assess 
appropriate S-ICD sensing of EMPOWER PG pacing and can only be performed after 
both the EMPOWER PG and S-ICD System have been implanted. 
For enrolled subjects who are already implanted with an S-ICD System, including those 
subjects getting an upgraded S-ICD/ changeout, an S-ICD Screening ECG is not required, 
and may proceed with the study. Baseline data will be collected from these subjects as 
included in Table 10-2.  
10.2.3 Enrollment Visit Source Documentation Requirements 
Enrollment data and source documentation requirements are listed in Table 10-2. 

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Table 10-2: Enrollment Data and Source Documentation 
Data Collection 
Retention of Original Source 
Documentation 
Informed consent documentation 
Study site 
Assessment of pregnancy for women of childbearing 
potential (method of assessment upon investigator’s 
discretion) 
Study site 
Results of S-ICD Screening: 
• 
Report and ECGs (appropriately annotated) 
when using the Patient Screening tool 
• 
 AST Report and associated ECGs 
(this requirement is only for subjects not previously 
implanted with an S-ICD System) 
Study site 
Baseline data: 
• 
Demographics 
• 
Physical Assessment 
• 
Medical History 
• 
Arrhythmia History  
• 
Cardiac Disease History 
• 
Cardiovascular Medications 
Study site 
10.3  Implant  
Subjects who do not already have a compatible S-ICD PG, Model A209 or A219, will 
undergo two implant procedures: one for the EMPOWER PG and one for the S-ICD 
System. 
For those subjects, it is recommended to implant the EMPOWER PG first and the S-ICD 
System second. The implant procedures may, but are not required, to occur on the same 
day; however, it is strongly recommended that both implant procedures be complete 
within 30 days of enrollment. 
Required data collection is outlined separately for each implantable device system in 
Section 10.3.1 and Section 10.3.2. Additionally, there are data requirements associated 
with the complete mCRM Coordinated System, which are outlined in Section 10.3.4.  
10.3.1 Implant of the EMPOWER PG 
The EMPOWER PG should be implanted in accordance with the implant procedure 
described in the EMPOWER MPS Physician’s Technical Manual (PTM) labeling. For a 
subject with an existing S-ICD System, an S-ICD Programmer must be available during 
the procedure. There are no protocol requirements for S-ICD programming during the 
EMPOWER PG implant. Ultimately, the two devices will be tested together as a 
coordinated system, as described in Section 10.3.2. 

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For a subject without an existing S-ICD System, there are special considerations for the 
implantation of an EMPOWER PG and S-ICD during a single procedure. This includes 
the appropriate preparation and pre-placement of external defibrillation patches, 
EMPOWER PG conducted communication patches, and surface ECG patches. 
Investigators should adhere to the implant technique described in the mCRM Modular 
Therapy System PTM labeling. 
The hospital’s standard implantation practices should be followed (e.g., maintenance of 
sterile technique, administration of anesthesia, external defibrillation, etc.), and in 
accordance with the EMPOWER MPS PTM for the implantation of the EMPOWER PG. 
The implant must be performed by an investigator who has completed the BSC 
standardized EMPOWER Training Program that covers the procedure to implant and the 
procedure to retrieve the EMPOWER PG.  
10.3.1.1 Procedure Medications 
There are no protocol requirements regarding procedure-related medications, however, 
data will be collected for management of anesthesia/sedatives, anticoagulants, 
antiplatelets, and antibiotics. 
10.3.1.2 Product Information 
Product identification information (e.g., model, serial, or lot number, as applicable) will 
be recorded, at minimum, for the following EMPOWER system devices: 
• EMPOWER MPS, consisting of a pacemaker and delivery catheter system 
• EMPOWER Retrieval System, including retrieval catheter and snares (if used) 
• EMPOWER Introducer Sheath  
Note: Another compatible introducer sheath may be used that is not part of the 
EMPOWER System accessories. Refer to Table 26-1 and the EMPOWER Modular 
Pacing System Physician’s Technical Manual and Label Supplement, as well as the 
EMPOWER Retrieval System Physician’s Technical Manual and Label Supplement for 
more information.   
• Sterile Tray Cable, Model 6157 
• Conducted Telemetry Cable, Model 6396 
10.3.1.3 EMPOWER PG Implant Procedure Duration 
Total procedure time of the EMPOWER PG implant will be derived from the following 
time points.  
• time of first venous access in preparation for the introducer sheath 
• time of the introducer sheath insertion 
• time of EMPOWER delivery catheter insertion 
• time of EMPOWER delivery catheter removal 
• time of introducer sheath removal 
• time of introducer sheath site closure 

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• total fluoroscopy time  
10.3.1.4 Fluoroscopy Imaging 
Fluoroscopy or cine images are required to be collected to document the final position of 
the EMPOWER PG once it is released from the tether and the delivery catheter has been 
retracted. A minimum of two orthogonal fluoroscopy/cine views approximately 90° apart 
are strongly recommended:  
• LAO 30°/45° and 
• RAO 30°/45° 
Note: It is also recommended to review the angle of the EMPOWER PG with respect to 
the sternum from LAO/RAO views, or from a separate fluoro/cine in AP view (to ensure 
the LCP is not implanted in a parallel orientation relative to the sternum) 
Save the images in an appropriate electronic format. These recorded images are kept at 
the study site and provided to BSC upon request. 
10.3.1.5 Device Position 
The position of the EMPOWER PG within the right ventricular chamber is required to be 
recorded. Investigators should follow recommendations provided in the EMPOWER MPS 
PTM regarding positioning of the EMPOWER PG. 
10.3.1.6 Implant Success Criteria 
There are no protocol requirements for the final position of the EMPOWER PG. 
Investigators should follow all labeling recommendations regarding the final implanted 
location within the right ventricle. 
Sensing, capture thresholds and impedance measurements should be considered in the 
acceptance of a final position, but any measurements made prior to full deployment are 
not collected as study data. Table 10-3 includes recommended measurements for optimal 
position of the EMPOWER PG. If the device stability and/or the electrical performance 
are inadequate, reposition the pulse generator as described in the EMPOWER MPS PTM. 
It is recommended to limit the number of times the active fixation talons are engaged to 5 
attempts. Note that the wound closure technique for the EMPOWER PG implant will be 
collected.  
Table 10-3: Recommended Measures for Optimal EMPOWER PG Position 
Programming Parameter 
Recommended Range of Value 
Pacing Capture Threshold 
≤ 1.0 V @ 0.4ms 
Pacing Impedance 
≥ 400 Ω to ≤ 1500 Ω 
R-Wave Amplitude 
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10.3.1.7 EMPOWER PG Evaluation 
Once the EMPOWER PG is released from the tether, perform the final implant device 
evaluation, including sensing amplitude, PCT and pacing impedance measurements must 
be recorded. 
It is required that the PCT measurement be collected using the Temp Brady programming 
screen in the following fashion:  
• Confirm connection of/ connect the Surface ECG Cable, Model 3153 or equivalent to 
the subject and the EMPOWER programmer 
• Assure that the surface electrogram is displayed on the programmer 
• The PCT test(s) shall be conducted at 0.4 ms pulse width 
• The starting voltage is discretionary and may be predetermined before documenting 
the PCT 
o Note: it is strongly recommended that the starting voltage to be at least 2 
programmable voltage steps above the highest pre-determined loss of 
capture   
• Start the real-time recording on the programmer as the means of documenting the 
PCT 
• Initiate temporary pacing at the desired voltage that consistently captures then stop 
temporary pacing and step down the voltage by one programmable value (0.1 V or 0.5 
V, as appropriate) and restart pacing. Continue in this manner until loss of capture is 
noted  
• Stop the real-time recording 
• The threshold is defined as one voltage level above the level where a single Loss of 
Capture (LOC) is noted.  
It is required to retain the “Real-time Log Report” from the programmer, documenting at 
a minimum the LOC portion of the threshold testing (i.e., the lowest voltage setting 
demonstrating capture and the highest voltage that fails to capture). This documentation 
will be retained at the study site. 
If more than one set of electrical measurements are recorded, the final set must be used 
for the study. 
Note: Additional testing is required once the S-ICD System is implanted and both devices 
can be tested as a system, as described in Section 10.3.4. 
10.3.1.8 EMPOWER PG Programming 
EMPOWER PG programming is left to physician discretion until mCRM Coordinated 
System testing is completed, as described in Section 10.3.4. 
10.3.1.9 EMPOWER PG Implant Data and Source Documentation 
EMPOWER PG implant data and source documentation requirements are summarized in 
Table 10-4.   

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Table 10-4: EMPOWER MPS Implant Source Documentation 
Data Collection 
Retention of Original Source 
Documentation 
Implant details:  
- Procedural medications (e.g., anesthesia, 
anticoagulants, antiplatelets, antibiotics) 
- EMPOWER implant procedure duration (all times 
listed in Section 10.3.1.3) 
- Fluoro or cine images of EMPOWER PG final position 
Study site 
Product information: 
- EMPOWER MPS details (model/serial, etc.) 
- Guidewire used to introduce introducer sheath 
(model/ lot, etc) 
Study site 
EMPOWER PG Combined Follow-up Report 
Study site 
EMPOWER PG Real-time Log Report (to document loss 
of capture) 
Study site 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source 
document will be collected on a TSF 
Study site 
10.3.1.10 
Unsuccessful EMPOWER PG Implant  
Subjects who are not successfully implanted with the EMPOWER PG (i.e., classified as 
“Attempt” subjects, as defined in Section 9.2) are to be withdrawn from the study after a 
minimum of 30 days from the implant procedure, including a required follow up either by 
phone or an in-clinic visit as included in Section 9.2. Attempted EMPOWER PG devices 
used in the implant procedure, but not implanted, must be reported on the appropriate 
Device Tracking Form in the database and returned to BSC.  
Subjects who are not implanted with the EMPOWER PG, but who are implanted with an  
S-ICD System as part of the MODULAR ATP Clinical Study, are classified as “Partial 
Implant” subjects. Refer to Section 9.2 for more information and follow-up requirements. 
10.3.2 Implant of the S-ICD  
This section pertains only to subjects who are receiving a new S-ICD System implant 
(de novo or changeout from TV-ICD or S-ICD). Note that product information data will 
be collected on those S-ICD systems that were implanted previously and intended to 
remain implanted. 
Implantation of the S-ICD System should be performed using the standard-of-care 
methods established by the study site. The EMBLEM S-ICD System User’s Manual 

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provides detailed instructions regarding the implantation and use of the S-ICD System, 
including the determination of the appropriate sensing vector.  
For a subject with an existing EMPOWER PG implanted, a Model 3300 Programmer 
must be available during the procedure, with Programmer Software Model 3870, as 
well as Conducted Telemetry Cables, Model 6396. Affix conducted telemetry patches 
to the subject and connect the conducted telemetry cable to the EMPOWER programmer.  
There are no protocol requirements for EMPOWER PG programming during the S-ICD 
System implant. Ultimately, the two devices will be tested together as a coordinated 
system, as described in Section 10.3.4. 
For a subject without an existing EMPOWER PG implanted, there are special 
considerations for the implantation of an S-ICD System and EMPOWER PG during a 
single procedure. This includes the appropriate preparation and pre-placement of external 
defibrillation patches and EMPOWER PG communication patches. Investigators should 
adhere to the implant technique described in the mCRM (Modular Cardiac Rhythm 
Management) Therapy System PTM. 
10.3.2.1 S-ICD Implant Procedure 
Implantation of the S-ICD System should be performed using the standard-of-care 
methods established by the study site, in conjunction with the S-ICD System User’s 
Manual. The S-ICD System User’s Manual provides detailed instructions regarding the 
implantation and use of the S-ICD System.  
10.3.2.2 Procedure Medications 
There are no protocol requirements regarding procedure-related medications; however, 
data will be collected for management of anesthesia/ sedatives, anticoagulants, 
antiplatelets, and antibiotics. 
10.3.2.3 Product Information 
Product identification information (e.g., model and serial number, or model and lot 
number) will be recorded, at minimum, for the following S-ICD system devices: 
• EMBLEM S-ICD PG 
• S-ICD Electrode 
• S-ICD Electrode Insertion Tool (EIT) 
• S-ICD Electrode Delivery Tool (EDS) 
10.3.2.4 S-ICD Implant Procedure Duration 
Total procedure time must be documented, specifically first incision to last incision 
closure for the S-ICD System implant.   
10.3.2.5 S-ICD Programming 
S-ICD programming is left to physician discretion until mCRM Coordinated System 
testing is completed, as described in Section 10.3.4. 

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Note: Until the Paced Morphology Sensing Test (PMST) has been completed (and 
passed), the EMPOWER LRL should be programmed to <1/3 of the lowest S-ICD 
detection limit per the mCRM PTM. Refer to Section 10.3.4.6.  
10.3.2.6 S-ICD Implant Data and Source Documentation 
S-ICD implant data and source documentation requirements are summarized in Table  
10-5.   
Table 10-5: S-ICD Implant Source Documentation 
Data Collection 
Retention of Original 
Source Documentation 
 Implant details: 
- Procedural medications (e.g., anesthesia, anticoagulants, 
antiplatelets, antibiotics) 
- S-ICD implant procedure duration 
Study site 
Product Information: 
- S-ICD and electrode details (model/serial, etc.) 
- EIT or EDS details (model/ lot) 
Study site 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source document 
will be collected on a TSF 
Study site 
10.3.2.7 Unsuccessful S-ICD Implant 
In the event of an unsuccessful S-ICD System implant, those subjects who are not already 
implanted with the EMPOWER PG (i.e., classified as “Attempt” subjects, refer to Section 
9.2), are to be withdrawn from the study after a minimum of 30 days from the attempted 
implant procedure including the required follow up either by phone or an in-clinic visit as 
included in Section 9.2. Pulse Generators and electrodes used in the S-ICD System 
implant procedure, but not implanted, must be reported in the database and should be 
returned to BSC.  
Those subjects already implanted with an EMPOWER PG are classified as “Partial 
Implant” subjects. Refer to Section 9.2 for more information and follow-up requirements. 
10.3.3 S-ICD Firmware Update 
Firmware on the S-ICD needs to be updated with mCRM clinical firmware to enable 
communication with the EMPOWER PG. This conversion takes about 4-8 minutes to 
complete. If telemetry is interrupted, the update ceases and the S-ICD reverts to the 
existing firmware.  
The mCRM clinical firmware update and access to mCRM Coordinated System 
programming requires a device-specific PIN. Each PIN is specific to the subject’s S-ICD 

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PG serial number, and a trained BSC representative or trained site personnel may obtain 
the number by contacting BSC Technical Services in the U.S. for sites in North America, 
and BSC Technical Services in the EU for sites in Europe and the United Kingdom.  
This mCRM clinical firmware update causes the S-ICD to be considered an 
investigational device. Therefore, it is to be used for enrolled MODULAR ATP Clinical 
Study subjects only. Do not proceed with the mCRM clinical firmware update until 
the EMPOWER PG is successfully implanted and the S-ICD is inserted into the 
pocket.  
Confirm successful mCRM clinical firmware update by printing the S-ICD 
Summary Report at the end of the visit.  
Continue with S-ICD implant; program mCRM “on” based on instruction in the mCRM 
PTM.  
10.3.4 mCRM Coordinated System Imaging and Testing 
mCRM Coordinated System testing occurs once both the S-ICD System and EMPOWER 
PG are implanted, the S-ICD clinical firmware update has been completed, and mCRM 
features are activated. 
Note that study-required follow ups will be determined based on the date that the mCRM 
Coordinated System is implanted (successful implant of both the S-ICD System, with 
clinical firmware, and EMPOWER PG). This date is referred to as “Time 0”.  
10.3.4.1 Communication Evaluation in the MODULAR ATP Clinical Study 
Communication is evaluated by one of two methods:  
The first method is a Communication Threshold Test. This method determines the 
minimum S-ICD PG Telemetry Setting value that achieves two successful 
communication tests, regardless of sequence. The Communication Threshold Test is 
required at Implant, Pre-Discharge, and the 1-Month Follow-up for all subjects in the 
study with an mCRM Coordinated System implanted. Further details are included in each 
follow up.  
The second method of communication testing is a Communication Test, which tests 
communication only at the initial programmed S-ICD PG Telemetry Setting and is 
recorded as a pass or fail at that single Telemetry Setting. A Communication Test is 
required at the 6-Month, Semi-Annual (Refer to Sections 10.7 and 10.8) and Additional 
Visits (if applicable, refer to Section 10.9). Note that if the Communication Test ends in 
unsuccessful communication, a Communication Threshold Test is required.  
Refer to Section 10.3.4.2 for information on setting up the EMPOWER PG and S-ICD 
for Communication testing.  
Note: During the Communication Test, the S-ICD will request the EMPOWER PG to 
pace for up to 10 beats slightly faster than the intrinsic rhythm. The subject should be 
judged medically able to tolerate this pacing before testing is conducted. 
Note: If intrinsic rhythm is not present, ATP pacing pulses in response to a 
communication request will not be delivered because a sensed beat is required. If the 

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S-ICD S-ECG Report indicates that a single paced beat follows the ATP request signal 
(denoted by an “A” marker; refer to Appendix C for an example), this may have been the 
case. If this occurs, the Communication Test may be repeated using the same parameters, 
and the results from the repeated test can be considered the official results. 
Requirements for communication testing in the study are included in Table 10-6, with 
more detail in each individual timepoint section. Medical discretion should be used to 
determine if testing beyond the stated requirement is warranted.  
Table 10-6: Communication Testing in the MODULAR ATP Clinical Study 
Test/ Visit 
Timepoint 
(Coordinated 
System) 
Implant 
Pre-
Discharge 
1-Month 
6-Month 
Semi-Annual 
Additional 
Visit 
Communication 
Threshold 
X 
X 
(Upright 
Posture Only) 
X 
4 postures as 
described in 
Section 10.5.3.1 
* 
* 
* 
Communication 
Test 
 
-- 
-- 
-- 
X 
4 postures as 
described in 
Section 10.7.3.1 
X 
(One Posture 
Only) 
X 
(One Posture 
Only, if 
applicable) 
X= Required; -- = Not required, *Required in the event of a Communication Test failure; see applicable visit section 
10.3.4.2 EMPOWER and S-ICD Setup for Communication Testing 
Both the EMPOWER PG and S-ICD PG need to be set up for communication testing. 
Refer to the mCRM PTM for full instructions.  
10.3.4.2.1 EMPOWER Communication Testing Setup 
• Program “mCRM Communication” On 
• Configure the backup pacing mode for the Communication Test (or Communication 
Threshold) 
o Since pacing has the potential to interfere with communication, it is 
recommended to select Off for the mCRM CommunicationTest backup 
pacing setting. However, if the subject is pacemaker dependent, configure 
the backup pacing mode at the lowest pacing rate needed for the subject, 
preferably 50 ppm or lower, for the duration of the Communication Test. 
Note:  During the Communication Test, the S-ICD will request that EMPOWER 
pace up to 10 beats slightly faster than the intrinsic rhythm. The subject should be 
judged medically able to tolerate this pacing before testing is conducted. 
Note:  If intrinsic rhythm is not present, pacing pulses in response to a 
communication request will not be delivered since a sensed beat is required. 

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• Confirm the EMPOWER PG is ready for Communciation testing by verifying with 
the mCRM Communication Test pop-up screen. This screen should remain on the 
EMPOWER programmer during S-ICD programming. 
10.3.4.2.2 S-ICD Communication testing Setup: 
• Program “mCRM Communication” On 
• Assure the subject’s specific EMPOWER PG information is entered in the mCRM 
Configuration screens on the S-ICD programmer  
• Conduct the Communication Test (or Communication Threshold Test) based on 
Section 10.3.4.4 and Section 10.3.4.5, respectively 
10.3.4.3 Communication Muscle Stimulation Testing 
Test for muscle stimulation by palpating around the location of the electrode shocking 
coil while performing a communication test at the maximum communication Telemetry 
Setting of 7. If stimulation is noted at 7, step down incrementally until loss of stimulation 
is noted and record the value where muscle stimulation is no longer perceived.  
Note: mCRM Communication for the EMPOWER PG does not need to be programmed 
to On for this testing to occur. 
10.3.4.4 Communication Test 
A Communication Test is required at the 6 Month Visit, all Semi-Annual Visits, as well 
as at Additional Visits (as applicable). See Section 10.7, Section 10.8, and Section 10.9 
respectively, for specifics related to each visit.  
Refer to the mCRM PTM, as well as Section 10.3.4.2 to prepare for a Communication 
Test. Source documentation for the Communication Test is included in Section 10.7, 
Section 10.8, and Section 10.9.  
• Conduct the Communication Test.  
• Determine success of the communication test and record in EDC   
o Review the S-ECG recorded during the test on the S-ICD programmer.  Move the 
slider to review the results of the entire Communication Test. If paced beats are 
noted after the S-ICD ATP request (indicated by the “A” marker on the S-ECG), 
the LCP successfully received the communication and paced in response at a rate 
slightly faster than the subject’s intrinsic rate. Up to 10 paced beats may be 
observed, but observation of fewer than 10 paced beats is still an indication of 
successful receipt of the S-ICD communication by the LCP. 
10.3.4.5 Communication Threshold Test 
Assure the EMPOWER PG and S-ICD PG are set up for communication testing as 
described in Section 10.3.4.2. 
There are no requirements for the Telemetry Setting value used to start this test. Choose a 
Telemetry Setting value to start the Communication Threshold Test. If successful, then 
step down incrementally by 0.5, and repeat the test. Continue stepping down by 0.5 and 

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repeating the test until an unsuccessful test occurs. After having a single unsuccessful 
test, step up by 0.5 and repeat the test as needed until success is achieved. The 
communication threshold is recorded as the minimum value that achieves two successful 
tests, regardless of sequence.  
It is required to retain the “Communication Test S-ECGs” documenting the maximum 
Telemetry Setting value demonstrating loss of communication, as well as the minimum 
Telemetry Setting value that achieves two successful tests. This documentation will be 
retained at the study site. 
Program the communication Telemetry Setting value 1 unit above the highest 
communication threshold value among all tested postures as applicable, with a minimum 
Telemetry Setting of 4. For example, if the threshold is 5, program the output to 6. 
Note: Short durations of oversensing are normal and expected when S-ICD sensing 
resumes after the communication is sent from the S-ICD. See Appendix C for more 
information.  
Note: If intrinsic rhythm is not present, pacing pulses in response to a communication 
request will not be delivered because a sensed beat is required. 
10.3.4.6 Paced Morphology Sensing Test (PMST) 
PMST is important to complete to determine appropriate S-ICD settings to avoid 
oversensing for subjects receiving pacing from the EMPOWER PG. A sensing vector that 
appropriately senses both the paced and intrinsic rhythms avoids S-ICD oversensing of 
the evoked response and the possibility of delivering inappropriate shock therapy (Refer 
also to Appendix D for a flow chart of decision-making of PMST testing).  
• Program the S-ICD to Therapy Off. 
Set the subject’s EMPOWER PG: 
• mode to VVI,  
• pacing output to ensure capture, and  
• LRL to 10-20 ppm above their intrinsic rate (with a maximum of 120 ppm) to 
promote pacing.  
Use the ’Capture All Sense Vectors’ feature of the S-ICD programmer to collect and 
retain S-ECG snapshots in the supine posture for each S-ICD sensing vector.  
Note: a deviation shall not be assessed for subjects who cannot tolerate this testing due to 
high-rate pacing. 
Document any oversensing, e.g., double counting, on the associated Form in EDC, and 
collect the “Captured S-ECG Reports” generated from the Manual Setup feature on the S-
ICD programmer. 
If there is an S-ICD vector that demonstrates appropriate sensing for both intrinsic and 
paced rhythms, this vector should be used, which will minimize the risk of oversensing 
and inappropriate shocks. If there is not an S-ICD vector that demonstrates appropriate 
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sensing of intrinsic rhythms should be used, and the EMPOWER PG’s LRL should be 
programmed to <1/3 of the lowest programmed S-ICD tachy detection zone. 
Note: The EMPOWER PG should not be programmed to VVIR mode unless appropriate 
sensing of both paced and intrinsic beats is observed. 
When the PMST is complete, program the S-ICD to Therapy On. 
10.3.4.7  S-ICD Conversion and Sensing Interaction Testing 
S-ICD Conversion and Sensing Interaction Testing is important to complete since the 
detection of LCP pulses by the S-ICD may alter S-ICD sensitivity, resulting in failure of 
the S-ICD to sense a tachyarrhythmia and failure to deliver therapy in the presence of 
pacing by the LCP. 
Conduct an S-ICD Conversion and Sensing Interaction Test to determine the appropriate 
S-ICD tachyarrhythmia sensing while the LCP is pacing (Refer also to Appendix E for a 
flow chart of decision-making for S-ICD Conversion and Sensing Interaction testing).  
Note: It is recommended to conduct the S-ICD Conversion and Sensing Interaction Test 
at implant. However, if the subject is not able to tolerate the test at implant, this testing 
may also be conducted prior to hospital discharge. 
During S-ICD Conversion and Sensing Interaction Testing, it is required that S-ICD 
therapy be programmed on and the EMPOWER PG be programmed to pace in VOO 
mode during the induction. It is recommended that the EMPOWER PG be programmed to 
the intended programmed LRL and 5.0 V @ 1.0 ms pulse width. More information is 
available in the mCRM Modular Therapy System PTM labeling. Following induction of a 
ventricular arrhythmia via the S-ICD, at least one S-ICD shock should be delivered at 
65J.  In the event there is a failure of the S-ICD to detect or convert the arrhythmia, 
professional medical judgment should be used to determine the appropriate course of 
action. 
Induction S-ECG Reports or external ECGs strips are to be retained at the study site, as 
well as uploaded to the EDC System for each induction that results in a shock by the S-
ICD or external defibrillator. Induced episodes that spontaneously convert prior to an S-
ICD shock do not require documentation.   
Shock polarity, shock energy, shock impedance, and conversion outcome must be 
included on the appropriate Technical Source Form or annotated directly on the 
“Induction S-ECG Report”.  
Note that Conversion Testing may also be performed at other times during the study at 
the discretion of the investigator (e.g., following system revision, S-ICD PG changeout). 
It is not required to repeat S-ICD Conversion and Sensing Interaction Tests after the Pre-
Discharge Visit.  
10.3.4.8 Fluoro Imaging of Final Placement for the mCRM Coordinated System 
Once the mCRM Coordinated System is fully implanted, final implant position must be 
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a minimum of the S-ICD electrode and EMPOWER PG in view. Additional images may 
be desirable to document system position and are allowed, but are not required. 
10.3.4.9 mCRM Coordinated System Chest X-Ray 
It is required to document final mCRM Coordinated System position via chest X-ray in 
Posterior/ Anterior and Lateral views. Please note that the S-ICD System and 
EMPOWER PG must be visible in the image. This X-ray may be collected at Implant or 
Pre-Discharge.  
10.3.5 S-ICD Evaluation 
10.3.5.1 S-ICD Summary Report  
It is required to retain the “S-ICD Summary Report” from the programmer, documenting 
initial and final parameter settings, episode counters, etc. 
10.3.5.2 Spontaneous Episodes 
All available “Full S-ECG Report(s)” and “Full S-ECG Report(s) Untreated” (AF 
diagnostic episodes labeled “Full S-ECG Report AF” are not required) not previously 
reported must be obtained and uploaded to BSC via the EDC System. Documentation of 
any symptomatic episodes associated with a spontaneous event will be collected, 
specifically any syncope.  
Note: any spontaneous stored episodes that occurred prior to enrollment should not be 
reported. Justification shall be provided for any missing episodes. 
10.3.6 S-ICD System Programming Considerations 
There are no device programming requirements for the S-ICD or EMPOWER PG at 
implant. Final programming from both devices will be documented in the database. 
10.3.7 mCRM Coordinated System Data and Source Documentation Requirements 
mCRM Coordinated System data and source documentation requirements are listed in 
Table 10-7. 

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Table 10-7: mCRM Coordinated System Implant Source Document Requirements 
Data Collection 
Retention of Original Source 
Documentation 
EMPOWER Programmer Reports: 
- Initial EMPOWER Combined Follow-up Report 
- Interim EMPOWER Combined Follow-up Report for S-
ICD Conversion and Sensing Interaction Testing 
- EMPOWER Real-Time Log Report (to document LOC) 
- Final EMPOWER Combined Follow-up Report 
Study site 
S-ICD Programmer Reports: 
- S-ICD Summary Report from the end of the visit 
- Captured S-ECG Reports from ‘Capture All Sense 
Vectors’ on S-ICD programmer for Paced Morphology 
Sensing Test 
- Full S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable 
- S-ICD Induction S-ECG Report for S-ICD Conversion and 
Sensing Interaction Testing, if performed 
- Shock polarity, shock energy, shock impedance, and 
conversion outcome documented on the Technical Source 
Form or annotated directly on the “Induction S-ECG 
Report” 
Study site; upload copy to BSC 
via study EDC System 
 
Communication Test S-ECG Report(s) 
Study site 
At least one fluoroscopy/ cine image in A/P view to 
document mCRM Coordinated System placement  
Study site, available upon 
request 
Chest x-ray (P/A and Lateral), to document mCRM 
Coordinated System placement, if performed at this visit 
Study site, available upon 
request 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source document 
will be collected on a TSF 
Study site 
10.4 Pre-Discharge Visit  
The Pre-Discharge Visit is to occur after the mCRM Coordinated System is fully 
implanted and prior to the subject’s discharge from the hospital. Note: It is strongly 
recommended the subject be able to sit upright for testing at this visit, which may include 
back support.  

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10.4.1 EMPOWER PG Evaluation 
PCT, Pacing Impedance, and R-wave Amplitude are required to be measured. Collect 
PCT measurements according to Section 10.3.1.7. 
It is required to retain the “Real-Time Log Report” from the programmer, documenting at 
a minimum the LOC portion of the threshold testing (i.e., the lowest voltage setting 
demonstrating capture and the highest voltage setting that fails to capture). This 
documentation will be retained at the study site. 
If more than one set of electrical measurements are recorded, the final set must be used 
for the study. 
It is required to document the following: 
• “%V paced” from the “Combined Follow up Report”,  
•  “Time remaining to EOS” from the “Combined Follow up Report”, 
• “Charge remaining to EOS” documented on the TSF.  
10.4.2 S-ICD Evaluation 
10.4.2.1 S-ICD Sensing Configuration Setup 
Conduct sensing configureation setup as described in the EMBLEM S-ICD/ EMBLEM 
MRI S-ICD User’s Manual. The method of selecting the sensing vector (Automatic Setup 
or manual), as well as the result will be collected on the Pre-Discharge TSF.  
10.4.2.2 S-ICD Summary Report 
It is required to retain the “S-ICD Summary Report” from the programmer, documenting 
initial and final parameter settings, episode counters, battery status, etc. 
10.4.2.3 Spontaneous Episodes 
All available “Full S-ECG Report(s)” and “Full S-ECG Report(s) Untreated” (AF 
diagnostic episodes labeled “Full S-ECG Report AF” are not required) not previously 
reported must be obtained and uploaded to BSC via the EDC System. Documentation of 
any symptomatic episodes associated with a spontaneous event will be collected, 
specifically any syncope.  
Note: any spontaneous stored episodes that occurred prior to enrollment should not be 
reported. Justification shall be provided for any missing episodes. 
10.4.3 mCRM Coordinated System Testing 
10.4.3.1 Communication Threshold Test 
Communication Threshold Testing is required at Pre-Discharge with the subject in an 
upright position.  
Refer to the mCRM PTM, as well as Section 10.3.4.2 to prepare for a Communication 
Threshold Test. Follow Communication Threshold Test methodology in Section 10.3.4.5. 

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Program the communication telemetry output 1 unit above the highest communication 
threshold value from the tested posture, with a minimum Telemetry Setting of 4. For 
example, if the threshold is 5, program the output to 6. 
Note: Short durations of oversensing are normal and expected when S-ICD sensing 
resumes after the communication is sent from the S-ICD. See Appendix C for more 
information.  
Note: If intrinsic rhythm is not present, pacing pulses in response to a communication 
request will not be delivered because a sensed beat is required. 
Since pacing has the potential to interfere with communication, it is recommended to 
select “Off” for the mCRM Communication Test backup pacing setting. However, if the 
subject is pacemaker dependent, configure the backup pacing mode at the lowest pacing 
rate needed for the subject, preferably 50 ppm or lower, for the duration of the 
Communication Test. 
10.4.3.2 Paced Morphology Sensing Test (PMST) 
Perform a PMST as described in Section 10.3.4.6, along with Appendix D.   
10.4.3.3 S-ICD Conversion and Sensing Interaction Testing 
If not performed at Implant, S-ICD Conversion and Sensing Interaction Testing is 
required to be performed at Pre-Discharge. Refer to Section 10.3.4.7.  
10.4.3.4 mCRM Coordinated System Chest X-Ray 
It is required to document final mCRM Coordinated System position via chest X-ray in 
Posterior/ Anterior and Lateral views. Please note that the S-ICD System and 
EMPOWER PG must be visible in the image. This X-ray may be collected at Implant or 
Pre-Discharge.  
10.4.4 mCRM Coordinated System Programming  
Programming parameters for the EMPOWER PG and S-ICD are included in the sections 
below. 
10.4.4.1 EMPOWER PG Programming 
Refer to Table 10-8 for recommended programming of the EMPOWER PG. Pacing 
pulses must be delivered at an adequate safety margin above the PCT. A minimum 2X 
voltage safety margin is recommended based on the PCT. The investigator should refer to 
the Projected Service Life information for the EMPOWER PG in the EMPOWER MPS 
PTM and determine the optimal Pacing Amplitude to meet the needs of the subject while 
maintaining an adequate safety margin. 
Note: Rate responsive pacing modes should not be programmed in the EMPOWER PG 
unless appropriate sensing of both paced and intrinsic beats is observed; refer to Section 
10.4.3.3.  

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Print out a copy of the final “Combined Follow-up Report” and a copy of the “S-ICD 
Summary Report”. Once all study activities are completed at the end of the visit, reset the 
EMPOWER PG brady counters/ histograms and tachy counters. 
Table 10-8: EMPOWER PG Programming 
EMPOWER PG Programming  
 (all Recommended programming, except where noted with *) 
Parameter 
Programming 
Safety Margin 
2X PCT voltage  
Pacing Mode 
VVI* 
Lower Rate Limit 
LRL should be programmed <1/3 of the lower bound of 
the conditional shock zone i.e., if Conditional Shock Zone 
= 180, Program LRL <60  
mCRM Communication 
On 
ATP Type 
Burst or Scan 
ATP Coupling Interval 
88%24,25 (Primary Prevention; no specific 
recommendation for Secondary Prevention) 
Pulses per Burst 
Per physician discretion, programmable at 5, 6, 8, or 10 
(10 is nominal) 
* The EMPOWER PG should not be programmed to the VVIR brady mode unless appropriate S-ICD 
sensing of both paced and intrinsic beats is observed; refer to Section 10.4.3.3 
10.4.4.2 S-ICD Programming 
Therapy zone and ATP settings are recommended to be programmed per Table 10-9 for 
primary prevention subjects and Table 10-10 for secondary prevention subjects. All other 
programming parameters (e.g., sensing vector, gain) are left to the discretion of the 
investigator. Rationale for not following the recommended programming parameters will 
be collected. 
Table 10-9: S-ICD Programming for Primary Prevention Subjects 
S-ICD Programming for Primary Prevention Subjects 
 (all Recommended programming, except where noted) 
Therapy Zone 
Rate 
ATP Parameters 
Conditional Shock Zone 
180-230 bpm26 
At least 1 ATP request Required; up to 3 
acceptable (ATP scheme is per physician 
discretion) 
Shock Zone 
>230 bpm 
Quick Convert ATP ON 
 
24 Stiles, Martin K., et. al 2019 HRS/EHRA/APHRS/LAHRS focused update to 2015 expert consensus statement on 
optimal implantable cardioverter-defibrillator programming and testing. Heart Rhythm 2019;17:220–228) 
25 Wilkoff BL, Fauchier L, Stiles MK, et al. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on 
optimal implantable cardioverter-defibrillator programming and testing. Europace. 2016 Feb;18(2):159-83 
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Table 10-10: S-ICD Programming for Secondary Prevention Subjects 
S-ICD Programming for Secondary Prevention Subjects 
 (all Recommended programming, except where noted) 
Therapy Zone 
Rate 
ATP 
Conditional Shock Zone 
Physician 
Discretion27 
At least 1 ATP request Required; up to 3 
acceptable (ATP scheme is per physician 
discretion) 
Shock Zone 
Physician 
Discretion 
Quick Convert ATP ON 
Note: As stated in the mCRM PTM, post-shock pacing interaction with LCP pacing could 
generate a ventricular arrhythmia. Do not program post-shock pacing On in the S-ICD if 
the LCP is programmed to a pacing mode.  
10.4.5 Pre-Discharge Source Documentation Requirements 
Pre-discharge data and source documentation requirements are listed in Table 10-11. 
 
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Table 10-11: Pre-Discharge Source Document Requirements 
Data Collection 
Retention of Original Source 
Documentation 
EMPOWER Programmer Reports: 
- Initial EMPOWER Combined Follow-up Report 
- Interim EMPOWER Combined Follow-up Report for S-ICD 
Conversion and Sensing Interaction Testing, if performed 
- EMPOWER Real-Time Log Report (to document loss of 
capture) 
- Final EMPOWER Combined Follow-up Report 
Study site 
S-ICD Programmer Reports: 
- S-ICD Summary Report from the end of the visit  
- Captured S-ECG Reports from ‘Capture All Sense 
Vectors’ on S-ICD programmer for Paced Morphology 
Sensing Test  
- Full S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable 
- S-ICD Induction S-ECG Report for S-ICD Conversion and 
Sensing Interaction Testing, if performed 
- Shock polarity, shock energy, shock impedance, and 
conversion outcome documented on the Technical Source 
Form or annotated directly on the “Induction S-ECG 
Report” 
Study site; upload copy to BSC 
via study EDC System 
Communication (Threshold) Test S-ECG Report(s) 
Study site 
Chest x-ray (P/A and Lateral), to document mCRM 
Coordinated System placement, if performed at this visit 
Study site 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source document 
will be collected on a TSF 
Study site 
10.5 1 Month Visit: (10 days – 42 days post-Coordinated System Implant) 
The 1 Month Visit must be performed as a clinic visit between 10 and 42 days after the 
mCRM Coordinated System is implanted.  
10.5.1 EMPOWER PG Evaluation 
PCT, Pacing Impedance, and R-wave Amplitude are required to be measured. Collect 
PCT measurements according to Section 10.3.1.7.  

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It is required to retain the “Real-Time Log Report” from the EMPOWER programmer, 
documenting at a minimum the LOC portion of the threshold testing (i.e., the lowest 
voltage setting demonstrating capture and the highest voltage setting that fails to capture). 
This documentation will be retained at the study site. 
If more than one set of electrical measurements are recorded, the final set must be used 
for the study. 
It is required to document the following: 
• “%V paced” from the “Combined Follow up Report”,  
•  “Time remaining to EOS” from the “Combined Follow up Report”, 
• “Charge remaining to EOS” documented on the TSF. 
10.5.2 S-ICD Evaluation 
10.5.2.1 S-ICD Summary Report 
It is required to retain the “S-ICD Summary Report” from the programmer, documenting 
initial and final parameter settings, episode counters, battery status, etc. Note whether 
MRI Protection Mode was programmed “On” since the Pre-Discharge Visit; if it was, 
report this in eDC in the Medically Necessary MRI Scan page.  
Any changes to the sensing vector will be documented in EDC. The method by which the 
change was determined will be documented on the visit-specific TSF.  
10.5.2.2 Spontaneous episodes 
All available “Full S-ECG Report(s)” and “Full S-ECG Report(s) Untreated” (AF 
diagnostic episodes labeled “Full S-ECG Report AF” are not required) not previously 
reported must be obtained and uploaded to BSC via the EDC System. Documentation of 
any symptomatic episodes associated with a spontaneous event will be collected, 
specifically any syncope.  
Note: any spontaneous stored episodes that occurred prior to enrollment should not be 
reported. Justification shall be provided for any missing episodes. 
10.5.3 mCRM Coordinated System Testing 
10.5.3.1 Four-Posture Communication Threshold Test  
Perform Communication Threshold Testing in each of the 4 postures included in Figure 
10-1. It is recommended to test postures in the order presented in Figure 10-1. Document 
the order of postures on the appropriate Technical Source Form.  
 
 

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Figure 10-1: Recommended Order of Postures for Four-Posture Communication 
Threshold Test 
10.5.3.2 Communication Threshold Test  
Communication Threshold Testing is required at the 1 Month Visit with the subject in 
each posture noted in Figure 10-1.  
Refer to the mCRM PTM, as well as Section 10.3.4.2 to prepare for a Communication 
Threshold Test. Follow Communication Threshold Test methodology in Section 10.3.4.5. 
All required testing should be completed in the selected posture before changing to 
another posture. 
Program the communication telemetry output 1 unit above the highest communication 
threshold value among all tested posture(s), with a minimum Telemetry Setting of 4. For 
example, if the threshold is 5, program the output to 6. 
Note: Short durations of oversensing are normal and expected when S-ICD sensing 
resumes after the communication is sent from the S-ICD. See Appendix C for more 
information.  
Note: If intrinsic rhythm is not present, pacing pulses in response to a communication 
request will not be delivered because a sensed beat is required. 
Note: Since pacing has the potential to interfere with communication, it is recommended 
to select Off for the mCRM Communication Test backup pacing setting. However, if the 
subject is pacemaker dependent, configure the backup pacing mode at the lowest pacing 
rate needed for the subject, preferably 50 ppm or lower, for the duration of the 
Communication Test. 
10.5.4 mCRM Coordinated System Programming  
Recommended programming parameters for the EMPOWER PG and S-ICD are included 
in Sections 10.4.4.1 and 10.4.4.2, respectively. 
Print out a copy of the final “Combined Follow-up Report” and a copy of the “S-ICD 
Summary Report”. Once all study activities are completed at the end of the visit, reset the 
EMPOWER PG brady counters/ histograms and tachy counters. 
10.5.5 Holter Substudy 
To demonstrate adequate performance of the EMPOWER PG, a subset of subjects 
enrolled in the MODULAR ATP Clinical Study (approximately the first 50 subjects 
enrolled in the study, at select sites) will undergo Holter monitoring. This will include up 

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to 30 minutes of pacing prior to continuing to wear the Holter monitor to provide an ECG 
recording ranging from 16 to 24 hours. The investigator should enroll subjects 
sequentially from the start of the clinical study but should use medical discretion in 
selecting subjects for participation in the Holter monitoring. Therefore, it is not a protocol 
deviation if the Holter monitoring is not performed on consecutive subjects.  
Holter monitoring equipment capable of recording continuously for 24 hours will be 
provided to select study sites participating in this substudy. Participating subjects will be 
provided with Holter monitoring equipment and instructions on their use, as well as 
instruction on returning the Holter monitor. A summary report of the EMPOWER PG 
performance and Holter data findings (e.g., pause, inappropriate sensing, LOC) will be 
provided by the core lab to the study site and to BSC within a mutually established 
timeframe. 
10.5.5.1 25-35 Minute Pacing  
Subjects in the MODULAR ATP Clinical Study are not expected to need a high level of 
pacing. Therefore, participating subjects will have a 30±5-minute pacing period prior to 
finalizing the 1-month follow-up. 
After the Holter is applied, and prior to the end of the visit, 30±5 minutes of pacing will 
be collected. Determine the subject’s intrinsic rate, and program LRL to approximately 5-
10ppm above the intrinsic rate, with EMPOWER in VVI. Investigator discretion and/or 
the subject’s tolerance of pacing should be considered when choosing the LRL or 
adjusting it after pacing has started. The subject should be instructed to sit calmly for 
30±5 minutes. Document the time of programming the higher LRL, and time of 
programming the LRL back to the intended programmed value. The investigator has the 
discretion to stop the pacing early due to subject condition; the rationale for early 
stopping will be collected.  
10.5.5.2 16 to 24 Hour Holter Monitoring 
Complete data recording consisting of at least 16 hours of usable data from a minimum of 
25 subjects are required, and it is expected that an enrollment of 50 subjects will be 
sufficient to provide the minimum number of datasets required. Once BSC determines 
that the requirement of 25 usable datasets is met, Holter substudy sites will be notified 
that the Holter monitoring is no longer needed for any additional subjects and the Holter 
monitoring part of the clinical study will be completed. 

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10.5.6 1 Month Visit Source Documentation Requirements 
The 1 Month Visit data and source documentation requirements are listed in Table 
10-12. 
Table 10-12: 1 Month Visit Source Document Requirements 
Data Collection 
Retention of Original Source 
Documentation 
EMPOWER Programmer Reports: 
- Initial EMPOWER Combined Follow-up Report 
- EMPOWER Real-Time Log Report (to document loss 
of capture) 
- Final EMPOWER Combined Follow-up Report 
Study site 
S-ICD Programmer Reports: 
- S-ICD Summary Report from the end of the visit 
- Full S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable28 
Study site; upload copy to BSC 
via study EDC system 
- Communication (Threshold) Test S-ECG Reports  
- Order of postures tested documented on TSF  
Study site 
Holter Substudy: 
- (Clock) Time of programming to LRL +5-10ppm above 
intrinsic 
- (Clock) Time of programming to intended LRL 
- Information regarding the Holter monitor 
distribution, and return 
- Information regarding submission to the core lab 
Study site 
Holter monitoring report and ECG strips 
Core lab; a report copy is sent 
to BSC 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source 
document will be collected on a TSF 
Study site 
 
 

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10.6 Rate Response Substudy (3 Month Visit (90±15 Days Post-implant))  
The 3 Month Visit is only for those in the Rate Response Substudy and must be 
performed as a clinic visit between 90±15 days after the mCRM Coordinated System is 
implanted.  
A subset of enrolled subjects (up to 59 subjects enrolled earlier in the trial, and preferably 
sequential enrollments at selected sites) at approximately 15-20 selected study sites with 
treadmill equipment and facility will complete an assessment of the Rate Response 
function of the EMPOWER PG. The investigator will review physical capabilities and 
clinical condition of enrolled subjects, as well as their willingness to perform and 
complete the Treadmill Walk protocol. This must include an evaluation of any clinical 
condition that predisposes the subject to higher risk of developing symptoms during the 
Treadmill Walk. A list of potential risks is described in Section 18.5. It is not a deviation 
if participation is from non-consecutive subjects at the selected Rate Response Substudy 
site.  
Usable datasets from 35 subjects are required to support Secondary Effectiveness 
Endpoint 2, and it is expected that an enrollment up to 59 subjects will be sufficient to 
provide the minimum number of datasets required. BSC will notify participating study 
sites once a sufficient number of datasets are obtained and additional Rate Response 
testing subjects are no longer needed. 
The Rate Response Substudy may consist of some or all of the following: 
• Tachometer Functionality Test 
• Initial Response Factor Set-up and Selection  
• Treadmill Walk  
• Hall Walk 
Specific information about each of these steps is included in the Rate Response Substudy 
strategy document (Document 92614291, provided separately).  
10.6.1 Paced Morphology Sensing Test (PMST) 
If the patient is to be programmed to VVIR after testing, consider performing a PMST as 
described in Section 10.3.4.6, along with Appendix D.   
10.6.2 Rate Response Substudy Source Documentation Requirements 
Refer to Table 10-13 for a list source documentation for the Rate Response Substudy and 
retention requirements. 
 
28 Note that AF diagnostic episodes labelled “Full S-ECG Report AF” are NOT required. 

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Table 10-13:  Rate Response Substudy Source Data 
Data Collection 
Retention of Original Source 
Documentation 
EMPOWER Programmer Reports: 
- Initial EMPOWER Combined Follow-up Report 
- EMPOWER Real-Time Log Report from PCT (to 
document loss of capture) 
- Interim Combined Follow-up Report(s) as described 
in Doc# 92614291 to document sequential 
programming changes 
- Captured S-ECG Reports from ‘Capture All Sense 
Vectors’ on S-ICD programmer for Paced Morphology 
Sensing Test, if performed 
- Final EMPOWER Combined Follow-up Report 
Study site 
S-ICD Programmer Reports: 
- Initial Summary Report 
- Full S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable29 
- Interim Summary Reports as described in Doc 
92614291 as needed to document sequential 
programming changes 
- Final Summary Report  
Study site 
Rate Response Testing: 
- Rate Response testing data recorded on the TSF 
including but not limited to handlebar usage and 
timing of blood pressure measurements 
- Reports from EMPOWER Programmer, as required, 
which may include Real-time Log, Combined Follow-
up, and Sensor Trending saved on USB following the: 
- Tachometer Functionality Test 
- Initial Response Factor Set-up 
- Treadmill Walk 
- Hall Walk  
Study site: 
- TSF 
- Copy of USB files 
BSC: 
-USB with associated files 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source 
document will be collected on a TSF 
Study site 
 
 
29 Note that AF diagnostic episodes labelled “Full S-ECG Report AF” are NOT required. 

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10.7 6 Month Visit (180 days ± 30 days Post-system Implant) 
The 6 Month Visit must be performed as a clinic visit between 180 ± 30 days after the 
mCRM Coordinated System is implanted.  
10.7.1 EMPOWER PG Evaluation 
PCT, Pacing Impedance, and R-wave Amplitude are required to be measured. Collect 
PCT measurements according to Section 10.3.1.7. 
It is required to retain the “Real-Time Log Report” from the programmer, documenting at 
a minimum the LOC portion of the threshold testing (i.e., the lowest voltage setting 
demonstrating capture and the highest voltage setting that fails to capture). This 
documentation will be retained at the study site. 
If more than one set of electrical measurements are recorded, the final set must be used 
for the study. 
It is required to document the following: 
• “%V paced” from the “Combined Follow up Report”,  
•  “Time remaining to EOS” from the “Combined Follow up Report”, 
• “Charge remaining to EOS” documented on the TSF. 
10.7.2 S-ICD Evaluation 
10.7.2.1 S-ICD Summary Report 
It is required to retain the “S-ICD Summary Report” from the programmer, documenting 
initial and final parameter settings, episode counters, battery status, etc. Note whether 
MRI Protection Mode was programmed “On” since the previous protocol-required visit; 
if it was, report this in EDC in the Medically Necessary MRI Scan page. 
10.7.2.2 Spontaneous Episodes 
All available “Full S-ECG Report(s)” and “Full S-ECG Report(s) Untreated” (AF 
diagnostic episodes labeled “Full S-ECG Report AF” are not required) not previously 
reported must be obtained and uploaded to BSC via the EDC System. Documentation of 
any symptomatic episodes associated with a spontaneous event will be collected, 
specifically any syncope. Justification shall be provided for any missing episodes. 
10.7.3 mCRM Coordinated System Testing 
10.7.3.1 Four-Posture Communication Test  
Perform communication testing in each of the 4 postures included in Figure 10-2, It is 
recommended to test postures in the order presented in Figure 10-2. Document the order 
of postures on the appropriate Technical Source Form. 
 
 

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Figure 10-2: Recommended Order of Postures for Four-Posture Communication 
Test 
10.7.3.2 Communication Test  
A single Communication Test is required to be performed at the initial programmed 
Telemetry Setting in each of the four postures noted in Figure 10-2. In the event that 
multiple communication tests are performed within a posture, only the first 
Communication Test S-ECG Report obtained at the initial programmed Telemetry Setting 
will serve as the source document for the endpoint. All required testing should be 
completed in the selected posture before changing to another posture. 
In the event of a communication failure in one or more of the four postures during the 
single test, perform a Communication Threshold Test (described in Section 10.3.4.5) in 
the posture(s) of communication failure. Use the highest value to program the Telemetry 
Setting output 1 unit above threshold among all tested posture(s). For example, if the 
threshold is 5, program the output to 6. 
Note: Short durations of oversensing are normal and expected when S-ICD sensing is re-
started after the communication is sent from the S-ICD. See Appendix C for more 
information. 
Note: If the next cardiac event observed by the EMPOWER PG following its successful 
receipt of the communication signal from the S-ICD is not an intrinsic signal (i.e., if the 
next cardiac event is a brady pacing pulse delivered at the temporary LRL chosen for the 
communication test), then the EMPOWER PG will intentionally withhold ATP pulses. In 
the event that this occurs (as can be confirmed from the Communication Test S-ECG 
Report), repeat the Communication Test using the same settings and use the results from 
this test as the official result. 
10.7.4 mCRM Coordinated System Programming 
Recommended programming parameters for the EMPOWER PG and S-ICD are included 
in Sections 10.4.4.1 and 10.4.4.2, respectively. 
Print out a copy of the final “Combined Follow-up Report” and a copy of the “S-ICD 
Summary Report”. Once all study activities are completed at the end of the visit, reset the 
EMPOWER PG brady counters/ histograms and tachy counters. 
10.7.5 6 Month Visit Source Documentation Requirements 
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Table 10-14: 6 Month Visit Data Collection Requirements 
Data Collection 
Retention of Original Source 
Documentation 
EMPOWER Programmer Reports: 
- Initial EMPOWER Combined Follow-up Report 
- EMPOWER Real-Time Log Report (to document LOC) 
- Final EMPOWER Combined Follow-up Report 
Study site 
S-ICD Programmer Reports: 
- S-ICD Summary Report from the end of the visit 
- Full S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable30 
Study site; upload copy to BSC 
via study EDC system 
- Communication Test S-ECG Reports, including 
Communication Test (Threshold) S-ECG Reports, if 
conducted 
- Order of postures tested documented on TSF  
Study site 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source 
document will be collected on a TSF 
Study site 
10.8 Semi-Annual Visits  
Semi-Annual Visits are required to be conducted as clinic visits for MODULAR ATP 
subjects, starting at 12 months post mCRM Coordinated System implant and continuing 
until study closure. Note subjects are required to be followed until the last enrolled 
subject is followed for at least 24 months post mCRM Coordinated System implant. 
Timing of the Semi-Annual Visits is based on the date the mCRM Coordinated System 
was fully implanted: 
• 12 Month: 360±45d 
• 18 Month: 540±45d 
• 24 Month: 720±45d 
• 30 Month: 900±45d 
• 36 Month: 1080±45d 
• Etc, until BSC notification of follow-up completion 
 
30 Note that AF diagnostic episodes labelled “Full S-ECG Report AF” are NOT required. 

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10.8.1 EMPOWER PG Evaluation 
PCT, Pacing Impedance, and R-wave Amplitude are required to be measured. Collect 
PCT measurements according to Section 10.3.1.7. 
It is required to retain the “Real-Time Log Report” from the programmer, documenting at 
a minimum the LOC portion of the threshold testing (i.e., the lowest voltage setting 
demonstrating capture and the highest voltage setting that fails to capture). This 
documentation will be retained at the study site. 
If more than one set of electrical measurements are recorded, the final set must be used 
for the study. 
It is required to document the following: 
• “%V paced” from the “Combined Follow up Report”,  
•  “Time remaining to EOS” from the “Combined Follow up Report”, 
• “Charge remaining to EOS” documented on the TSF. 
10.8.2 S-ICD Evaluation 
10.8.2.1 S-ICD Summary Report 
It is required to retain the “S-ICD Summary Report” from the programmer, documenting 
initial and final parameter settings, episode counters, battery status, etc. Note whether 
MRI Protection Mode was programmed “On” since the previous protocol-required visit; 
if it was, report this in eDC in the MRI Scan page. 
10.8.2.2 Spontaneous Episodes 
All available “Full S-ECG Report(s)” and “Full S-ECG Report(s) Untreated” (AF 
diagnostic episodes labeled “Full S-ECG Report AF” are not required) not previously 
reported must be obtained and uploaded to BSC via the EDC System. Documentation of 
any symptomatic episodes associated with a spontaneous event will be collected, 
specifically any syncope. Justification shall be provided for any missing episodes. 
10.8.3 Communication Test in One Posture  
A single Communication Test is required to be performed at the initial programmed 
telemetry value with the subject in one selected posture. The upright posture shown in 
Figure 10-2 is recommended, but the posture to be used is at the physician’s discretion. 
For example, a different posture might be appropriate for subjects in which the highest 
mCRM communication threshold has been observed for a different posture or for subjects 
that have experienced ambulatory VT events in another posture. The actual posture tested 
must be recorded. In the event that multiple communication tests are performed within the 
selected posture, only the first “Communication Test S-ECG Report” obtained at the 
initial programmed Telemetry Setting value will serve as the source document for the test. 
Refer to the mCRM PTM, as well as Section 10.3.4.2 to prepare for a Communication 
Test. Follow Communication Test methodology in Section 10.3.4.4.  
In the event of a communication failure in the selected posture during the single test, 
perform a Communication Threshold Test in the selected posture; refer to Section 

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10.3.4.5. Use the resulting value from that test to program the Telemetry Setting output 1 
unit above threshold. For example, if the threshold is 5, program the output to 6. 
10.8.4 mCRM Coordinated System Programming 
Therapy zone and ATP settings are to be programmed per Table 10-9 for primary 
prevention subjects and Table 10-10 for secondary prevention subjects. All other 
programming parameters (e.g., sensing vector, gain) are left to the discretion of the 
investigator. Rationale for not following the recommended programming parameters will 
be collected. 
Recommended Programming Parameters for the EMPOWER PG and S-ICD are included 
in Sections 10.4.4.1 and 10.4.4.2, respectively. 
Print out a copy of the final “Combined Follow-up Report” and a copy of the “S-ICD 
Summary Report”. Once all study activities are completed at the end of the visit, reset the 
EMPOWER PG brady counters/ histograms and tachy counters. 
10.8.5 Semi-Annual Visit Source Documentation Requirements 
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Table 10-15: Semi-Annual Visit Data Collection Requirements 
Data Collection 
Retention of Original Source 
Documentation 
EMPOWER Programmer Reports: 
- Initial EMPOWER Combined Follow-up Report 
- EMPOWER Real-Time Log Report (to document loss 
of capture) 
- Final EMPOWER Combined Follow-up Report 
Study site 
S-ICD Programmer Reports: 
- S-ICD Summary Report from the end of the visit 
- Full S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable31 
Study site; upload copy to BSC 
via study EDC system 
Communication Test S-ECG Report(s), including 
Communication Test (Threshold) S-ECG Reports, if 
conducted 
Study site 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source 
document will be collected on a TSF 
Study site 
10.9 Additional Visits 
Additional Visits must be collected if they are associated with a reportable adverse 
event,32 spontaneous episode, or device deficiency. Routinely scheduled office visits for 
purposes other than these events, do not require Additional Visit forms to be completed. 
In the event of an adverse event related to communication of the mCRM Coordinated 
System, a Communication Test, and possibly a Communication Threshold Test (as 
described in Section 10.8.3) is required. In the event of an adverse event related to the 
EMPOWER device, an evaluation of that device is required as described in Section 
10.3.1.7. 
10.9.1 EMPOWER PG Evaluation 
Device evaluation is optional at these visits. If performed, collect PCT measurements 
according to Section 10.3.1.7, except that a pulse width of 0.4 ms is recommended. 
It is required to document the following: 
 
31 Note that AF diagnostic episodes labelled “Full S-ECG Report AF” are NOT required. 
32 Refer to Section 25.2 for definition of reportable adverse event 

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• “%V paced” from the “Combined Follow up Report”,  
•  “Time remaining to EOS” from the “Combined Follow up Report”, 
• “Charge remaining to EOS” documented on the TSF. 
10.9.2 S-ICD Evaluation 
10.9.2.1 S-ICD Summary Report 
It is required to retain the “S-ICD Summary Report” from the programmer, documenting 
initial and final parameter settings, episode counters, battery status, etc. Note whether 
MRI Protection Mode was programmed “On” since the previous protocol-required visit; 
if it was, report this in eDC in the MRI Scan page. 
10.9.2.2 Spontaneous Episodes 
All available “Full S-ECG Report(s)” and “Full S-ECG Report(s) Untreated” (AF 
diagnostic episodes labeled “Full S-ECG Report AF” are not required) not previously 
reported must be obtained and uploaded to BSC via the EDC System. Documentation of 
any symptomatic episodes associated with a spontaneous event will be collected, 
specifically any syncope.  
Note: any spontaneous stored episodes that occurred prior to enrollment should not be 
reported. Justification shall be provided for any missing episodes. 
Print out a copy of the final “Combined Follow-up Report” and a copy of the “S-ICD 
Summary Report”. Once all study activities are completed at the end of the visit, reset the 
EMPOWER PG brady counters/ histograms and tachy counters. 
10.9.3 Additional Visit Source Documentation Requirements 
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Table 10-16: Additional Visit Data Collection Requirements 
Data Collection 
Retention of Original Source 
Documentation 
EMPOWER Programmer Reports: 
- Initial EMPOWER Combined Follow-up Report 
- EMPOWER Real-Time Log Report (to document loss 
of capture), if applicable 
- Final EMPOWER Combined Follow-up Report 
Study site 
S-ICD Programmer Reports: 
- S-ICD Summary Report 
- FULL S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable33 
Study site; upload copy to BSC 
via study EDC system 
Communication Test S-ECG Report(s), if applicable, 
including Communication Test (Threshold) S-ECG 
Reports, if conducted 
Study site 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source 
document will be collected on a TSF 
Study site 
10.10 Medically Necessary MRI Scans 
During the MODULAR ATP Clinical Study, if a subject requires a medically necessary 
MRI scan, BSC recommends the subject be directed to have the scan at the study site. 
The investigational EMPOWER PG is MR Conditional during the course of the clinical 
study, as is the mCRM System. Labeled recommendations for device testing included in 
relevant PTMs will be collected in the MODULAR ATP Clinical Study, as well as any 
adverse events that may occur. Refer to “mCRM and EMPOWER MRI Tech Guide” for 
the Conditions of Use for the mCRM System, and programming recommendations for the 
EMPOWER PG. Refer to the S-ICD MRI Tech Guide for programming guidance for the 
S-ICD during the scan.  
Based on the PTMs listed above, collect the following data prior to and after the MRI 
Scan:  
• PCT (refer to Section 10.3.1.7), pace impedance, and sensed amplitude from the 
EMPOWER PG  
 
33 Note that AF diagnostic episodes labelled “Full S-ECG Report AF” are NOT required. 

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• Communication Test in a single posture (refer to Section 10.3.4.2 and Section 
10.3.4.4). It is recommended to use the same posture for the pre- and post-MRI 
scan Communication Test.  
• PMST (refer to Section 10.3.4.6) 
Interrogation of the EMPOWER PG, Model B170, requires a programmer with 
Programmer Software Model 3870 or newer, as well as Conducted Telemetry 
Cables, Model 6396, both of which are investigational during all, or part of the 
MODULAR ATP Clinical Study. Conducted telemetry cables, Model 6396, are only 
available for use by trained study personnel (ie, BSC personnel or trained site personnel). 
Therefore, trained study personnel (ie, BSC personnel or trained site personnel) will need 
to be present any time the investigational EMPOWER PG, Model B170, is interrogated. 
This will continue to be a requirement during the MODULAR ATP Clinical Study 
until the EMPOWER PG is approved for commercial release per study geography. 
Furthermore, should the MRI scan occur at a facility that is not an investigational 
site, then the use of the Model 3870 software will be reported by the BSC 
representative.  
Access to mCRM Coordinated System programming requires a device-specific PIN. 
Each PIN is specific to the subject’s S-ICD PG serial number, and a trained BSC 
representative or trained site personnel may obtain the number by contacting BSC 
Technical Services in the U.S. for sites in North America, and BSC Technical Services in 
the EU for sites in Europe and the United Kingdom. 
10.10.1Medically Necessary MRI Scan Source Documentation Requirements 
Data and source documentation requirements for medically necessary MRI scans are 
listed in Table 10-17.  

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Table 10-17: Medically Necessary MRI Scan Visit Data Collection and Source 
Documentation Requirements 
Data Collection 
Retention of Original Source 
Documentation 
EMPOWER Programmer Reports: 
- Initial EMPOWER Combined Follow-up Report 
- Interim Combined Follow-up Report with MRI 
settings documented (based on the mCRM and 
EMPOWER MRI Tech Guide) 
- EMPOWER Real-Time Log Report (to document LOC 
prior to and after MRI scan) 
- Final EMPOWER Combined Follow-up Report 
Study site 
 S-ICD Programmer Reports: 
- S-ICD Summary Report showing MRI Protection 
Mode programming 
- S-ICD Summary Report After the MRI Scan 
- Full S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable34 
Study site; upload copy to BSC 
via study EDC system  
Communication Test S-ECG Reports 
Study site 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source 
document will be collected on a TSF 
Study site 
10.11 LATITUDE Monitoring  
Subjects may be followed using the LATITUDE™ NXT Patient Management System 
from the time they are implanted with the S-ICD System. Note that LATITUDE 
surveillance of the EMPOWER PG will not be available during the study.  
Spontaneous episodes can be collected via the LATITUDE NXT System, if applicable, 
but this does not replace the Semi-Annual in-clinic visits, nor does it replace the 
requirement to upload all device episodes in the study database. Required MODULAR 
ATP Clinical Study follow ups cannot be substituted with a LATITUDE remote follow 
up. 
 
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10.12 Revisions, Replacements and Explants 
If the S-ICD electrode, S-ICD PG, and/or EMPOWER PG are surgically revised, 
explanted, or removed from service after the initial implant procedure, or the S-ICD PG, 
EMPOWER PG is permanently programmed off, or disabled, the associated Device 
Tracking Form is used to record changes to the system, including rationale for the change.  
Subjects with the EMPOWER PG or S-ICD with clinical firmware implanted will 
continue to be followed in the study. Subjects undergoing explant of the mCRM 
Coordinated System must be followed at least 30 days post-explant (either in-clinic or 
phone contact) to assure there are no associated adverse events, or to assure the resolution 
of any adverse events associated with the explant. These subjects must be withdrawn 
from the study after satisfying the follow-up period of at least 30 days; refer to Section 
9.5 for more information on study withdrawal.  
If the EMPOWER PG is retrieved, procedure times of the device retrieval including 
fluoroscopy time, sheath in/out times, and retrieval catheter in/out times, as well as the 
outcome of the retrieval procedure will be collected. The explanted EMPOWER PG must 
be returned to BSC for returned product analysis. A copy of the Combined Follow-up 
Report from the programmer before the EMPOWER PG is taken out of service or 
explanted should be obtained. If the S-ICD with clinical firmware is explanted, it must be 
returned to BSC for returned product analysis. A copy of the S-ICD Summary Report 
before the S-ICD is taken out of service or explanted should be obtained. Table 10-18 
lists the data required for system revisions. 
Document any subsequent implant of another EMPOWER PG or S-ICD, regardless 
whether the previous EMPOWER PG is explanted or not, on the appropriate eCRF. These 
subjects should continue with the original follow-up schedule established using the initial 
Time 0.  
Regardless of which device is revised or replaced, collect the following data.  
10.12.1 EMPOWER PG Evaluation  
PCT, Pacing Impedance, and R-wave Amplitude are required to be measured. Collect 
PCT measurements according to Section 10.3.1.7.  
It is required to retain the “Real-Time Log Report” from the EMPOWER PG 
programmer, documenting at a minimum the LOC portion of the threshold testing (i.e., 
the lowest voltage setting demonstrating capture and the highest voltage setting that fails 
to capture). This documentation will be retained at the study site. 
If more than one set of electrical measurements are recorded, the final set must be used 
for the study. 
10.12.2 S-ICD Evaluation 
It is required to retain the “S-ICD Summary Report” from the programmer, documenting 
initial and final parameter settings, episode counters, etc.  

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10.12.3 mCRM Coordinated System Programming 
Recommended programming parameters for the EMPOWER PG and S-ICD are included 
in Sections 10.4.4.1 and 10.4.4.2, respectively. 
Print out a copy of the final “Combined Follow-up Report” and a copy of the “S-ICD 
Summary Report”. Once all study activities are completed at the end of the visit, reset the 
EMPOWER PG brady counters/ histograms and tachy counters. 
10.12.4 Revisions, Replacements, and Explants Data and Source Documentation 
Requirements 
Data and source documentation requirements for revisions, replacements, and explants 
are listed in Table 10-18. 
Table 10-18: Revisions, Replacements, and Explants Data and Source 
Documentation Requirements 
10.13 Study Completion 
All subjects enrolled in the MODULAR ATP Clinical Study will be followed per the 
defined follow-up schedule until they withdraw from the study or until BSC notifies study 
sites of follow-up completion for the study. Subjects will receive standard of care by their 
 
35 Note that AF diagnostic episodes labelled “Full S-ECG Report AF” are NOT required. 
Data Collection 
Retention of Original Source 
Documentation 
- Newly implanted product and accessories utilized for 
S-ICD System (model/serial/lot/batch/etc.), if applicable 
- Newly implanted product and accessories utilized for 
the EMPOWER MPS (model/serial/lot/batch/etc.), if 
applicable 
Study site 
S-ICD Programmer Printouts: 
- S-ICD Summary Report 
- Full S-ECG Report(s) Treated, if applicable 
- Full S-ECG Report(s) Untreated, if applicable35 
Study site; upload copy to BSC 
via study EDC System 
- Chest x-ray (P/A and Lateral), to document mCRM 
Coordinated System placement 
- Fluoro or cine images of EMPOWER PG final position 
Study site 
Reportable Adverse Events, Device Deficiencies, and 
Protocol Deviations, if applicable 
Study site 
Data items that do not have an original source 
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physician after their study participation is completed. Refer to Section 9.8 for more 
information.  
10.14 Source Documents 
It is preferable that original source documents are maintained, when available. In lieu of 
original source documents, certified copies are required to be maintained. A certified 
copy is a copy (irrespective of the type of media used) of the original record that has been 
verified (i.e., by a dated signature or by generation through a validated process) to have 
the same information, including data that describe the context, content, and structure, as 
the original.  
11 Statistical Considerations 
11.1 MODULAR ATP Clinical Study Endpoints  
Each MODULAR ATP Clinical Study endpoint will describe which subjects are eligible 
for inclusion in the analysis of that endpoint. 
11.1.1 Safety Endpoint 1: Major EMPOWER MPS System- and Procedure-related 
Complication-Free Rate from Implant through 6 Months Post-Implant 
Safety Endpoint 1 will be assessed for subjects who undergo any portion of the 
EMPOWER PG implant procedure. Safety will be confirmed by evaluating the Major 
EMPOWER MPS-related Complication-free rate (CFR) between the EMPOWER PG 
implant procedure date and 180 days (6 months) post-implant procedure date. For the 
purpose of this endpoint, a major EMPOWER MPS-related complication will be defined 
as those complications that are related to the EMPOWER MPS (pacemaker and/or 
delivery catheter), or its implant procedure and that are identified as major complications. 
Major complications are defined as those adverse events resulting in:  
• Death 
• Permanent loss of device (EMPOWER PG) function due to mechanical or electrical 
dysfunction of the device (e.g., pacing function disabled, leaving device abandoned 
electrically) 
• Hospitalization36 
• Prolonged Hospitalization by at least 48 hours37 
• System revision (reposition, replacement, explant). 
At a minimum all complications that the study site reports as EMPOWER MPS-related 
will be adjudicated by an external committee to identify events that will meet the 
endpoint definition. Major complications that are determined to be related to the 
EMPOWER PG or its implant procedure by the external committee will be considered  
 
36 Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational 
plan, without serious deterioration in health, is not considered a serious adverse event or Major 
complication. 
37 Hospitalization is extended by ≥48 hours beyond expected hospital discharge (from implant or hospital 
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major EMPOWER MPS-related complications and will count against this endpoint. For 
the purpose of this endpoint, the adjudication of the CEC will be used.  
11.1.1.1 Hypotheses 
The following hypotheses will be used to evaluate Safety Endpoint 1 from implant 
through 6 months post implant: 
H0: The Major EMPOWER MPS System- and Procedure-related complication-
free rate through 6 months is ≤ 86%  
HA: The Major EMPOWER MPS System- and Procedure -related complication-
free rate through 6 months is > 86%. 
11.1.1.2 Sample Size  
A group sequential design based on the z test of a binomial proportion will be used to 
assess the Safety Endpoint 1. The assumptions and parameters pertaining to this endpoint 
are as follows: 
• Expected performance:  93% Major EMPOWER MPS System- and Procedure-related 
CFR through 6 months post-implant  
• Performance Goal:  86% Major EMPOWER MPS System- and Procedure-related 
CFR through 6 months post-implant 
• Attrition: 25% of enrolled subjects through the 6-month visit 
• Power = 90% 
• Alpha < 2.5% (1-sided) 
• Alpha boundary determination: A power error spending function will be used with 
ρ=1.5   
• Early study submission conditions:  The study submission will occur at the time of the 
interim analysis if the null hypothesis is successfully rejected  
• Number of analyses: 2 
• Timing of analyses:  The single interim endpoint analysis will occur after a minimum 
of 134 subjects who have undergone any portion of the EMPOWER PG implant 
procedure have been followed for 6-months (based on a required 0.6 Information 
Fraction for the interim analysis). The final analysis of this endpoint may occur when 
223 subjects who have undergone any portion of the EMPOWER PG implant 
procedure have been followed for 6-months if the null hypothesis of Safety Endpoint 
1 is not rejected at the interim analysis. 
Sample size calculations were performed using Cytel East 6 software. Based on these 
assumptions and parameters, a sample size of 134 subjects is required for the interim 
analysis with an alpha of 1.2%. If the null hypothesis is not rejected at the interim 
analysis, a sample size of 223 subjects is required for the final analysis with an alpha of 
1.9%. 
The expected performance of Safety Endpoint 1 is based on a literature review of similar 
products, with results showing an observed rate of similar events ranging from 92.4% to 
97.5%. Based on this literature review and an analytical comparison of the EMPOWER 

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System to these similar products and adjusting for expected differences in population 
demographic characteristics and comorbidities, BSC deems it reasonable to expect a 
similar rate for the EMPOWER System within the modified MODULAR ATP Clinical 
Study. The performance goal of 86% is the same as was used for St. Jude Medical’s 
LEADLESS II Study of Nanostim (NCT02030418). 
11.1.1.3 Statistical Methods 
Endpoint analysis will be performed on data from subjects that have undergone any 
portion of the EMPOWER PG implant procedure, including subjects that do not have the 
EMPOWER PG successfully implanted. The major EMPOWER MPS System and 
Procedure-related CFR from the date of the EMPOWER PG implant procedure through 6 
months (180 days) post-implant will be calculated using Kaplan-Meier methodology.  
The interim analysis will be conducted once 134 subjects have undergone the 
EMPOWER PG implant procedure and have been followed for 6 months (180 days). 
Using the allocated alpha level of 1.2% for the interim analysis, the 98.8% one-sided 
lower pointwise confidence limit of the Major CFR will be calculated via log-log 
methodology and compared to the performance goal of 86%. If the lower confidence limit 
exceeds 86%, the null hypothesis will be rejected. 
If the interim analysis does not result in the rejection of the null hypothesis, the final 
analysis will be conducted once 223 subjects have undergone the EMPOWER PG implant 
procedure and have been followed for 6 months (180 days). Using the allocated alpha 
level of 1.9% for the final analysis, the 98.1% one-sided lower pointwise confidence limit 
of the Major CFR will be calculated via log-log methodology and compared to the 
performance goal of 86%. If the lower confidence limit exceeds 86%, the null hypothesis 
will be rejected. 
The Kaplan-Meier methodology was chosen for this endpoint to utilize all available data 
for each subject. To assess the robustness of this analysis method and the potential impact 
missing data could have had on the analysis results, a tipping point analysis will be 
conducted that will include subjects that have undergone any portion of the EMPOWER 
PG implant procedure, including subjects that do not have the EMPOWER PG 
successfully implanted. The tipping point analysis will assign each subject with missing 
data as either having or not having a Major EMPOWER MPS System- and Procedure-
related complication. All possible combinations of these subjects’ data will be evaluated 
along with the actual observed data to find the point, if any, at which the endpoint is 
failed. 
11.1.2 Safety Endpoint 2:  Major EMPOWER MPS System- and Procedure-related 
Complication-free Rate from Implant through 12 Months Post-Implant 
Safety Endpoint 2 will be assessed for subjects who undergo any portion of the 
EMPOWER PG implant procedure. Safety will be confirmed by evaluating the Major 
EMPOWER MPS System- and Procedure-related CFR between the EMPOWER PG 
implant procedure date and 365 days (12 months) post-implant procedure date. The same 
definition of Major EMPOWER System- and Procedure-related Complication that was 
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2. This endpoint will support both the CE Mark and FDA’s requirements for Post Market 
1 submissions. 
11.1.2.1 Hypotheses 
The following hypotheses will be used to evaluate Safety Endpoint 2 from implant 
through 12 months post-implant: 
H0: The Major EMPOWER MPS System- and Procedure-related CFR through 12 
months is ≤ 81%  
HA: The Major EMPOWER MPS System- and Procedure-related CFR through 12 
months is > 81% 
The performance goal was selected to be consistent with the initial recommendations for 
study of leadless cardiac pacemaker therapy, written by the Medicines & Healthcare 
Products Regulatory Agency (MHRA) Expert Advisory Group38. 
11.1.2.2 Sample Size – CE Mark Cohort 
Endpoint analysis will be performed on subjects that undergo an EMPOWER PG implant 
procedure, including subjects that do not have an EMPOWER PG successfully implanted. 
The CE Mark cohort analysis must include at least 112 subjects that underwent an 
EMPOWER PG implant procedure with data at 12 months to be sufficiently powered. 
Sample size estimates were obtained using the normal approximation to the binomial and 
verified through simulations based on Kaplan-Meier methodology using SAS 9.4; 
Kaplan-Meier methodology will be used for the analyses.  
Sample size was calculated using the following assumptions: 
• Performance goal = 81%37 
• Expected rate = 92%37 
• One-sided significance level = 2.5% 
• Power = 90% 
The sample size for this study was not determined by this endpoint. 
11.1.2.3 Sample Size – Post-Market 1 Cohort39 
The Post-Market 1 cohort analysis will be done on the full subject enrollment (n=300). 
Given a 30% attrition rate, it is expected that 210 subjects will be followed through 1 
year. Using the normal approximation to the binomial method and the assumptions 
outlined below, the Post-Market 1 analysis will be powered at 99.8%. 
• Performance goal = 81% 
• Expected rate = 92% 
 
38 Leadless cardiac pacemaker therapy: design of pre- and post-market clinical studies. Recommendations 
from MHRA Expert Advisory Group. October 2018. 
39 DCD / IEDB Improved Submission Paradigm for Leadless Cardiac Pacemakers (2015) 

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• One-sided significance level = 2.5% 
• Attrition Rate = 30% 
11.1.2.4 Statistical Methods 
Endpoint analysis will be performed on subjects that undergo an EMPOWER PG implant 
procedure, including subjects that do not have the EMPOWER PG successfully implanted 
(i.e., both implant and attempt subjects), using two different cohorts. The CE Mark cohort 
will consist of the minimum number of subjects required to evaluate this endpoint - 112 
subjects who undergo an EMPOWER PG implant procedure and have been followed for 
12 months. The FDA Post-Market 1 cohort will consist of all  subject enrollments who 
undergo an EMPOWER PG implant procedure and are followed for 12 months.  
The Major EMPOWER MPS System- and Procedure-related CFR from the date of the 
EMPOWER PG implant procedure through 365 days post implant will be calculated 
using Kaplan-Meier methodology.  
The 97.5% one-sided lower pointwise confidence limit of the Major EMPOWER MPS 
System- and Procedure-related CFR will be calculated via log-log methodology and 
compared to the performance goal of 81%. If the lower confidence limit exceeds 81%, the 
null hypothesis will be rejected. 
The Kaplan-Meier methodology was chosen for this endpoint to utilize all available data 
for each subject. To assess the robustness of this analysis method and the potential impact 
missing data could have had on the analysis results, a tipping point analysis will be 
conducted that will include subjects with the EMPOWER PG implanted and the 
attempted subjects. The tipping point analysis will assign each subject with missing data 
as either having or not having a Major EMPOWER MPS System- and Procedure-related 
Complication. All possible combinations of these subjects’ data will be evaluated along 
with the actual observed data to find the point, if any, at which the endpoint is failed.  
11.1.3 Secondary Safety Endpoint: All-Cause Survival from Implant through 2 
Years Post-Implant 
The Secondary Safety Endpoint will be assessed for all implant subjects. Safety will be 
confirmed by evaluating the 2-Year all-cause survival rate post implant. Deaths due to 
any reason will count against this endpoint. Data from this endpoint will be used to  
evaluate the longer-term safety of the EMPOWER PG for the purposes of obtaining CMS 
approval and Medicare reimbursement. This analysis will be performed when all 
implanted subjects have been followed for a minimum of 730 days. In order to control the 
overall study Type I error rate, this endpoint will only be evaluated if Safety Endpoint 
1,the primary effectiveness endpoints, and the Secondary Effectiveness endpoint are 
successful. 
11.1.3.1 
Hypotheses 
The following hypotheses will be used to evaluate the Secondary Safety Endpoint: 
H0: The all-cause survival rate through 2 years post-implant ≤ 85%  
HA: The all-cause survival rate through 2 years post-implant > 85%. 

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11.1.3.2 
Sample Size 
A sample size of 123 implanted subjects followed for 2 years is required to evaluate the 
Secondary Safety Endpoint. This sample size was calculated based on a one-sided normal 
approximation for a single binomial proportion, using SAS Version 9.4 with the 
following assumptions:  
• Performance goal = 85% 
• Expected 2-Year Survival Rate = 92.7% 
• Significance level = 2.5% one-sided 
• Power = 80% 
Given an expected attrition rate of 40%, 275 subjects are needed, which is less than the 
300 enrolled subjects. This means that the overall study sample size is not being driven by 
this endpoint. 
11.1.3.3 
Statistical Methods 
Endpoint analysis will be performed on all implanted subjects. 
The survival rate from the implant through 730 days post-implant will be calculated using 
Kaplan-Meier methodology. Deaths for any reason will count as an event for this 
endpoint. The 5% one-sided lower pointwise confidence limit of the survival rate will be 
calculated via log-log methodology and compared to the performance goal of 85%. If the 
lower confidence limit exceeds 85%, the null hypothesis will be rejected. 
 
11.1.4 Primary Effectiveness Endpoint 1: Communication Success between the S-
ICD and EMPOWER PG at the 6 Month Visit 
Primary Effectiveness Endpoint 1 will be assessed at the time of the interim analysis of 
Safety Endpoint 1 if its null hypothesis is rejected, or at the final analysis if its null 
hypothesis is not rejected at the interim analysis (refer to Section 11.3). The assessment 
will include subjects who are successfully implanted with both the EMPOWER PG and 
S-ICD. Effectiveness will be confirmed by evaluating the communication between S-ICD 
and the EMPOWER PG in four postures: upright, supine, and right and left side. The test 
unit for this endpoint will be the result from each posture. Communication success will be 
defined as any evidence of a paced beat during communication testing in a given posture 
at the initial programmed communication Programmed Telemetry Setting.  
11.1.4.1 Hypotheses 
The following hypotheses will be used to evaluate Primary Effectiveness Endpoint 1 at 
the 6 Month Visit: 
H0: The communication success rate is ≤ 88%  
HA: The communication success rate is > 88%. 

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11.1.4.2 Sample Size  
The sample size estimates were obtained using the normal approximation to the binomial 
and verified through simulations. The required sample size of 152 tests from a minimum 
of 38 subjects (220 tests including attrition) was calculated using the following 
assumptions: 
• Performance goal = 88% 
• Expected rate = 95% 
• One-sided significance level = 2.5% 
• Power = 80% 
• Attrition = 30% 
The sample size for this study was not determined by this endpoint. 
11.1.4.3 Statistical Methods 
The analysis for this endpoint will be performed once, either in conjunction with the 
interim analysis of Safety Endpoint 1, if the analysis of Safety Endpoint 1 is successful in 
rejecting the null hypothesis, or at the time of the final analysis of Safety Endpoint 1. The 
analysis for this endpoint will use the communication results taken at the 6 Month Visit 
and the communication success rate will be calculated using the data from all postures.  
A repeated measure logistic regression will be fit with an indicator of communication 
success of each posture test as the response and subject as the repeated measure in an 
intercept only model to calculated the adjusted communication success rate and the 
97.5% one-sided lower pointwise confidence limit. An unstructured correlation matrix 
will be used, unless a different structure is found to be more appropriate. The adjusted 
communication success rate and the 97.5% one-sided lower pointwise confidence limit by 
converting the intercept estimate and 97.5% one-sided upper pointwise conficence limit 
from the model previously described into an event rate and corresponding confidence 
limit. This adjusted 97.5% one-sided lower pointwise confidence limit of the 
communication success rate will compared to the performance goal of 88%. If the lower 
confidence limit exceeds 88%, the null hypothesis will be rejected. Please see the 
Statistical Analysis Plan (SAP) for more specifics. The unadjusted rate and 97.5% one-
sided lower pointwise confindence limit calculated using the one-sided Score 
methodology will also be presented as sensitivity analysis. 
A subject-level evalution of the communication success rate across the four postures is 
being analyzed as an ancillary objective. See Section 11.2. 
Missing posture testing data due to missed 6 Month Visits or a missing posture of the 4 
tested will be considered missing data. To assess the potential impact missing data could 
have had on the analysis results, a tipping point analysis will be conducted. The tipping 
point analysis will assign each missing posture test as either a failure or success. All 
possible combinations of these posture tests’ data will be evaluated along with the actual 
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The poolability of the communication success rate will be assessed across postures. As 
part of this analysis the communication success rate will be presented for each posture, 
and the poolability will be assessed as outlined in pooling analysis in Section 11.7.3.  
11.1.5 Primary Effectiveness Endpoint 2:  Proportion of Subjects with Adequate 
PCT at the 6 Month Visit 
Primary Effectiveness Endpoint 2 will be assessed at the time of either the interim 
analysis of Safety Endpoint 1, if its null hypothesis is rejected, or at the final analysis, if 
its null hypothesis is not rejected at the interim analysis (refer to Section 11.3). 
Effectiveness will be confirmed by evaluating the percentage of subjects considered to be 
a Pacing Capture Threshold (PCT) Responder, defined as a subject with a PCT 
measurement of ≤ 2.0 V @ 0.4 ms pulse width. 
11.1.5.1 Hypotheses 
H0: PCT Responders at 6-Month Visit is ≤ 80% 
HA: PCT Responders at 6-Month Visit is > 80%, 
11.1.5.2 Sample Size 
A total of 57 measurements (6-month PCT @ 0.4 ms) are required to sufficiently power 
the Primary Effectiveness Endpoint 2. The following assumptions were used to calculate 
the sample size: 
• Performance goal = 80% 
• Expected rate = 95% 
• One-sided significance level = 2.5% 
• Power = 90% 
The sample size for this study was not determined by this endpoint. 
11.1.5.3 Statistical Methods 
The analysis for this endpoint will be performed once, either in conjunction with the 
interim analysis of Safety Endpoint 1, if the analysis of Safety Endpoint 1 is successful in 
rejecting the null hypothesis, or at the time of the final analysis of Safety Endpoint 1. Two 
groups of subjects will be included in the endpoint evaluation: (1) PMA Sample cohort 
subjects with an EMPOWER PG PCT measurement taken at the 6 Month Visit (with a 
0.4 ms pulse width), and (2) PMA Sample cohort subjects with a Major EMPOWER MPS 
System- and Procedure-related Complication between implant and 6 months due to an 
elevated threshold. The number of responders (PCT at 6 Month Visit ≤ 2.0 V @ 0.4 ms) 
divided by the total number of subjects included in the endpoint evaluation will be 
calculated. The one-sided 2.5% binomial exact lower confidence limit will be calculated 
and compared to the performance goal of 80%. If the lower confidence limit exceeds 
80%, the null hypothesis will be rejected. 
To assess the potential impact missing data could have had on the analysis results, a 
tipping point analysis will be conducted that will include subjects with the EMPOWER 
PG implanted. The tipping point analysis will assign each subject with missing data as 

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either being a PCT responder or a PCT non-responder. All possible combinations of these 
subjects’ data will be evaluated along with the actual observed data to find the point, if 
any, at which the endpoint is failed.   
11.1.6 Secondary Effectiveness Endpoint:  Mean Metabolic-Chronotropic Relation 
(MCR) Slope from the Kay-Wilkoff Model at the 3 Month Visit 
The Secondary Effectiveness Endpoint evaluates the adequacy of the EMPOWER PG 
Rate Response feature using the Metabolic-Chronotropic Relation Slope (MCR Slope). 
Data for this endpoint will be obtained from the subset of subjects who performed 
treadmill testing at 3 months. Using the Kay-Wilkoff model, the Secondary Effectiveness 
Endpoint will evaluate the proportionality of the EMPOWER PG’s sensor-indicated rate 
to the subject’s workload during the treadmill test. In order to control the overall study 
Type I error rate, this endpoint will only be evaluated if Safety Endpoint 1 and the 
primary effectiveness endpoints are successful. 
11.1.6.1 Hypotheses 
The following set of hypotheses will be used to evaluate the Secondary Effectiveness 
Endpoint: 
H0: Mean slope < 0.65 or Mean slope > 1.35 
HA: 0.65 ≤ Mean slope ≤ 1.35, 
where the mean slope is calculated from the Kay-Wilkoff model. 
11.1.6.2 Sample Size 
A minimum of 35 usable datasets is required to sufficiently power the Secondary 
Effectiveness Endpoint. A usable dataset is defined as one for which the subject 
completes at least treadmill Stage 4 without continuous use of the treadmill handlebars in 
either treadmill Stage 3 or Stage 4, as described further in Document 92614291 (provided 
separately).  
Sample size estimates were obtained using two one-sided t-tests (TOST).   
The sample size of 35 usable datasets was calculated using the following assumptions: 
• Performance goals = mean slope between 0.65 and 1.35 
• Expected mean slope = between 0.85 and 1.15 
• Expected standard deviation = 0.35 
• One-sided significance level = 2.5% 
• Power = 90% 
Assuming that 40% of subjects will not have usable datasets, at least 59 subjects will be 
included in the treadmill test in order to obtain at least 35 usable datasets.  
The sample size for this study was not determined by this endpoint. 

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11.1.6.3 Statistical Methods 
All datasets from treadmill tests at 3 months with at least 4 stages of data will be included 
in the endpoint evaluation. Normalized sensor-indicated rate and normalized 
workload (METS) will be used for evaluation; the range of values for each normalized 
value will be between 0 and 1. The normalized rates will be calculated as follows: 
𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟= (𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 − 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟)
(𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑚𝑚𝑚𝑚𝑚𝑚 − 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟)  
𝑤𝑤ℎ𝑒𝑒𝑒𝑒𝑒𝑒 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟= 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝐿𝐿𝐿𝐿𝐿𝐿 𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑𝑑 𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡 𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡  
𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁𝑁 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤= (𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 − 1)
(𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑚𝑚𝑚𝑚𝑚𝑚 − 1)  
Subject-specific slopes from each test will be calculated by performing a general linear 
model with normalized sensor rate as the outcome and normalized workload as the 
predictor. These subject-specific slopes will be used in a TOST using an alpha of 2.5% 
for each test. If the lower limit of the 95% confidence interval is greater than 0.65 and the 
upper limit of the 95% confidence interval is less than 1.35, then the null hypothesis will 
be rejected. Each comparison represents a one-sided 2.5% test. Per Union-Intersection 
Test methodology, the overall alpha is maintained at 2.5%. 
11.2 Ancillary Objectives 
The following data will be collected in the MODULAR ATP Clinical Study and 
summarized at the time of endpoint analysis for all subjects, where applicable, and the 
data are available. Additional information regarding the ancillary objectives can be found 
in the MODULAR ATP SAP. 
• Summary of the mCRM Therapy System implant procedure characteristics 
o Initial implant success rate of the EMPOWER PG  
o Initial implant success rate of the S-ICD (de novo Implants)  
• Summary of pacing impedance and sensing amplitude at protocol-required follow ups 
• Summary of ventricular tachycardia (VT)/ ventricular fibrillation (VF) conversion and 
sensing interaction testing 
• Summary of Communication Threshold Test at Implant, Pre-Discharge, 1 Month Visit 
and available Semi-Annual visits 
• Summary of Communication Test results at available Semi-Annual visits 
• Summary of incidence and threshold for Communication Muscle Stimulation at 
Implant 
• Summary of number of postures with a successful Communication Test at the 6 
Month Visit 
• Summary of EMPOWER PG PCT at protocol-required follow ups 
• Summary of spontaneous treated VT/ VF episodes 
• Incidence of syncope related to treated and untreated spontaneous episodes of VT/ VF 
above the lowest programmed rate cutoff 
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• Summary of Inappropriate Therapy 
• Summary of Major EMPOWER MPS System- and Procedure-related Complications 
through both 6 and 12 months after the implant procedure 
• Summary of mCRM Therapy System-related complications through both 6 and 
12 months after the implant procedure* 
• Summary of the EMPOWER PG performance from Holter Monitor recording 
• Summary of EMPOWER PG battery charge remaining to End of Service (EOS) at 
protocol-required follow ups  
• Summary of S-ICD PG remaining battery to Elective Replacement Indicator (ERI) 
per protocol-required follow ups (baseline adjusted to time of enrollment for S-ICD 
PGs implanted prior to enrollment in MODULAR ATP) 
*S-ICD PG replacement due to normal battery depletion will not be included in this 
analysis 
11.3 PMA Submission Cadence 
The PMA submission containing the results of Safety Endpoint 1, Primary Effectiveness 
Endpoint 1 and 2, Secondary Effectiveness Endpoint and Ancillary Objectives will be 
submitted according to the outcome of the interim analysis of Safety Endpoint 1 and is 
outlined in Figure 11-1. 
 
Figure 11-1: PMA Submission Cadence for MODULAR ATP 
11.4 Sample Size Summary  
The study will enroll up to 300 subjects, which is approximately what is required for the 
sample size of the final analysis of Safety Endpoint 1, 223 subjects followed for 6 months 
or 298 subjects enrolled and accounting for an estimated 25% attrition rate (223 ≈ 298 × 
75%).  
Safety Endpoint 1 H0 
Successfully Rejected at 
Interim Analysis at 
α=1.2% 
 
Evaluate Primary 
Effectiveness Endpoints 1 
and 2, and Secondary 
Effectiveness Endpoint 
and Ancillary Objectives 
Submit PMA Report 
  
 
N=134 
Evaluate Safety Endpoint 
1 at Final Analysis at 
α=1.9% 
 
 
Evaluate Primary 
Effectiveness Endpoints 1 
and 2, and Secondary 
Effectiveness 
Endpoint and Ancillary 
Objectives 
Submit PMA Report 
  
  
N=223 
Yes 
No 

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11.5 General Statistical Methods 
11.5.1 Study Success Criteria and Control of Type I Error 
The study will be considered successful if Safety Endpoint 1 and all primary effectiveness 
endpoints are passed. 
Safety Endpoint 1 and the primary effectiveness endpoints can be tested at the 
significance level of 2.5% while still maintaining the overall type I error level at no 
greater than 2.5%. This follows the methodology of the Intersection-Union Test (IUT). 
Additionally, in order to control the overall type I error level a gating approach will be 
employed. The Secondary Effectiveness Endpoint and Secondary Safety Endpoint will 
only be evaluated if Safety Endpoint 1 and the primary effectiveness endpoints are 
successful.  The secondary endpoints will be tested in the following order: 
• Secondary Effectiveness Endpoint 
• Secondary Safety Endpoint, which will only be tested if Seconardy 
Effectiveness Endpoint is successful. 
11.5.2 Control of Systematic Error/Bias 
Selection of patients will be made from the Investigator’s usual patient population. All 
patients meeting the eligibility criteria and having signed the ICF will be eligible for 
enrollment in the study. To control for inter-observer variability among sites, an 
independent CEC will determine the EMPOWER MPS System- and Procedure-related 
complications to be used in the analysis of Safety Endpoint 1.Number of Subjects per 
Study Site 
To avoid any study site effect and bias, no study site will be authorized to implant or 
attempt more than 20% of the maximum number of subjects without approval from BSC. 
A minimum of 50% of total enrollments from North America will be maintained.  
11.6 Data Analyses 
11.6.1 Interim Analyses  
11.6.1.1 Adverse Events and Device Deficiencies 
Analyses of adverse events and device deficiencies will occur at frequent intervals during 
the study. Results of these analyses will be reviewed by the BSC Medical Safety Group to 
evaluate the safety of the subjects under study. 
11.6.1.2 Endpoints 
As stated in Section 11.3 the single interim endpoint analysis will occur after a minimum 
of 134 subjects who have undergone an EMPOWER PG implant procedure have been 
followed for 6 months. The final analysis of this endpoint may occur when 223 subjects 
who have undergone an EMPOWER PG implant procedure have been followed for 6 
months if the null hypothesis of Safety Endpoint 1 is not rejected at the interim analysis. 
The hypothesis test for Primary Effectiveness Endpoints 1 and 2 and the Secondary 
Effectiveness Endpoint will be performed in conjunction with either the interim analysis 
of Safety Endpoint 1 if the null hypothesis is successfully rejected or at the time of final 
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11.6.2 Subgroup Analyses 
Analyses will be performed for each endpoint to determine whether significant 
differences exist in endpoint results between subgroups. The list of subgroups (with 
applicable definitions in parentheses) includes, but is not necessarily limited to: 
• Sex (Female vs. Male), 
• BMI (Obese – BMI ≥ 30 vs. Non-Obese – BMI < 30) for effectiveness endpoints 
only, 
• Geography (North America vs. Other Countries), 
• Age (< 65 years vs. ≥ 65 years), 
• Race (Black or African heritage vs. other races) 
The subgroup variable will be added to a logistic regression model. A test for significance 
at the 15% level will be performed. For each subgroup variable in which a significant 
difference exists, the results for each subgroup will be presented separately. BSC does not 
plan to seek labeling for these subgroups based on these analyses. 
11.6.3 Pooling Analyses 
11.6.3.1 
Assessment of Pooling Across Communication Test Postures  
The poolability of the Primary Effectiveness Endpoint 1 data by communication test 
postures will be performed to determine whether there are differences among the four 
postures: upright, supine, and right and left side. 
Communication test posture heterogeneity will be assessed by performing fixed effects 
logistic regression analyses. Communication test posture will be added into the model as 
a fixed effect. Postures will be deemed to be heterogeneous if the variance of the fixed 
posture effect is found to significantly differ from zero. A significance level of 15% will 
be used for the test.  
11.6.3.2 
Assessment of Pooling Across Geographies and Study Sites  
The poolability of data by geography and investigational study site will be performed to 
determine whether there are differences between the US and international geographies, 
and from study site-to-study site. 
Study site-to-study site heterogeneity will be assessed for each endpoint by performing 
random effects logistic regression analyses. Study sites enrolling 5 subjects or fewer will 
be combined within region (North America versus other countries) into pooled sites of 6 
or more subjects for this pooling analysis. 
Study site will be added into the model as a random effect. Study sites will be deemed to 
be heterogeneous if the variance of the random study site effect is found to significantly 
differ from zero. A significance level of 15% will be used for each test.  
11.6.3.3 
Assessment of Pooling Across Introducer Sheaths 
The poolability of data by introducer sheath will be performed to determine whether there 
are differences between the EMPOWER Introducer Sheath and any commercially 
available introducer sheaths. The poolabilty of introducer sheaths will only be assessed 
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Introducer sheath heterogeneity will be assessed by performing random effects logistic 
regression analyses. Introducer sheath will be added into the model as a random effect. 
Introducer sheaths will be deemed to be heterogeneous if the variance of the random 
introducer sheath effect is found to significantly differ from zero. A significance level of 
15% will be used for the test.  
11.6.4 Multivariable Analyses 
Univariable analyses of various baseline covariates and their relationship to each endpoint 
are outlined in Section 11.7.2. For each endpoint, all baseline characteristics found to be 
significantly associated with the outcome will be included as covariates in a multivariable 
regression model. The impact of each baseline characteristic’s subgroups will be 
presented along with the multivariable model results.  
11.7 Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will 
be documented in a SAP 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 Health Economics Outcomes 
A formal health economics analysis may be completed as part of the MODULAR ATP 
Clinical Study, given meaningful clinical results are obtained. This will take into 
consideration survival rates, complication rates, and resource utilization. These inputs 
may be used in health economics analyses performed.  
13 Data Management 
13.1 Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by Medidata EDC System. 
All changes made to the clinical data will be captured in an electronic audit trail and 
available for review by the sponsor or its representative. The associated Rave software 
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 signatures. Database 
backups are performed regularly. 
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 regulations. 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 
discrepancies. Manual and/or automatic queries will be created in the Medidata EDC 

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system and will be issued to the site for appropriate response. Site staff will be 
responsible for resolving all queries in the database. 
Boston Scientific will provide all participating study sites eCRF Completion Guidelines 
along with training on completion of the eCRFs for the MODULAR ATP Clinical Study.  
All access to the clinical database will be changed to “Read only” after all data is either 
“Hard Locked” or “Entry Locked”. Once acceptance of the final report or finalization of 
publications (as applicable) is received, final database storage and archiving activities can 
begin. Once all of the closeout activities are completed a request to IT is submitted to 
have the “Database Locked” and all database access revoked. 
13.2 Data Retention 
The Principal Investigator, his/her designee, or study site will maintain all essential study 
documents and source documentation that support the data collected on the study subjects 
in compliance with applicable regulatory requirements.   
The Principal Investigator or his/her designee will take measures to prevent accidental or 
premature destruction of these documents. If for any reason the Principal Investigator or 
his/her designee 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. Sites are required to inform 
BSC in writing where paper or electronic files are maintained in case files are stored off 
site and are not readily available. 
13.3 Technical Source Forms 
A Technical Source Form (TSF) is developed by BSC or by the investigational site to 
capture protocol required data elements that are not duplicated in any other source 
documents. These forms are to be used by the study sites as a source document. A BSC 
representative may complete the TSF at the request of the Principal Investigator. The TSF 
will be reviewed and signed for approval by the Principal Investigator or his/her designee 
at the end of each procedure. 
13.4 Core Laboratory 
A Holter core lab will be used to provide Holter Monitoring equipment and Holter data 
analysis for subjects enrolled in this portion of the trial. Details are provided in Section 
10.5.5 and separate study instructions may be provided to the participating sites. 
14 Deviations 
An Investigator must not make any changes or deviate from this 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/REB of any deviation from the 
investigational plan to protect the life or physical well-being of a 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 5 working 
days after the emergency occurred, or per prevailing local requirements, if sooner than 5 
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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 using the EDC system. 
Sites may also be required to report deviations to the IRB/EC/REB, per local guidelines 
and government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, 
appropriate corrective and preventive actions, notification, site re-training, or site 
discontinuation/termination will be put into place by the sponsor. 
15 Device Accountability 
Items labeled as Investigational shall be securely controlled, managed and used only as 
authorized by the Sponsor.  
The Sponsor shall keep records documenting the location of items labeled as 
Investigational from shipment/transference to the study sites until disposal at site or return 
from the site to the Sponsor or designee. 
The principal investigator or an authorized designee shall document the receipt, 
disposition, return and disposal of all consigned items labeled as Investigational, as 
directed by the Sponsor. At minimum, this shall include the following: 
• Date of receipt and by whom 
• Identification (and quantity) of each item (batch number or unique code) 
• Date or dates of use (or other disposition) and by whom 
• Date of return (and number) of items, as applicable. 
The principal investigator or an authorized designee shall keep records documenting the 
assignment/usage of study-related devices as per the Sponsor’s data collection 
requirements (see protocol Section 16.2). Study-related devices designated for data 
collection, may or may not be labeled as investigational. 
16 Compliance 
16.1 Statement of Compliance 
This study will be conducted in accordance with 21 CFR 814.20, part 56, part 50 and part 
812, European Medical Device Regulation, EN ISO 14155 Clinical Investigation of 
Medical Devices for Human Subjects, relevant parts of the ICH Guidelines for Good 
Clinical Practice, 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/REB and/or regulatory authority 
has been obtained, if appropriate. Also, the study shall not begin prior to issuance of the 
site Authorization to Enroll, as provided by the sponsor. Any additional requirements 
imposed by the IRB/EC/REB or regulatory authority shall be followed, if appropriate.  
16.2 Investigator Responsibilities 
The Principal Investigator of a study site is responsible for ensuring that the study is 
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plan, ISO 14155, ethical principles that have their origins in the Declaration of Helsinki, 
any conditions of approval imposed by the reviewing IRB/EC/REB, and prevailing local 
and/or country laws and/or regulations, whichever affords the greater protection to the 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   
• Prior to beginning the study, sign the Investigator Brochure Signature Page and 
Protocol Signature page documenting his/her agreement to conduct the study in 
accordance with the protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study 
or interpretation of results. 
• Make no changes in or deviate from this 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 clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all 
clinical-investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to 
the sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) 
every adverse event as applicable per the protocol and observed device deficiency. 
• Report to sponsor, per the protocol requirements, all SAEs and device deficiencies 
that could have led to a SADE and potential/USADE or UADE. 
• Report to the IRB/EC/REB and regulatory authorities any SAEs and device 
deficiencies that could have led to a SADE and potential/USADE or UADE, if 
required by applicable laws or regulations or this protocol or by the IRB/EC/REB, 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, be accessible to the 
clinical research monitor or auditor, and respond to questions during monitoring visits 
or audit(s). 
• Allow and support regulatory authorities and the IRB/EC/REB when performing 
auditing activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC/REB requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in 
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• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the 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 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 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 subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation. 
16.3 Delegation of Responsibility 
When specific tasks are delegated by the Principal Investigator, including but not limited 
to, conducting the informed consent process, the Principal Investigator is responsible for 
providing appropriate training, assessing that the delegate(s) is/ are competent to perform 
the tasks they have been delegated, and providing adequate supervision of those to whom 
tasks are delegated. Where there is a sub-investigator at a site, the sub-investigator should 
not be delegated the primary supervisory responsibility for the site. The Principal 
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/ Research Ethics Board 
The study site will obtain the written and dated approval/favorable opinion of the 
IRB/EC/REB for the clinical study before recruiting subjects and implementing all 
subsequent amendments, if required. 
A copy of the written IRB/EC/REB and/or competent authority approval of the protocol 
(or permission to conduct the study) and ICF, must be received by the sponsor before 
recruitment of subjects into the study and shipment of investigational product/equipment. 
Prior approval must also be obtained for other materials related to subject recruitment or 
which will be provided to the subject. 
Any amendment to the protocol will require review and approval by the IRB/EC/REB 
before the changes are implemented to the study. All changes to the ICF will be 

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IRB/EC/REB approved; a determination will be made regarding whether a new ICF needs 
to be obtained from participants who provided consent, using a previously approved ICF. 
Annual IRB/EC/REB approval and renewals will be obtained throughout the duration of 
the study as required by applicable local/ country laws or regulations or IRB/EC/REB 
requirements. Copies of the study reports and the IRB/EC/REB continuance of approval 
must be provided to the sponsor.  
16.5 Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this 
study will be considered confidential by BSC and will be kept confidential in accordance 
with all applicable laws and regulations. Only authorized BSC personnel or a BSC 
representative including, but not limited to Contract Research Organization (CRO) will 
have access to this information. Authorized regulatory personnel have the right to inspect 
and copy all records pertinent to this study. Study data collected during this study may be 
used by BSC for the purposes of this study, publication, and to support future research 
and/or other business purposes, such as overseeing and improving the performance of its 
device, new medical research and proposals for developing new medical products and 
procedures. All data used in the analysis and reporting of this study or shared with a third-
party researcher will be without identifiable reference to specific subjects 
Information received during the 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 can provide technical support to the investigator and other 
health care personnel (collectively HCP) as needed during implant, testing required by the 
protocol, and follow-ups. Support may include HCP training, addressing HCP questions, 
or providing clarifications to HCPs concerning the operation of BSC equipment/devices 
(including programmers, analyzers, and other support equipment). 
At the request of the investigator and while under investigator supervision, BSC 
personnel may operate equipment during implant or follow-up, assist with the conduct of 
testing specified in the protocol, and interact with the subject to accomplish requested 
activities.  
Typical tasks may include the following: 
• Interrogating the device or programming device parameters to investigator-requested 
settings as well as operating investigational equipment 
• Performing device diagnostic testing using a programmer to obtain pacing, sensing, 
and impedance measurements 
• Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel 
• Assisting with the collection of study data from programmers, and other equipment 
• Entering technical data on a Technical Source Form if the responsible investigator 
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• Obtain programming reports directly from the programmer and provide original 
reports to the clinical site as source documentation 
• Provide technical expertise/support to subjects during office visits and/or during 
teleconference calls/electronic communications with the principal investigator or their 
delegated site staff and the subject.  
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 protocol 
compliance 
• Use of Remote Case Support Technology to establish a tele-mentoring 
communication stream/live stream to perform R&D technical support and physician 
mentoring. The streaming will be in a secure and encrypted high-definition format 
which has been proven and is robust. The streaming will not be recorded. The use of 
remote case support will be in compliance with applicable regulations governing 
patient privacy. The BSC personnel on the live stream will not have any direct contact 
with the subject and in no instance will the subject be shown on video. 
• Reviewing collected data and study documentation for completeness and accuracy 
• Reporting the use of programmer application software Model 3870 or investigational 
features of Model 2877 and/or Model 3877 software for medically necessary patient 
care at facilities not participating in the clinical study. 
Boston Scientific personnel will not do the following:  
• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject  
• Independently collect critical study data (defined as primary or secondary endpoint 
data) 
• Enter data in electronic data capture systems or on paper case report forms (with the 
exception of reporting the use of programmer application software Model 3870 or 
investigational features of Model 2877 and/or Model 3877 software for medically 
necessary patient care at facilities not participating in the clinical study) 
16.7 Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by 
BSC for subjects in the study will be obtained. 
17 Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the clinical research 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 Principal Investigator 
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The Principal Investigator/ institution guarantees direct access to original source 
documents by BSC personnel, their designees, and appropriate regulatory authorities. 
The sponsor will put a plan in place to document the specific monitoring requirements. 
 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 Principal 
Investigator and relevant study personnel are available during on-site and/or remote 
monitoring visits or audits and that sufficient time is devoted to the process. 
18 Potential Risks and Benefits 
Refer to Sections 18.1 and 18.2 for Potential Adverse Events relating to implant and 
operation of the EMPOWER PG, and the mCRM Coordinated System, respectively. 
Section 18.4 includes Potential Adverse Events related to retrieval of the EMPOWER 
PG, in the event it is necessary. The Potential Adverse Events listed in 18.2 are in 
addition to the established risks for the S-ICD Pulse Generator and S-ICD Electrode 
(including subcutaneous Electrode Insertion Tool and the Electrode Delivery System) 
included in the respective users manuals. 
Refer to Section 18.3 for Potential Adverse Events related to performing an MRI scan of 
subjects with the mCRM Coordinated System or those in the study that are “Partial 
Implant” subjects and are implanted only with the EMPOWER PG.  
18.1 Risks Associated with the EMPOWER MPS 
Potential adverse events and risks related to the EMPOWER MPS and the implantation of 
the EMPOWER PG may include, but are not limited to, the following40:  
• Aneurysm or pseudoaneurysm 
• Allergic reaction 
• Arterial injury 
• Arteriovenous (AV) fistula 
• Bleeding  
• Bradycardia 
• Breakage/ failure of instruments 
• Cardiac arrest 
• Cardiac injury, such as rupture, tear, or perforation, possibly resulting in pericardial 
effusion or cardiac tamponade 
• Cerebrovascular accident 
• Complications due to prolonged fluoroscopic radiation, such as skin burn 
• Component failure 
 
40 EMPOWER™ MODULAR PACING SYSTEM Leadless Cardiac Pacemaker with Delivery Catheter 
Physician’s Technical Manual 

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• Damage to cardiac structures, such as tissue damage, valve damage, or coronary 
arterial constriction 
• Death 
• Device embolism 
• Disabling device unintentionally 
• Electrolyte imbalance/dehydration 
• Elevated thresholds 
• Embolism, such as pulmonary embolism 
• Extracardiac (muscle/nerve) stimulation 
• Fixation deformation and/ or breakage 
• Fluid accumulation 
• Foreign body reaction/ rejection phenomena 
• Heart failure following chronic RV apical pacing 
• Heart failure, worsening 
• Hematoma or seroma 
• Inability to communicate with device, including inability to reprogram  
• Inappropriate or ineffective rate response 
• Incision site complications, such as excessive fibrotic tissue growth 
• Induction or acceleration of arrhythmia 
• Infection, including endocarditis 
• Local tissue reaction 
• Loss of capture 
• Nerve damage 
• Oversensing/undersensing leading to loss of pacing or inappropriate pacing 
• Pacemaker syndrome 
• Pain  
• Pericardial rub, effusion, or pericarditis 
• Pulse generator dislodgment or migration 
• Renal failure from contrast media 
• Surgery for early replacement or implantation of a new device, such as due to 
premature battery depletion 
• Syncope 
• Thrombosis, such as deep vein thrombosis 
• Tissue necrosis, such as myocardial infarction (MI) 
• Toxicity 
• Valve damage 
• Vasovagal response 
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• Venous trauma, such as perforation, dissection, or erosion 
• Vessel spasm 
Patients may develop psychological intolerance to a pulse generator and may experience 
the following: 
• Dependency 
• Depression 
• Fear of premature battery depletion 
• Fear of device malfunction 
18.2 Risks Associated with the mCRM Coordinated System 
Potential adverse events and risks related to the mCRM Coordinated System may include, 
but are not limited to, the following41:  
• Bleeding 
• Bradycardia 
• Cardiac arrest 
• Change in amount of energy required to convert arrhythmia due to the presence of the 
LCP 
• Communication failure between the S-ICD and the LCP 
• Death 
• Delayed therapy delivery 
• Extracardiac (muscle/nerve) stimulation 
• Failure to convert arrhythmia 
• Failure to deliver therapy 
• Hematoma or seroma 
• Inability to defibrillate or pace 
• Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP] where 
applicable, pacing) 
• Induction or acceleration of arrhythmia 
• LCP damaged by a shock from S-ICD 
• Oversensing/undersensing 
• Stroke 
• Surgical revision or replacement of the mCRM System 
• Syncope 
• Thromoboemboli 
 
41mCRM™ Modular Cardiac Rhythm Management System Model A209/ A219 (EMBLEM™), B170 
(EMPOWER™) Physician’s Technical Manual 

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Patients may develop psychological intolerance to a pulse generator system and may 
develop psychological disorders that include, but are not limited to, the following: 
• Anxiety 
• Depression 
• Fear of device malfunction 
• Fear of shocks 
18.3 Risks Associated with MRI Scans 
Potential adverse events differ depending on whether the MRI Conditions of Use are met. 
Refer to “MR Conditional mCRM™ Modular Cardiac Rhythm Management System 
(EMBLEM™ S-ICD and EMPOWER™ Leadless Cardiac Pacemaker) or MR 
Conditional Standalone EMPOWER™ Leadless Cardiac Pacemaker (LCP) MRI 
Technical Guide” for information on Conditions of use for the mCRM System, or 
standalone EMPOWER PG.  
18.3.1 mCRM System Conditions of Use MET 
• arrhythmia induction 
• bradycardia 
• damage to mCRM System component(s) 
• muscle stimulation 
• patient death 
• patient discomfort due to slight movement and/or heating of mCRM System 
component(s) 
• side effects of asynchronous pacing at elevated fixed rate and increased output 
including reduced exercise capacity, acceleration of heart failure, and competitive 
pacing/arrhythmia induction 
• syncope 
• worsening heart failure 
18.3.2 mCRM System Conditions of Use NOT MET 
• arrhythmia induction 
• bradycardia 
• damage to mCRM System component(s) 
• defibrillation therapy not available 
• erratic LCP and/or S-ICD behavior 
• inappropriate pacing, inhibition of pacing, failure to pace 
• inappropriate shock 
• increased rate of LCP migration or dislodgement (within six weeks of LCP implant or 
revision) 
• irregular or intermittent capture or pacing 
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• patient death 
• patient discomfort due to movement and/or heating of mCRM System component(s) 
• physical movement of LCP 
• sensing changes 
• syncope 
• worsening heart failure 
18.3.3 EMPOWER-only Conditions of Use MET 
• arrhythmia induction 
• bradycardia 
• patient death 
• patient discomfort due to slight movement and/or heating of the LCP 
• side effects of asynchronous pacing at elevated fixed rate and increased output 
including reduced exercise capacity, acceleration of heart failure, and competitive 
pacing/arrhythmia induction 
• syncope 
• worsening heart failure 
18.3.4 EMPOWER-only Conditions of Use NOT MET 
• arrhythmia induction 
• bradycardia 
• damage to the LCP 
• erratic LCP behavior 
• inappropriate pacing, inhibition of pacing, failure to pace 
• increased rate of LCP migration or dislodgement (within six weeks of LCP implant or 
revision) 
• irregular or intermittent capture or pacing 
• pacing threshold changes 
• patient death 
• patient discomfort due to movement and/or heating of the LCP 
• physical movement of LCP 
• sensing changes 
• syncope 
• worsening heart failure 
18.4 Risks Associated with Retrieval of the EMPOWER PG 
Potential adverse events and risks related to retrieval of the EMPOWER PG may include, 
but are not limited to, the following42:  
 
42EMPOWER™ Retrieval System Physician’s Technical Manual 

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• Aneurysm or pseudoaneurysm 
• Allergic reaction 
• Arterial injury 
• Arteriovenous (AV) fistula 
• Bleeding  
• Bradycardia 
• Breakage/ failure of instruments 
• Cardiac arrest 
• Cardiac injury, such as rupture, tear, or perforation, possibly resulting in pericardial 
effusion or cardiac tamponade 
• Cerebrovascular accident 
• Complications due to prolonged fluoroscopic radiation, such as skin burn 
• Component failure 
• Damage to cardiac structures, such as tissue damage, valve damage, or coronary 
arterial constriction 
• Death 
• Device embolism 
• Disabling device unintentionally 
• Electrolyte imbalance/dehydration 
• Embolism, such as pulmonary embolism 
• Extracardiac (muscle/nerve) stimulation 
• Fixation deformation and/ or breakage 
• Fluid accumulation 
• Foreign body reaction/ rejection phenomena 
• Heart failure, worsening 
• Hematoma or seroma 
• Inability to communicate with device, including inability to reprogram  
• Incision site complications, such as excessive fibrotic tissue growth 
• Induction or acceleration of arrhythmia 
• Infection, including endocarditis 
• Local tissue reaction 
• Nerve damage 
• Pain  
• Pericardial rub, effusion, or pericarditis 
• Pulse generator dislodgment or migration 
• Renal failure from contrast media 
• Surgery for device removal 
• Syncope 

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• Thrombosis, such as deep vein thrombosis 
• Tissue necrosis, such as myocardial infarction (MI) 
• Valve damage 
• Vasovagal response 
• Venous occlusion 
• Venous trauma, such as perforation, dissection, or erosion 
• Vessel spasm 
18.5 Other Risks Associated with Participation in the Clinical Study 
Treadmill walks and Holter monitoring are commercially approved procedures frequently 
used in patients, like those enrolled in the MODULAR ATP Clinical Study, with 
cardiovascular conditions and who receive CIEDs. However, they are not mandatory 
when a patient receives an S-ICD or a leadless pacemaker. Therefore, the potential risks 
of these procedures are considered to be related to the clinical study when required per 
protocol. 
Subjects participating in the Rate Response Substudy portion of the MODULAR ATP 
Clinical Study will have added risks associated with the Treadmill Walk which may 
include, but are not limited to, the following: 
• Arrhythmias 
• Chest pain or discomfort 
• Dyspnea 
• Hypotension or hypertension 
• Muscular or joint pain 
• Myocardial infarction 
• Pre-syncope or syncope 
• Skin irritation or allergic reaction resulting from applications of adhesive patches 
• Trauma from falling off the treadmill 
Subjects participating in the Holter Monitor Substudy will have an added risk associated 
with the use of the Holter Monitor, which may include, but is not limited to, the 
following: 
• Skin irritation or allergic reaction resulting from prolonged applications of the 
adhesive patches 
There may also be additional risks which are unknown at this time. 
18.6 Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this 
protocol, performing procedures in the appropriate hospital environment, adherence to 
subject selection criteria, close monitoring of the subject's physiologic status during 
research procedures and/or follow-ups and by promptly supplying BSC with all pertinent 
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18.7 Anticipated Benefits 
Anticipated benefits of the Coordinated System include the potential avoidance of shocks 
for monomorphic ventricular tachycardias that can be safely terminated with ATP. This 
could also positively impact the overall number of shocks that a given patient will receive 
during the device’s life and their associated morbidity. As with the traditional transvenous 
ICD, the Coordinated System provides ATP and shock therapy while limiting the 
exposure to the risks frequently associated with long-term intravascular lead implantation. 
This is of particular importance for patients with challenging vascular access or high risk 
of infection who might not be candidates for transvenous ICD and whose arrhythmias 
might be successfully converted by ATP. 
An additional anticipated benefit of the Coordinated System is the option to implant a 
leadless pacemaker in a patient with an existing S-ICD System who has developed a new 
indication for single-chamber right ventricular pacing. The alternative to this option 
would be the explant or inactivation of the S-ICD System and the implantation of a 
traditional transvenous ICD system, which would expose the patients to the risks 
frequently associated with long-term intravascular lead implantation. 
18.8 Risk to Benefit Rationale 
The implantation of an S-ICD has proven to be a successful/effective therapy to reduce 
sudden cardiac death without the complications associated with having leads in the 
vasculature and the heart. As such, it may be the only option for patients at high risk of 
sudden cardiac death with challenging or no venous access or complex congenital heart 
disease.  For patients at risk of sudden cardiac death who do not require pacing or cardiac 
resynchronization therapy and are at high risk of infection, or have inadequate vascular 
access, implantation of an S-ICD is a Class I or Class IIb recommendation based on  2017 
AHA/ACC/HRS and 2015 ESC guidelines, respectively.  Furthermore, contemporary 
guidelines suggest that the advantages of the system compared to TV-ICDs make S-ICD 
implant beneficial in the broad population of patients at risk for sudden cardiac arrest if 
they do not have an indication for pacing or cardiac resynchronization therapy (Class I 
recommendation in the 2017 AHA/ACC/HRS guidelines, Class IIa recommendation in 
the 2015 ESC guidelines). According to the published data of the 2-year results from a 
pooled analysis of the S-ICD IDE Study and the EFFORTLESS registry43, the S-ICD 
terminated spontaneous ventricular tachyarrhythmias in 90.1% of events with the first 
shock and in 98.2% of events within the 5 available shocks. Data from the 
UNTOUCHED Study revealed first shock conversion rate is 92.2%, and final shock 
conversion rate is 98.4%44. The addition of the EMPOWER PG, which can communicate 
with the S-ICD (Coordinated System), will provide the option of delivering ATP, which 
may reduce the number of unnecessary shocks and improve patients’ quality of life and 
 
43 Burke MC, Gold MR, Knight BP, et al. Safety and Efficacy of the Totally Subcutaneous Implantable 
Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am 
Coll Cardiol. 2015 Apr 28;65(16):1605-1615. 
44 Gold MR, Lambiase PD, El-Chami MF, et al. Understanding Outcomes with the S-ICD in Primary 
Prevention Patients with Low Ejection Fraction (UNTOUCHED) Trial Primary Results. Heart Rhythm 
Society. Presented by  Michael Gold, Heart Rhythm, D-LBCT02-05, 2020.  

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device longevity45. The incremental benefits related with providing ATP through the 
communication between S-ICD and the EMPOWER PG are expected to be greater than 
the risks related to implanting both systems. The benefit might be significantly greater for 
those patients who are not candidates to receive a TV-ICD for the reasons outlined above.   
19 Safety Reporting 
19.1 Reportable Events by Study Sites to Boston Scientific 
Only events as described below are reportable in the MODULAR ATP Clinical Study. 
For this study, the mCRM Coordinated System will be referred to as the study device. 
Reporting starts from the date of informed consent. Refer to Sections 18.1, 18.2, 18.3, 
and 18.4 of this protocol, as well as the EMPOWER MPS PTM, mCRM PTM, and S-ICD 
User’s Manual, for the known risks associated with the study devices.  
ISO 14155, MDCG 2020-10/1, and 21 CFR Part 812 define various types of safety 
events. Definitions of those events are included in Appendix F. For this study, a subset of 
those events is reportable to the sponsor.  
19.2 Reportable Adverse Events for this Study 
Reportable adverse events for this study include those defined as a serious adverse event 
(SAE), adverse device effect (ADE), serious adverse device effect (SADE), unanticipated 
adverse device effect (UADE), and unanticipated serious adverse device effect (USADE). 
Refer to Table 26-3 for definitions of each of these event types.  
Specifically, adverse events to be reported in the MODULAR ATP Clinical Study include 
any untoward medical occurrence, unintended disease or injury, or any untoward clinical 
signs (including an abnormal laboratory finding) in subjects, users or other persons, if 
they meet any one of the following criteria: 
- 
Led to death, 
- 
Led to serious deterioration in the health of the subject as defined by either: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolongation of existing hospitalization 
(excluding planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without a serious 
deterioration in health), or 
 
45 Wathen MS, DeGroot PJ, Sweeney MO, et al. Prospective Randomized Multicenter Trial of Empirical 
Antitachycardia Pacing Versus Shocks for Spontaneous Rapid Ventricular Tachycardia in Patients With 
Implantable Cardioverter-Defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies 
(PainFREE Rx II) Trial Results. Circulation. 2004;110:2591–2596. 
 

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o medical or surgical intervention to prevent life-threatening illness or injury 
or permanent impairment to a body structure or a body function 
- 
Led to fetal distress, fetal death, or a congenital abnormality or birth defect, 
- 
Are related to the investigational medical device, procedure or protocol, 
o This includes events resulting from insufficiencies or inadequacies in the 
instructions for use, use error, or intentional abnormal use of the 
investigational medical device. 
- 
Are unanticipated in nature, severity, or degree of incidence in the investigational 
plan, or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects. 
- 
Any reportable event experienced by the study subject after informed consent and 
once considered enrolled in the study (as defined in study subject classification 
Section 9.2), whether prior to, during, or subsequent to the study implant 
procedure, must be recorded in the eCRF. 
- 
Underlying diseases and chronic conditions are not reported as AEs unless there is 
an increase in severity or frequency during the course of the investigation. Death 
should not be recorded as an AE, but should only be reflected as an outcome of 
one (1) specific SAE (refer to Table 26-3). 
Note: S-ICD replacement due to normal battery depletion is not considered an adverse 
event for the MODULAR ATP Clinical Study and does not need to be reported. 
19.3 Reportable Device Deficiencies 
Reportable Device Deficiencies include any inadequacy of a medical device related to its 
identity, quality, durability, reliability, safety or performance. This may include 
malfunctions, use error, or inadequacy in the information supplied by the manufacturer.  
19.4 Subject Death Reporting 
A subject death during the study should be reported to BSC as soon as possible and, in 
any event, within three (3) calendar days of site notification. The site’s IRB/EC/REB 
must be notified of any deaths in accordance with that site’s IRB/EC/REB policies and 
procedures.  
Notification of death must include a detailed narrative (death letter) that provides 
detailed information describing the circumstances surrounding the death and is signed 
and dated by the Principal Investigator or authorized sub-Investigator. A death 
narrative in the local language is acceptable, and will be translated to English by 
BSC (signed by an authorized translator). The details listed below must be addressed 
in the death narrative, for BSC to understand the circumstances surrounding the death:  
• Date and time of death  
• Place death occurred  
• Immediate cause of death  
• Cardiac rhythm at the time of death, if known (include any available documentation)  

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• Whether the death was related to the S-ICD System and/ or the EMPOWER System, 
clinical investigation, procedure, or patient condition  
• Whether or not the death was witnessed  
• S-ICD System and/ or the EMPOWER PG status and/or activity at the time of death 
(device recipients only – pacing, ATP, and defibrillation: active or inactive)  
• Whether the patient had worsening heart failure  
• Any other circumstances surrounding the death  
• Approximate time interval from the initiating event to death (temporal course); items 
to consider include, but are not limited to: information regarding last time subject was 
seen by investigator, last office visit, etc. 
• Investigator or sub-investigator signature and date  
Also submit the following documentation:  
• If the patient expired in the hospital: 
• A copy of the medical records for that admission (e.g., H & P, consults, test 
results, operative reports, and/or progress notes from the hospital chart)  
• Death certificate (if available)  
• Autopsy report (if applicable)  
• If the patient expired outside of the hospital (e.g., at home):  
• A copy of the most recent clinic visit (if not already submitted to BSC)  
• Death certificate (if available)   
• Autopsy report (if applicable)  
Whenever possible, the Coordinated System should be interrogated. The investigational 
Coordinated System (both S-ICD System and EMPOWER PG) should be removed intact 
and returned promptly to BSC for analysis, if possible. In the event of a death during the 
implant and/ or retrieval procedure, the EMPOWER delivery catheter, introducer sheath, 
and snare(s), and/or retrieval catheter must be returned to BSC for analysis.  
The Clinical Events Committee (CEC) must review information regarding subject deaths, 
refer to Section 21.2. 
19.5 Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 19-1. Only 
events as described in Section 19.2 are reportable in the MODULAR ATP Clinical Study. 
 Adverse events should always be reported through the EDC system for the MODULAR 
ATP Clinical Study. However, in case of any issues where an alternative method of 
reporting is necessary (i.e. the EDC is not available), please report the adverse event to 
BSC by sending the AE Notification Form via email to the following email address: 
ModularATP.Safety@bsci.com   

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Source documentation for UADE/USADE, SAE/SADE and BSC requested AE’s can 
either be uploaded in the EDC system or sent via email, with the accompanying source 
document checklist to the following email address: 
ModularATP.Safety@bsci.com 
The Investigator must assess the relationship of the reportable AE to the study device, 
therapy/stimulation or procedure. See criteria in Table 19-1. 
Table 19-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline Pre-Market 
Studies* 
( 21 CFR 812; MDCG 2020-10/1:  
 
Serious Health Threat 
Complete applicable 
eCRF/paper form with all 
available new and updated 
information 
• Within 1 business day of first becoming aware 
of the event 
• Reporting required through the end of the 
study 
 
Provide all relevant source 
documentation 
(deidentified/pseudonymized 
for reported event 
• Upon request of sponsor 
Unanticipated Adverse 
Device Effect / 
Unanticipated Serious 
Adverse Device Effect  
 
Complete AE eCRF page with 
all available new and updated 
information  
 
• Within 1 business day of first becoming aware 
of the event 
• Reporting required through the end of the 
study 
Provide all relevant source 
documentation (deidentified/ 
pseudonymized) for reported 
event  
• Upon request of sponsor  
Serious Adverse Event  
Complete AE eCRF page with 
all available new and updated 
information  
• Immediately, but not later than 3 calendar 
days of first becoming aware of the event or as 
per local/regional regulations 
• Reporting required through the end of the 
study 
Provide all relevant source 
documentation (deidentified/ 
pseudonymized) for reported 
event 
• Upon request of sponsor 
Serious Adverse Device 
Effects 
 
Complete AE eCRF page with 
all available new and updated 
information 
• Immediately, but not later than 3 calendar 
days of first becoming aware of the event or as 
per local/regional regulations 
• Reporting required through the end of the 
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Table 19-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline Pre-Market 
Studies* 
( 21 CFR 812; MDCG 2020-10/1:  
 
Provide all relevant source 
documentation (deidentified/ 
pseudonymized) for reported 
event  
• When documentation is available 
• Upon request of sponsor  
Device Deficiencies 
(including but not limited 
to malfunctions, use 
errors, and inadequacy in 
information supplied by 
the manufacturer, 
including labeling) 
Note:  Any Device 
Deficiency that might have 
led to a serious adverse 
event if anappropriate 
action had not been 
taken, intervention had 
not occurred, 
circumstances had been 
less fortunate is 
considered a reportable 
event 
Complete Device Deficiency 
section of the AE eCRF with all 
available new and updated 
information  
• Immediately, but not later than 3 calendar 
days of first becoming aware of the event  
• Reporting required through the end of the 
study 
Provide all relevant source 
documentation (deidentified/ 
pseudonymized) for reported 
event 
• Upon request of sponsor 
Adverse Event including 
Adverse Device Effects 
Complete AE eCRF page, 
which contains such 
information as date of AE, 
treatment of AE resolution, 
assessment of seriousness and 
relationship to the device  
• In a timely manner (e.g., recommend within 10 
business days) after becoming aware of the 
information 
• Reporting required through the end of the 
study  
• Upon request of sponsor 
Provide all relevant source 
documentation 
(deidentified/pseudonymized) 
for reported event as 
requested by the sponsor 

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Table 19-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline Pre-Market 
Studies* 
( 21 CFR 812; MDCG 2020-10/1:  
 
* Please note that pre-market studies are clinical studies with investigational devices or with medical devices that bear the 
regulatory approval and are not being used for the same approved indications. 
19.6 Sponsor and CEC Definitions and Classification 
Events reported to BSC during the study will be reviewed and reported to comply with 
applicable regulations (relevant parts of ISO 14155 and/or 21 CFR Part 812). 
Investigators will be asked to classify whether an adverse event is considered serious or 
non-serious, whether it is anticipated or unanticipated (meets USADE/ UADE definition) 
as defined in Table 26-3 in Appendix F, and whether it is considered device or procedure 
related, as defined in Table 26-4. Any event that is determined to be an unanticipated 
serious adverse device effect (USADE; ISO 14155) will also be considered an 
unanticipated adverse device effect (UADE; CFR Part 812), as defined in Table 26-3. 
Death should not be recorded as an adverse event. Death should be recorded as an 
outcome of only one serious adverse event. 
Adverse event definitions are provided in Appendix F. Administrative edits were made 
on the safety definitions from ISO 14155 and MDCG 2020-10/1  for clarification 
purposes. 
20 Informed Consent 
Subject participation in this clinical study is voluntary. Informed Consent is required from 
each subject. 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 applicable national regulations, 
and local Ethics Committee and/or Regulatory authority, as applicable. The ICF must be 
accepted by BSC or its delegate (e.g., CRO), and approved by the site’s IRB/EC/REB, or 
central IRB, if applicable. 
Boston Scientific 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 site’s IRB/EC/REB. Any modification requires acceptance from BSC 
prior to use of the form. The ICF must be in a language understandable to the subject and 
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consent forms must also have IRB/EC/REB 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 at a minimum include the following 
steps, as well as any other steps required by applicable laws, rules, regulations and 
guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the 
process,  
• include a description of all aspects of the clinical study that are relevant to the 
subject’s decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout 
the clinical study.  
The ICF shall always be signed and personally dated by the subject competent to sign the 
ICF under the applicable laws, rules, regulations and guidelines and by the investigator 
and/or an authorized designee responsible for conducting the informed consent process. 
The original signed ICF will be retained by the site 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 subject consent will be reported by BSC to the applicable regulatory 
authority according to their requirements (e.g., FDA requirement is within 5 working 
days of learning of such an event). Any violations of the informed consent process must 
be reported as deviations to the sponsor and local regulatory authorities (e.g., 
IRB/EC/REB), as appropriate. 
If new information becomes available that can significantly affect a 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 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 applicable laws, protocol, a change in Principal Investigator, 
administrative changes, or following annual review by the IRB/EC/REB. The new 
version of the ICF must be approved by the IRB/EC/REB. Acceptance by Boston 
Scientific is required if changes to the revised ICF are requested by the site’s 
IRB/EC/REB. The IRB/EC/REB will determine the subject population to be re-
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21 Committees 
21.1 Data Monitoring Committee 
The Data Monitoring Committee (DMC) is responsible for the oversight review of all 
AEs. The DMC will include leading experts in cardiology, and biostatistics who are not 
participating in the study and who have no affiliation with BSC. During the course of the 
study, the DMC will review accumulating safety data to monitor the incidence of CEC 
events and other trends that would warrant modification or termination of the study. 
Responsibilities, qualifications, membership, and committee procedures are outlined in 
the DMC Charter.  
Any DMC recommendations for study modification or termination because of concerns 
over subject safety or issues relating to data monitoring or quality control will be 
submitted in writing to BSC for consideration and final decision. However, if the DMC at 
any time determines that a potentially serious risk exists to subjects in this study, the 
DMC chairman will immediately notify both BSC and the Principal Investigators. 
21.2 Clinical Events Committee 
A Clinical Events Committee (CEC) is an independent group of individuals with pertinent 
expertise that reviews and adjudicates all treated spontaneous episodes with available 
source documentation, relevant AEs, and all subject deaths reported by study 
investigators. Relevant AEs are those deemed to be attributed to either/ both of the PGs in 
the mCRM Coordinated System, the S-ICD electrode, or the procedure to implant the 
EMPOWER PG. The CEC will review a safety event dossier for each submitted AE or 
death, which may include copies of subject source documents provided by study sites,  
BSC reserves the right to submit other AEs as well, if deemed necessary. 
Committee membership will include practitioners of cardiology, as well as other experts 
with the necessary therapeutic and subject matter expertise to adjudicate the event 
categories outlined above. CEC responsibilities, qualifications, membership, and 
committee procedures are outlined in the CEC charter. 
22 Suspension or Termination 
22.1 Premature Termination of the Study 
Boston Scientific reserves the right to terminate the study at any stage but intends to 
exercise this right only for valid scientific or business reasons and reasons related to 
protection of subjects. Investigators, associated IRBs/ECs/REBs, and regulatory 
authorities, as applicable, will be notified in writing in the event of study termination. 
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. 
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• A decision on the part of Boston Scientific to suspend or discontinue development of 
the device. 
22.3 Termination of Study Participation by the Investigator or Withdrawal of IRB/ 
EC/ REB Approval 
Any investigator, or associated IRB/EC/REB, or regulatory authority may discontinue 
participation in the study or withdraw approval of the study, respectively, with suitable 
written notice to Boston Scientific. Investigators, associated IRBs/ECs/REBs, and 
regulatory authorities, as applicable, will be notified in writing in the event of these 
occurrences. 
22.4 Requirements for Documentation and 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 sites by BSC. The 
IRB/EC/REB and regulatory authorities, as applicable, will be notified. Detailed 
information on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB, REB or EC terminates participation in the study, participating 
investigators, associated IRBs/ECs/REBs, and regulatory authorities, as applicable, will 
be notified in writing. Detailed information on how enrolled subjects will be managed 
thereafter will be provided by BSC. 
In the event a Principal Investigator terminates participation in the study, study 
responsibility will be transferred to another investigator, if possible. In the event there are 
no opportunities to transfer Principal Investigator responsibility; detailed information on 
how enrolled subjects will be managed thereafter will be provided by BSC. 
The Principal Investigator or his/her designee must return all study-related documents and 
investigational product, including the PRM software pen drive, to BSC, unless this action 
would jeopardize the rights, safety, or welfare of the subjects. 
22.5 Criteria for Suspending/ Terminating a Study Site 
Boston Scientific reserves the right to stop the inclusion of subjects at a study site at any 
time after the study initiation visit if no subjects have been enrolled for a period beyond 3 
months after site initiation, or if the site has multiple or severe protocol 
violations/noncompliance without justification and/or fails to follow remedial actions. 
In the event of termination of site 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 subjects. The IRB/EC/REB and regulatory authorities, as 
applicable, will be notified. Study participants will be contacted, as applicable, and be 
informed of changes to study visit schedule.  
23 Study Registration and Results 
23.1 Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
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23.2 Clinical Investigation Report 
Study results will be made available in accordance with the legal requirements and the 
recognized ethical principles, in accordance with the Boston Scientific Policy. A Clinical 
Investigation Report will be made available to all investigators, IRB/EC/REB and 
regulatory authorities, as applicable in accordance with the Boston Scientific Policy and 
local requirements. As applicable an abbreviated Clinical Investigation Report will be 
made available on a publicly accessible database.  
23.3 Publication Policy 
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. BSC will submit study 
results for publication (regardless of study outcome) following the conclusion or 
termination of the study. The study results submitted will include the number of subjects 
that enroll into the study, as well as the number of subjects that complete the study, a 
summary of results for primary and secondary outcome measures, statistical analyses, and 
adverse events.  
Boston Scientific adheres to the Contributorship 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 in publication preparation provided the following 
guidelines are followed:  
• All authorship and contributorship 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/Steering Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding 
publication content, review, approval, and submission.  
The data, analytic methods, and study materials for this clinical trial may be made 
available to other researchers in accordance with the Boston Scientific Data Sharing 
Policy (https://www.bostonscientific.com/)  
24 Reimbursement and Compensation for Subjects 
24.1 Subject Reimbursement 
Travel and other expenses incurred by subjects as a result of participation in the study 
will be reimbursed in accordance with pertinent country laws and regulations and per the 
study site’s regulations.   
24.2 Compensation for Subject’s Health Injury 
Boston Scientific will purchase an insurance policy to cover the cost of potential health 
injury for study subjects, if required by applicable law.  
 
 

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25 Abbreviations and Definitions  
25.1 Abbreviations 
Abbreviations are shown in Table 25-1.   
Table 25-1: Abbreviations 
Abbreviation/Acronym 
Term 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
A/P 
Anterior/ Posterior 
AST 
Automated Screening Tool 
ATP 
Anti-tachycardia Pacing 
BSC 
Boston Scientific 
CA 
Competent Authority 
CEC 
Clinical Events Committee 
CFR (within stats sections) 
Complication-free Rate 
CFR 
Code of Federal Regulations 
CIED 
Cardiac Implantable Electronic Device 
CMS 
Center for Medicare and Medicaid Services  
CRF 
Case Report Form 
CRM 
Cardiac Rhythm Management 
DMC/ DSMB 
Data Monitoring Committee/ Data and Safety Monitoring Board 
DXA 
Dexamethasone Acetate 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDS 
Electrode Delivery System (for S-ICD) 
EIT  
Electrode Insertion Tools (for S-ICD) 
EMPOWER MPS 
EMPOWER Modular Pacing System; consists of the EMPOWER 
PG and implant delivery catheter 
EMPOWER PG 
EMPOWER Pulse Generator 
EOS 
End of Service (pertaining to EMPOWER PG battery) 
ERI 
Elective Replacement Indicator (pertaining to S-ICD PG battery) 
Fr 
French, a measurement system commonly used to measure the 
size of a catheter 
FDA 
Food and Drug Administration 
ICD 
Implantable Cardioverter Defibrillator 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
ISO 
International Standard Organization 

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Table 25-1: Abbreviations 
Abbreviation/Acronym 
Term 
J 
Joules 
LAO 
Left Anterior Oblique views 
LCP 
Leadless Cardiac Pacemaker 
LOC 
Loss of Capture 
LRL 
Lower Rate Limit 
LVAD 
Left Ventricular Assist Device 
MCR 
Metabolic-Chronotropic Relation 
MPS 
Modular Pacing System 
MVT 
Monomorphic Ventricular Tachycardia 
P/A 
Posterior/ Anterior 
PCT 
Pacing Capture Threshold 
PG 
Pulse Generator 
PMDA 
Pharmaceuticals and Medical Devices Agency 
PMST 
Paced Morphology Sensing Test 
PRM 
Programmer/ Recorder/ Monitor 
PTM 
Physician’s Technical Manual 
REB 
Research Ethics Board 
RV 
Right Ventricle 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis System 
SCD 
Sudden Cardiac Death 
S-ECG 
Subcutaneous electrocardiogram 
S-ICD 
Subcutaneous ICD 
TSF 
Technical Source Form 
TV-ICD 
Transvenous ICD 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
VF 
Ventricular Fibrillation 
VOO 
Asynchronous pacing mode 
VT 
Ventricular Tachycardia 
 
 
 

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25.2 Definitions 
Terms used in this protocol are defined in Table 25-2.  
Table 25-2: Definitions 
Term 
Definition 
 S-ICD System 
(EMBLEM/ EMBLEM MRI) S-ICD Pulse Generator, Models A209/ A219 
or future BSC S-ICD Pulse Generator + (EMBLEM) S-ICD Electrode Model 
3400/3401, Model 3501 or future BSC S-ICD Electrode46 
EMPOWER MPS  
EMPOWER Modular Pacing System, Model B170, which consists of the 
EMPOWER leadless pacemaker and the delivery catheter 
EMPOWER PG 
EMPOWER Pulse Generator: the leadless pacemaker  
EMPOWER System 
• EMPOWER MPS (EMPOWER pacemaker and Delivery Catheter) and 
Luer Cap (Model B170) 
• EMPOWER MPS accessories: 
o EMPOWER Retrieval Catheter, Snare Catheter Lock, Luer Caps, 
and Hemostasis Valve (Model 8780) 
o EMPOWER Introducer Sheath (Model 8782)47 
o EMPOWER Conducted Telemetry Cable (Model 6396) 
o EMPOWER Sterile Tray Cable (Model 6157) 
o EMPOWER Single-loop Snare (Model 8784) or EMPOWER Tri-loop 
Snare (Model 8785) 
• LATITUDE Programming System (Model 3300) 
• Programmer Application Software (Model 3870) and associated 
Programmer Firmware 
• Guidewire 
• Electrocardiogram electrodes (supplied by clinical center) 
Communication Success 
Any evidence of a paced beat during communication testing in a given 
posture at the initial programmed communication Programmed 
Telemetry Setting 
Communication Threshold 
Test 
This is a communication test that results in determining the minimum 
Telemetry Value that achieves two successful communication tests, 
regardless of sequence. A Communication Threshold test is required at 
 
46 Note that Cameron Health Q-Trak Electrode Model 3010 is the same as BSC Models 3400/3401, and is also 
allowable. 
47 Note: Another compatible introducer sheath may be used that is not part of the EMPOWER System 
accessories. Refer to Table 26-1 and the EMPOWER Modular Pacing System Physician’s Technical 
Manual and Label Supplement, as well as the EMPOWER Retrieval System Physician’s Technical Manual 
and Label Supplement for more information. 

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Table 25-2: Definitions 
Term 
Definition 
Implant, Pre-Discharge, and the 1-Month Follow-up in one or more 
postures, as described in the specific follow-up section. A 
Communication Threshold test is required at any other protocol-
required follow-up in the event of a failed Communication Test.  
Communication Test 
This is a communication test that is initiated at the initial programmed 
Telemetry Setting. A Communication Test is required at the 6-Month, 
and Semi-Annual Visits, as well as any Additional Visits which are 
conducted due to an adverse event related to communication of the 
mCRM Coordinated System. Note that if the Communication Test ends 
in unsuccessful communication, a Communication Threshold Test is 
required. 
Coordinated System/ 
mCRM Coordinated 
System/  mCRM Therapy 
System 
(EMBLEM) S-ICD System + EMPOWER PG 
Major complication 
related to EMPOWER MPS 
Major complications are those adverse events resulting in: 
• 
Death 
• 
Permanent loss of device function due to mechanical or electrical 
dysfunction of the device  
• 
Hospitalization 
• 
Prolonged Hospitalization by at least 48 hours* 
• 
System revision, including reposition, replacement, and explant. 
*Hospitalization is extended by ≥48 hours beyond expected hospital 
discharge (from implant or hospital admission for another cause) 
mCRM Programmable 
Parameters 
The S-ICD parameters listed below are not accessible without the PIN.  
These parameters are all related to ATP. 
• mCRM (On/Off) 
• Number of ATP Requests in Conditional Shock Zone (0, 1, 2, 3) 
• QUICK CONVERT™ ATP in Shock Zone (On/Off) 
• Telemetry Setting (1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7) 
Normal battery depletion 
A pulse generator that is not associated with a complaint and has 
reached its elective replacement indicator(s) with implant time that 
meets or exceeds the nominal (50th percentile) predicted longevity at 
default (labeled) programmable settings OR with implant time 
exceeding 75% of the expected longevity using the longevity calculation 
tool available at time of product introduction, calculated using the 
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Table 25-2: Definitions 
Term 
Definition 
Permanent Loss of Device 
Function 
Refers to: 1) the permanent loss of shock therapy and/or post shock 
pacing (S-ICD only); 2) permanent loss of appropriate sensing in all 
available sensing configurations (oversensing that results in persistent 
inappropriate shocks or undersensing that could lead to undetected 
arrhythmias) (S-ICD only). Loss of device function includes 
programming the PG permanently off or temporarily off in advance of 
an explant/revision (applies to both EMPOWER and S-ICD. 
Patient/ Potential Subject 
A person who is a potential candidate for the MODULAR ATP Clinical 
Study 
Subject 
A person who has been enrolled into the MODULAR ATP Clinical Study 
Spontaneous episode 
Any arrhythmia that is stored by the S-ICD pulse generator. For the 
purpose of the MODULAR ATP Clinical Study, only ventricular 
arrhythmias will be collected.  
Time 0 
Timing of study-required follow ups will be determined based on the 
date that the mCRM Coordinated System is implanted (successful 
implant of both the S-ICD System, with clinical firmware, and 
EMPOWER PG) 
Note: Subjects classified as a Partial Implant that are implanted with an 
EMPOWER PG must be followed according to this protocol, with all 
relevant EMPOWER PG device data and testing collected. Time 0 for 
the purpose of determining timing of follow ups for these subjects is 
the day it is determined the S-ICD will not be implanted. 
Time to therapy for 
inductions 
Time to therapy for induced episodes is defined as the interval starting 
2000ms after the last induction artifact (the time of the post induction 
refractory) and ending at the onset of the shock deflection on the S-
ECG recording.  
Time to therapy for 
spontaneous episodes 
Time to therapy for spontaneous episodes is defined as the interval 
starting when the cycle length of the patient’s rhythm is greater or 
equal to the lowest programmed zone cutoff and measured until the 
start of delivery of ATP pulses or the shock marker. 
 
 

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26 Appendices 
26.1 APPENDIX A: Detailed Implantable Device Descriptions 
26.1.1 EMPOWER™ Modular Pacing System (MPS) 
The Model B170 EMPOWER MPS is the first-generation LCP developed by BSC. The 
EMPOWER PG provides cardiac pacing wherein the entire implantable portion of the 
system resides within the right ventricle of the heart. The EMPOWER PG has a self-
contained power source, electrodes, and active-fixation talons that ensure reliable chronic 
anchoring. The EMPOWER PG does not require a pacing lead or a subcutaneous implant 
pocket. 
The EMPOWER MPS consists of the implantable pulse generator and the non-
implantable delivery catheter (refer to Section 26.2.1.1). The EMPOWER System also 
includes accessories and specialized EMPOWER PG delivery tools, retrieval tools, and 
programmer support (refer to Sections 26.2.1.2 and 26.2.1.3, respectively). 
The EMPOWER PG (Figure 26-1) is a single-chamber pacemaker with features that are 
common to BSC single-chamber pacemakers including, but not limiting to: 
• Cardiac pacing with brady modes of VVI(R)* 
• Programmable pace amplitude and pulse width 
• Fixed threshold sensing with programmable sense threshold 
• Rate-responsive pacing based on an accelerometer* 
• Sensor trending 
*Refer to Section 10.3.4.6 for more information regarding programming rate response 
in the context of the mCRM System. 
 
Figure 26-1: EMPOWER PG 
The main characteristics of the EMPOWER PG are summarized as: 
• Volume: 0.8 cm3 
• Mass: 2.0 g 
• Dimension: 6.00 mm x 32.10 mm with a 20.7F outer diameter delivery catheter 
• Fixation: active (talons) 

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• Tether loop/snare groove design for recapture or retrieval of the EMPOWER PG 
• Battery: ~144 mAh (usable capacity) 
• Contains ~0.96 mg Dexamethasone Acetate (DXA) on the distal end 
• Conducted telemetry 
The recommended introducer and guidewire for the EMPOWER PG are as follows: 
Table 26-1: Recommended Introducer and Guidewire for EMPOWER PG Implant 
Recommended introducer (without guidewire) 
Recommended guidewire 
21F (7.0 mm) or larger inner diameter; 50 to 56 
cm (19.7 to 22.0 inch) long 
As recommended in the manufacturer’s 
instructions for use for the introducer  
Refer to the EMPOWER Modular Pacing System Physician’s Technical Manual and 
Label Supplement, as well as the EMPOWER Retrieval System Physician’s Technical 
Manual and Label Supplement for more information. 
26.1.2 EMBLEM™ S-ICD and EMBLEM MRI S-ICD Pulse Generator 
The EMBLEM S-ICD and EMBLEM MRI PG consist of an inner structure of discrete 
electrical components, interconnected hybrid assemblies, batteries, and high-energy 
capacitors. The inner assembly is enclosed in a hermetically sealed can with an 
overmolded epoxy header for electrode connection. The header contains a single port for 
connection of the subcutaneous electrode to accommodate sensing, pacing, and 
defibrillation. The EMBLEM S-ICD and EMBLEM MRI S-ICD PG are designed to 
provide high-energy defibrillation shocks using a constant-tilt biphasic waveform and is 
capable of delivering bradycardia demand pacing for a period up to thirty seconds 
following defibrillation therapy. Future generations of BSC S-ICD PGs approved by the 
appropriate regulatory bodies may be included in the study. 
26.1.3 EMBLEM™ S-ICD Subcutaneous Electrode 
The EMBLEM™ S-ICD subcutaneous electrode features one high-voltage defibrillation 
coil for the purpose of providing defibrillation energy. It is constructed using a multifilar 
coil. Two sense electrodes (proximal and distal) are used for sensing. These sense 
electrodes are electrically insulated from the shock electrode by a multi-lumen polymeric 
tube. 
Electrical connectivity to the S-ICD PG is provided using multiple strands of insulated 
metallic cable inserted into the same multi-lumen polymeric tube. This tube comprises the 
body of the subcutaneous electrode and is subcutaneously implanted from the device 
pocket along the rib margin to the sternum. The proximal termination comprises a multi-
pole connector to plug into the header of the S-ICD PG. The connector is designed to be 
compatible with the BSC S-ICD PGs only. Future generations of BSC S-ICD electrodes 
approved by the appropriate regulatory bodies may be included in the study. 

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26.2 APPENDIX B: Detailed Non-implantable Device Descriptions 
26.2.1 EMPOWER MPS Delivery and Retrieval Accessories 
The EMPOWER MPS and associated delivery and retrieval accessories consist of both 
investigational and market-approved devices. The non-implantable EMPOWER System 
components that may be used during the implant and/or retrieval procedures, as well as 
during the course of the clinical study at clinical sites include:  
• Delivery Catheter portion of the EMPOWER MPS, Model B170 (refer to Section 
26.2.1.1). 
• EMPOWER™ Introducer Sheath, Model 8782 
• Note: Another compatible introducer sheath may be used that is not part of the 
EMPOWER System accessories. Refer to Table 26-1 and the EMPOWER 
Modular Pacing System Physician’s Technical Manual and Label Supplement, as 
well as the EMPOWER Retrieval System Physician’s Technical Manual and 
Label Supplement for more information. 
• Amplatz Super Stiff™ Guidewire Model M001465010, or equivalent stiff 0.035″ 
(0.89 mm) guidewire 
o A 5-pack of Amplatz Super Stiff™ Guidewires carries Model Number 
M00146511, where each individual guidewire in that pack includes Model 
Number M00146510 
• EMPOWER™ Retrieval System (refer to Section 26.2.1.2) 
o EMPOWER™ Retrieval Catheter, Model 8780 
o EMPOWER™ Single-Loop Snare and Catheter, Model 8784 
o EMPOWER™ Tri-Loop Snare and Catheter, Model 8785 
• Sterile Tray Conducted Telemetry Cable, Model 6157 
• Non-sterile Conducted Telemetry Cable, Model 6396 
• Surface ECG Cable, Model 3153 or equivalent 
• LATITUDE™ Programming System, Model 3300 and applicable accessories, 
with Programmer Application Software installed 
• Programmer Application Software, Model 3870  
• Physical media containing the Programmer Software Application, such as a pen 
drive, Model 6226 
• LATITUDE™ Programming System-Feature Key, Model 6252 
• Laser Tachometer, Advent Model A2103/LSR/K 
• Tachometer-to-Programmer Cable, BSC equipment number E90017-100 
At the start of the MODULAR ATP Clinical Study, the investigational status of the study 
devices is shown in Table 26-2. The investigational status may change throughout the 

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duration of the clinical study as products receive regulatory approval for commercial 
release in different geographies. 
Table 26-2: Study Device Status at Start of MODULAR ATP Clinical Study 
Study Devices 
Investigational or Commercial 
Status 
• EMPOWER Pacemaker and Delivery Catheter 
• EMPOWER Retrieval Catheter 
• Sterile and Non-sterile Conducted Telemetry Cables 
• Programmer Software Application and the physical media 
containing the Software Application  
Investigational globally 
EMPOWER Introducer Sheath 
Commercial in US; investigational 
in EU, UK, and Canada 
Compatible Introducer Sheath 
Commercial globally 
• EMPOWER Single-Loop Snare and Catheter 
• EMPOWER Tri-Loop Snare and Catheter 
Commercial in US, UK,and EU; 
investigational in Canada 
• Amplatz Super Stiff Guidewire or equivalent 
• Surface ECG Cable 
Commercial globally 
• LATITUDE™ Programming System–Feature Key 
• Laser Tachometer 
• Tachometer-to-Programmer Cable 
Available only to authorized 
Boston Scientific personnel 
26.2.1.1 EMPOWER Delivery Catheter 
The EMPOWER PG is shipped loaded in the non-implantable 20.7-Fr outer diameter 
delivery catheter (Figure 26-2 and Figure 26-3), which consists of the proximal delivery 
handle, catheter shaft, and a distal sleeve to house the pacemaker. The delivery catheter 
uses femoral vein access via the introducer sheath to navigate through the inferior vena 
cava to the right atrium, across the tricuspid valve, and to the right ventricle. 
 

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Figure 26-2: EMPOWER Delivery Catheter 
Figure 26-3 shows the distal portion of the EMPOWER Delivery Catheter, including its 
deflection shaft, extension shaft, sleeve and tether to the EMPOWER PG. 
 
Figure 26-3: Distal portion of the EMPOWER Delivery Catheter 
26.2.1.2 Retrieval System for the EMPOWER Pacemaker  
The EMPOWER Retrieval Catheter is a customized 20.7-Fr outer diameter retrieval tool 
that is designed to integrate with a single- or tri-loop snare system (Figure 26-4). Once 
the tether has been cut and removed from the proximal end of the EMPOWER PG, the 
EMPOWER Retrieval Catheter can be used to remove an already implanted EMPOWER 
PG from within a patient’s right ventricle, provided that the extent of the tissue 
encapsulation allows safe removal of the EMPOWER PG. The EMPOWER Retrieval 
Catheter uses the same femoral vein access as the EMPOWER Delivery Catheter to reach 
the right ventricle.  
 
Figure 26-4: Retrieval System for the EMPOWER PG 
26.2.1.3 Programming System for the EMPOWER PG 
The programming system for the EMPOWER PG consists of the Model 3870 
Programmer Application Software installed on the commercially available Model 3300 
LATITUDE Programming System. 

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26.2.2 EMBLEM™ S-ICD Delivery Accessories  
26.2.2.1 EMBLEM S-ICD Electrode Insertion Tool (EIT) 
The EMBLEM™ S-ICD EIT is a single-use, disposable subcutaneous tunneling tool that 
is used to facilitate predictable placement of the subcutaneous electrode. The EIT is 
designed to create an appropriately sized subcutaneous sinus for the subcutaneous 
electrode such that the electrode will fit securely and not loosely in the subcutaneous 
sinus. The tip of the EIT and the tip of the subcutaneous electrode are equipped with 
suture holes which enable the two devices to be temporarily sutured together during the 
implant procedure. Once the two devices are sutured together, the EIT can be used to pull 
the subcutaneous electrode through a subcutaneous sinus. Future generations of the BSC 
subcutaneous electrode insertion tool approved by the appropriate regulatory bodies may 
be included in the study. 
26.2.2.2 EMBLEM™ S-ICD Electrode Delivery System (EDS) 
The EMBLEM™ S-ICD EDS consists of a pair of single-use, disposable subcutaneous 
tunneling tools with splittable sheaths that is used to facilitate predictable placement of 
the subcutaneous electrode. The two tools differ only in their lengths, with the shorter of 
the two designed for tunneling along the sternum and the longer of the two designed for 
tunneling laterally between the xiphoid process and the S-ICD PG pocket. The EDS is 
designed to create an appropriately sized subcutaneous sinus for the subcutaneous 
electrode such that the electrode will fit securely and not loosely in the subcutaneous 
sinus. The splittable sheaths facilitate insertion of the subcutaneous electrode without the 
need to temporarily suture it to the tool when inserting it through the tunneled 
subcutaneous sinus. The EDS is designed to facilitate the two-incision technique, 
whereby the subcutaneous electrode is sutured in place only at the suture sleeve near the 
xiphoid process, eliminating the suture at the distal end of the subcutaneous electrode 
near the cranial end of the sternum. Future generations of the BSC subcutaneous electrode 
delivery system approved by the appropriate regulatory bodies may be included in the 
study. 
 
 
 

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26.3 APPENDIX C: Communication Test S-ECG Report 
Communication is tested by commanding a communication signal from the S-ICD 
System that, when successfully received by the EMPOWER PG, results in the 
EMPOWER PG delivering ATP therapy for up to 10 beats slightly faster than the 
subject’s intrinsic rate. 
An example of the Communication Test S-ECG Report is included in Figure 26-5. Note 
the definitions of each marker, including the possibility of a short duration of S-ICD 
System oversensing during ATP, as a part of testing communication. 
 
Figure 26-5: Communication Test S-ECG Report 
1: S-ICD telemetry setting used during test; 2: C marker (Charge Start) indicates high-
voltage capacitors are being charged to a low voltage to send the communication; 3: A 
marker (ATP Request) indicates when the communication was sent by the S-ICD; 4: The 
change in trace morphology from intrinsic beats after 6.0 sec indicates LCP pacing in 
response to receipt of the communication; 5: A period of oversensing may be observed.  

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26.4 APPENDIX D: Paced Morphology Sensing Test Decision Tree 
 
 
 
 
 

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26.5 APPENDIX E: Conversion and Sensing Interaction Testing Decision Tree 
 
 

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26.6 APPENDIX F: ISO 14155 Adverse Event Definitions 
Only events as described in Section 19.1 are reportable in the MODULAR ATP Clinical 
Study. For this study, the mCRM Coordinated System will be referred to as the study 
device. Reporting starts from the date of each subject’s informed consent. Refer to 
Sections 18.1, 18.2, and 18.3 of this protocol, as well as the EMPOWER MPS PTM, 
mCRM PTM, and S-ICD User’s Manual, for the known risks associated with the study 
devices.  
Definitions of those events are included in Table 26-3, and Table 26-4. Administrative 
edits were made on the safety definitions from applicable regulations and guidance 
including (but not limited to) ISO 14155, EU MDR 2017/745/MDCG 2020-10/1 
Guidance on Safety Reporting in Clinical Investigations, and 21 CFR Part 812 for 
clarification purposes. 
Table 26-3: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
 
Any untoward medical occurrence, unintended disease or injury, 
or any untoward clinical signs (including an abnormal laboratory 
finding) in subjects, users or other persons, in the context of a 
clinical investigation, whether or not related to the investigational 
medical device.  
NOTE 1: This includes events related to the investigational 
medical device or comparator. 
NOTE 2: This definition includes events related to the 
procedures involved. 
NOTE 3: For users or other persons, this definition is restricted 
to events related to the investigational medical device.  
Adverse Device Effect 
(ADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
Adverse event related to the use of an investigational medical 
device 
NOTE 1: This includes any adverse event resulting from 
insufficiencies or inadequacies in the instructions for use, the 
deployment, the implantation, the installation, the operation, 
or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use 
error or intentional misuse of the investigational medical 
device. 
NOTE 3: This includes ‘comparator’ if the comparator is a 
medical device 
Serious Adverse Event 
(SAE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1  
Note: This definition meets the reporting objectives and 
requirements of ISO 14155 and MDCG 2020-10/1. 
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject as defined by 
either: 
1) a life-threatening illness or injury, or 

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Term 
Definition 
2) a permanent impairment of a body structure or a body 
function, including chronic dieseases, or 
3) in-patient hospitalization or prolongation of existing 
hospitalization, or 
4) medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment to 
a body structure or a body function 
c) fetal distress, fetal death, or a congenital abnormality or birth 
defect including physical or mental impairment. 
NOTE 1: Planned hospitalization for a pre-existing condition, or 
a procedure required by the clinical investigational plan, 
without a serious deterioration in health, is not considered a 
serious adverse event.  
Serious Adverse Device 
Effect (SADE) 
 
Ref: ISO 14155 
Ref: MDCG 2020-10/1  
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
 
Unanticipated Adverse 
Device Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
Any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, a 
device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary 
plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or 
welfare of subjects. 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
 
Ref: ISO 14155 
Ref: MDCG 2020-10/1  
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the current 
version of the risk analysis report. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an 
effect which by its nature, incidence, severity or outcome has 
been identified in the risk assessment. 
Serious Health Threat 
 
Ref: ISO 14155 
 
Signal from any adverse event or device deficiency that indicates 
an imminent risk of death or a serious deterioration in the health 
in subjects, users or other persons, and that requires prompt 
remedial action for other subjects, users or other persons. 
Note 1: This would include events that are of significant and 
unexpected nature such that they become alarming as a potential 
serious health hazard or possibility of multiple deaths occurring at 
short intervals. 
Device Deficiency 
 
Ref: ISO 14155 
An inadequacy of a medical device related to its identity, quality, 
durability, reliability, usability, safety or performance.  

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Term 
Definition 
 
Ref: MDCG 2020-10/1 
NOTE 1: Device deficiencies include malfunctions, use errors, 
and inadequacy in the information supplied by the 
manufacturer including labelling. 
NOTE 2: This definition includes device deficiencies related to 
the investigational medical device or the comparator. 
The following definitions will be used for defining hospitalization or prolongation of 
hospitalization for SAE classification purposes: 
Hospitalization 
Hospitalization does not include: 
• 
emergency room visit that does not result in in-patient 
admission  
Note: although an emergency room visit does not itself 
meet the definition for hospitalization, it may meet other 
serious criteria (e.g., medical or surgical intervention to 
prevent permanent impairment or damage) 
• 
elective and pre-planned treatment/surgery for a pre-
existing condition that is documented in the subject’s 
record at the time of consent/enrollment 
• 
admission for social reasons and/or respite care in the 
absence of any deterioration in the subject’s general 
condition (e.g., subject is homeless, caregiver relief) 
• 
pre-planned, protocol-specified admission related to the 
clinical study (e.g., procedure required by protocol) 
Prolongation of 
hospitalization  
In-patient admission to the hospital that is prolonged beyond the 
expected standard duration for the condition under treatment. 
Note: new adverse events occurring during the hospitalization are 
evaluated to determine if they prolonged hospitalization or meet 
another SAE criteria. 
 

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Table 26-4: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event 
Classification 
Description 
Not Related 
Ref: MDCG 2020-
10/1 
Relationship to the device, comparator, or procedures can be excluded 
when: 
- the event has no temporal relationship with the use of the 
investigational device or the procedures related to the use of the 
investigational device; 
- the serious event does not follow a known response pattern to the 
medical device (if the response pattern is previously known) and is 
biologically implausible; 
- the discontinuation of medical device application or the reduction of 
the level of activation/exposure - when clinically feasible – and 
reintroduction of its use (or increase of the level of 
activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ that cannot be affected by 
the device or procedure; 
- the serious event can be attributed to another cause (e.g. an 
underlying 
or concurrent illness/ clinical condition, an effect of another device, 
drug, treatment or other risk factors); 
- the event does not depend on a false result given by the 
investigational device used for diagnosis, when applicable;  
- In order to establish the non-relatedness, not all the criteria listed 
above might be met at the same time, depending on the type of 
device/procedures and the serious event. 
Possibly Related 
Ref: MDCG 2020-
10/1 
The relationship with the use of the investigational device is weak but 
cannot be ruled out completely. Alternative causes are also possible 
(e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment). Cases were relatedness 
cannot be assessed or no information has been obtained should also be 
classified as possible. 
Probably Related 
Ref: MDCG 2020-
10/1 
The relationship with the use of the investigational device or, 
comparator, or the relationship with the procedures seems relevant 
and/or the event cannot reasonably be explained by another cause. 

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Table 26-4: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event 
Classification 
Description 
Causal Relationship 
Ref: MDCG 2020-
10/1 
The serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 
- the event is a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
- the event has a temporal relationship with investigational device 
use/application or procedures; 
- the event involves a body-site or organ that 
-the investigational device or procedures are applied to; 
-the investigational device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical 
device (if the response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the 
level of activation/exposure) and reintroduction of its use (or increase 
of the level of activation/exposure), impact on the serious event (when 
clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment) have 
been adequately ruled out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the investigational device 
used for diagnosis, when applicable; 
- In order to establish the relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of 
device/procedures and the serious adverse event. 
 
 
 

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26.7 APPENDIX G: Affect to Medicare Beneficiaries (US Only) 
Sudden Cardiac Arrest (SCA) refers to the cessation of cardiac activity with 
hemodynamic collapse and progression to Sudden Cardiac Death (SCD) if corrective 
measures are not initiated rapidly1. The life-threatening conditions most often associated 
with SCA and SCD are sustained ventricular tachyarrhythmias: ventricular tachycardia 
(VT) or ventricular fibrillation (VF).2  
The incidence of SCD increases markedly with age regardless of sex or race: the annual 
incidence for 50 year-old men is approximately 100 per 100,000 population compared to 
800 per 100,000 for 75 year-old men3. The data suggests that SCD is uniformly more 
common in men than in women at all age groups4. In contrast, the population of children, 
adolescents, and young adults has an overall annual risk of 1 per 100,000, and there is a 
somewhat higher risk of SCD at the younger end of that age range4.  
The use of ICDs is an established therapy for the prevention of death from ventricular 
arrhythmias.5 Transvenous ICDs are capable of delivering defibrillation, bradycardia 
pacing as well as antitachycardia pacing that can terminate many VTs4. S-ICDs do not 
provide either ATP or antibradycardia pacing. The need for ATP and/or bradycardia 
pacing may be present at initial implant or may develop over time. According to 2018 
Medicare Outpatient Prospective Payment Systems (OPPS) claims data, Medicare is the 
payer for 48.4 % of patients who are implanted with an ICD system (APC 5232)6; 2018 
Medicare Provider Analysis and Review (MedPAR) data show that Medicare is the payer 
for 65.7% of patients implanted with an ICD system (MS-DRGs 222-227)7.  
The subjects selected for participation in the MODULAR ATP Clinical Study will be 
from the investigators’ general adult patient population (with no upper age limit) who 
meet all inclusion criteria and have none of the exclusion criteria. It is not anticipated the 
device under investigation will affect Medicare beneficiaries differently than it would 
patients found in the investigators' general population for these same conditions. Because 
the incidence of SCD is known to increase with age, the results of this study are expected 
to be generalizable to the Medicare eligible population primarily due to age.  
The MODULAR ATP Clinical Study results on all pre-specified outcomes, including 
negative outcomes, will be submitted to www.ClinicalTrials.gov not later than one year 
after the completion date of the study, where the completion date is defined as the date 
that the final subject was examined or received an intervention for purposes of data 
collection for the primary outcome measure. Results submission could be delayed if an 
extension is granted to the results submission deadline; however, the release of all results 
on pre-specified outcomes will be hastened if the study is terminated early. 
 
1Suryanarayana P, Garza HK, Klewer J, Hutchinson MD. Electrophysiologic Considerations After Sudden Cardiac 
Arrest. Curr Cardiol Rev. 2018;14(2):102-108. doi:10.2174/1573403X14666180507164443 
2 Centers for Medicare & Medicaid Services. Decision Memo for Implantable Cardioverter Defibrillators (CAG-
00157R4)  CMS website.  https://www.cms.gov/medicare-coverage-database/details/nca-
decision-memo.aspx?NCAId=288.  Accessed June 30, 2020 
3Deo R, Albert CM. Epidemiology and genetics of sudden cardiac death. Circulation. 2012;125(4):620-637. 
doi:10.1161/CIRCULATIONAHA.111.023838 
4Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, 
Fonarow GC, Gillis AM, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page 

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RL, 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of 
sudden cardiac death. Heart Rhythm 2018;15(10):e73-e189.  doi:10.1016/j.hrthm.2017.10.036. 
5Olde Nordkamp LR, Knops RE, Bardy GH, et al. Rationale and design of the PRAETORIAN trial: a Prospective, 
RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. Am Heart 
J. 2012;163(5):753-760.e2. doi:10.1016/j.ahj.2012.02.012 
6 CMS OPPS 2018 database 
7 MedPAR 2018 database 
 
 

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26.8 APPENDIX H: Protocol Revision History 
Detailed protocol revisions starting with changes to Version E (released for study use) are 
included in the tables below. Summarized changes made to the protocol prior to Version 
E are included in the Protocol Synopsis, Section 2. 
Table 26-5: Changes Made to Protocol Version H to Create Version I 
Protocol Section 
Key Changes 
Reason for Change 
Protocol Synopsis 
Changed “multi-study site” to “multi-site study” 
Corrected error; 
incorrect to state 
multi-study site 
Changed Exclusion Criterion from “Inability to 
access femoral vein with a 21-French (inner 
diameter / 23.5-French outer diameter) 
introducer sheath due to known anatomy 
condition, recent surgery, and/ or other relevant 
condition” to “Inability to access femoral vein 
with a 21-French or larger inner diameter 
introducer sheath due to known anatomy 
condition, recent surgery, and/or other relevant 
condition” 
Added use of 
compatible Introducer 
Sheaths  
5.3.1 Non-Implantable Study 
Devices Associated with the 
EMPOWER System 
Added statement that compatible Introducer 
Sheaths may be used during the MODULAR ATP 
Clinical Study 
Added use of 
compatible Introducer 
Sheaths 
Referenced EMPOWER Modular Pacing System 
PTM and Label Supplement and EMPOWER 
Retrieval System PTM and Label Supplement, and 
Table 26-1 for more information 
Added use of 
compatible Introducer 
Sheaths.  BSC 
recommends that the 
user follow 
information provided 
in the applicable PTM 
and Label Supplement 
for the indicated 
sections of the PTM 
and labels 

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Reason for Change 
7 Study Design 
Changed “multi-study site” to “multi-site study” 
Corrected error; 
incorrect to state 
“multi-study site” 
8.3 Exclusion Criteria 
Table 8-2:  Changed Exclusion Criterion from 
“Inability to access femoral vein with a 21-French 
(inner diameter / 23.5-French outer diameter) 
introducer sheath due to known anatomy 
condition, recent surgery, and/ or other relevant 
condition” to “Inability to access femoral vein 
with a 21-French or larger inner diameter 
introducer sheath due to known anatomy 
condition, recent surgery, and/or other relevant 
condition” 
Added use of 
compatible Introducer 
Sheaths  
10.3.1.2 Product Information 
Added statement that compatible Introducer 
Sheaths may be used during the MODULAR ATP 
Clinical Study 
Added use of 
compatible Introducer 
Sheaths 
Referenced EMPOWER Modular Pacing System 
PTM and Label Supplement and EMPOWER 
Retrieval System PTM and Label Supplement, and 
Table 26-1 for more information 
Added use of 
compatible Introducer 
Sheaths.  BSC 
recommends that the 
user follow 
information provided 
in the applicable PTM 
and Label Supplement 
for the indicated 
sections of the PTM 
and labels 

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Reason for Change 
10.3.1.3 EMPOWER PG 
Implant Procedure Duration 
Removed “EMPOWER” from Introducer sheath 
references 
Removed “EMPOWER” 
references to enable 
use of compatible 
Introducer Sheaths 
11.6.3.1 Assessment of 
Pooling Across 
Communication Test Postures 
Changed “Postures will be deemed to be 
heterogeneous if the variance of the fixed study 
site effect is found to significantly differ from 
zero” to “Postures will be deemed to be 
heterogeneous if the variance of the fixed 
posture effect is found to significantly differ from 
zero” 
Corrected error; 
incorrect to state 
“study site” 
Added “posture” for 
clarity 
11.6.3.3 Assessment of 
Pooling Across Introducer 
Sheaths 
Added pooling analysis across Introducer Sheaths 
Enables quantifying 
the effect that use of 
compatible Introducer 
Sheaths in the 
MODULAR ATP Clinical 
Study may have on the 
Safety Endpoints of 
the MODULAR ATP 
Clinical Study 
16.6 Role of Boston Scientific 
Representatives 
Added statement to “Role of BSC 
Representative” to allow for remote case 
support, if needed. 
• 
Use of Remote Case Support Technology to 
establish a tele-mentoring communication 
stream/live stream to perform R&D 
technical support and physician mentoring. 
The streaming will be in a secure and 
encrypted high-definition format which has 
been proven and is robust. The streaming 
will not be recorded. The use of remote case 
support will be in compliance with 
applicable regulations governing patient 
privacy. The BSC personnel on the live 
stream will not have any direct contact with 
the subject and in no instance will the 
subject be shown on video. 
Added to align with 
updated internal 
procedural 
requirements 
25.2 Definitions 
Added statement that compatible Introducer 
Sheaths may be used during the MODULAR ATP 
Clinical Study 
Added use of 
compatible Introducer 
Sheaths 
26.1 Appendix A EMPOWER 
Modular Pacing System (MPS) 
 
Table 26-1:  Changed recommended Introducer 
and Guidewire 
Changes align with the 
EMPOWER Modular 
Pacing System PTM 
and Label Supplement  
26.2.1 Appendix B EMPOWER 
MPS Delivery and Retrieval 
Accessories 
Added statement that compatible Introducer 
Sheaths may be used during the MODULAR ATP 
Clinical Study 
Added use of 
compatible Introducer 
Sheaths 
Referenced EMPOWER Modular Pacing System 
PTM and Label Supplement and EMPOWER 
Retrieval System PTM and Label Supplement, and 
Table 26-1 for more information 
Added use of 
compatible Introducer 
Sheaths.  BSC 
recommends that the 

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user follow 
information provided 
in the applicable PTM 
and Label Supplement 
for the indicated 
sections of the PTM 
and labels 
Table 26-1:  Added recommended compatible 
Introducer Sheaths and Guidewire 
Added use of 
compatible Introducer 
Sheaths 
Abbreviations:  BSC=Boston Scientific Corporation, PTM=Physician’s Technical Manual 
 
 
Table 26-6: Changes Made to Protocol Version G (not released for study use) to 
Create Version H 
Protocol Section 
Key Changes 
Reason for Change 
11.1.3 Secondary Safety Endpoint 
 
11.5.1 Study Success Criteria  
Updated  both sections to state the 
secondary safety endpoint will only be 
analzyed if secondary effectiveness is 
sucessful 
 
Added per FDA 
recommendation to 
control for multiplicity 
16.1 Statement of Compliance 
Added reference to European Medical Device 
Regulation 
Correction of error: 
missed this update in 
Version F of protocol 
 
Table 26-7: Changes Made to Protocol Version F (not released for study use) to 
Create Version G 
Protocol Section 
Key Changes 
Reason for Change 
Protocol Synopsis  
Updated statistical alpha level (Final) from 
1.3% to 1.9% 
Corrected Safety 
Endpoint 1 final 
analysis alpha level 
error  
11.1.1.2 Sample Size 
Updated statistical alpha level (Final) from 
1.3% to 1.9% 
Corrected Safety 
Endpoint 1 final 
analysis alpha level 
error 
11.1.1.3 Statistical Methods 
Updated statistical alpha level (Final) from 
1.3% to 1.9% 
Corrected Safety 
Endpoint 1 final 
analysis alpha level 
error 
One-sided lower pointwise confidence limit of 
the Major CFR updated from 98.7 to 98.1 
Corrected Safety 
Endpoint 1 final 
analysis alpha level 

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Reason for Change 
error resulting from 
updated alpha 
11.1.3 Secondary Safety Endpoint 
Added the following statement:  
“In order to control the overall study Type I 
error rate, this endpoint will only be 
evaluated if Safety Endpoint 1 and the 
primary effectiveness endpoints are 
successful.” 
Added per FDA 
recommendation to 
control for multiplicity 
11.1.3.2 Sample Size 
Updated one-sided significance level from 5% 
to 2.5% 
Updated per FDA 
recommendation to 
match significance 
level of other 
endpoints 
Updated sample size for Secondary Safety 
Endpoint from 205 to 275  
Change results from 
change in significance 
level to 2.5% 
11.1.6 Secondary Effectiveness 
Endpoint 
Added the following statement:  
“In order to control the overall study Type I 
error rate, this endpoint will only be 
evaluated if Safety Endpoint 1 and the 
primary effectiveness endpoints are 
successful.” 
Added per FDA 
recommendation to 
control for multiplicity 
19 Safety Reporting 
Updated requirement from MEDDEV 2.7/3 to 
MDCG 2020-10/1 throughout section 
Updated per 
MDCG 2020-10/1 
safety reporting 
requirements aligning 
with European 
Medical Device 
Regulation, 
MDR 2017/745 
Table 19-1 Investigator Reporting 
Requirements 
Updated wording for required reporting 
timeline for a Serious Adverse Event from 
“Within 3 calendar days…” to “Immediately, 
but not later than 3 calendar days…” 
Updated per 
MDCG 2020-10/1 
safety reporting 
requirements aligning 
with European 
Medical Device 
Regulation, 
MDR 2017/745 
Updated wording for required reporting 
timeline for Serious Adverse Device Effects 
from “Within 3 calendar days…” to 
“Immediately, but not later than 3 calendar 
days…” 
Updated wording for required reporting 
timeline for Device Deficiencies from “Within 
3 calendar days…” to “Immediately, but not 
later than 3 calendar days…” 
Updated “Event Classification” for Device 
Deficiencies from “(including but not limited 
to failures, malfunctions, and product 
nonconformities)”, to “(including but not 
limited to malfunctions, use errors, and 
inadequacy in information supplied by the 
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Updated “Note” within “Event Classification” 
for Device Deficiencies from “Note:  Any 
Investigational Device Deficiency that might 
have led to a serious adverse event if 
a) suitable action had not been taken, or 
b) intervention had not been made, or c) if 
circumstances had been less fortunate is 
considered a reportable event”,  
to  
“Note:  Any Device Deficiency that might have 
led to a serious adverse event if an 
appropriate action had not been taken, 
intervention had not occurred, circumstances 
had been less fortunate, is considered a 
reportable event” 
Table 26-3: Safety Definitions 
Changed “MEDDEV 2.7/3” to “MDCG 
2020-10/1” in Serious Adverse Event 
definition 
Correction of error: 
missed this update in 
Version F of protocol 
Table 26-4: Criteria for Assessing 
Relationship of Study Device or 
Procedure to Adverse Event 
Update to “Classification: Not Related”: 
• 
Removed: “the event is not a known side 
effect of the product category the device 
belongs to or of similar devices and 
procedures”, 
• 
Updated: “the event has no temporal 
relationship with the use of the 
investigational device or the procedures” 
to “the event has no temporal 
relationship with the use of the 
investigational device or the procedures 
related to the use of the investigational 
device”, 
• 
Updated: “the event involves a body-site 
or an organ not expected to be affected 
by the device or procedure” to “the event 
involves a body-site or an organ that 
cannot be affected by the device or 
procedure”, 
• 
Updated: “the event does not depend on 
a false result given by the investigational 
device used for diagnosis, when 
applicable; harms to the subject are not 
clearly due to use error”, to “the event 
does not depend on a false result given 
by the investigational device used for 
diagnosis, when applicable” 
Updated per 
MDCG 2020-10/1 
safety reporting 
requirements aligning 
with European 
Medical Device 
Regulation, 
MDR 2017/745 
Updated “Classification: Probably Related”: 
“The relationship with the use of the 
investigational device, comparator, or the 
relationship with the procedures seems 
relevant and/or the event cannot reasonably 
be explained by another cause, but additional 
information may be obtained” to “The 

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Reason for Change 
relationship with the use of the 
investigational device or, comparator, or the 
relationship with the procedures seems 
relevant and/or the event cannot reasonably 
be explained by another cause” 
Abbreviations:  CFR=Complication Free Rate, MDCG=Medical Device Coordination Group, 
MEDDEV 2.7/3=Guidelines on Medical Devices Clinical Investigations:  Serious Adverse Event Reporting 
Under Directives 90/385/EEC and 93/42/EEC. 
 
Table 26-8: Changes Made to Protocol Version E to Create Version F (not released 
for study use) 
Protocol Section 
Key Changes 
Reason for Change 
Protocol Synopsis 
Added Secondary Safety Endpoint 
Added Secondary 
Safety Endpoint 
Updated follow-up schedule 
6 Study Objectives and Endpoints 
Added Secondary Safety Endpoint 
Added Secondary 
Safety Endpoint 
7.1 Scale and Duration 
Updated number of subjects 
Removed Phase 2 
Removed “Phase 1” and “Phase 2” references 
Updated follow-up schedule 
Added Secondary 
Safety Endpoint 
Deleted Figure 7-2 MODULAR ATP Clinical 
Study Design Phase 2 
Removed Phase 2 
7.2 Justification for the Study 
Design 
Removed “Phase 1” reference 
Removed Phase 2 
Updated follow-up schedule 
Added Secondary 
Safety Endpoint 
9.7 End-of-Study Definition 
Removed “Phase 1” references 
Removed Phase 2 
Updated follow-up schedule 
Added Secondary 
Safety Endpoint 
Removed Phase 2 end-of-study information 
Removed Phase 2 
10.1 Data Collection 
Removed “Phase 1” and “Phase 2” references 
Removed Phase 2 
10.3.1.3 EMPOWER PG Implant 
Procedure Duration 
Changed “will be collected, including” to “will 
be derived from” 
Added clarity to how 
data are created; 
overall procedure time 
is being derived, not 
collected 
10.3.1.7 EMPOWER PG 
Evaluation 
Changed “impedance measurements and 
record on the appropriate case report form” 
to “impedance measurements must be 
recorded” 
Added clarity; data are 
recorded first on a 
technical source form, 
not directly to the 
Case Report Form 
10.3.4.1 Communication 
Evaluation in the MODULAR ATP 
Clinical Study 
Removed “Phase 1” references 
Removed Phase 2 
Removed Phase 2 Communication Test 
information 

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10.4.2.3 Spontaneous Episodes 
Changed “syncopal” to “symptomatic” when 
referring to episodes associated with 
spontaneous events that will be collected 
Corrected error; 
incorrect to state 
syncopal episodes are 
collected, including 
syncope.  Aligns with 
Section 10.3.5.2 text 
10.4.4.2 S-ICD Programming 
Changed “burst” to “request” for 
recommended S-ICD ATP programming 
parameters in the Conditional Shock Zones for 
primary and secondary prevention subjects 
Added clarity; burst is 
a type of ATP therapy.  
Change aligns protocol 
with labeling and 
Programmer 
10.5.2.2 Spontaneous Episodes 
Changed “syncopal” to “symptomatic” when 
referring to episodes associated with 
spontaneous events that will be collected 
Corrected error; 
incorrect to state 
syncopal episodes are 
collected, including 
syncope.  Aligns with 
Section 10.3.5.2 text 
10.5.3.1 Four-Posture 
Communication Threshold Test 
Removed “Phase 1” reference 
Removed Phase 2 
Removed Phase 2 Communication Test 
information 
10.5.3.2 Communication 
Threshold Test 
Removed “Phase 1” references 
Removed Phase 2 
Removed Phase 2 Communication Test 
information 
10.5.5.2 16 to 24 Hour Holter 
Monitoring 
Removed “Phase 1” reference 
Removed Phase 2 
10.7.2.2 Spontaneous Episodes 
Changed “syncopal” to “symptomatic” when 
referring to episodes associated with 
spontaneous events that will be collected 
Corrected error; 
incorrect to state 
syncopal episodes are 
collected, including 
syncope.  Aligns with 
Section 10.3.5.2 text 
10.7.3.1 Four-Posture 
Communication Test 
Removed “Phase 1” references 
Removed Phase 2 
Removed Phase 2 Communication Test 
information 
10.7.3.2 Communication 
Threshold Test 
Removed “Phase 1” references 
Removed Phase 2 
Removed Phase 2 Communication Test 
information 
10.7.5 6 Month Visit Source 
Documentation Requirements 
Removed “Phase 1” reference 
Removed Phase 2 
10.8 Semi-Annual Visits 
Removed “Phase 1” references 
Removed Phase 2 
Updated follow-up schedule 
Added Secondary 
Safety Endpoint 
Removed Phase 2 reference and follow-up 
information 
Removed Phase 2 
10.8.2.2 Spontaneous Episodes 
Changed “syncopal” to “symptomatic” when 
referring to episodes associated with 
spontaneous events that will be collected 
Corrected error; 
incorrect to state 
syncopal episodes are 
collected, including 

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syncope.  Aligns with 
Section 10.3.5.2 text 
10.9.2.2 Spontaneous Episodes 
Changed “syncopal” to “symptomatic” when 
referring to episodes associated with 
spontaneous events that will be collected; 
added “specifically any syncopy” 
Corrected error; 
incorrect to state 
syncopal episodes are 
collected, including 
syncope.  Aligns with 
Section 10.3.5.2 text 
11.1 MODULAR ATP Clinical 
Study Endpoints 
Removed “Phase 1” reference 
Removed Phase 2 
11.1.1 Safety Endpoint 1: Major 
EMPOWER MPS System- and 
Procedure-related 
Complication-Free Rate from 
Implant through 6 Months 
Post-Implant 
Removed “Phase 1” reference 
Removed Phase 2 
11.1.1.2 Sample Size 
Removed “Phase 1” references 
Removed Phase 2 
11.1.1.3 Statistical Methods 
Removed “Phase 1” reference 
Removed Phase 2 
11.1.2 Safety Endpoint 2:  Major 
EMPOWER MPS System- and 
Procedure-related 
Complication-free Rate from 
Implant through 12 Months 
Post-Implant 
Removed “Phase 1” reference 
Removed Phase 2 
11.1.2.2 Sample Size – CE Mark 
Cohort 
Removed “Phase 1” references 
Removed Phase 2 
11.1.2.3 Sample Size – 
Post-Market 1 Cohort 
Removed “Phase 1” references 
Removed Phase 2 
11.1.2.4 Statistical Methods 
Removed “Phase 1” references and 
associated sample size 
Removed Phase 2 
11.1.3 Secondary Safety 
Endpoint: All-Cause Survival from 
Implant through 2 Years 
Post-Implant 
NEW  
Added Secondary 
Safety Endpoint 
11.2 Ancillary Objectives 
Removed “Phase 1” and “Phase 2” references 
Removed Phase 2 
11.4 Sample Size Summary 
Removed Phase 1 reference 
Removed Phase 2 
Removed Phase 2 sample size information 
11.5.2 Control of Systematic 
Error / Bias 
Removed “Phase 1” references 
Removed Phase 2 
Removed Phase 2 information 
11.6.1.2 Endpoints 
Removed “Phase 1” references 
Removed Phase 2 
26.6 Appendix F 
Added EU MDR 2017/745/MDCG 2020-10/1 
Guidance on Safety Reporting in Clinical 
Investigations reference 
Added updated 
standard reference 
since last protocol 
revision; inadvertently 
absent from previous 
protocol revision