Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies
Phase: NA
Conditions: Ventricular Fibrillation
Sponsor: Boston Scientific Corporation

 
 
 
 
Protocol & Statistical Analysis Plan  
Cover Page 
 
 
 
[ASE Study]  
Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for 
Reduction of Defibrillation Energies 
 
 
 
CLINICAL INVESTIGATION PLAN 
ver. F, dated 20 Jan 2021  
 
 
 
ClinicalTrials.gov Registration: NCT03802110 
 
 
 
 
 
 
 
 

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Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for 
Reduction of Defibrillation Energies 
 
[ASE Study]  
 
CLINICAL INVESTIGATION PLAN 
 
Project Number C2081 
National Clinical Trial (NCT) Identified Number: NCT03802110 
Eudamed Number: CIV-NL-18-11-026204 
 
Sponsored By 
Boston Scientific International S.A. 
Rhythm Management Clinical Department  
Green Square, 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. 
 
 
 
 
 
 
 
 
 

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Original Release: September 5, 2017 
Current Version: Nov 20th , 2019 
 
Revision History 
Revision 
version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
section 
modified  
Summary of changes 
Justification for 
Modification 
A 
Sept 5, 
2017 
90702637 
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NA 
Original Release 
NA 
B 
Mar 6, 
2018 
90702637 
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Section 9.3 
 
 
 
 
 
 
Section 22.2 
Modified Exclusion 
Criteria 22 to: Women 
of childbearing 
potential who are or 
might be pregnant at 
the time of the S-ICD 
implant procedure. 
 
Added a section for 
DMC 
Clarified that exclusion to 
pregnancy is only at the 
time of the S-ICD implant 
procedure; there is no 
exclusion after the implant 
procedure. 
 
 
Per AMC Central EC’s 
request. 
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May 22, 
2019 
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NA 
NA 
Major revision to support 
the testing of a 2-electrode 
configuration (Parallel and 
90º)   
C 
May 22, 
2019 
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Contact 
information 
Updated clinical 
contact 
Change of CTM 
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May 22, 
2019 
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Synopsis 
Updated  
Updated for consistency 
with the changes made 
throughout the protocol - 
see description of the 
major changes below 
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May 22, 
2019 
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Section 
4.2.4-
Background, 
Figure 4-2, 
Table 4-1,  
Added background 
information, figures 
and clarifying text to 
describe 2-electrode 
configuration (Parallel 
and 90º) “parallel” 
electrodes, described 
previously and a new 
“90º” configuration 
Provide background 
information to justify 
adding testing of the 2-
electrode configuration 
(Parallel and 90º).    
C 
May 22, 
2019 
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8.0 – Study 
Design, 
Figure 8-1 
New text and updated 
Figure 8-1 to describe 
the new 90º angle 
electrode configuration 
Supports changes to the 
study procedure (see 
section 11.4 below) 

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Revision History 
Revision 
version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
section 
modified  
Summary of changes 
Justification for 
Modification 
C 
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2019 
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8.1 – Scale 
and 
Duration 
Increased enrollment 
from 30 to 42 and 
complete data sets 
from 20 to 30. 
Twenty complete data sets 
are needed with the new 
test procedure described in 
section 11.4. Ten data sets 
have already been 
obtained from 14 enrolled 
subjects. So, the 
enrollment and complete 
date set numbers were 
increased proportionally. 
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May 22, 
2019 
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8.2 
Treatment 
Assignment 
Added description of 
how the order of 
testing will be 
determined based on 
subject enrollment #. 
Testing of 2-electrode 
configuration (Parallel and 
90º) was added so a 
method to determine the 
order of testing was 
needed to reduce the 
possibility of a test order 
bias. 
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2019 
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Table 11-1 
Added collection of 
post-operative x-rays 
when available as part 
of standard of care. 
Clarification.  When 
available, post-op x-rays 
may aid in the 
interpretation of study 
results. 
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2019 
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11.4 SICD 
Implant 
Visit, Figure 
11-1 
Completely re-written 
and new Figure added. 
Describes the flow of 
the overall procedure 
with testing two-
electrode 
configurations (Parallel 
and 90º )”.  The new 
Figure 11-1 describes a 
new energy test step 
sequence that starts at 
30 J, rather than 50 J, 
and requires only 2 VF 
inductions per shock 
configuration.   
New computer modeling 
data suggests two shock 
coils inserted at a 90° 
angle (an “L” 
configuration) might 
perform as well as two 
electrodes inserted in 
parallel but could result in 
a more favorable product.  
The original protocol 
envisioned this possibility 
but was not clear about 
how testing in another 
configuration should be 
done. So, changes to the 
test procedure were 
needed to allow testing of 
both configurations.  This 
is the main reason for the 
protocol revision.   

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Revision History 
Revision 
version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
section 
modified  
Summary of changes 
Justification for 
Modification 
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2019 
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11.4.2 
Temporary 
Insertion of 
the Second 
S-ICD 
Electrode 
Added more specific 
description of how the 
2nd electrode is inserted 
in both parallel and 90º 
configurations   
Clarification – to support 
changes in 11.4 (see 
above)  
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May 22, 
2019 
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11.4.3 
Figure 11-1 
Clarifications to the 
DFT testing procedure 
and stopping rules.  
The old Figure 11-1, 
originally shown in 
section 11.4.3 was 
removed and a new 
Figure 11-1 was added 
to section 11.4 (see 
above).    
Needed to support testing 
of 2-electrode 
configuration (Parallel and 
90º) per 11.4 above.  
Current results showed 
that all subjects were 
converting at 40 J or 
lower, so the starting 
energy was reduced to 30 
J and the new testing only 
require 2 VF inductions 
per test configuration.   
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11.4.4 – 
Allowable 
Test 
Sequence 
Revisions  
Added section 11.4.4 
to describe the range, 
and limits, of possible 
changes that could be 
made to the test 
procedure.   
Provide clarity about the 
scope and limits of 
changes that can be made 
without need for a new 
protocol revision.   
C 
May 22, 
2019 
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All sections 
Minor changes made 
throughout the 
document to support 
the major changes 
described above.  
Consistency, clarity with 
the major changes  
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2019 
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20.4 
Investigator 
Reporting 
Requirement
s 
Updated AE reporting  
Updated per current 
Boston Scientific 
requirement 
D 
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2019 
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Table 4-1. 
Results of 
computer 
models of 
defibrillatio
n electrical 
fields in a 
realistic 
human torso 
Peak current and peak 
voltage added for Two 
parasternal electrodes 
at ~90º angle 
Question from CEC 

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Revision History 
Revision 
version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
section 
modified  
Summary of changes 
Justification for 
Modification 
D 
July 1 
2019 
90702637 
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20.4 
Investigator 
Reporting 
Requirement
s 
Updated AE timelines  
Corrections  
E 
20 Nov 
2019 
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11.4.1 and 
11.4.3 
Added Safety Criteria 
to Stop In-procedure 
Acute Testing 
Updated due to 
unexpected system event 
in 2 enrolled patients. 
F 
20 Jan 
2021 
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All 
Adoption of sponsor 
protocol template 
which was modified to 
conform with the with 
the updated ISO 14155 
and EU MDR 
Added number of 
Investigational devices 
to be used per patient 
Added statement that 
the study population is 
a reasonable 
representation of the 
population that would 
be targeted for a future 
SICD product 
Added a list of 
technical and 
functional features of 
the Investigational 
device and their related 
expected outcome 
Added the product 
clinical development 
stage 
Added a clarification 
on final database lock 
and storage 
Added a statement that 
the sponsor will not 
approve protocol 
waivers 
Added necessity for a 
site to enter in a 
Adoption of updated ISO 
14155 and EU MDR 
requirements 

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Revision History 
Revision 
version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
section 
modified  
Summary of changes 
Justification for 
Modification 
Clinical Study 
Agreement with the 
sponsor before 
commencing the trial 
Added that study is 
conducted in 
conformance to 
European Medical 
Device Regulation 
Added requirements 
for investigators on 
their qualifications and 
disclosure of interests 
Added requirement for 
the sponsor to have a 
monitoring strategy in 
place 
Clarified instances 
when the clinical 
investigation can be 
suspended or 
terminated 
Added obligation to 
register the study on a 
public database and to 
have a clinical 
investigation report 
available 
Added Boston 
Scientific data sharing 
policy 
Added definitions of 
source document and 
source data 
F 
20 Jan 
2021 
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Synopsis 
9.3  
 
Exclusion 
Criteria 
Removed 2 exclusion 
criteria (main driver 
of the protocol 
amendment): 
Previously #7 and #8: 
− 7.Subject has 
hypertrophic 
cardiomyopathy. 
BSC initially excluding 
these patients who are 
known to have or might 
have a higher 
defibrillation threshold. 
BSC and the ASE Steering 
Committee have agreed 
that it is safe to include 
them given the literature 

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Revision History 
Revision 
version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
section 
modified  
Summary of changes 
Justification for 
Modification 
− 8.Subject has 
Brugada syndrome. 
evidence and the 
significant potential 
benefit for these types of 
indicated patients. 
F 
20 Jan 
2021 
90702637 
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16 Device 
Accountabili
ty 
Clarified Device 
Accountability 
requirements for both 
Sponsor and 
Investigator  
Updates to the ISO 14155 
standard 
F 
20 Jan 
2021 
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20.2 
Definitions 
and 
classificatio
ns 
Change to the Adverse 
events definitions  
Addition of the 
definition of Serious 
Health Threat 
Addition of the 
definition of 
hospitalization and 
prolongation of 
hospitalization 
Updates to the ISO 14155 
standard 
F 
20 Jan 
2021 
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20.3 
Relationship 
to Study 
Device(s) 
and/or Study 
Procedure 
Removal of one 
relatedness category 
(“unlikely related”) 
 
Updates to the ISO 14155 
standard 
F 
20 Jan 
2021 
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22 
Committees 
Clarification of the role 
of the internal safety 
Monitoring Process 
Updated per current 
Boston Scientific 
requirement 

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2. Protocol Synopsis 
Acute Feasibility Investigation of a New S-ICD Electrode Arrangement 
for Reduction of Defibrillation Energies 
[ASE Study]  
Study 
Objective(s) 
The primary objective of this acute feasibility study is to assess the 
defibrillation threshold (DFT) when adding a second left parasternal 
electrode to an S-ICD system.  The secondary objective is to assess the 
efficacy of the 2-electrode configurations (Parallel and 90º) to convert 
VF. 
Background 
The current S-ICD system pulse generator (PG) is 59 cc in size and 
delivers a maximum energy shock of 80 J.  Any significant reduction in 
PG size would require a reduction in the maximum energy output.  
Reducing the defibrillation energy requirement would increase the 
percentage of S-ICD subjects that could receive a smaller PG. 
Computer modeling of the electrical fields in a realistic human torso 
showed that either a wider parasternal electrode, or two parallel standard 
S-ICD electrodes, or two S-ICD electrodes inserted at a 90º angle, 
reduced shock impedance, improved current delivery and reduced 
defibrillation energy.  Swine defibrillation studies of the subcutaneous 
systems with one vs. two left parasternal electrodes showed smaller and 
less consistent reduction in shock impedance and delivered energy than 
the computer models.  However, swine have anatomy and 
electrophysiologic properties that are substantially different than 
humans that affect defibrillation efficiency. 
Thus, an acute human study with two left parasternal electrodes is 
necessary to determine the feasibility of improving the defibrillation 
efficacy using new electrode configurations.       
Planned 
Indication(s) for 
Use  
The Investigational S-ICD Y-Adapter is intended to facilitate ventricular 
fibrillation (VF) conversion testing of a novel S-ICD subcutaneous 
electrode configuration.  
The Investigational S-ICD Y-Adapter is a sterile, single-use, acute 
implant accessory.  It is intended for short-term use during a testing 
procedure and must be disconnected at the end of the testing procedure.  

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Acute Feasibility Investigation of a New S-ICD Electrode Arrangement 
for Reduction of Defibrillation Energies 
[ASE Study]  
Test System 
The S-ICD Defibrillation System Components and Investigational S-
ICD Y-Adapter are shown in the table below: 
Commercial S-ICD System Components 
Device Name 
Model Number 
EMBLEM S-ICD Family 
of Pulse Generators 
A209, A219 (future models allowed when 
commercially released) 
EMBLEM S-ICD 
Electrode  
3401, 3501 (future models allowed when 
commercially released) 
Investigational Components 
Device Name 
Model Number 
Investigational S-ICD 
Y-Adapter 
3598 
About 1 Y-Adapter will be used per patient, unless there is a deficiency 
noted during the procedure.  If this occurs, the Y-Adapter will be 
replaced by a new one. Overall, about 42 Y-Adapters will be used. 
Study Design 
This is a prospective, multi-site, single-arm, acute feasibility study.   
Investigational 
Implant 
Technique and 
Testing 
Methodology 
First, a commercial S-ICD system implant will be initiated via 
techniques used in one-electrode configuration.  The first electrode is 
connected to the PG via the PRIMARY port of the Investigational S-
ICD Y-Adapter and the S-ICD system is tested, including a standard VF 
induction and test shock at 65 J.  The subject may proceed to additional 
investigational testing only if the 65 J shock converts the VF and all 
protocol defined safety criteria are met.   
All acute testing will be completed at the index S-ICD implant 
procedure.  For subjects proceeding to the additional investigational 
testing, testing in two different 2-electrode configurations (Parallel and 
90º) is planned. The second S-ICD electrode will be inserted from the 
same incision created for the first S-ICD electrode and positioned in a 
separate tunnel either parallel to, or at an angle to, and more lateral to 
the first electrode (with a range of either 0.5-2 cm inter-electrode 
spacing, or 0 to 90º angles). See the 2-electrode configuration (Parallel 
or 90º) in the figure below. Both S-ICD electrodes are connected to the 
PG using the Investigational S-ICD Y-Adapter.  DFT testing is then 
performed with the first 2-electrode configuration (Parallel or 90º) using 

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Acute Feasibility Investigation of a New S-ICD Electrode Arrangement 
for Reduction of Defibrillation Energies 
[ASE Study]  
2 additional VF inductions and shocks per the protocol specified testing 
sequence. After testing is completed in the first configuration, the 
second configuration will be tested using 2 additional VF inductions.   
Lastly, after the DFT testing is completed, the second S-ICD electrode 
and Investigational S-ICD Y-Adapter are disconnected and removed, 
and the S-ICD system implant is completed per investigator’s usual 
practice and experience.  
A schematic representation of the Investigational S-ICD Y-Adapter and 
the electrode/PG connection during investigational testing is shown 
below. The second electrode is either parallel to the first with 0.5-2 cm 
spacing (left figure) or is inserted at an ~90 degree angle from the first 
(right figure). 
 
Planned 
Number of 
Subjects 
A maximum of 42 subjects will be enrolled to obtain at least 30 
complete datasets. 
Planned 
Number of 
Investigational 
Sites / Countries 
A maximum of 10 sites are allowed in Europe and possibly in the 
United States. 
Primary Safety 
Data  
All S-ICD system and procedure related adverse events 

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Acute Feasibility Investigation of a New S-ICD Electrode Arrangement 
for Reduction of Defibrillation Energies 
[ASE Study]  
Primary 
Effectiveness 
Data  
Defibrillation Threshold (DFT) of the 2-electrode configuration (Parallel 
and 90º) 
Additional Data  • VF conversion success for the 2-electrode configurations (Parallel 
and 90º) 
• Shock impedance of both the one- and 2-electrode configuration 
(Parallel and 90º) 
Method of 
Assigning 
Subjects to 
Treatment 
All enrolled subjects are intended to have the 2nd electrode inserted and 
undergo acute testing. 
The order of 2-electrode configuration (Parallel and 90º) testing will be 
alternated based on the subject’s ID # to help reduce the possibility of a 
test order bias.  
Follow-up 
Schedule 
Study procedures/visits will occur at the following time periods: 
• Consent and enrollment visit 
• S-ICD implant procedure visit  
• 90-day follow-up visit (to be conducted in clinic or by telephone at 
90±45 days post-implant)  
Study Duration 
Duration of the study, from the first enrollment to the last subject’s final 
visit is expected to be approximately 20-28 months.  Individual subjects 
will be followed from enrollment until their 90-day follow-up visit. 
Inclusion 
Criteria 
1. 
Subject is scheduled to receive a de novo S-ICD system implant per 
labeled indication.  
2. 
Passing S-ICD screening ECG performed per applicable user’s 
manual. 
3. 
Subject is expected to be implanted with a left parasternal S-ICD 
electrode. 
4. 
Subject’s planned S-ICD implant procedure will include at least 
one VF conversion testing at 65 J.   
5. 
Subject is willing and capable of providing informed consent 
specific to local and national laws. 

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Acute Feasibility Investigation of a New S-ICD Electrode Arrangement 
for Reduction of Defibrillation Energies 
[ASE Study]  
6. 
Subject is age 18 or above, or of legal age to give informed consent 
specific to local and national law. 
Exclusion 
Criteria 
1.    Subject has an unusual chest anatomy (eg. pectus excavatum and 
pectus carinatum) that might impede the ability to temporarily 
insert a second S-ICD electrode. 
2. 
Subject has a left ventricular ejection fraction ≤ 20% within 3 
months prior to enrollment. 
3. 
Subject has NYHA Class IV or unstable Class III heart failure.  
4. 
Subject that, in the opinion of the investigator, cannot tolerate the 
DFT testing required by this protocol.  
5. 
Subject that, in the opinion of the investigator, is at increased risk 
for VF conversion failure. 
6. 
Subject is morbidly obese, defined as BMI ≥ 35. 
7. 
Subject has an active infection or has been treated for infection 
within the past 30 days. 
8. 
Subject that, in the opinion of the investigator, has an increased risk 
of infection. 
9. 
Subject is currently requiring/receiving dialysis. 
10. Subject has insulin-dependent diabetes. 
11. Subject had/has any prior or planned other surgical procedure 
within ±30 days of enrollment. 
12. Subject is receiving immunosupressive therapy or has a condition 
that compromises their immune system.  
13. Subject had episodes of atrial fibrillation or atrial flutter within the 
4-week period prior to enrollment or during the period of time 
between enrollment and the start of implant procedure. 
14. Subject that, in the opinion of the investigator, has an increased risk 
for thromboembolic event.  
15. Subject that, in the opinion of the investigator, has an increased risk 
of excessive bleeding. 
16. Subject is currently on an active heart transplant list.  
17. Subjects with documented life expectancy of less than 12 months. 
18. Subject has any other electrically active implanted device that 
cannot be temporarily deactivated during the implant (includes 

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Acute Feasibility Investigation of a New S-ICD Electrode Arrangement 
for Reduction of Defibrillation Energies 
[ASE Study]  
components or accessories present such as pulse generators, non-
capped leads or leads with breached insulation, implantable cardiac 
monitors, implantable stimulators). 
19. Subject is enrolled in a concurrent study, with the exception of 
local mandatory governmental registries and observational 
studies/registries, without prior written approval from Boston 
Scientific. 
20. Women of childbearing potential who are or might be pregnant at 
the time of the S-ICD implant procedure. 
Safety Criteria 
to Stop In-
procedure 
Acute Testing 
• 
The 65 J shock from the standard S-ICD system did not convert VF 
on the first attempt 
• 
The time from VF induction to 65 J shock delivery was >25 
seconds measured from the end of the induction to the first 
delivered shock 
• 
The subject required more than 1 rescue shock to convert one 
induced VF 
• 
Hemodynamic instability per investigator’s medical judgment 
• 
Excessive bleeding that requires medication, blood transfusion, or 
the use of blood derivatives 
• 
Any other unexpected clinical or system-related event occurs. 
Statistical Methods  
Primary 
Statistical 
Hypothesis 
This is an early-stage feasibility study.  There is no formal hypothesis 
due to this study not being powered for its sample size and no control 
group for comparison.  This study seeks to characterize the performance 
of new, 2-electrode configurations (Parallel and 90º) by collecting DFT 
test and shock impedance data. 
Statistical Test 
Method 
There are no statistical tests or comparisons.  Summary statistics will be 
provided on DFT and VF conversion success.  
Sample Size 
Parameters 
There is no statistically computable sample size.  It is anticipated that 30 
complete data sets could provide a reasonable assessment of the 

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Acute Feasibility Investigation of a New S-ICD Electrode Arrangement 
for Reduction of Defibrillation Energies 
[ASE Study]  
defibrillation efficacy. Up to 42 subjects will be enrolled to account for 
attrition.  
 
 
 

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3. Table of Contents 
1. 
TITLE PAGE  .......................................................................................................................1 
2. 
PROTOCOL SYNOPSIS .........................................................................................................9 
3. 
TABLE OF CONTENTS .......................................................................................................16 
3.1. Table of Figures .....................................................................................................19 
3.2. Table of Tables ......................................................................................................20 
4. 
INTRODUCTION ................................................................................................................21 
4.1. Background ............................................................................................................22 
4.2. Bench Test, Computer Modeling, and Pre-clinical Study Results ...................23 
4.2.1. 
Computer Modeling and Bench Tests of Alternative S-ICD Electrode 
Systems .....................................................................................................23 
4.2.2. 
Pre-Clinical Testing of an Alternative S-ICD Electrode System .............25 
4.3. Safety of Acute VF Conversion Testing ..............................................................28 
4.3.1. 
ICD Experience ........................................................................................28 
4.3.2. 
S-ICD Experience .....................................................................................29 
4.3.3. 
Summary of Clinical Experience ..............................................................29 
5. 
DEVICE DESCRIPTION ......................................................................................................30 
5.1. Commercially Available Components: ...............................................................30 
5.2. Investigational S-ICD Y-Adapter ........................................................................30 
5.3. Required Medical Equipment ..............................................................................32 
6. 
STUDY OBJECTIVES .........................................................................................................32 
7. 
STUDY DATA .....................................................................................................................33 
8. 
STUDY DESIGN .................................................................................................................33 
8.1. Scale and Duration ................................................................................................34 
8.2. Treatment Assignment..........................................................................................34 
8.3. Justification for the Study Design ........................................................................35 
9. 
SUBJECT SELECTION ........................................................................................................35 

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9.1. Study Population and Eligibility ..........................................................................35 
9.2. Inclusion Criteria ..................................................................................................35 
9.3. Exclusion Criteria .................................................................................................36 
10. SUBJECT ACCOUNTABILITY .............................................................................................38 
10.1. Point of Enrollment ...............................................................................................38 
10.2. Withdrawal ............................................................................................................38 
10.3. Subject Status and Classification .........................................................................38 
10.4. End-of-Study Action Plan ....................................................................................39 
11. STUDY METHODS .............................................................................................................39 
11.1. Data Collection ......................................................................................................39 
11.2. Study Candidate Screening ..................................................................................40 
11.3. Informed Consent/Enrollment Visit ....................................................................40 
11.4. S-ICD Implant Visit ..............................................................................................40 
11.4.1. S-ICD Implant and Initial Testing ............................................................41 
11.4.2. Temporary Insertion of the Second S-ICD Electrode ...............................45 
11.4.3. VF Conversion Testing of Two-Electrode Configurations ......................46 
11.4.4. Allowable Test Sequence Revisions .........................................................47 
11.4.5. Completion of Test and Implant Procedure ..............................................48 
11.4.6. Adverse Event Notification during Acute Clinical Testing in the S-ICD 
Implant Procedure Visit ............................................................................50 
11.5. 90-Day Follow-up Visit .........................................................................................50 
11.5.1. Adverse Event Notification On or Prior to the 90-day Follow-up Visit...50 
11.6. Study Completion ..................................................................................................51 
11.7. Source Documents .................................................................................................51 
12. STATISTICAL CONSIDERATIONS ......................................................................................52 
12.1. Study Data .............................................................................................................52 
12.1.1. Primary Data and Secondary Data ............................................................52 
12.2. General Statistical Methods .................................................................................53 
12.2.1. Analysis Sets .............................................................................................53 
12.2.2. Number of Subjects per Investigative Site ...............................................53 
12.3. Data Analyses ........................................................................................................54 
12.3.1. Interim Analyses .......................................................................................54 

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12.3.2. Changes to Planned Analyses ...................................................................54 
13. DATA MANAGEMENT .......................................................................................................54 
13.1. Data Collection, Processing, and Review ............................................................54 
13.2. Data Retention .......................................................................................................55 
14. AMENDMENTS ..................................................................................................................55 
15. DEVIATIONS .....................................................................................................................55 
16. DEVICE/ACCOUNTABILITY ..............................................................................................56 
17. COMPLIANCE ....................................................................................................................57 
17.1. Statement of Compliance ......................................................................................57 
17.2. Investigator Responsibilities ................................................................................58 
17.2.1. Delegation of Responsibility ....................................................................60 
17.3. Ethics Committee ..................................................................................................60 
17.4. Sponsor Responsibilities .......................................................................................60 
17.4.1. Role of Boston Scientific Representatives ...............................................61 
17.5. Insurance ................................................................................................................62 
18. MONITORING ....................................................................................................................62 
19. POTENTIAL RISKS AND BENEFITS ...................................................................................62 
19.1. Anticipated Adverse Events .................................................................................62 
19.2. Incremental Risks Associated with the ASE Study Participation ....................64 
19.3. Incremental Risks Associated with the Investigational S-ICD Y-Adapter ......64 
19.4. Risk Minimization Actions ...................................................................................65 
19.5. Anticipated Benefits ..............................................................................................65 
19.6. Risk to Benefit Rationale ......................................................................................65 
20. SAFETY REPORTING .........................................................................................................65 
20.1. Reportable Events by investigational site to Boston Scientific .........................65 
20.2. Definitions and Classification ..............................................................................66 
20.3. Relationship to Study Device(s) and/or Study Procedure .................................70 
20.4. Investigator Reporting Requirements .................................................................72 
20.5. Boston Scientific Device Deficiencies ...................................................................74 

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20.6. Reporting to Regulatory Authorities /ECs / Investigators ................................75 
20.7. Subject Death Reporting ......................................................................................75 
21. INFORMED CONSENT........................................................................................................76 
22. COMMITTEES ...................................................................................................................77 
22.1. Safety Monitoring Process ....................................................................................77 
22.2. Data Monitoring Committee (DMC) ...................................................................77 
23. SUSPENSION OR TERMINATION .......................................................................................78 
23.1 Premature Termination of the Study ..................................................................78 
23.1.1 
Criteria for Premature Termination of the Study ......................................78 
23.2 Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval ................................................................................................................78 
23.3 Requirements for Documentation and Subject Follow-up ................................79 
23.4 Criteria for Suspending/Terminating a Study Site ............................................79 
24. STUDY REGISTRATION AND RESULTS .............................................................................79 
24.1. Study Registration .................................................................................................79 
24.2. Clinical Investigation Report ...............................................................................80 
25. PUBLICATION POLICY ......................................................................................................80 
26. BIBLIOGRAPHY .................................................................................................................81 
27. ABBREVIATIONS AND DEFINITIONS .................................................................................83 
27.1. Abbreviations ........................................................................................................83 
27.2. Definitions ..............................................................................................................84 
 
 
3.1. Table of Figures 
Figure 4-1. Commercially available S-ICD system shown in the typical implanted locations.
 ............................................................................................................................. 21 
Figure 4-2. Four S-ICD electrode shock configurations studied by computer modeling. ...... 24 
Figure 4-3. Results of VF conversion testing in swine. .......................................................... 27 
Figure 5-1. Investigational S-ICD Y-Adapter. ....................................................................... 31 

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Figure 8-1. The shock configurations to be used in this study. .............................................. 34 
Figure 11-1.  Overall flow of the S-ICD implant and ASE study testing ............................... 41 
 
3.2. Table of Tables 
Table 4-1. Results of computer models of defibrillation electrical fields in a realistic human 
torso. .................................................................................................................... 25 
Table 5-1. Investigational S-ICD Y-Adapter Specifications .................................................. 32 
Table 9-1: Inclusion Criteria ................................................................................................... 35 
Table 9-2: Exclusion Criteria .................................................................................................. 37 
Table 11-1: Data Collection Schedule .................................................................................... 39 
Table 11-2: Source Documentation Requirements ................................................................. 51 
Table 19-1. Potential Adverse Events for Implantation of the S-ICD System ....................... 62 
Table 19-2. Potential Incremental Risks Related to the Participation of the ASE Study ....... 64 
Table 19-3. Potential Incremental Risks Related to the Investigational S-ICD Y-Adapter ... 64 
Table 20-1: Safety Definitions ................................................................................................ 66 
Table 20-2: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event .................................................................................................................... 71 
Table 20-3: Investigator Reporting Requirements .................................................................. 72 
Table 26-1: Abbreviations ...................................................................................................... 83 
Table 26-2: Definitions ........................................................................................................... 84 
 

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4. Introduction 
The Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system has been shown to 
be a safe and effective alternative to transvenous ICD systems and thus may be appropriate 
for many patients at risk for sudden cardiac death.  The key advantage of the S-ICD system 
vs the traditional ICD system is that it is completely subcutaneous with no leads inserted in 
the heart chambers or vasculature.  The S-ICD system therefore avoids the majority of issues 
associated with the transvenous ICD systems including lead dislodgement and mechanical 
lead failure as well as adverse events associated with the insertion of a transvenous lead.  The 
S-ICD system is implantable using readily identifiable anatomical landmarks and thus avoids 
the routine need for fluoroscopy during system implant.  
The current S-ICD system consists of the EMBLEM S-ICD electrode and S-ICD pulse 
generator. Figure 4-1 illustrates the standard locations of the electrode insertion and pulse 
generator (PG).  The electrode is inserted subcutaneously, typically along the left sternal 
margin, using a subcutaneous insertion tool from a small incision in the paraxiphoid region.  
A commercially available peelable sheath is often used as part of the electrode insertion 
process.  The pulse generator is placed in a subcutaneous pocket on the postero-lateral aspect 
of the left thorax from a lateral incision along the 5th or 6th intercostal space.  The proximal 
end of the electrode is tunneled subcutaneously to the pulse generator pocket.  The 
defibrillation shock is delivered between the left parasternal coil electrode and the pulse 
generator. 
   
Figure 4-1. Commercially available S-ICD system shown in the typical implanted locations.   
 

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While the S-ICD system has gained considerable commercial adoption as an alternative to 
transvenous ICD systems, a factor limiting its more widespread usage is the size of the 
S-ICD pulse generator.  The first commercially available S-ICD pulse generator introduced 
by Cameron Health (model 1010) was 69 cc.  After acquisition of Cameron Health, Boston 
Scientific employed technological enhancements to key components that allowed for a size 
reduction to 59 cc.  However, commercially available transvenous ICD pulse generators are 
still significantly smaller, in the range of ~30-35 cc.  The most important factor contributing 
to the larger size of the S-ICD is the significantly higher energy output required in the S-ICD.  
The S-ICD delivers an 80 J shock, while the transvenous ICD systems typically deliver 
~35-40 J.    
Technology advances will likely allow additional reduction in S-ICD size.  Engineering 
assessment suggests that a pulse generator near 50 cc in size might be possible.  A more 
substantial reduction in pulse generator size can only be accomplished by reducing the 
energy output of the S-ICD.  Energy output of the S-ICD pulse generator can only be reduced 
if the energy required to successfully convert ventricular fibrillation (VF) is low enough 
while ensuring an appropriate safety margin.   
Therefore, the primary objective of this study is to investigate a new parasternal electrode 
configuration that uses a second parasternal electrode to reduce shock impedance and reduce 
defibrillation energy requirements.  If results are favorable, Boston Scientific could use the 
information to design a new parasternal electrode and a new, smaller, lower energy pulse 
generator. The study will enroll patients already scheduled for an S-ICD implant and 
therefore the investigational population should be a reasonable representation of the 
population that would be targeted for a future SICD product.   
4.1. Background 
Transvenous ICD and S-ICD systems have traditionally used acute VF conversion testing at 
the time of system implantation to demonstrate successful VF conversion at an energy level 
lower than the maximum energy of the pulse generator to allow for a safety margin.  ICD 
safety margins have typically been set ~10 J.  In the US S-ICD Pre-market Clinical Study 
(G090013, commenced 11Dec09), a 15 J safety margin was tested.  Thus, acute VF 
conversion efficacy at 65 J is typically tested during an S-ICD implant.  If patients could be 
converted at energies lower than 65 J, they could potentially receive a smaller, lower energy 
S-ICD pulse generator.  Engineering analysis suggests that a 60 J S-ICD pulse generator 
could be close to 40 cc in size, which is a substantial reduction compared to 59 cc in an 80 J 
device.    
Data collected from an early S-ICD study of 49 subjects showed that the S-ICD system had 
mean DFT of ~37±20 J, and that 38 out of 49 subjects had at least one successful conversion 
at 50 J or lower1.  Data from two other studies showed the S-ICD system converted VF at 
energies less than or equal to 50 J in 12 out of 16 subjects with hypertrophic    
cardiomyopathy 2 and 11 out of 15 subjects in a subset of the US S-ICD Post-Approval Study 
(P110042, commenced 28Sep12 as conditions of approval).  Thus, while small in number, 

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4.3. Safety of Acute VF Conversion Testing 
4.3.1. ICD Experience 
The implantation of ICD and S-ICD systems has a long history of performing VF conversion 
testing at the time of system implant.  The rationale for such testing is threefold: 1) to ensure 
appropriate sensing and detection of VF, 2) to obtain evidence of successful VF conversion 
of the system and, 3) to help ensure a safety margin exists between an energy level known to 
convert VF and the maximum output of the device.     
Available data suggests that VF conversion testing and evaluation of the DFT is safe when 
conducted by experienced implanters with the right training and backup defibrillation 
support.  There are many published studies that evaluated paired DFT of new shock 
electrodes6-8, different shock vectors9-11, and different shock waveforms12-25.  Such testing 
would typically require 3 to 5 VF inductions and shocks per test configuration to assess the 
DFT of each test configuration.  One large trial of DFT testing was the Low Energy Safety 
Study (LESS)26, sponsored by Boston Scientific Corporation .  Seven hundred and thirty-
three (733) subjects underwent extensive VF conversion testing at implant, and a subset of 
392 subjects had additional VF conversion testing at pre-discharge, 3 months, and 12 months.  
Implant testing consisted of the determination the DFT (in which the lowest energy level that 
succeeds was reconfirmed twice, for a total of 3 tests without failure).  This testing typically 
required 4 to ~14 VF inductions and shocks delivered per subject.  Follow-up testing in the 
Phase 1 subset of 392 subjects consisted of 3 VF inductions and shocks at each of the three 
follow-up visits, for a total of 9 additional VF conversion tests.  Testing was generally well 
tolerated. 
While VF conversion testing is generally well tolerated, some physicians began questioning 
whether it was routinely necessary.  The landmark SIMPLE Study, funded by Boston 
Scientific Corporation , randomized 2500 subjects receiving their first ICD or CRT-D system 
to implantation with or without VF conversion testing27.  After a median follow-up of 3.1 
years outcomes including total mortality and failed appropriate shocks or arrhythmic death 
were similar.  All planned non-inferiority tests showed no disadvantage of the strategy of 
implanting without a VF conversion test.  While this study is most often cited to support the 
practice of implantation of an ICD without VF conversion test, the data also shows that VF 
conversion testing was well tolerated.  There were no deaths attributable to VF conversion 
testing and there was no difference in the safety composite between subjects with VF 
conversion test at implant versus those without.  Retrospective and underpowered 
sub-analysis suggested a slight increase in the need for temporary chest compressions (0.4%) 
and non-elective intubation (0.6%) in the group with VF conversion tests; however, 
unplanned stay in the Intensive Care Unit (ICU) was slightly higher in the group without VF 
conversion tests (0.3%).   
While the results of SIMPLE Study have led most transvenous ICD implanters to stop 
routine VF conversion testing at implant and medical society consensus statement suggests 
that it is reasonable to omit VF conversion testing in ICD implant under specified conditions 

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28, it’s important to note that Boston Scientific’s instructions for use of ICD products still 
suggest VF conversion testing.  Thus, while the practice of ICD implantation is changing it 
should not be inferred that VF conversion testing is unsafe. 
4.3.2. S-ICD Experience 
S-ICDs are a new addition to the range of devices available to protect subjects at risk for 
sudden cardiac death.  Because of the differences in implant location, implant technique and 
the lower level of experience physicians have with S-ICD implantation, VF conversion 
testing at implant is recommended and still routinely performed.  The 2015 
HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable 
cardioverter-defibrillator programming and testing recommends defibrillation efficacy testing 
in subjects undergoing an S-ICD implantation28.  Boston Scientific’s instructions for use of 
S-ICD system also recommend VF conversion testing at S-ICD implant.  All major trials of 
S-ICD have suggested that VF conversion testing be performed.  In the US S-ICD 
Pre-market Clinical Study (G090013)29, the protocol required physician investigators to 
demonstrate two consecutive successful VF conversions at 65 J.  To accomplish this, the 
protocol required up to 8 total VF conversion tests.  In this study subjects received an 
average of 2.56 VF inductions and shocks (range: 2 to 8).  The overall VF conversion success 
rate in the study was 98.4%.    
In the initial stages of S-ICD exploration, prior to commercialization, several acute clinical 
studies were performed using fairly extensive DFT testing to investigate the use of various 
electrodes designs, shock configurations and shock waveforms1.  No serious adverse events 
were reported.   
Thus, the totality of experience with S-ICD suggests that VF conversion testing, including 
multiple VF inductions and DFT testing, can be safely performed.   
 
4.3.3. Summary of Clinical Experience 
The available data, as described above, shows that VF conversion testing in both ICD and S-
ICD recipients has been a widely performed and generally accepted practice that is well 
tolerated in the vast majority of subjects.  While adverse events related to VF induction 
testing may occur, they are rare.  One commonly reported adverse events related to VF 
induction testing is slow hemodynamic recovery following VF conversion27, and it can be 
effectively managed with little long-term consequence to the subject.   
Based on these clinical experiences, a set of safety principles for conducting VF conversion 
tests acutely in humans is applied to the design of this study.  These include: 1) subject will 
only proceed to two-electrode VF conversion test if VF conversion at 65 J using one-
electrode is successful; 2) subjects who are hemodynamically unstable or unable to tolerate 
VF conversion test, and those with increased risk of infection and excessive bleeding are 
excluded from study participation; 3) backup defibrillation equipment is required; 4) Pre-

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The secondary objective is to assess the efficacy of 2-electrode configurations (Parallel and 
90º) to convert VFJ.   
The tertiary objective is to assess factors that influence the DFT when adding the second 
electrode (e.g. spacing and orientation or angle between electrodes). 
 
7. Study Data 
Primary Data: 
• All device- and procedure-related adverse events  
• The DFTs for the 2-electrode configuration (Parallel and 90º) consisting of two left-
parasternal electrodes to left lateral PG  
Secondary Data: 
 
• The shock impedance for each of the two S-ICD shock configurations (one 
parasternal electrode and two parasternal electrodes)  
• VF conversion success for the 2-electrode configuration (Parallel and 90º) 
8. Study Design 
The clinical development stage of the 2-electrode configuration S-ICD system is a pilot stage 
(per ISO 14155, annex I). As such, the study has an exploratory design with no pre-specified 
hypotheses and implies an interventional burden on the study subjects (e;g; additional testing 
at implant that is not standard of care). 
 
This study is a multicenter, single-arm, early feasibility assessment of new S-ICD shock 
configurations (See Figure 8-1) that consist of two S-ICD electrodes inserted from the left-
parasternal region.   
 

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8.3. Justification for the Study Design 
This is an early feasibility study designed to assess the performance of a second parasternal 
electrode as part of an S-ICD system.  Computer modeling and VF conversion testing in 
swine have already been done (see Section 4.2).  All data suggests the use of either a second 
coil electrode or a single “wider” electrode can reduce both the shock impedance and the 
energy required for defibrillation.  However, only clinical testing can determine the actual 
performance in shock impedance and energy requirements in humans.  This study will 
determine if a new electrode configuration will decrease energy requirement that would 
enable a reduction in the size of the S-ICD pulse generator.  Size reduction would have a 
significant benefit to future S-ICD recipients. 
9. Subject Selection  
9.1. Study Population and Eligibility  
Subjects will be identified by the physician investigator from the general population of 
subjects being implanted with a new S-ICD system.   
9.2. Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 9-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 9.3) is 
met.  
Table 9-1: Inclusion Criteria 
Inclusion 
Criteria 
1. 
Subject is scheduled to receive a de novo S-ICD system implant per labeled 
indication. 
2. 
Passing S-ICD screening ECG performed per applicable user’s manual. 
3. 
Subject is expected to be implanted with a left parasternal S-ICD electrode. 
4. 
Subject’s planned S-ICD implant procedure will include at least one VF 
conversion testing at 65 J.   
5. 
Subject is willing and capable of providing informed consent specific to local 
and national laws. 
6. 
Subject is age 18 or above, or of legal age to give informed consent specific to 
local and national law. 
Abbreviations: VF : ventricular fibrillation 
 

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9.3. Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 9-2) will be excluded from this 
clinical study. 

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Table 9-2: Exclusion Criteria 
Exclusion 
Criteria 
1. 
Subject has an unusual chest anatomy (eg. pectus excavatum and pectus 
carinatum) that might impede the ability to temporarily insert a second S-ICD 
electrode. 
2. 
Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to 
enrollment. 
3. 
Subject has NYHA Class IV or unstable Class III heart failure.  
4. 
Subject that, in the opinion of the investigator, cannot tolerate the DFT testing 
required by this protocol.  
5. 
Subject that, in the opinion of the investigator, is at increased risk for VF 
conversion failure. 
6. 
Subject is morbidly obese, defined as BMI ≥ 35. 
7. 
Subject has an active infection or has been treated for infection within the past 
30 days. 
8. 
Subject that, in the opinion of the investigator, has an increased risk of 
infection. 
9. 
Subject is currently requiring/receiving dialysis. 
10. Subject has insulin-dependent diabetes. 
11. Subject had/has any prior or planned other surgical procedure within ±30 days 
of enrollment. 
12. Subject is receiving immunosupressive therapy or has a condition that 
compromises their immune system.  
13. Subject had episodes of atrial fibrillation or atrial flutter within the 4-week 
period prior to enrollment or during the period of time between enrollment 
and the start of implant procedure. 
14. Subject that, in the opinion of the investigator, has an increased risk for 
thromboembolic event.  
15. Subject that, in the opinion of the investigator, has an increased risk of 
excessive bleeding. 
16. Subject is currently on an active heart transplant list.  
17. Subjects with documented life expectancy of less than 12 months. 
18. Subject has any other electrically active implanted device that cannot be 
temporarily deactivated during the implant (includes components or 
accessories present such as pulse generators, non-capped leads or leads with 
breached insulation, implantable cardiac monitors, implantable stimulators). 
19. Subject is enrolled in a concurrent study, with the exception of local 
mandatory governmental registries and observational studies/registries, 
without prior written approval from Boston Scientific. 
20. Women of childbearing potential who are or might be pregnant at the time of 
the S-ICD implant procedure. 
 

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10. Subject Accountability 
10.1. Point of Enrollment 
Subjects meeting all the inclusion criteria and not meeting any of the exclusion criteria may 
be approached for enrollment.  Subjects will be considered enrolled at the point they sign the 
informed consent form.  All subjects signing the informed consent form and having acute 
testing attempt (reached Attempt Classification, see Section 10.3) will count towards the 
enrollment ceiling.  
10.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the study or lost 
to follow-up) shall be accounted for and documented.  If a subject withdraws from the 
clinical investigation, the reason(s) shall be reported.  If such withdrawal is due to problems 
related to investigational device safety or performance, the investigator shall ask for the 
subject’s permission to follow his/her status/condition outside of the clinical study.  
10.3. Subject Status and Classification 
The status of study subjects will be classified as follows: 
Enrolled: a subject who has signed and dated the informed consent form 
Intent: a subject who signs the informed consent form but does not initiate any part of the S-
ICD implant procedure.  These include subjects who were found ineligible after consent but 
prior to S-ICD implant.  A withdrawal form will be submitted and the subject is exited from 
the study and will not be counted towards enrollment ceiling. 
Attempt: a subject who has any part of the S-ICD implant procedure started.  
Partial Treatment: a subject who has the Investigational S-ICD Y-Adapter connected to the 
S-ICD pulse generator and the first electrode. 
Treatment: a subject who initiates the investigational testing in the 2-electrode configuration 
(Parallel and 90º) Enrollment Controls 
Study sites will be allowed to enroll until the enrollment ceiling of 42 subjects.  
    
 
 

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10.4. End-of-Study Action Plan 
The Investigational S-ICD Y-Adapter and the second S-ICD electrode are temporarily used 
during the testing procedure and will be returned to Boston Scientific.  Upon completion of 
the implant procedure the subjects will have a commercial S-ICD system implanted.  The 
study will end when the last subject who has either attempted or completed the acute study 
procedure has completed the 90-day follow-up phone call or visit.  Upon completion of the 
study, subjects will be followed per standard of care.    
11. Study Methods 
11.1. Data Collection 
Data are collected at the following time points specified in Table 11-1.  Reportable adverse 
events and device deficiencies are reported on an ongoing basis and throughout a subject’s 
participation of the trial.  
Table 11-1: Data Collection Schedule 
Procedure/Assessment 
Enrollment 
Visit 
S-ICD Implant 
Procedure Visit 
(within 30 days after 
Enrollment) 
90-day Follow-
up Visit (90±45 
days Post-
implant) 
Informed consent form, including 
informed consent signature and date 
X 
 
 
Demographics, including date of birth, 
gender, and race and ethnicity 
X 
 
 
Physical assessment, including weight 
and height 
X 
 
 
Medical history and current medication 
X 
 
 
S-ICD System information and implant 
data collection 
 
X 
 
65 J VF conversion test (one-electrode 
configuration) data collection 
 
X 
 
Acute DFT Testing (2-electrode 
configuration (Parallel and 90º ) data 
collection, including:  
• 
Temporary insertion of the 
second electrode and 
documentation of electrode 
locations with fluoroscopy 
(saved images) 
 
 
X 
X 
 
 
Transfer of S-ICD firmware and 
programmer log files 
 
X 
 

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Table 11-1: Data Collection Schedule 
Procedure/Assessment 
Enrollment 
Visit 
S-ICD Implant 
Procedure Visit 
(within 30 days after 
Enrollment) 
90-day Follow-
up Visit (90±45 
days Post-
implant) 
Post-operative x-rays, if standard of care 
 
X 
 
Adverse events/device deficiencies* 
Collected throughout the trial starting from the time of 
the subject’s enrollment 
X = required 
*See Section 20.1 for a summary of reportable adverse events in the study. 
 
11.2. Study Candidate Screening 
There is no formal screening process for this study and no screening logs will be required. 
11.3. Informed Consent/Enrollment Visit 
Subjects who sign and date the informed consent form are considered enrolled in the study.  
Consent/enrollment may take place prior to or on the same day of the S-ICD system implant 
but must occur within 30 days prior to the implant procedure.  Subject informed consent will 
be obtained prior to any data collection or study procedures.   
Subject’s demographics, baseline medical history, current medication, and physical 
assessment will be obtained at the enrollment visit.  
11.4. S-ICD Implant Visit 
 
The overall flow of the ASE study testing, after the initial S-ICD implant, will follow Figure 
11-1.  Overall flow of the S-ICD implant and ASE study testing. First, the S-ICD system implant 
will be started per standard of care. The electrode will be connected to the PG with the 
Investigational S-ICD Y-Adapter and the single coil configuration tested at 65 J. If the S-ICD 
system successfully converts VF with 65 J and the safety criteria described in section 11.4.1 
are met, the additional investigational testing will proceed. There are two different 2-
electrode configurations (Parallel and 90º) that will be tested. The order of testing of 2-
electrode configuration (Parallel and 90º ) will alternate based on the subject’s ID number to 
help reduce the possibility of a test order bias. Each subject follows only one path in the flow 
chart of Figure 11-1.   
Section 11.4.2 describes how the 2nd electrode is inserted for the parallel and 90º 
configurations.  

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Any study reportable adverse events that have not been reported previously will be submitted 
on the Adverse Event case report form (CRF).  See Section 20.1 for a summary of all 
reportable adverse events in the study. 
11.6. Study Completion 
A subject’s participation in the study will end after completion of the 90-day follow-up visit.  
After completion in the study, subjects will be followed per standard of care. 
11.7. Source Documents 
Participating investigators must maintain original source documents that are accurate, 
complete, and current related to the subject’s participation in this study.  Source 
documentation must include but is not limited to those listed in Table 11-2: 
Table 11-2: Source Documentation Requirements 
Requirement 
Disposition 
• 
Signed informed consent forms for each 
enrolled subject  
• 
S-ICD pre-implant screening report 
• 
Demographics, medical history and 
medication use per center’s subject 
records (EMR, etc.)  
• 
Physical assessment including height 
and weight 
• 
Acute procedure data Technical Source 
Form 
• 
Adverse events and device deficiencies 
• 
If VF conversion test was performed: 
Induced VT/VF episode and Induction 
Report for all episodes shocked 
• 
Programmer Printouts: 
- Final Summary Report 
- Device Episode Report(s), if 
applicable 
• 
Reportable Adverse Events, Device 
Deficiencies, and Protocol Deviations if 
applicable 
Retain at site 
• 
Fluoroscopic images or X-rays, if taken 
in-procedure, or post-operatively, to 
Retain at site and send a copy to Boston 
Scientific 

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Table 11-2: Source Documentation Requirements 
Requirement 
Disposition 
confirm the electrode and pulse 
generator locations 
• 
Save S-ICD programmer log files to SD 
card at the completion of the acute 
testing 
Retain SD card at site and transfer data 
electronically to BSC via LATITUDE Link or 
Camelion Server 
 
 
12. Statistical Considerations 
12.1. Study Data  
12.1.1. Primary Data and Secondary Data  
Primary Data  
1. Safety: All device- and procedure-related adverse events through 90 days post-
implant procedure. 
2. Effectiveness: defibrillation threshold (DFT) of the two-electrode shock configuration 
- two left-parasternal electrodes to the left lateral PG. 
Secondary Data  
1. Shock impedance of the electrode conversion tests using both the single electrode (at 
65 J) and the 2-electrode configurations (Parallel and 90º). 
2. Percentage of defibrillation success of VF conversion at each of the tested energy 
level 
Hypotheses 
This is an early-stage feasibility study.  There is no formal hypothesis due to study not being 
powered for its sample size and no control group for comparison.  This study seeks to 
characterize the performance of the new electrode shock configuration by collecting 
defibrillation conversion and shock impedance data.  
Sample Size  
This is an early-stage feasibility study and there is no formal sample size calculation.  It is 
estimated that 20 subjects with complete testing, within an electrode configuration, will allow 
for a reasonable confidence in assessing defibrillation performance.  For example, if 19 out 
of 20 subjects are successfully converted at 50 J (95% success) the resulting 95% confidence 
interval will be 75.13% to 99.87% using exact test, which is considered acceptable for this 
early feasibility assessment.   

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Since some enrolled subjects may not start and/or complete testing due to a variety of 
reasons, including exceeding the protocol-required safety criteria per Sections 11.4.2 and 
11.4.3, and since a protocol revisions was made to add testing of a 2nd 2-electrode 
configuration (90º configuration), the study will enroll up to 42 subjects  so that 30 complete 
datasets can be expected.   
Statistical Methods 
This is an early-stage feasibility study to assess performance of the new electrode shock 
configurations.  No specific statistical tests will be performed.  Descriptive statistics will be 
provided as follows,  
• Subject demographic and medical history data will be reported as raw numbers and 
percentage for categorical variables and mean ± standard deviation for continuous 
variables. 
• DFTs and shock impedances will be reported as mean ± standard deviation. 
• Defibrillation success at a given energy level (eg 50 J, etc.) will be reported as a 
percentage and 95% confidence interval. 
• System and procedure related adverse events occurrence and percentage will be 
collected and reported starting from the time of the subject enrollment. 
12.2. General Statistical Methods 
12.2.1. Analysis Sets 
Primary Safety analyses will include all Attempt, Partial Treatment, and Treatment subjects, 
as defined in Section 10.3.   
Primary Effectiveness analyses will include all Treatment subjects. 
Secondary Effectiveness analyses of one-electrode shock data will include both Partial 
Treatment and Treatment subjects.  Secondary Effectiveness analyses of 2-electrode 
configuration (Parallel and 90º) shock data will include Treatment subjects. 
12.2.2. Number of Subjects per Investigative Site 
It is expected that 42 subjects will be enrolled in up to 10 investigative sites. 

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12.3. Data Analyses 
12.3.1. Interim Analyses  
Boston Scientific will monitor the data and perform ongoing analyses on test procedures, and 
to identify possible safety or futility concerns.  For a small early-stage feasibility study such 
interim analysis cannot be statistically planned or derived.  However, the following 
effectiveness futility triggers are being established and a test configuration may be dropped, 
or the study will end if these criteria are met. 
• <10% reduction in mean shock impedance (after a minimum of 10 subjects enrolled) 
• >3 subjects that fail conversion success with 40 J shocks (4 subjects need to fail) 
12.3.2. Changes to Planned Analyses 
Changes from the planned statistical methods outlined in this protocol will be documented in 
the clinical study report along with a reason for the deviation. 
13. Data Management 
13.1. Data Collection, Processing, and Review 
Subject data will be recorded on the Technical Source Forms (TSF) and paper case report 
forms (CRFs) provided by Boston Scientific, and on source documentation.  The CRF data 
shall be derived from and consistent with the source documents and TSFs.  Any 
discrepancies must be explained in writing.  Per Good Clinical Practice (GCP), any change or 
correction made to the original clinical data will be initialed, dated, and explained, if 
necessary, and shall not obscure the original entry.  A written audit trail shall be maintained 
which will be made available for review by Boston Scientific. 
The TSFs are intended to be used to document procedure data during the S-ICD implant 
where source documentation is not available, and are to be completed by trained, qualified 
and investigator-authorized staff or Boston Scientific representative.  The investigator and 
the Boston Scientific representative (if present to document the procedure data) will both 
sign the TSFs to confirm that the forms are a true source of procedure data. 
The Principal Investigator will provide their signature on the appropriate source documents, 
TSFs, and CRFs in compliance with local regulations.  A copy of the paper CRFs must be 
submitted to Boston Scientific.  Changes to data previously submitted to the sponsor require 
a new signature by the Investigator or his/her designee to acknowledge and approve the 
changes. 

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Visual review of source documents, TSFs, and CRFs will be performed to identify possible 
data discrepancies.  Manual queries will be created and issued to the site for appropriate 
response. Site staff will be responsible for resolving all queries.  
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 will be 
completed.  
13.2. Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain, at the 
investigative site, all essential study documents and source documentation that support the 
data collected on the study subjects in compliance with ICH/GCP (International Conference 
on Harmonization/Good Clinical Practice) guidelines.  Documents must be retained until at 
least 2 years have elapsed since the formal discontinuation of the clinical investigation of the 
product or until they are no longer needed to support regulatory applications by the study 
sponsor.  These documents will be retained for a longer period of time by agreement with 
Boston Scientific or in compliance with other country/regional/local regulations. 
The Principal Investigator or his/her designee will take measures to ensure that these 
essential documents are not accidentally damaged or destroyed.  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 Boston Scientific must receive written notification of this custodial 
change.  Sites are required to inform Boston Scientific in writing where paper or electronic 
files are maintained in case files are stored off site and are not readily available. 
14. Amendments  
If there are any changes to the study that affect the rights, safety or welfare of the subject or 
the scientific integrity of the data, an amendment to this Clinical Investigation Plan is 
required.  Appropriate approvals (e.g., EC/CA) of the revised Clinical Investigation Plan 
must be obtained prior to implementation. 
15. 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 EC , and the regulatory authority, if applicable 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 

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days after the emergency occurred, or per prevailing local requirements, if sooner than 5 
working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using paper CRF.  Sites may 
also be required to report deviations to the EC and the regulatory authority, per national 
guidelines and government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including EC notification, Regulatory authority 
notification, site re-training, or site discontinuation/termination) will be put into place by the 
sponsor. 
The sponsor will not approve protocol waivers. 
 
16. Device/Accountability 
The investigational devices shall be securely maintained, controlled, and used only in this 
clinical study.  The investigational device inventory log will be used to track device usage 
during the study.  The Investigational S-ICD Y-Adapter is considered an investigational 
device in this study. 
For the Y-Adapters labelled as investigational, the principal investigator or an authorized 
designee shall do the following: 
• Securely maintain and control access to these items to ensure they are used only 
in this clinical study and only per the protocol.  
• Ensure the storage environment for these items is appropriate for maintaining 
conditions per the items’ labeling (e.g. temperature, humidity, etc., as applicable).  
• Return used Y-Adapters after use and return unused or expired Y-Adapters at the 
end of the study or upon Sponsor request. . 
 
The sponsor shall keep records to document the physical location of all investigational 
devices from shipment of investigational devices from Boston Scientific or designated 
facility to the investigation sites until return. 
Records shall be kept by the Principal Investigator or his/her designee to document the 
physical location and conditions of storage of all investigational devices.  
•  Maintain records of the physical location and conditions of storage of items 
labelled as investigational.  
 

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The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, and return of the investigational devices, which shall include the following: 
•  Maintain accurate and timely Device Accountability Records, providing copies to 
Sponsor upon request. Such records shall include the following content, at 
minimum: 
o Name of person who received, used, returned or disposed of each item 
o Date of receipt 
o Identification and quantity of each item  (examples of identification: batch 
number, serial number or unique code) 
o Expiry date for each item (or batch of items), as applicable 
o Date or dates of use 
o Subject identification 
o Date on which the item was returned /explanted from subject, if applicable 
o Date of return (and number) of unused, expired, no longer needed or 
malfunctioning item, as applicable 
Date and documentation of item disposal, as directed by sponsor, if applicable. 
Written procedures may be required by national regulations. 
The sponsor may provide commercially approved devices upon logistics and preferences of 
the individual study sites. All shipment, disposition and return of such devices should be 
tracked and unused devices should be returned to the sponsor. 
17. Compliance 
17.1. Statement of Compliance 
This clinical investigation is financed by the study sponsor. Before the investigational site 
can be “Authorized to Enroll,” the investigational site must enter into a Clinical Study 
Agreement with the sponsor that details the financing of the study as well as the rights and 
obligations of the investigational site and the investigator.  
This study will be conducted in accordance with the European Medical Device Regulation, 
ISO14155 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical 
Practice, the relevant parts of the ICH Guidelines for Good Clinical Practices, ethical 
principles that have their origins in the Declaration of Helsinki, and pertinent country laws 
and regulations.  The study shall not begin until the required approval/favorable opinion from 
the EC and regulatory authority has been obtained.  Any additional requirements imposed by 
the EC or regulatory authority shall be followed, if appropriate. An Investigator Brochure is 
created to support the study.  

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17.2. Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigation 
plan, ISO 14155, ethical principles that have their origins in the Declaration of Helsinki, any 
conditions of approval imposed by the reviewing EC, 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 course of 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 reportable events. 
• Report to the EC and regulatory authorities any SAEs and device deficiencies that could 
have led to a SADE and potential/USADE, if required by the national regulations or this 
protocol or by the EC, and supply Boston Scientific 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 for use. 

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• Allow the sponsor to perform monitoring and auditing activities, and 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 EC when performing auditing activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local EC requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• 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. 
• 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. 
• Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
All investigators will provide their qualifications and experience to assume responsibility for 
their delegated tasks 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. 
 

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17.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for providing 
appropriate training and adequate supervision of those to whom tasks are delegated.  The 
investigator is accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of the clinical study.  
17.3. Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational site will provide to the sponsor 
documentation verifying that their Ethics Committee (EC) is registered or that registration 
has been submitted to the appropriate agency, if applicable according to national/regulatory 
requirements.   
A copy of the written EC and competent authority (CA) approval of the protocol (or 
permission to conduct the study), and Informed Consent Form, must be received by the 
sponsor before recruitment of subjects into the study and shipment of investigational product.  
Prior approval must also be obtained for other materials related to subject recruitment or 
which will be provided to the subject. 
Annual EC approval and renewals will be obtained throughout the duration of the study as 
required by local/country or EC requirements.  Copies of the Investigator’s reports and the 
EC continuance of approval must be provided to the sponsor.  
17.4. Sponsor Responsibilities 
All information and data sent to Boston Scientific concerning subjects or their participation 
in this study will be considered confidential by Boston Scientific.  Only authorized Boston 
Scientific personnel or a Boston Scientific representative will have access to these 
confidential records.  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 Boston 
Scientific for the purposes of this study, publication, and to support future research and/or 
other business purposes.  All data used in the analysis and reporting of this study will be 
without identifiable reference to specific subject name. 
Boston Scientific will keep subjects’ identifiable health information confidential in 
accordance with all applicable laws and regulations.  Boston Scientific may use subjects’ 
health information to conduct this research, as well as for additional purposes, such as 
overseeing and improving the performance of its device, new medical research and proposals 
for developing new medical products or procedures, and other business purposes.  
Information received during the 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.  

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17.4.1. 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 Boston Scientific equipment/devices 
(including the Investigational S-ICD Y-Adapter, PG and electrodes, programmers, analyzers, 
and other support equipment). 
At the request of the investigator and while under investigator supervision, Boston Scientific 
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. 
• Provide instructions for the safe return of investigational products. For potentially 
hazardous items, provide specialized instructions and materials, as applicable. 
• Interrogating the device or programming device parameters to investigator-requested 
settings as well as operating investigational equipment 
• Assisting in performing PG and lead testing using a programmer to obtain DFT, lead 
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 investigational S-ICD system, the 
programmers and other equipment 
• Entering technical data on technical source form as long as the responsible investigator 
verifies and signs the completed worksheet  
• Print out programming reports directly from the clinician programmer and provide 
original to clinical site as source documentation 
• Provide technical expertise/support to subjects during the implant procedure and/or 
during teleconference calls/electronic communications with the principal investigator or 
their delegated site staff and the subject.  
In addition, Boston Scientific 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 
• Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following.  
• Practice medicine 

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19.4. 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 Boston Scientific with all pertinent 
information required by this protocol. 
19.5. Anticipated Benefits 
Individual subjects may not receive direct benefit from participation in this study.  
The study may have a significant benefit to future S-ICD recipients if the results of this study 
are favorable and allow the development of new S-ICD systems that reduce defibrillation 
energies with significantly smaller pulse generators.  Thus, a subject participating in this 
study may receive an indirect benefit at a later date – for example at the time of pulse 
generator replacement. 
19.6. Risk to Benefit Rationale 
While the risks of VF conversion testing are not zero, the risks in a carefully controlled 
clinical trial with experienced investigators are very low.  Many such studies have been 
performed previously that led to many important developments in ICD and S-ICD therapy 
that have benefited hundreds of thousands of recipients.  Improvements to S-ICD therapy 
simply cannot be made without studies of this type. 
The risk to benefit ratio for this study is reasonable because the subject is already undergoing 
an S-ICD implant that includes sedation and/or anesthesia, insertion of a subcutaneous 
electrode and VF conversion testing.  Since the standard implant and VF conversion test will 
be done prior to investigational procedures, it provides a high degree of assurance that the VF 
conversion testing is well tolerated.  The protocol includes criteria to exclude subjects from 
the investigational testing should the initial standard of care VF conversion test suggest that 
the subject may be at higher risk for adverse events. 
20. Safety Reporting 
20.1. Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to Boston Scientific any event 
which occurs in any of following categories: 
• All Serious Adverse Events regardless of cause 

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• All Device and/or Procedure Related Adverse Events regardless whether considered 
serious or not 
• All Device Deficiencies  
• Unanticipated Adverse Device Effects (UADE) /Unanticipated Serious Adverse 
Device Effects (USADE) previously not defined in the physician’s manual 
• Certain adverse events must be reported to the sponsor in a shortened time frame, per 
Section 11.4.6 and 11.5.1. 
• New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
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 10.3), 
whether prior to, during or subsequent to the study procedure, must be recorded in the paper 
CRF. 
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 (see 
Table 20.2-1 for AE definitions). 
Refer to Section 19 for the known risks associated with the study device(s). 
20.2. Definitions and Classification 
Adverse event definitions are provided in Table 20-1. Administrative edits were made on the 
definition of serious adverse event from ISO 14155 and MEDDEV 2.7/3 for clarification 
purposes. 
Table 20-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3 
 
 
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 and whether 
anticipated or unanticipated.  
NOTE 1: This includes events related to the investigational medical 
device or comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 

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Table 20-1: Safety Definitions 
Term 
Definition 
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: MEDDEV 2.7/3-2015  
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 
from 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: MEDDEV 2.7/3 
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, users or other persons 
as defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, 
including chronic diseases, 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) foetal distress, foetal 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: MEDDEV 2.7/3 
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) 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current risk assessment. 

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Table 20-1: Safety Definitions 
Term 
Definition 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3 
 
 
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 
 
Ref: MEDDEV 2.7/3 
An inadequacy of a medical device related to its identity, quality, 
durability, reliability, usability, safety or performance.  
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. 
 
Clinical Observation 
Ref: FDA Guidance for the 
Submission of 
Research and Marketing 
Applications for Permanent 
Pacemaker Leads and for 
Pacemaker Lead Adapter 
510(k) Submissions 
A clinical observation is a clinical event that did not result in invasive 
intervention, injury, or death, and is not an unanticipated adverse event.  
Corrective actions were simple adjustments such as reprogramming of the 
pulse generator or antibiotic treatment of a pocket infection 
Clinical Complication 
 Ref: FDA Guidance for the 
Submission of 
Research and Marketing 
Applications for Permanent 
Pacemaker Leads and for 
Pacemaker Lead Adapter 
510(k) Submissions 
A clinical complication is a clinical event that required an invasive 
intervention, injury, or death (e.g., surgical evacuation of a hematoma, 
lead dislodgment requiring lead repositioning, generator replacement, loss 
or abandonment of therapy). 
The following definitions will be used for defining hospitalization or prolongation of hospitalization for SAE 
classification purposes: 
 
Hospitalizations 
Hospitalization does not include: 
 
• 
emergency room visit that does not result in in-patient admission  

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Table 20-1: Safety Definitions 
Term 
Definition 
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. 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 

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20.3. Relationship to Study Device(s) and/or Study Procedure 
The Investigator must assess the relationship of the AE to the study device and/ or study 
procedure.  See criteria in Table 20-2:  

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Table 20-2: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event 
Classification 
Description 
Not Related 
Relationship to the device, comparator or procedures can be excluded when: 
- the event is not a known side effect of the product category the device belongs to 
or of similar devices and procedures; 
- the event has no temporal relationship with the use of the investigational device or 
the procedures; 
- 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 not expected to 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; harms to the subject are not clearly due to use 
error; 
- 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 
The relationship with the use of the investigational device or comparator, or the 
relationship with procedures 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 
The relationship with the use of the investigational device or comparator, or the 
relationship with procedures seems relevant and/or the event cannot reasonably 
explained by another cause, but additional information may be obtained. 

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Table 20-2: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event 
Causal Relationship 
The serious event is associated with the investigational device or comparator 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 
o the investigational device or procedures are applied to; 
o 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. 
 
20.4. Investigator Reporting Requirements 
The communication requirements for reporting to Boston Scientific are as shown in Table 
20-3. 
Table 20-3: Investigator Reporting Requiremen
Event Classification 
Communication 
Method  
Communication Timeline pre-market studies* 
(MEDDEV 2.7/3:  
CLINICAL INVESTIGATIONS: SERIOUS 
ADVERSE EVENT REPORTING UNDER 
DIRECTIVES 90/385/EEC AND 93/42/EEC) 
Unanticipated Adverse 
Device Effect / 
Unanticipated Serious 
Adverse Device Effect  
 
Complete AE CRF page 
with all available new 
and updated information.  
 
• 
Within 1 business day of first becoming 
aware of the event. 
• 
Terminating at the end of the study 
Provide all relevant 
source 
• 
Upon request of sponsor. 

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Table 20-3: Investigator Reporting Requiremen
Event Classification 
Communication 
Method  
Communication Timeline pre-market studies* 
(MEDDEV 2.7/3:  
CLINICAL INVESTIGATIONS: SERIOUS 
ADVERSE EVENT REPORTING UNDER 
DIRECTIVES 90/385/EEC AND 93/42/EEC) 
documentation 
(deidentified/ 
pseudonymized) 
for reported event. 
Serious Adverse Event  
Complete AE CRF page 
with all available new 
and updated information.  
• 
Within 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/pseudonymi
zed) for reported event. 
• 
Upon  request of sponsor 
Serious Adverse Device 
Effects 
Complete AE CRF page 
with all available new 
and updated information. 
• 
Within 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 
(unidentified/pseudonymi
zed) for reported event 
• 
When documentation is available  
• 
Upon request of sponsor 
Device Deficiencies 
(including but not limited to 
failures, malfunctions, and 
product nonconformities) 
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. 
 
Complete Device 
Deficiency CRF with all 
available new and 
updated information.  
• 
Within 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 

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Table 20-3: Investigator Reporting Requiremen
Event Classification 
Communication 
Method  
Communication Timeline pre-market studies* 
(MEDDEV 2.7/3:  
CLINICAL INVESTIGATIONS: SERIOUS 
ADVERSE EVENT REPORTING UNDER 
DIRECTIVES 90/385/EEC AND 93/42/EEC) 
Adverse Event including 
Adverse Device Effects 
Complete AE CRF 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 90-day 
follow-up visit 
• 
 Upon request of sponsor 
Provide all relevant 
source • 
documentation 
(deidentified/ 
pseudonymized) 
for reported event as 
requested by sponsor. 
Abbreviations: AE=adverse event; CRF=case report form; UADE=unanticipated adverse device effect 
* 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. 
20.5. Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and inadequacy in the information supplied by the manufacturer) 
will be documented and reported to Boston Scientific.  If possible, the device(s) should be 
returned to Boston Scientific for analysis.  Instructions for returning the investigational 
device(s) will be provided in the study’s device management plan.  If it is not possible to 
return the device, the investigator should document on the Device Deficiency CRF why the 
device was not returned and the final disposition of the device on the Investigational Device 
Inventory Log.  Device failures and malfunctions should also be documented in the subject’s 
medical record. 
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not adverse events.  However, an adverse event that results from a 
device failure or malfunction would be recorded as an adverse event on the AE CRF. 
Any 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. 

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20.6. Reporting to Regulatory Authorities /ECs / Investigators 
Boston Scientific is responsible for reporting adverse event information to all participating 
Principal Investigators and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the EC and regulatory authorities of 
USADE and SAE as required by local/regional regulations. 
20.7. Subject Death Reporting 
A subject death during the study should be reported to Boston Scientific within 24 hours of 
site notification.  The site’s EC must be notified of any deaths in accordance with that site’s 
EC policies and procedures.  
Notification of death must include a detailed narrative (death letter) that provides detailed 
information describing the circumstances surrounding the death.  A death narrative in the 
local language is acceptable, if accompanied by a translation in English.  The details listed 
below should be addressed in the death narrative, in order for Boston Scientific to understand 
the circumstance surrounding the death:  
• Date and time of death  
• Place death occurred  
• Immediate cause of death  
• Rhythm at the time of death, if known (include any available documentation)  
• Whether the death was related to the pulse generator, electrode, Investigational S-ICD Y-
Adapter, clinical investigation, procedure, or subject condition  
• Whether or not the death was witnessed  
• Device status and/or activity at the time of death (device recipients only – pacing and 
defibrillation, active or inactive)  
• Whether the subject 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 subject 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)  

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• Death certificate (if available)  
• Autopsy report (if applicable)  
If the subject expired outside of the hospital (e.g., home):  
• A copy of the most recent clinic visit (if not already submitted to Boston Scientific)  
• Death certificate (if available)   
Whenever possible, the PG should be interrogated.  Leads and related Boston Scientific RM 
system components (e.g., PGs) should be removed intact and returned promptly to Boston 
Scientific RM for analysis.  The Boston Scientific Medical Safety must review information 
regarding subject deaths. 
21. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
each subject or his/her legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable.  The ICF must be 
accepted by Boston Scientific, and approved by the site’s EC, or central EC, 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 EC.  Any modification requires acceptance from Boston Scientific 
prior to use of the form.  The ICF must be in a language understandable to the subject and if 
needed, Boston Scientific will assist the site in obtaining a written consent translation. 
Translated informed consent forms must also have EC approval prior to their use.  Privacy 
language shall be included in the body of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall 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, 

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• 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 or legal representative 
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.  If a legal representative signs, the subject shall be asked to provide 
informed consent for continued participation as soon as his/her medical condition allows.  
The original signed ICF will be retained by the 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 Boston Scientific to the applicable 
regulatory body according to their requirements.  Any violations of the informed consent 
process must be reported as deviations to the sponsor and local regulatory authorities (e.g. 
EC), 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 EC.  The new version of the ICF must be approved by the 
EC.  Acceptance by Boston Scientific is required if changes to the revised ICF are requested 
by the site’s EC. The EC will determine the subject population to be re-consented. 
22. Committees 
22.1. Safety Monitoring Process 
The BSC personnel from the Medical Safety and Safety Trial Operation Teams review safety 
data as it is reported by the sites throughout the duration of the study. During scheduled 
monitoring activities, clinical research monitors will further support this review. The Boston 
Scientific Medical Safety and Safety Trial Operations team includes health care providers 
with expertise in cardiovascular disease treatment and with the necessary therapeutic and 
subject matter expertise to evaluate and classify the events into the categories outlined above. 
22.2. Data Monitoring Committee (DMC) 
The Data Monitoring Committee (DMC) is responsible for the safety oversight of the study.  
The DMC will be composed of two to three members, with extensive clinical trial experience 
and expertise in electrophysiology and Subcutaneous Implantable Cardioverter Defibrillator 

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(S-ICD) implants.  The DMC members will not participate in the study.  The DMC will meet 
periodically, or as needed, to review aggregate study data and to evaluate any safety issues 
that may arise during the course of the study.  Responsibilities, qualifications, membership, 
and committee procedures are outlined in the DMC Charter.  
The DMC will have access to study data throughout the course of the study.  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 study’s Coordinating Principal 
Investigator.  Any other DMC recommendations for study modification or termination 
because of concerns over subject safety will be submitted in writing to the Coordinating 
Principal Investigator and BSC for consideration and final decision.  
23. Suspension or Termination 
23.1 Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of subjects.  Investigators, associated ECs, and regulatory authorities, as 
applicable, will be notified in writing in the event of study termination. 
23.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
•  Suspicion of an unacceptable risk, including serious health threat. In this case, the 
sponsor shall suspend the clinical investigation while the risk is assessed. The sponsor 
shall terminate the clinical investigation if an unacceptable risk which cannot be 
controlled is confirmed. 
• Instructions by the EC/REB or regulatory authorities to suspend or terminate the clinical 
investigation. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
• Recommendation of the DMC because of concerns over subject safety. 
• A decision on the part of Boston Scientific to suspend or discontinue the study per its 
internal business review. 
23.2 Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval 
Any investigator or EC in the ASE Study may discontinue participation in the study or 
withdrawal approval of the study, respectively, with suitable written notice to Boston 

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Scientific.  Investigators, associated ECs, and regulatory authorities, as applicable, will be 
notified in writing in the event of these occurrences. 
23.3 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 Boston Scientific.  The 
EC 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 EC terminates participation in the study, participating investigators, 
associated ECs, and regulatory authorities, as applicable, will be notified in writing.  Detailed 
information on how enrolled subjects will be managed thereafter will be provided by Boston 
Scientific. 
In the event 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 Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and 
investigational product to Boston Scientific, unless this action would jeopardize the rights, 
safety, or welfare of the subjects. 
23.4 Criteria for Suspending/Terminating a Study Site 
Boston Scientific Corporation 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 Boston Scientific unless this action would jeopardize the 
rights, safety or well-being of the subjects.  The EC and regulatory authorities, as applicable, 
will be notified. All subjects enrolled in the study at the site will continue to be followed until 
the last subject completes the 90-days follow-up visit.  The Principal Investigator at the site 
must make provision for these follow-up visits unless Boston Scientific notifies the 
investigational site otherwise. 
24.     Study Registration and Results 
24.1. Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
accessible database. 

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24.2. 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. 
 
25. Publication Policy 
Boston Scientific requires disclosure of its involvement as a sponsor or financial supporter in 
any publication or presentation relating to a Boston Scientific study or its results.  Boston 
Scientific may submit study results for publication (regardless of study outcome) following 
the conclusion or termination of the study. Boston Scientific Corporation 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, Boston Scientific 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. 
• Boston Scientific involvement in the publication preparation and the Boston Scientific 
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/). 
 
 

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SG, Ardashev AV, Oduro A, Boersma L, Maass AH, Van Gelder IC, Wilde AA, van Dessel 
PF, Knops RE, Barr CS, Lupo P, Cappato R and Grace AA. An entirely subcutaneous 
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Weinstock J, Bader YH, Maron MS, Rowin EJ and Link MS. Subcutaneous 
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Rinaldi CA, Simon RD, Geelen P, Reek S, Baszko A, Kuehl M and Gill JS. A 
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Block M, Hammel D, Bocker D, Borggrefe M, Seifert T, Fastenrath C, Scheld HH 
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Bahu M, Knight BP, Weiss R, Hahn SJ, Goyal R, Daoud EG, Man KC, Morady F and 
Strickberger SA. Randomized comparison of a 90 uF capacitor three-electrode defibrillation 
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Olsovsky MR, Shorofsky SR and Gold MR. Effect of shock polarity on biphasic 
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Neuzner J, Pitschner HF, Schwarz T, Dursch M and Schlepper M. Effects of 
electrode polarity on defibrillation thresholds in biphasic endocardial defibrillation. Am J 
Cardiol. 1996;78:96-7. 
18. 
Bardy GH, Poole JE, Kudenchuk PJ, Dolack GL, Mehra R, DeGroot P, Raitt MH, 
Jones GK and Johnson G. A prospective randomized comparison in humans of biphasic 
waveform 60-microF and 120-microF capacitance pulses using a unipolar defibrillation 
system. Circulation. 1995;91:91-5. 
19. 
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27. Abbreviations and Definitions  
27.1. Abbreviations 
Abbreviations are shown in Table 26-1.  
Table 26-1: Abbreviations 
Abbreviation/Acronym 
Term 
A 
Ampere 
2IT 
Two-incision Technique 
AE  
Adverse Event 
AF  
Atrial Fibrillation 
CA 
Competent Authority 
CRF 
Case Report Form 
DFT 
Defibrillation Threshold 
EC 
Ethics Committee 
EIT 
Electrode Insertion Tool 
EMR 
Electronic Medical Record 
GCP 
Good Clinical Practice 
HCP 
Healthcare Personnel 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonization 
ICU 
Intensive Care Unit 
ISO 
International Standards Organization 
J 
Joules 
NYHA  
New York Heart Association 
Ω 
Ohms 
PG 
Pulse Generator 
PI  
Principal Investigator 
R&D 
Research and Development 
RM  
Rhythm Management 

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Table 26-1: Abbreviations 
Abbreviation/Acronym 
Term 
S-ICD 
Subcutaneous ICD 
TSF 
Technical Source Form 
UADE/USADE 
Unanticipated Adverse Device Effect/ Unanticipated Serious Adverse Device Effect 
V 
Voltage 
VF 
Ventricular Fibrillation 
27.2. Definitions 
Table 26-2: Definitions 
Term 
Definition 
DFT testing (Defibrillation 
Threshold testing) 
Multiple VF conversion tests performed at step-wise energy level to determine 
the minimum shock energy needed to convert an induced VF episode  
VF conversion test 
A VF episode is first induced, and a defibrillation shock is then delivered to test 
whether the shock could convert the VF.   
Source document 
Ref: ISO 14155 
Original or certified copy of printed, optical or electronic document containing 
source data. 
Source data 
Ref: ISO 14155 
All information in original records, certified copies of original records of clinical 
findings, observations, or other activities in a clinical investigation, necessary for 
the reconstruction and evaluation of the clinical investigation 
Note 1 to entry: This includes source data initially recorded in an electronic 
format. 
Abbreviations are defined in Table 26.1-1.