ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)
Phase: NA
Conditions: Death, Sudden, Cardiac
Sponsor: Kestra Medical Technologies, Inc.

Kestra Medical Technologies, Inc. 
 
Clinical Study Protocol 3333934_C 
 
 
  
 
 
 
PROTOCOL TITLE: 
ASSURE WCD Clinical Evaluation – Conversion 
Efficacy Study (ACE-CONVERT) 
PROTOCOL NUMBER: 
3333934_C 
INVESTIGATIONAL 
THERAPY: 
ASSURE WCD 170 Joule biphasic defibrillation 
waveform 
STUDY DESIGN: 
Multicenter single arm open label evaluation 
SPONSOR: 
Kestra Medical Technologies, Inc. 
3933 Lake Washington Blvd NE, Suite 200 
Kirkland, WA 98033 
DATE OF PROTOCOL: 
10/4/2019 
 
 
 
The information contained in this document, particularly unpublished data, is the property or under control of 
Kestra Medical Technologies, Inc. and is provided to you in confidence for review by you, your staff, and an 
applicable Institutional Review Board or Independent Ethics Committee.  The information is only to be used by 
you in connection with authorized clinical studies described in the protocol.  You will not disclose any of the 
information to others without written authorization from Kestra Medical Technologies, Inc., except to the extent 
necessary to obtain informed consent from those persons participating in the study. 
This study will be conducted in accordance with the International Conference on Harmonisation guideline E6 
(R1): Good Clinical Practice: Consolidated Guideline and the principles of the World Medical Association 
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects 1964, including 
all amendments and Notes of Clarification. 

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2 KEY ROLES AND CONTACTS 
Key roles may be updated by written notification to the clinical sites without a protocol 
amendment. 
 
Sponsor: 
Kestra Medical Technologies, Inc. 
3933 Lake Washington Blvd NE 
Kirkland, WA 98033 
Study Principal Investigator: 
Marye Gleva, MD 
Professor of Medicine 
Faculty Electrophysiologist 
Washington University in St. Louis  
mgleva@gmail.com 
work: (314) 621-1291 
Sponsor Study Manager: 
Ron Rowbotham 
Sr. Clinical Research Specialist 
Kestra Medical Technologies, Inc. 
ron.rowbotham@kestramedical.com 
work: (425) 526-4913 
cell: (206) 816-5701 
 
CRO: 
Barb Duerr 
Principal Clinical Project Manager 
RCRI, Inc. 
bduerr@rcri-inc.com  
work: (952) 746-8077 
 

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3 PROTOCOL SUMMARY 
Protocol Number: 
3333934_C 
Protocol Title: 
ASSURE WCD Clinical Evaluation – Conversion Efficacy Study (ACE-
CONVERT) 
Study Population: 
Patients who are scheduled for any of the procedures specified in Inclusion 
Criterion 3 (below). 
Study Design: 
Multicenter single arm open label 
Number of Subjects: 
20 
Study Sites: 
Subjects will be enrolled at up to 5 clinical sites in the United States where 
procedures specified in Inclusion Criterion 3 (below) are routinely performed.  
There is no minimum or maximum number of subjects that may be enrolled at 
each site. 
Eligibility Criteria: 
Subjects who meet all Inclusion Criteria and no Exclusion Criteria may be 
enrolled in the study. 
 
Inclusion Criteria:   
1) Males or females, age ≥ 18 years 
2) Able and willing to provide written informed consent before undergoing 
any study-related procedures 
3) Scheduled for any of the following procedures: 
a) Electrophysiology study for induction of ventricular arrhythmias 
b) Non-invasive electrophysiology testing using an existing implantable 
defibrillator 
c) ICD replacement procedure during which induction of a ventricular 
arrhythmia is planned 
d) Ablation of ventricular tachycardia (patients undergoing ventricular 
tachycardia ablation in which ONLY a substrate modification approach 
is planned, with no intention of inducing a ventricular arrhythmia, 
should not be included) 

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Exclusion Criteria:  
1. Any condition that by the judgement of the physician investigator precludes 
the subject’s ability to comply with the study requirements 
2. Pregnancy 
3. Use of mechanical circulatory support (e.g. LVAD, Total Artificial Heart, 
intraaortic balloon pump or Impella) 
4. Documented nonchronic cardiac thrombus 
5. Atrial fibrillation or atrial flutter without therapeutic systemic 
anticoagulation 
6. Critical aortic stenosis 
7. Unstable coronary artery disease (CAD) 
8. Recent stroke or transient ischemic attack (TIA) 
9. Hemodynamic instability 
10. Currently implanted Boston Scientific S-ICD (due to location of implant 
relative to test system) 
11. Unstable angina 
12. New York Heart Association (NYHA) Class IV 
13. Left Ventricular Ejection Fraction (LVEF) < 20% 
14. Any medical condition that by the judgement of the physician investigator, 
patient participation in this study is not in the best interest of the patient 
15. History of difficulty of ventricular arrhythmia induction 
16. Amiodarone use within 3 months before the study procedure 
Investigational 
Therapy: 
ASSURE 170 Joule biphasic defibrillation waveform 
Energy Delivery 
Protocol: 
Up to two 170 Joule shocks will be delivered from the Test System.  If the 
second shock is unsuccessful, additional rescue shocks will be delivered using a 
commercially available internal or external defibrillator. 
Study Procedures: 
Cardiac patients will be screened for eligibility by the clinical site staff 
members in advance of the procedure date.  Eligible patients will be provided 
the informed consent form and will be allowed enough time to review the 
consent, and have any questions adequately addressed.  Only patients who 
provide written informed consent to participate will be enrolled as study 
subjects.  Conscious sedation or general anesthesia will be administered per 
investigator preference.  Participating subjects will have two sets of 
commercially available disposable adhesive defibrillation pads applied in 
advance of the procedure.  One set will be placed in defined locations and used 
to deliver the experimental defibrillation shock using the Test System.  The 
other pair will be located on the subject’s torso according to physician 
preference and will be attached to a commercially available external 
defibrillator for backup rescue defibrillation.  Backup rescue defibrillation can 

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also be done using an internal defibrillator per the physician preference.  
Commercially available ECG monitoring electrodes will be positioned as 
needed. The ASSURE WCD Monitor will be configured to Manual Shock 
mode, which allows the experimental shock to be delivered by a Kestra Clinical 
Specialist on command of the physician Investigator or Sub-Investigator. 
A single sustained episode of rapid VT or VF will be induced during an 
electrophysiologic study from a catheter or an implanted defibrillator or may 
occur spontaneously.  If the Arrhythmia is > 150bpm, then a 170J shock will be 
delivered from the Test System to convert the arrhythmia.  A second shock at 
170J will be delivered from the Test System if the first shock is unsuccessful.   
Further rescue shocks may be delivered via an internal or external defibrillator 
at the Investigator’s discretion. 
Conversion is defined as the presence of a non-shockable rhythm after shock 
delivery.  Documentation that will be collected includes captured screen shots 
and log files from the Tablet programmer, paper copies of ECG strips from the 
EP monitoring system, and a study-specific physician procedure report.    
 
Efficacy Objective: 
 
Primary Endpoint: 
 Secondary Endpoint: 
Safety Objective: 
 
 
Safety Endpoint: 
To evaluate conversion efficacy of the ASSURE WCD Waveform 
Estimated cumulative first and second shock VT/VF conversion efficacy ≥ 94% 
First shock VT/VF conversion efficacy (report only) 
To collect information on adverse events at least possibly related to use of the 
investigational Test System 
Summary of adverse events that are at least possibly related to use of the 
investigational Test System, including classification of Unanticipated Adverse 
Device Effects 
Study Duration: 
Individual subject participation is during acute intra-procedural testing only.  
Subjects can be enrolled only once.  Total Study Duration from first subject in 
to last subject out will be approximately two months. 
 
 
 

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Table of Contents 
1 
SPONSOR SIGNATURE PAGE ................................................................................................... 2 
2 
KEY ROLES AND CONTACTS ................................................................................................... 3 
3 
PROTOCOL SUMMARY ............................................................................................................. 4 
4 
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS .................................... 11 
5 
INTRODUCTION ........................................................................................................................ 12 
Background ................................................................................................................................... 12 
Rationale for Approach ................................................................................................................ 12 
PRECLINICAL STUDIES ........................................................................................................... 14 
6 
OVERALL STUDY PLAN .......................................................................................................... 17 
Number of Subjects ...................................................................................................................... 17 
Study Sites .................................................................................................................................... 17 
Study Population........................................................................................................................... 17 
Eligibility Criteria ......................................................................................................................... 17 
Participation Period ...................................................................................................................... 18 
Subject Withdrawals ..................................................................................................................... 18 
Medical Monitor ........................................................................................................................... 19 
Sponsor or Regulatory Agency Termination of the Study ........................................................... 19 
End of Study ................................................................................................................................. 19 
7 
STATISTICAL PLAN ................................................................................................................. 20 
Data Sources ................................................................................................................................. 20 
Study Objectives and Endpoints ................................................................................................... 20 
Sample Size Considerations ......................................................................................................... 20 
Analysis Populations .................................................................................................................... 20 
Handling of Missing Data ............................................................................................................. 21 
8 
TEST SYSTEM ............................................................................................................................ 25 
Safety and Device Accountability ................................................................................................ 28 
Reuse of System Components ...................................................................................................... 28 
9 
STUDY PROCEDURES .............................................................................................................. 29 
Informed Consent and Enrollment................................................................................................ 29 
Assessments .................................................................................................................................. 29 
Demographic Data ........................................................................................................................ 29 
Medical History ............................................................................................................................ 29 
Clinical Laboratory Tests ............................................................................................................. 30 
Supply, Packaging, Labeling, and Storage ................................................................................... 30 
Electrophysiology (EP) Procedure ............................................................................................... 30 
Screen Failures ............................................................................................................................. 32 
Handling of Withdrawals .............................................................................................................. 32 
10 ADVERSE EVENT REPORTING .............................................................................................. 34 
11 DATA HANDLING AND QUALITY ASSURANCE ................................................................ 38 
Subject Identification Numbers .................................................................................................... 38 
Case Report Forms ....................................................................................................................... 38 
Study Data and Conduct Monitoring ............................................................................................ 38 
Inspection of Records ................................................................................................................... 39 
Study Record Retention ................................................................................................................ 39 
Ethical Conduct of the Study ........................................................................................................ 40 
Informed Consent ......................................................................................................................... 40 
Institutional Review Board ........................................................................................................... 40 

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12 ADMINISTRATIVE CONSIDERATIONS ................................................................................ 41 
Confidentiality .............................................................................................................................. 41 
Modification of the Protocol ......................................................................................................... 41 
Protocol Deviations ...................................................................................................................... 41 
Study Reporting Requirements ..................................................................................................... 42 
Financial Disclosure ..................................................................................................................... 42 
Financial Obligations .................................................................................................................... 42 
Investigator Documentation ......................................................................................................... 42 
Clinical Trial Agreement .............................................................................................................. 43 
Policy for Publication and Presentation of Data ........................................................................... 43 
13 INVESTIGATOR AGREEMENT ............................................................................................... 44 
14 APPENDIX A - ASSURE DEFIBRILLATION WAVEFORM .................................................. 45 
15 APPENDIX B - MEDICARE IDE STUDY CRITERIA ............................................................. 46 
16 BIBLIOGRAPHY ........................................................................................................................ 47 
 

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LIST OF IN-TEXT FIGURES 
Figure 1: Example Test System and Monitoring Setup ............................................................................... 26 
Figure 2: Test System Defibrillation Pad and ECG Electrode Placement ................................................... 27 
Figure 3: Time to shock ............................................................................................................................... 32 
Figure 4: Defibrillation Waveform Profiles into 50 ohms ........................................................................... 45 
 
 

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LIST OF IN-TEXT TABLES 
Table 1: Spontaneous Defibrillation Efficacy Observed in ZOLL LifeVest Registry 
Studies ........................................................................................................................... 13 
Table 2: Summary of Reduced Energy Level Study in Swine Results ........................................................ 15 
Table 3: Steps to Minimize Missing Data for the Primary Endpoint ........................................................... 21 
Table 4: Pass/Fail Criteria - Estimated Conversion Rate Based on Study Results ...................................... 23 
 

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4 GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS 
ABBREVIATION 
DEFINITION 
AADE 
Anticipated Adverse Device Effect 
ADAM 
ASSURE Defibrillation Adapter Module 
AE 
Adverse Event 
AED 
Automated External Defibrillator 
CAD 
Coronary Artery Disease 
CFR 
Code of Federal Regulations 
CIED 
Cardiac Implantable Electronic Device 
CPVT 
Catecholaminergic Polymorphic Ventricular Tachycardia 
CRA  
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
ECG 
Electrocardiogram 
EPS 
Electrophysiology Study 
FPI 
First Patient In 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice (Guidelines) 
GDR 
General Document Record 
ICD 
Implantable Cardioverter-Defibrillator 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IEC 
International Electrotechnical Commission 
ILR 
Implantable Loop Recorder 
IRB 
Institutional Review Board 
LPO 
Last Patient Out 
LVAD 
Left Ventricular Assist Device 
LVEF 
Left Ventricular Ejection Fraction 
MI 
Myocardial Infarction 
PP 
Per-Protocol 
PEA 
Pulseless Electrical Activity 
SAE 
Serious Adverse Event 
SCA 
Sudden Cardiac Arrest 
S-ICD 
Subcutaneous Implantable Cardioverter-Defibrillator 
TIA 
Transient Ischemic Attack 
UADE 
Unanticipated Adverse Device Effect 
VF 
Ventricular Fibrillation 
VT 
Ventricular Tachycardia 
WCD 
Wearable Cardioverter Defibrillator 

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5 INTRODUCTION 
Background 
The Wearable Cardioverter-Defibrillator (WCD) is indicated for adult patients who are 
at risk of sudden cardiac arrest (SCA) and are not immediate candidates for or decline an 
implantable defibrillator.  The study Sponsor has developed a new wearable defibrillator, 
the ASSURE WCD, to address this clinical situation.   
The ASSURE WCD uses a biphasic truncated exponential waveform to deliver 170 
Joules from a 140µF capacitor.  The waveform is like that used by existing 
commercially available devices, including Physio-Control LifePak12®, the Philips 
Heartstart® Automated External Defibrillator (AED), and the ZOLL LifeVest® Wearable 
Cardiac Defibrillator (APPENDIX A). 
This study is part of a comprehensive set of evaluation protocols which has been 
proposed to establish safety and effectiveness of the ASSURE WCD and will be 
included in support of the Premarket Approval (PMA) application for the ASSURE 
WCD. 
 
Rationale for Approach 
Defibrillation efficacy testing was once considered a standard part of ICD implantation.  
Decades of clinical experience with biphasic waveforms and other significant 
improvements in ICD technology over the years raised the question of the value of 
routine defibrillation testing resulting in the initiation of several large, prospective 
randomized controlled studies.  Based on the results of these studies, the following 
recommendation was issued in a joint statement by the four continental 
electrophysiology societies in 2015 (Wilkoff B):   
“It is reasonable to omit defibrillation efficacy testing in patients undergoing 
initial left pectoral transvenous ICD implantation procedure where appropriate 
sensing, pacing, and impedance values are obtained with fluoroscopically well-
positioned RV leads.” 
As a result, defibrillation threshold testing is less frequently performed, and a strategy 
which minimizes dependence on human defibrillation testing to establish safety and 
effectiveness for new devices is necessary.   
The Sponsor’s strategy includes a comprehensive set of bench and animal tests that have 
been conventionally used to evaluate defibrillation efficacy of biphasic waveforms in 
AEDs with characteristics that are proven and well-understood.  These bench and animal 
studies include: 

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1. 
Demonstration of fundamental electrode characteristics required for 
successful defibrillation (Impedance and active area meet IEC 
standards and conventional Anterior-Posterior placement).  
2. 
Assessment of efficacy by a rigorous study of waveform and dose in 
animals (Non-inferior to the predicate to establish equivalence): Sponsor 
Protocol 3337920 Comparing Efficacy of the ASSURE Wearable 
Automated External Defibrillator (AED) and the ZOLL LifeVest 
Defibrillation Waveforms.   
3. 
Assessment of ASSURE full energy waveform: Sponsor Protocol 
3338359 ASSURE Full Energy Shock Efficacy. 
4. 
Assessment of ASSURE full energy waveform: Sponsor Protocol 
3337766 Waveform Safety Study. 
 
In addition, this clinical study is being conducted in humans who are undergoing 
electrophysiologic procedures for ventricular arrhythmias to demonstrate full energy 
shock conversion in humans.   
Recent, prospective published registry studies of the ZOLL LifeVest provide a relevant 
reference for establishing a point estimate of defibrillation efficacy for this study.   
Spontaneous defibrillation efficacy observed in these registry studies is summarized in 
Table 1. 
 
Table 1: Spontaneous Defibrillation Efficacy Observed in ZOLL LifeVest Registry Studies 
Registry Study 
Number 
of 
Subjects 
Number of 
Subjects 
with Events 
Number of 
Successful 
Conversions 
Conversion Rate 
US Registry (WEARIT-II) (Kutyifa V) 
2,000 
22 
22 
100% (C.I.  0.873 – 1.000) 
German Registry (Wäßnig NK) 
6,043 
94 
88 
94% (C.I.  0.866 – 0.977) 
 
 
 

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PRECLINICAL STUDIES 
The following preclinical studies have been completed to demonstrate safety and 
effectiveness of the waveform in animals: 
 
Efficacy of the ASSURE and LifeVest Waveforms at Full-Energy in Swine 
(Protocol 3338359) 
This prospective block-randomized study compared the efficacy of the ASSURE 
defibrillation waveform at full energy output (170J) in treating electrically-induced VF 
in a closed chest porcine model of short duration cardiac arrest in comparison to the 
ZOLL LifeVest defibrillation waveform at full energy output (150J). Six swine were 
treated for 20 VF episodes each. The VF episodes were organized in 10 blocks, with 
each block consisting of one shock from each device in random order. Both devices 
produced a 100% shock success rate in all six animals. This study was designed to 
measure the difference in success rate between the two devices. Because there was no 
variation in the data, the lower-bound 95% confidence interval of the difference in 
success rates (ASSURE shock success rate – LifeVest shock success rate) between the 
two devices is 0% which meets the non-inferiority criteria. 
Overall, this study provides evidence that the ASSURE WCD waveform is non-inferior 
to the LifeVest waveform in treating VF with full-energy shocks. 
 
Efficacy of the ASSURE and LifeVest Waveforms at Reduced Energy Levels in 
Swine (Protocol 3337920) 
This prospective block-randomized study compared the efficacy of the ASSURE 
defibrillation waveform at attenuated energy output (ED50) in treating electrically-
induced VF in a closed chest porcine model of short duration cardiac arrest compared to 
the currently marketed ZOLL LifeVest defibrillation waveform attenuated energy 
output.  Waveform voltages were attenuated to provide greater sensitivity to detect 
waveform efficacy differences.  Probability of defibrillation shock success was 
compared at three impedance levels (50, 85, and 125 Ω).  Thirty-six (36) animals were 
studied.   
A summary of the protocol that was followed for each animal is as follows: (1) The 
ASSURE WCD shock voltage was attenuated to the level that produced an approximate 
50% shock success rate (ED50); (2) The LifeVest shock voltage was attenuated by the 
same percentage; (3) With these voltage levels, ten block-randomized shocks were 
delivered with each waveform and shock successes and failures were recorded; (4) steps 
1, 2, and 3 were repeated at each of the three impedance levels (50, 85, and 125Ω); and 

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(5) The success rate was calculated for each waveform at each impedance level.  The 
lower-bound 95% confidence interval for the difference between the two devices was 
compared (ASSURE WCD shock success – LifeVest shock success). The results from 
this calculation are shown in Table 2, below. 
Table 2: Summary of Reduced Energy Level Study in Swine Results 
Impedance 
Level 
Effect Size 
Lower-Bound 
95% 
Confidence 
Interval 
Pass/Fail 
Limit 
Pass or Fail 
Non-Inferiority 
Criteria? 
50Ω 
1.11% 
-4.22% 
-10% 
Pass 
85Ω 
7.22% 
1.38% 
-10% 
Pass 
125Ω 
12.50% 
7.62% 
-10% 
Pass 
Effect size = ASSURE waveform shock success – LifeVest waveform shock success 
Overall, this study provides evidence that the ASSURE WCD waveform is non-inferior 
to the LifeVest waveform at 50Ω, 85Ω, and 125Ω. 
 
Waveform Safety Study in Swine (Protocol 3337766) 
This study compared the safety of the ASSURE WCD waveform at full energy output 
(170J) in swine to a commercially-available external defibrillator (LIFEPAK 12) 
waveform at 200J. The following protocol was followed for each animal (N = 8): (1) at 
baseline, blood was drawn and ECG collection was started; (2) five shocks were 
delivered from the randomly assigned study device; (3) ECG collection continued until 
at least 1 hour post-shock; (4) 6 hours post shock, another blood sample was drawn and 
10 minutes of ECG collected; (5) at least 24 hours post shock, another blood sample was 
drawn, animal was euthanized, and tissue samples were collected for histological 
evaluation; and finally (6) the change in biomarkers from the baseline to 6 hour time 
point and baseline to 24 hour timepoint were analyzed with a student’s t-test to see if 
there was a significant difference between the two devices. 
The results from this study met the pre-specified acceptance criteria for the primary 
endpoints:  Change in Troponin I levels from baseline to 6 hours post shock and baseline 
to 24 hours post shock were not significantly different than LIFEPAK 12 (p=0.45 and 
p=0.89, respectively); and the mean histopathology injury score difference across all 
tissue sections was less than 0.4.  There were also no significant differences in secondary 
endpoints including Creatine Kinases (CPK, CK-MB, and CK-MM), CBC and serum 
chemistry levels and ECG characteristics between the two groups.  

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Overall, this study provides the evidence that the ASSURE WCD waveform does not 
cause more injury than the LIFEPAK 12 waveform. 

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6 OVERALL STUDY PLAN 
The objective of this study is to obtain human clinical experience with the ASSURE 
WCD defibrillation waveform in adult subjects.  This is a multicenter single arm open 
label study using the ASSURE WCD defibrillation waveform to convert shockable 
rhythms (VT and VF).  Subjects who consent to participate will be screened for 
eligibility before the enrollment visit is scheduled.  The Investigator will verify 
eligibility at the time of enrollment. 
Number of Subjects 
This is a fixed study design with 20 subjects.   
Study Sites 
Subjects will be enrolled at up to 5 clinical sites in the United States where the 
procedures specified in Inclusion Criterion 3 are performed routinely.  There is no 
minimum or maximum number of subjects that may be enrolled at each site. 
Study Population 
Patients who are scheduled for any of the procedures specified in Inclusion Criterion 3 
(below). 
Eligibility Criteria 
Subjects who meet all Inclusion Criteria and none of the Exclusion Criteria may be 
enrolled in the study. 
 
Inclusion Criteria: 
1. Males or females, age ≥ 18 years 
2. Able and willing to provide written informed consent before undergoing any 
study-related procedures 
3. Scheduled for any of the following procedures: 
a. Electrophysiology study for induction of ventricular arrhythmias 
b. Non-invasive electrophysiology testing using an existing implantable 
defibrillator 
c. ICD replacement procedure during which induction of a ventricular 
arrhythmia is planned 
d. Ablation of ventricular tachycardia (patients undergoing ventricular 
tachycardia ablation in which ONLY a substrate modification approach is 
planned, with no intention of inducing a ventricular arrhythmia, should 
not be included) 

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Exclusion Criteria: 
1. Any condition that by the judgement of the physician investigator precludes the 
subject’s ability to comply with the study requirements 
2. Pregnancy 
3. Use of mechanical circulatory support (e.g. LVAD, Total Artificial Heart, 
intraaortic balloon pump or Impella) 
4. Documented nonchronic cardiac thrombus 
5. Atrial fibrillation or atrial flutter without adequate systemic anticoagulation 
6. Critical aortic stenosis 
7. Unstable coronary artery disease (CAD) 
8. Recent stroke or transient ischemic attack (TIA) 
9. Hemodynamic instability 
10. Currently implanted Boston Scientific S-ICD (due to location of implant relative 
to test system) 
11. Unstable Angina 
12. New York Heart Association (NYHA) Class IV 
13. Left Ventricular Ejection Fraction (LVEF) < 20% 
14. Any medical condition that by the judgement of the physician investigator, 
patient participation in this study is not in the best interest of the patient 
15. History of difficulty of ventricular arrhythmia induction 
16. Amiodarone use within 3 months before the study procedure 
 
Participation Period 
Individual subject participation is during acute intra-procedural testing only.  Subjects 
can be enrolled only once.  Overall study duration will be approximately two months. 
Subject Withdrawals 
Subjects may withdraw from the study for any reason.  Subjects may also be removed 
from the study due to adverse events or Investigator/Sponsor decision.  Subjects who are 
withdrawn from the study will not be replaced. 

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Medical Monitor 
The Medical Monitor (an independent physician not participating as a clinical 
investigator in the clinical study) will review and assess in conjunction with the Sponsor 
all AEs considered by the investigator to be at least possibly related to the use of the Test 
System to determine if they are reportable to the FDA as Unanticipated Adverse Device 
Effects (UADEs) per the definition in Section 10.  The Medical Monitor will also review 
all Serious Adverse Events considered by the investigator to be at least possibly related 
to the use of the Test System to verify relatedness and the Serious classification. 
Sponsor or Regulatory Agency Termination of the Study 
Although the Sponsor intends to complete the study, the right is reserved to discontinue 
the study at any time for clinical or administrative reasons, or if required by the local 
regulatory authority. 
End of Study 
The end of study will be defined as the date of the last visit of the last subject unless 
open AEs remain in which case the end of study will be when that follow up is 
completed (the AE is resolved, or the subject is lost to follow up).  A summary of the 
End of Study report will be sent to relevant regulatory authorities and Institutional 
Review Boards (IRBs) within 6 months of the end of the study. 
 
 

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7 STATISTICAL PLAN 
Data Sources 
• Case Report Form (CRF) Data will include: Subject ID, Subject Demographics, 
Confirmation of Eligibility, Cardiac Medical History, Procedure Data (induction 
attempt number, method, time, arrhythmia type, arrhythmia duration, arrhythmia 
rate, shock(s) delivered, shock converted), Adverse Events (AEs), Missing data 
rationale, Deviations and Investigator Signature page. 
• EP Study/Testing, ICD changeout, or Ablation procedure documentation 
including ECG recordings in which conversion was attempted per Section 9 of 
this protocol, and procedure summary. 
Study Objectives and Endpoints 
Efficacy Objective: To evaluate conversion efficacy of the ASSURE WCD Waveform 
Primary Endpoint: Estimated cumulative first and second shock VT/VF 
conversion efficacy ≥ 94% 
Secondary Endpoint: First shock conversion efficacy (report only) 
Safety Objective:  To collect information on adverse events at least possibly related to 
use of the investigational Test System 
Safety Endpoint: Summary of adverse events that are at least possibly related to 
use of the investigational Test System, including classification of Unanticipated 
Adverse Device Effects 
Sample Size Considerations 
The sample size set for this study has been scaled to obtain human clinical experience in 
a comparable number of subjects with attempted shock conversion as reported in the 
published US LifeVest registry study (Kutyifa V), and account for the potential for 
missing data (e.g., subjects who fail to have a ventricular arrhythmia induced).  The 
sample size is not power-driven. 
Analysis Populations 
The primary endpoint will be analyzed using the data sets as defined below: 
1. Intention to Treat (ITT) analysis population will include all subjects who signed 
informed consent and for whom the study procedure was initiated.   
2. Per Protocol (PP) analysis population will include all subjects who met all eligibility 
criteria, signed informed consent, and for whom the procedure was completed as 

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specified in section 9 without deviation. The PP analysis population is a subset of the 
ITT population. If there are no differences in the ITT and PP analysis populations, 
separate analyses will not be presented. 
The determination of any subjects excluded from the PP analysis population will be 
made prior to locking the study database for final analysis.  All safety summaries will be 
based on the ITT analysis population. 
 
Handling of Missing Data  
CRFs will be monitored for accuracy and missing data, and queries will be issued to the 
sites for resolution.  Every attempt will be made to maximize the likelihood of obtaining 
data to support the study endpoint 
The table below lists anticipated situations which may occur resulting in missing data for 
the primary endpoint, and the steps that will be taken to minimize the occurrence.  
Table 3: Steps to Minimize Missing Data for the Primary Endpoint 
Source of missing data 
Steps to minimize missing data 
Unable to induce a ventricular arrhythmia 
History of difficulty of ventricular arrhythmia 
induction has been specified in the exclusion 
criteria. 
Unable to induce a ventricular arrhythmia 
with heart rate greater than 150 bpm 
History of difficulty of ventricular arrhythmia 
induction has been specified in the exclusion 
criteria. 
No induction attempted due to change in 
patient’s hemodynamic status 
Conditions which place the patient at 
perceived high risk have been specified in the 
exclusion criteria. 
Rescue shock delivery before either a 1st or 
2nd shock from the Test System 
Protocol training will be provided for the 
investigator and EP staff. 
Pacing or shock therapy from CIED delivered 
before either a 1st or 2nd shock from the Test 
System 
1. Protocol training will be provided for the 
investigator and EP staff. 
2. Instruction to program CIED therapies 
OFF is specified in the EP procedure 
(Section 9). 
Pacing from external EP system delivered 
before either a 1st or 2nd shock from the Test 
System 
Protocol training will be provided for the 
investigator, EP staff and operators 
No shock delivered from the Test System due 
to procedure setup or operator error 
1. Protocol training will be provided for the 
investigator, EP staff and operators. 
2. Operators will be trained on the Test 
System. 
No shock delivered from the Test System due 
to equipment failure 
Each Test System must pass manufacturing 
test before shipment to the clinical site.  In 

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addition, the ASSURE WCD Monitor 
executes a self-test upon boot-up.  
Occurrence of any of these situations shall be reviewed with the Sponsor and the Study 
PI prior to enrolling any additional subjects at that site.  If there still are missing data 
despite efforts to minimize it the investigator will document on a CRF the 
reason/rationale for the missing data. 
 
Primary Endpoint Analysis 
The primary endpoint analysis will be performed after all subjects have completed the 
study and the study database has been cleaned, verified and locked.  The data from all 
clinical sites that participate in this study will be combined so that the target sample size 
will be available for analysis. 
The primary endpoint will be calculated as the ratio of the number of subjects with 
successful (first or second shock) arrhythmia conversion using the Test System to the 
number of total inductions attempted with shocks delivered by the Test System in the 
respective data set.  A successful arrhythmia conversion is defined as termination of an 
induced ventricular rhythm (>150 bpm) by first or second shock from the Test System to 
a non-shockable rhythm (rhythms other than VT or VF). 
Performance criteria will be based on comparison to the published conversion efficacy 
point estimate of 94% reported for the ZOLL LifeVest (Wäßnig NK), which is the only 
comparable commercially-available device.   
The Pass/Fail criteria will be based on the primary endpoint using the PP analysis 
population (See Table 3).   
 
 

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Table 4: Pass/Fail Criteria - Estimated Conversion Rate Based on Study Results 
Successful 
Conversion 
Estimated Conversion Rate 
95% Confidence Interval 
20 out of 20 
100.0% 
(83.2%, 100.0%) 
19 out of 20 
95.0% 
(75.1%, 99.9%) 
< 18 out of 20 
Failure to Meet Primary Endpoint 
N/A 
19 out of 19 
100.0% 
(82.4%, 100.0%) 
18 out of 19 
94.7% 
(74.0%, 99.9%) 
< 17 out of 19 
Failure to Meet Primary Endpoint 
N/A 
18 out of 18 
100.0% 
(81.5%, 100.0%) 
17 out of 18 
94.4% 
(72.7%, 99.9%) 
< 16 out of 18 
Failure to Meet Primary Endpoint 
N/A 
17 out of 17 
100.0% 
(80.5%, 100.0%) 
16 out of 17 
94.1% 
(71.3%, 99.9%) 
< 15 out of 17 
Failure to Meet Primary Endpoint 
N/A 
Two analyses of the primary endpoint will be conducted, one using the PP data set and a 
second using the ITT data set.   The ITT analysis will include all 20 subjects regardless 
of missing data.  If there is missing data, a tipping point analysis (including best- and 
worst-case scenarios) will be used to assess sensitivity of the analysis to the missing 
data.  The difference between the conversion rate estimates from the PP and ITT 
analyses will be used to assess the magnitude of missing data bias. 
 
Secondary Endpoint Analysis 
This secondary endpoint is exploratory and does not have pre-specified performance 
criteria.  Data will be summarized for both the ITT and PP analysis populations. 
 

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Analysis of Demographic and Baseline Data 
Subject demographic and baseline data will be summarized for the PP analysis 
population.  Continuous variables will be summarized using descriptive statistics 
(number of subjects, mean, standard deviation, median, minimum and maximum), and 
categorical variables will be summarized using the count and percentage of subjects in 
each category. 
 
Safety Analysis 
Safety will be analyzed based on the ITT analysis population.  The assessment of safety 
will be based on the summaries of AEs, vital signs, physical examination findings, and 
ECGs.  The Medical Monitor’s assessment of seriousness and relatedness, rather than 
the investigator’s assessment, will be used for summarizing and analyzing safety data. 
Separate summaries of AEs related to use of the Test System and by severity will be 
prepared.  The number of deaths and UADEs will also be presented, and events leading 
to discontinuation from the study will be listed and tabulated. 
Continuous variables will be summarized by descriptive statistics, and categorical 
variables will be summarized using the count and percentage of subjects in each 
category. 
 
Subject Disposition 
Subject disposition including the number of subjects enrolled and number of subjects 
completing the study will be tabulated.  The percentage of subjects completing the study 
will be based on the total number enrolled.  Protocol deviations will also be summarized.  
Subject discontinuations and the reasons for discontinuation will also be summarized. 
 
 
 
   
 
. 
     

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8 TEST SYSTEM 
The Test System consists of a production-equivalent ASSURE WCD Monitor that will 
deliver the ASSURE defibrillation waveform (APPENDIX A).  The ASSURE WCD 
Monitor will be from controlled inventory that is designated for clinical evaluations 
only.  The Monitor will be connected to an ASSURE Defibrillation Adapter Module 
(ADAM) that allows use of a commercially-available Physio-Control LIFEPAK15 
Therapy cable, and a commercially-available Physio-Control LIFEPAK15 5-wire ECG 
cable for patient connections. 
Commercially available Physio-Control QUIK-COMBO RTS standard adhesive 
defibrillation electrodes will be applied in anterior and posterior positions that 
correspond to the defibrillation pad locations in the ASSURE WCD Garment.  Standard 
adhesive defibrillation electrodes are used to limit interference with the 
electrophysiology procedure that the subject is otherwise undergoing.  Otherwise, 
ASSURE WCD electrodes would also require the ASSURE Garment to hold the 
defibrillation electrodes in place on the body which may compromise the sterile field.   
Defibrillation efficacy using the QUIK-COMBO RTS electrodes is expected to be 
representative of defibrillation efficacy using ASSURE WCD electrodes since both 
types of electrodes have been designed and tested to meet the defibrillator electrode 
requirements as specified in IEC 60601-2-4 for electrode AC small signal impedance, 
AC large signal impedance and active area.     
ECG signals will be monitored using 5 lead locations.  Figure 1 shows an example of the 
Test System and EP monitoring setup to be used for the study, including the ASSURE 
WCD Monitor, the ADAM, and the EP monitor and backup rescue defibrillator.  Figure 
2 provides specific detail regarding the Test System defibrillation pad and ECG 
electrode placement. 
Delivery of the ASSURE defibrillation waveform will be initiated by setting the 
ASSURE WCD Monitor to Manual Shock Mode.  The Kestra Clinical Specialist will 
initiate the shock delivery on Investigator/Sub-Investigator command using the 
ASSURE Tablet that communicates with the ASSURE WCD Monitor via a Bluetooth 
connection (the Test System shock decision algorithm will not be used).

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Figure 1: Example Test System and Monitoring Setup 
 
 

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Figure 2: Test System Defibrillation Pad and ECG Electrode Placement 
 

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Safety and Device Accountability 
Risks of this study have been identified through systematic hazard analysis, and the 
Sponsor has documented risk mitigation in a controlled Safety Risk Management 
Report.   
Each ASSURE WCD Monitor and each ADAM will be assigned a unique serial number 
that is included on the labeling.  Labeling also includes “For Investigational Use Only”.  
The Sponsor will maintain tracking records for all system components. 
All Test System components will be accounted for by Kestra Clinical staff.   
 
Reuse of System Components 
Adhesive ECG and defibrillation electrodes will be disposed of after use.  Cables and 
Test System components will be cleaned between uses. 

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9 STUDY PROCEDURES 
Informed Consent and Enrollment 
Cardiac patients will be screened for eligibility by the clinical site staff members in 
advance of the procedure date.  Eligible patients will be provided the informed consent 
form and allowed enough time to review the consent, and to have any questions they 
may have adequately addressed.  Only patients who provide written informed consent to 
participate can be enrolled as study subjects.  Subjects will be considered enrolled after 
they have provided Informed Consent and when the Test System is connected to the 
defibrillation electrodes in step 5 of the Electrophysiology procedure below. 
Assessments 
Demographic Data 
Demographic data, including age, height, weight, gender, race, and ethnicity will 
be collected on the CRF. 
Medical History 
Medical history including information specified in the following list will be 
recorded on the CRF for each subject: 
1. 
Disease process (ex., CAD, Dilated Cardiomyopathy, Hypertrophic 
Cardiomyopathy, Long QT/Brugada/CPVT) 
2. 
Co-morbidities (ex., Diabetes, Renal disease, Hypertension, 
Hyperlipidemia, COPD) 
3. 
Prior cardiac surgery (ex., PCI, CABG, other) 
4. 
NYHA Class 
5. 
The most recent left ventricular ejection fraction (%) measured by 
echocardiography, nuclear imaging (including MRI), or left ventricular 
angiography 
6. 
History of Atrial arrhythmia 
7. 
Prior Stroke/TIA 
8. 
Baseline medications including any antiarrhythmic agents 
9. 
Cardiac Implanted Electronic Device (i.e., pacemaker, ICD, CRT, ILR) 
10. 
Shock therapy history from implantable or external devices 

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Clinical Laboratory Tests 
Pregnancy testing will be performed by urine HCG for women of child bearing potential 
prior to enrollment. 
 
Supply, Packaging, Labeling, and Storage 
The Test System components will be provided by the Sponsor, including disposable 
defibrillation and ECG electrodes. 
If Test System components are stored temporarily onsite, they must be stored at ambient 
room temperature in a securely locked cabinet or enclosure.  Neither the Investigators 
nor any designees may provide devices to any individual not participating in this 
protocol. 
 
Electrophysiology (EP) Procedure 
The following procedure will be performed during a single study visit corresponding to 
the EP procedure.  A Kestra Clinical Specialist must be present. 
1. (Investigator or qualified designee) Explain the purpose and conduct of the study 
visits to the subject, answer the subject’s questions, and obtain written informed 
consent.  Provide the subject with a copy of the informed consent.  Consent can 
be completed in advance of the procedure date, or on the day of the Study Visit.  
2. (Investigator) Review inclusion/exclusion criteria prior to any procedural 
activities 
3. (Investigator or qualified designee) Assign Subject ID number 
4. (Investigator or qualified designee) Record demographic data and protocol-
specified medical history on case report form 
5. (Investigator or qualified designee in consult with Kestra Clinical Specialist) 
Position two sets of disposable adhesive defibrillation pads on the patient’s torso: 
o Locate one set provided by the Sponsor in the left anterior and left-
subscapular posterior positions to be connected to the Test System (see 
Figure 2).  This configuration will be used to deliver the experimental 
therapeutic defibrillation shock(s).   
o Locate the other set of defibrillation pads (not provided by the Sponsor) 
for the backup rescue defibrillator) on the subject’s torso according to 
physician preference but separated from the Test System defibrillation 

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pads to prevent arching or current shunt, and at least one inch away from 
a CIED if applicable. 
o (Kestra Clinical Specialist) Obtain anterior and posterior photographs of 
the torso (not including subject’s head/face) to document electrode 
placement. 
6. (Kestra Clinical Specialist) Create a new patient in the ASSURE WCD Monitor, 
enter the subject ID number, and configure the ASSURE WCD Monitor to 
manual shock mode.  (Manual shock mode allows the Study Shocks to be 
delivered on command by the physician)   
7. (Investigator or Sub-Investigator) Induce a single sustained episode of rapid VT 
or VF ≥ 150 bpm via the CIED or an electrophysiology catheter. 
o If this protocol is performed as part of an ICD replacement procedure, the 
test procedure must be performed prior to surgical opening of the CIED 
pocket. 
o If using a CIED for induction, ventricular therapy (i.e., ATP and Shocks) 
must be programmed OFF or temporarily suspended while therapy from 
the Test System is delivered. 
o If the arrhythmia is less than 150 bpm, convert the patient’s arrhythmia 
using the backup rescue defibrillator and/or standard of care procedures.   
o Repeated induction attempts may be performed to induce the ventricular 
rhythm.  The investigator may stop induction attempts at any point if in 
their judgement it is no longer in the best interest of the patient. 
o Conversion is defined as the presence of a non-shockable rhythm 
(rhythms other than VT or VF) after shock delivery 
8. (Kestra Clinical Specialist under the direction of the Investigator or Sub-
Investigator) If the Arrhythmia is estimated to be greater than 150 bpm, deliver a 
170J shock from the Test System. 
9. (Kestra Clinical Specialist under the direction of the Investigator or Sub-
Investigator) Deliver a second shock at 170J from the Test System if the first 
shock is unsuccessful. 
10.  (Investigator or Sub-Investigator) If both attempts to convert using the Test 
System are unsuccessful, convert the patient’s arrhythmia using the backup 
rescue defibrillator, implantable defibrillator and/or standard of care procedures.   

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Time to the first shock from the Test System will be approximately 6 seconds.  Total 
time to an external rescue shock, if needed, is estimated to be approximately 20 seconds. 
11. (Kestra Clinical Specialist) After conversion of the arrhythmia, disconnect the 
Test System from the adhesive pads. 
12. Obtain copies of procedure documentation 
o Download the manual shock log from the tablet 
o Electronic or paper record of the ECG signals from the EP monitoring 
system (from induction through conversion) 
o Study-specific physician procedure report (de-identified) 
 
The following situations are examples of protocol deviations: 
a) Rescue shock delivered before a first or second Test System shock delivered  
b) Therapy delivered from external EP system (e.g. ATP/pacing), or CIED 
(ATP/shock) before a first or second Test System shock delivered 
c) No shock delivered from Test System (equipment failure or operator error) 
d) No induction attempted after enrollment due to change in patient’s hemodynamic 
status 
 
Screen Failures 
Subjects will be screen-failed if they do not meet eligibility, refuse consent to 
participate, or choose to withdraw consent to participate before they are enrolled as 
defined in paragraph 1 of this Section. 
Handling of Withdrawals 
When a subject is withdrawn from the study for any reason, the reason(s) for withdrawal 
will be recorded on the appropriate case report form (CRF).  For any subject who is 
Figure 3: Time to shock 

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withdrawn due to adverse events (AEs), the reason for withdrawal must be recorded as 
an AE and not any other reason.   
In the event of a subject death during the study, the date of death (as listed on the death 
certificate) will be used as the date of study withdrawal. 
It is vital to obtain follow-up data on any subject who is withdrawn because of an AE.  
In any case, every effort must be made to undertake protocol-specified safety follow-up 
procedures and the site principal investigator will be required to document that follow 
up. 

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10 ADVERSE EVENT REPORTING 
Adverse events (AEs) as defined below will be monitored during the study procedure.  
AEs may be reported by the subject, discovered by Investigator questioning, or detected 
through physical examination or other means at the study visit.  All AEs must be 
recorded on the CRF.  The following information about each AE will be collected:  
description, severity, onset and resolution dates, seriousness, relationship to the Test 
System, action taken, and outcome. 
 
Definitions 
For the purposes of this study, an AE is defined as any untoward medical occurrence in a 
subject during the study that in the opinion of the investigator is at least possibly-related 
to use of the Test System during the EP procedures specified in Section 9. 
A serious adverse event (SAE) is defined as any adverse event that: 
• 
Leads to death 
• 
Leads to serious deterioration in the health of a subject that: 
o Results in a life-threatening illness or injury, or 
o Results in a permanent impairment of a body structure or a body function, 
or 
o Requires in inpatient or prolonged hospitalization ≥ 24 hours, or 
o Results in medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure or function, 
or 
• 
Leads to fetal distress, fetal death or a congenital anomaly or birth defect 
Adverse Device Effect (ADE) is an adverse event related to the use of an 
investigational medical device (the Test System). 
 
 

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Anticipated Adverse Device Effects (AADEs) are those events related to the use of the 
Test System that are reasonably expected to occur as a result of the subject’s 
participation in the study. The following are AADEs based on complications reported 
associated with defibrillation threshold testing (Wilkoff BL), complications associated 
with ICD pulse generator replacement (Poole JE), and the Test System engineering 
hazard analysis: 
• Acute kidney injury  
• Acute liver injury 
• Blisters 
• Burn 
• Cardiac arrest 
• Cardiac Perforation 
• Cellulitis 
• Central nervous system injury 
• Death 
• Deep vein thrombosis 
• Depression of contractile function 
leading to worsening of heart failure 
• Heart failure needing intravenous 
treatment with inotropes or diuretics 
• Hematoma at catheter site requiring 
evacuation or long-term treatment 
with antiplatelet or anticoagulation 
medication 
• Hemodynamic instability 
• Hemothorax 
• Hospital readmission 
 
• Infection  
• Itching under Test System defibrillation or 
ECG electrodes 
• Lead dislodgment or malfunction 
(requiring re-operation) 
• Myocardial Injury 
• Pain persistent > 7 days 
• Peripheral arterial embolus 
• Persistent hypotension 
• Pleural effusion 
• Pneumothorax 
• Prolonged hospitalization 
• Pulseless electrical activity (PEA) 
• Recurrent VT 
• Refractory VF 
• Respiratory arrest/depression 
• Skin Rash 
• Stroke or transient ischemic attack (TIA) 
• Tamponade 
• Thromboembolic events 
An Unanticipated Adverse Device Effect (UADE) is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with 
the study device (the Test System), if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in this protocol; or any other 
unanticipated serious problem associated with the device that relates to the rights, safety, 
or welfare of subjects.   
All AEs will be assessed by the investigator And the Medical Monitor according to: 
• Whether the event is serious (SAE); 
• The severity of the event (mild, moderate, severe): 

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o Mild: Awareness of signs and symptoms, but easily tolerated; are of 
minor irritant type, causing no loss of time from normal activities; 
symptoms would not require medication or a medical evaluation; signs 
and symptoms are transient. 
o Moderate: Discomfort severe enough to cause interference with usual 
activities; requiring treatment, but not extended hospitalization or 
intensive care for the subject.  
o Severe: Incapacitating with inability to do work or usual activities; signs 
and symptoms may be systemic in nature or require medical evaluation 
and/or treatment; requiring additional hospitalization or intensive care 
(prolonged hospitalization). 
• The relationship of the event to use of the Test System:  
o Possibly Related: There is a reasonable possibility that the AE may have 
been primarily caused by device use.  The AE has a reasonable temporal 
relationship to the use of the device and follows a known or expected 
response pattern to device, but alternative etiology is equally or more 
likely compared to the potential relationship to the use of the device. 
o Probably Related: There is a reasonable probability that the AE may have 
been primarily caused by device use.  The AE has a reasonable temporal 
relationship to the use of the device and follows a known or expected 
response pattern to device.  Note: this definition assumes no alternative 
etiology is equally or more likely compared to the potential relationship 
to the use of the device. 
o Definitely Related: The AE has a strong causal relationship to device use.  
The AE follows a strong temporal relationship to the use of the device, 
follows a known response pattern to the device, and cannot be reasonably 
explained by known characteristics of the subject’s clinical state, other 
therapies, or change in clinical status during the electrophysiologic 
procedure. 
Whenever possible, the Investigator should group signs or symptoms that constitute a 
single diagnosis under a single AE term (e.g. redness and swelling can be combined 
under skin irritation). 
Baseline conditions are not considered adverse events unless the condition worsens 
because of Test System use.  
 

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Adverse Event Reporting Procedures 
SAEs deemed at least possibly related to the use of the Test System will reviewed by the 
investigator and will be recorded on the CRF.   
Upon awareness of a SAE, the study site must enter the data into the CRF within 3 
working days.  If the eCRF is not accessible the Sponsor or Sponsor representative must 
be notified of any SAE via telephone (1-866-694-7476).   
UADEs must be reported by the investigator to the approving IRB as soon as possible, 
but not later than 10 working days after the investigator first learns of the effect. 
 
Reporting UADEs to Regulatory Agencies 
The Sponsor is responsible for the ongoing safety evaluation of the device.  The Sponsor 
should promptly notify all concerned Investigators/Institutions and the FDA of findings 
that could adversely affect the safety of subjects, impact the conduct of the study, or alter 
IRB approval to continue the study.  The Sponsor will report UADEs to the Food and 
Drug Administration (FDA) and other IRBs within ten days of the Sponsor's learning of 
them. 
Follow-up of Adverse Events  
Resolution means the subject has returned to the baseline state of health or the 
Investigator does not expect any further improvement in the subject’s condition or does 
not expect worsening of the AE. 
AEs deemed at least possibly related to the use of the Test System persisting at the time 
of the subject’s study exit will be followed by the investigator until the events are 
resolved, the subject is lost to follow-up or the adverse events are otherwise explained.  
If further evaluations are required, the investigator will ensure that relevant additional 
information is documented in the CRF. 

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11 DATA HANDLING AND QUALITY ASSURANCE 
Subject Identification Numbers 
Each subject will be assigned a unique study identification (ID) number that will be a 
combination of the site ID and the subject ID when enrolled in the study.  The first two 
characters of the ID number will reflect the study site number (e.g. S1).  The remaining 
two digits will be separated by a hyphen from the site ID and will be assigned based on 
the enrollment sequence (e.g. the first subject enrolled at each site will be assigned 01).  
This number will be used on the Case Report Form (CRF) and on the ECG data 
collection file.  The Sponsor will not collect Personal Health Information that would 
allow specific subject identification (e.g. date of birth, name, initials, medical record 
number) on the CRF or in the system data. 
Case Report Forms 
As part of the responsibilities assumed by participating in the study, the Investigator 
agrees to maintain adequate case histories for the subjects treated as part of the research 
under this protocol.  The Investigator agrees to maintain an accurate CRF and source 
documentation as part of the case history for each subject.  Source documentation may 
include chart notes, laboratory reports, and ECG strips. 
All requested information is to be filled in on the CRF.  If an item is not available or is 
not applicable, this should be indicated.  Blank data fields should not be present unless 
otherwise directed. 
CRFs must be reviewed, signed, and dated by the Investigator as required in a timely 
manner. 
Study Data and Conduct Monitoring 
The sponsor or sponsor representative will follow the study closely and will maintain 
necessary email, telephone, fax, and/or mail contact with the Investigators and study 
sites and will visit the study sites at periodic intervals.  The study monitor will maintain 
current personal knowledge of the study through observation, review of study records 
and source documentation, and discussion of the conduct of the study with the 
Investigators and study site staff.  During those visits, the study monitor will compare 
the subject data recorded in the CRF against source documents at the clinical site.  The 
study monitor will specifically review CRFs to verify that the procedures were followed, 
e.g. was the test therapy delivered per protocol. 
All aspects of the study will be carefully monitored by the Sponsor or its designee for 
compliance with applicable government regulations. 

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Inspection of Records 
Investigators and institutions involved in the study will permit study-related monitoring, 
audits, IRB review, and regulatory inspection(s) by providing direct access to all study 
records.  The Investigator or study site may be audited by the Sponsor or its 
representatives and/or regulatory agencies at any time.  In the event of an audit, the 
Investigator agrees to allow the Sponsor, representatives of the Sponsor, the Food and 
Drug Administration (FDA), or other regulatory agency access to all study records. 
The Sponsor will review case report form data and perform electronic edit checks on the 
data. 
The Investigator should promptly notify the Sponsor of any audits scheduled by any 
regulatory authorities and promptly forward copies of any audit reports received to the 
Sponsor. 
Study Record Retention 
Government agency regulations and directives require that all study documentation 
pertaining to the conduct of a clinical study in the subject files as original source 
documents for the study must be retained by the Investigator until notified by the 
Sponsor in writing that retention is no longer necessary.  Study documentation includes 
records of laboratory tests, clinical notes, and subject medical records.  It is the 
responsibility of the Sponsor to inform the Investigator/institution as to when this 
documentation no longer needs to be retained. 
Records containing subject medical information must be handled in accordance with the 
requirements of the applicable privacy rules and consistent with the terms of the subject 
authorization contained in the Informed Consent Form (ICF) for the study.  Care should 
be taken to ensure that such records are not shared with any person or for any purpose 
not contemplated by the ICF.  Furthermore, CRFs and other documents to be transferred 
to the Sponsor should be completed in strict accordance with the instructions provided 
by the Sponsor, including the instructions regarding the coding of subject identities.  
Should the Investigator wish to assign the study records to another party or move them 
to another location, written agreement must be obtained from the Sponsor.  If requested, 
the Investigator will provide the Sponsor, applicable regulatory agencies, and applicable 
IRB with direct access to original source documents. 
Investigators shall maintain all study-related documentation for a period of two (2) years 
following completion of the study, or the date of marketing approval or as per the local 
regulatory authority’s guidelines and practices, whichever is longer.  The Investigator 
should contact the Sponsor prior to destroying any study related documents. 

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Ethical Conduct of the Study 
The Investigator agrees that the study will be conducted according to the applicable FDA 
regulations 21CFR 812.100 and 21CFR812.110.  The Investigator will conduct all 
aspects of this study in accordance with all national, state, and local laws or regulations. 
Informed Consent 
Written informed consent in compliance with Title 21 of the CFR Part 50 shall be 
obtained from each subject prior to entering the study or performing any study 
procedures including pre-procedure preparation.  An ICF template will be provided by 
the Sponsor or designee to investigative sites.  The ICF will be submitted by the 
Investigator to his or her IRB for review and approval prior to the start of the study.  If 
any institution-specific modifications to study-related procedures are proposed or made 
by the site, the ICF should be reviewed by the Sponsor and/or its designee, if 
appropriate, prior to IRB submission.   
Before recruitment and enrollment, each prospective subject will be given a full 
explanation of the nature of the study and the action of the Test System.  The subject 
will be informed that participation is voluntary and that they can withdraw from the 
study at any time.  The subject will be allowed to read the approved ICF.  Once the 
Investigator is assured that the subject agrees to participate in the study, the subject will 
be asked to give consent by signing the ICF. 
The Investigator shall provide a copy of the signed and dated ICF to the subject.  The 
original shall be maintained in the subject’s medical records at the site. 
Institutional Review Board  
Federal regulations require that approval be obtained from an IRB prior to participation 
of subjects in research studies. Prior to subject enrollment, a signed copy of the IRB 
approval letter must be submitted to the sponsor. In addition, the protocol, informed 
consent form, advertisements to be used for subject recruitment, and any other written 
information regarding this study to be provided to the subject must be approved by the 
IRB. Documentation of all IRB approvals will be maintained by the site and will be 
available for review by the sponsor or its designee. 
All IRB approvals should be signed by the IRB chairperson or designee and must 
identify the IRB by name and address, the clinical protocol by title and/or protocol 
number, and the date approval was granted. 
The Investigator is responsible for submitting and obtaining initial and continuing 
review of the study at intervals not exceeding 1 year or as otherwise directed by the IRB. 
The investigator must provide written documentation of continued study review to the 
Sponsor or its designee. 

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12 ADMINISTRATIVE CONSIDERATIONS 
Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified 
in a manner designed to maintain subject confidentiality.  All records will be kept in a 
secure storage area with limited access.  Clinical information will not be released 
without the written permission of the subject, except as necessary for monitoring and 
auditing by the Sponsor, its designee, the FDA, or the IRB. 
The Investigator and all employees and coworkers involved with this study may not 
disclose or use for any purpose other than performance of the study any data, record, or 
other unpublished confidential information disclosed to those individuals for the purpose 
of the study.  Prior written agreement from the Sponsor or its designee must be obtained 
for the disclosure of any said confidential information to other parties. 
Modification of the Protocol 
The Investigator may implement a change from the protocol without prior Sponsor and 
IRB approval only to eliminate an immediate hazard to a subject, in which case, Sponsor 
and IRB must be notified of the change within 24 hours. 
Amendments to the protocol must be submitted in writing to the IRB and approved prior 
to subjects being enrolled into an amended protocol. 
Protocol Deviations 
A protocol deviation occurs when the Investigator or subject has failed to adhere to 
significant protocol requirements. Specific categories to be documented include but are 
not limited to: 
• Subjects who enter the study even though they do not satisfy the entry criteria 
• Subjects who develop withdrawal criteria during the study but are not 
withdrawn 
• Deviations from the Study Procedure specified in Section 9 
• Any non-adherence to the protocol that results in a significant additional risk 
to the subject. 
Any deviation involving eligibility criteria, or the Study Procedure specified in Section 
9, shall be reviewed with the Study PI and the Sponsor prior to additional enrollment at 
that site. The Investigator must document and explain any protocol deviation in the 
subject’s source documentation.  Protocol deviations should be reported to the IRB 
according to their requirements.  Protocol deviations may also be documented by the 

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clinical monitor during monitoring visits and those observations will be reviewed with 
the Investigator. 
The Investigator is responsible for enrolling subjects who have met protocol eligibility 
criteria.  If the Investigator has a question concerning a subject who may not meet an 
entry criterion, they should contact the Sponsor to discuss the specifics.  Waivers for 
protocol eligibility will not be granted in this study. 
Study Reporting Requirements 
By participating in this study, the Investigator agrees to submit reports of SAEs 
according to the time line and method outlined in the protocol.  In addition, the 
Investigator agrees to submit periodic reports to his/her IRB as appropriate. 
Financial Disclosure 
Principal Investigators and Sub-Investigators are required to provide financial disclosure 
information to allow the Sponsor to submit the complete and accurate certification or 
disclosure statements required under Title 21 CFR 54.  In addition, the Investigator must 
provide to the Sponsor a commitment to update this information promptly, if any 
relevant changes occur during the investigation and at the completion of the trial. 
Financial Obligations 
The Sponsor is not financially responsible for further testing/treatment of any medical 
condition that may be detected during the screening process.  In addition, in the absence 
of specific arrangements, the Sponsor is not financially responsible for further treatment 
of the subject’s disease. 
Investigator Documentation 
Prior to beginning the study, the Investigator will be asked to comply with 21CFR812 by 
providing the following essential documents, including but not limited to: 
• An Investigator-signed Investigator Agreement page of the protocol  
• An IRB -approved ICF, samples of site advertisements for recruitment for this 
study, and any other written information regarding this study that is to be provided 
to the subject  
• IRB approval of the Investigator, the Protocol, and the subject-facing materials 
• Curricula vitae for the Principal Investigator and each Sub investigator listed.  
Current licensure must be noted on the curricula vitae or a copy of the license 
provided.  The curricula vitae must be signed and dated by the Principal 

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Investigators and Sub investigators within 1 year of study start-up, indicating that 
they are accurate and current. 
• Financial disclosure information to allow the Sponsor to submit complete and 
accurate certification or disclosure statements required under Title 21 CFR 54.  In 
addition, the Investigators must provide to the Sponsor a commitment to promptly 
update this information if any relevant changes occur during the investigation, at 
the completion of the trial and 1 year following the completion of the study. 
 
Clinical Trial Agreement 
Payments by the Sponsor to Investigators and institutions conducting the study, 
requirements for Investigators’ insurance, and other requirements are specified in the 
Clinical Trial Agreement. 
 
Policy for Publication and Presentation of Data 
Following completion of the study at all sites, data may be considered for reporting at a 
scientific meeting and/or for publication in a scientific journal.  Draft manuscripts of any 
public disclosure shall be provided to the Sponsor 60 days prior to presentation or 
publication to enable the Sponsor to review and comment and take any steps necessary 
to protect its intellectual property rights, consistent with the Clinical Trial Agreement. 

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13 INVESTIGATOR AGREEMENT 
I agree to conduct the study as outlined in the protocol entitled, “ASSURE WCD 
Clinical Evaluation – Conversion Efficacy Study (ACE-CONVERT)”, and in 
accordance with generally accepted standards of Good Clinical Practice, and all 
applicable guidelines and government regulations including Title 21 CFR 54.  I agree to 
provide the Sponsor with accurate financial information to allow the Sponsor to submit 
complete and accurate certification and disclosure statements as required by applicable 
regulations. 
I have read and understand all sections of the protocol, including the section on ethical 
conduct of the study (Section 11) and administrative considerations (Section 12). 
 
 
 
Principal Investigator’s Name 
 
 
 
 
 
Principal Investigator’s Signature 
 
 
Date 
 
 
 

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14 APPENDIX A - ASSURE DEFIBRILLATION WAVEFORM 
Figure 4: Defibrillation Waveform Profiles into 50 ohms 

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15 APPENDIX B - MEDICARE IDE STUDY CRITERIA 
 
The study protocol describes the method and timing of release of results on all pre-
specified outcomes, including release of negative outcomes and that the release should 
be hastened if the study is terminated early. 
 
The study results on all pre-specified outcomes, including negative outcomes, will be 
submitted to ClinicalTrials.gov not later than one year after the study completion date, where 
the completion date is defined as the date that the final subject was examined or received an 
intervention for purposes of data collection for the pre-defined outcome measures. Results 
submission could be delayed if an extension is granted to the results submission deadline; 
however, the release of all results on pre-specified outcomes will be hastened if the study is 
terminated early. The final clinical study report of the conclusions of this study will be written 
within six (6) months of the closing of the database at the end of the study. Following 
completion of the study at all sites, data may be considered for reporting at a scientific meeting 
and/or for publication in a scientific journal. 
 
The study protocol must describe how Medicare beneficiaries may be affected by the device 
under investigation, and how the study results are or are not expected to be generalizable 
to the Medicare beneficiary population. Generalizability to populations eligible for 
Medicare due to age, disability, or other eligibility status must be explicitly described. 
 
Medicare patients that meet the study’s eligibility requirements included will be enrolled in this 
study. It is not anticipated that the device under investigation will treat a Medicare population 
different than the demographics found in the investigators' general population for this same 
condition (adult patients who are at risk of sudden cardiac arrest (SCA) and are not immediate 
candidates for or decline an implantable defibrillator), including populations eligible for 
Medicare due to age (e.g., 65 years or older), disability, or other eligibility status. According to 
a science advisory prepared by the AHA and endorsed by the Heart Rhythm Society and 
European Society of Cardiology (ESC), Wearable Cardioverter Defibrillator (WCD) use is 
reasonable when there is an indication for an ICD but a temporary contraindication/interruption 
(eg, a waiting period, infection) to ICD care exists (class IIa), or when patients are awaiting 
more definitive treatment (eg, cardiac transplant candidate) (class IIa). VT/VF remains an 
important and potentially avoidable cause of SCD in high-risk patients. Moreover, WCDs are 
successful in terminating VT/VF in patients with an elevated risk of SCD and appear to be 
appropriate for use while long-term risk management strategies are being determined.1 
Additionally, it has been reported that the use of WCD use in patients ≥ 65 years old who are at 
risk of SCD is similar to that reported in general WCD patients; and, the majority of patients 
either recovered or proceeded to ICD implantation after ending use.2 For these reasons, the 
results of this study are expected to be generalizable to the Medicare population primarily due 
to age (E.g., 65 years or older).
                                                 
1 Wearable Cardioverter-defibrillators for the Prevention of Sudden Cardiac Death: A Meta-analysis. The 
Journal of Innovations in Cardiac Rhythm Management, 9 (2018), 3151–3162 
2 The Wearable Cardioverter Defibrillator Protects Older Patients from Sudden Cardiac Death. Abstract 
341. Circulation. 2014;130:A341 

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16 BIBLIOGRAPHY 
Kutyifa V, Moss AJ, Klein H, et al. "Use of the Wearable Cardioverter Defibrillator in High-
Risk Cardiac Patients: Data from the Prospective Registry of Patients Using the 
Wearable Cardioverter Defibrillator (WEARIT-II Registry)." Circulation 132 (2015): 
1613-1619. 
Poole JE, Gleva MJ, Mela T, et al. "Complication rates associated with pacemaker or 
implantable cardioverter-defibrillator generator replacements and upgrade 
procedures: results from the REPLACE registry." Circulation (2010): 122(16): 1553-
61. 
Wäßnig NK, et al. "Experience with the Wearable Cardioverter-Defibrillator in Patients at 
High Risk for Sudden Cardiac Death." Circulation (2016): 134:635-643. 
Wilkoff B, Fauchier L, Stile M, et al. "2015 HRS/EHRA/APHRS/SOLAECE expert 
consensus statement on optimal implantable cardioverter-defibrillator programming 
and testing." J Arrhythm 32 (2016): 1-28. 
Wilkoff BL, et al. "2015 HRS/EHRA/APHSR/SOLAECE expert consensus statement on 
optimal implantable cardioverter-defibrillator programming and testing." Heart 
Rhythm (2016): Vol 13, No 2, e71.