ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)
Phase: NA
Conditions: Cardiac Arrest, Sudden
Sponsor: Kestra Medical Technologies, Inc.

Kestra Medical Technologies, Inc. 
Clinical Study Protocol 
Protocol 3324582_B 
08/17/2018 
PROTOCOL TITLE: 
ASSURE WCD Clinical Evaluation - Detection and 
Safety Study (ACE-DETECT) 
PROTOCOL NUMBER: 
3324582_B 
INVESTIGATIONAL 
DEVICE: 
ASSURE™ WCD (Wearable Cardioverter-
Defibrillator) 
DEVICE REGULATORY 
CLASSIFICATION: 
Non-Significant Risk (NSR) Medical Device; 21 CFR 
812.2 (b) Abbreviated Investigational Device 
Exemption (IDE) requirements apply 
INDICATION: 
Adult Patients at Risk for Sudden Cardiac Arrest 
DEVELOPMENT PHASE: 
Validation 
STUDY DESIGN: 
Multicenter single arm open label evaluation  
SPONSOR: 
Kestra Medical Technologies, Inc. 
3933 Lake Washington Blvd NE 
Kirkland, WA 98033 
DATE OF PROTOCOL: 
08/17/2018 
The information contained in this document, particularly unpublished data, is the property or under control of 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 regarding the authorized clinical study 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. 
NCT03887052

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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: 
Jeanne E. Poole, MD 
Professor of Medicine 
Section Head, Electrophysiology, Division 
of Cardiology 
University of Washington 
Seattle, WA 98195  
jpoole@cardiology.washington.edu  
work: (206) 598-4176 
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: 
3324582_B 
Protocol Title: 
ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-
DETECT) 
Study Objectives 
 
Primary:  To evaluate ambulatory detection performance of the ASSURE 
Wearable Cardioverter Defibrillator (WCD) 
Secondary: To evaluate arrhythmia detection performance and safety of the 
ASSURE WCD  
Study Population: 
Adult cardiac patients at risk for sudden cardiac arrest 
Study Design: 
Multicenter single arm open label evaluation  
Number of 
Subjects: 
At least 130 subjects (maximum 135) with at least 35 of each sex, male and 
female  
Study Sites: 
Subjects will be enrolled at approximately 10 clinical sites in the United States, 
with each site enrolling a maximum of 18 subjects. 
Eligibility 
Criteria: 
Candidates are eligible for participation if they meet all Inclusion Criteria and 
none of the Exclusion Criteria.  
Inclusion Criteria:   
1. Males or females, age ≥ 18 years 
2. Patients with an active Implantable Cardioverter Defibrillator (ICD)  
3. Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the 
past year (12 months) by echocardiography, nuclear imaging (including 
MRI), or left ventricular angiography 
4. Able and willing to provide written informed consent before undergoing 
any study-related procedures 

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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, 
including cognitive and/or physical limitations that would prevent the 
subject from interacting with the device as intended   
2. Any known skin allergy or sensitivity to the study garment materials that 
will be next to the skin 
3. Any breached or compromised skin on the upper body that would be 
exacerbated by wearing the study garment 
4. Work with or are frequently around equipment that produces high 
electromagnetic fields, for example magnetic resonance imaging devices, 
power supply facilities, or welding equipment 
5. Any planned surgical or medical procedures during the participation 
period that would require the subject to remove the study device for more 
than 12 hours 
6. Any planned air travel during the participation period  
7. Pregnancy  
8. Use of mechanical circulatory support, including but not limited to Left 
Ventricular Assist Device (LVAD) or Total Artificial Heart   
9. Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D) 
10. Simultaneous plan/prescription for Holter monitor, mobile cardiac 
outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry 
11. Use of any electronic medical device that is worn on or near the body 
requires Sponsor approval, other than continuous positive airway pressure 
(CPAP), continuous blood glucose monitor, or pulse oximeter oxygen 
saturation (SpO2) monitor. 
12. Under bust chest circumference greater than 52 inches or less than 28 
inches 
13. Current hospital inpatient 
Device: 
ASSURE™ WCD with shock alarms and shock functionality disabled.   Shock 
Alarm Event Markers are recorded by the WCD and will be used for analysis of 
the primary outcome measure. 
Study Procedures: 
At Visit 1 subjects will be fitted with the WCD and will be trained and provided 
written instructions for use, including safety precautions and adverse event 
reporting.  Demographic data and limited medical history will be collected and 
subjects will be asked to complete a baseline comfort scale.  Subjects will wear 
the device for approximately 30 days during normal daily activities including 
sleep.  Research Coordinators will conduct weekly phone interviews with the 
subjects during the participation period to address subject questions, review 
potential adverse events, and review usage.  Subjects will return for a final visit, 
Visit 2, at the end of the wear period.  At Visit 2 subjects will be interviewed 

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regarding any adverse events they may have experienced since the most recent 
phone follow up, and status of any adverse events that were recorded during the 
participation period.  They will be asked to complete a Device Usability Survey.  
The device will be removed and returned.  They will be asked to complete a 
follow up comfort survey.  All episodes recorded by the ASSURE WCD and/or 
the subject’s ICD will be reviewed by independent clinical experts.  
Study Endpoints: 
Primary: 
Secondary: 
 
 
 
WCD False Positive Alarm Rate (False Positive Alarms per subject-day)   
Summary of WCD True Positive Detections and Missed Events (False Negative 
Detections) 
Estimated Inappropriate Shock Rate 
Adverse Events 
Study Duration: 
Individual subject participation is approximately 30 days.  Total study duration 
from first subject in to last subject out is approximately 4 Months. 

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4 TABLE OF CONTENTS 
TITLE PAGE ......................................................................................................................................... 1 
1 
SPONSOR SIGNATURE PAGE ................................................................................................... 2 
2 
KEY ROLES AND CONTACTS ................................................................................................... 3 
3 
PROTOCOL SUMMARY ............................................................................................................. 4 
4 
TABLE OF CONTENTS ............................................................................................................... 7 
5 
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS .................................... 10 
6 
INTRODUCTION ........................................................................................................................ 11 
Background ................................................................................................................................... 11 
Previous Clinical Studies .............................................................................................................. 11 
Study Rationale ............................................................................................................................ 13 
7 
INVESTIGATIONAL DEVICE .................................................................................................. 15 
Description ................................................................................................................................... 15 
Device Regulatory Classification ................................................................................................. 17 
Safety and Accountability ............................................................................................................ 17 
Sizes and Fitting ........................................................................................................................... 17 
Reuse of System Components ...................................................................................................... 17 
Device Accountability .................................................................................................................. 17 
8 
INVESTIGATIONAL PLAN ....................................................................................................... 19 
Number of Subjects ...................................................................................................................... 19 
Study Sites .................................................................................................................................... 19 
Participation Period ...................................................................................................................... 19 
Study Objectives and Endpoints ................................................................................................... 19 
Target Population ......................................................................................................................... 20 
Eligibility Criteria ......................................................................................................................... 20 
9 
GENERAL STUDY PROCEDURES .......................................................................................... 22 
Screening ...................................................................................................................................... 22 
Enrollment and Screen Failures .................................................................................................... 22 
Subject Identification Numbers .................................................................................................... 22 
Subject Withdrawals ..................................................................................................................... 23 
Medical Monitor ........................................................................................................................... 24 
Endpoint Review Committee ........................................................................................................ 24 
Replacements ................................................................................................................................ 24 
Sponsor or Regulatory Agency Termination of the Study ........................................................... 24 
End of Study ................................................................................................................................. 24 
10 STUDY VISIT PROCEDURES ................................................................................................... 25 
Visit 1 (Day 0): Screening and Enrollment .................................................................................. 25 
Weekly Phone Calls to Study Subject .......................................................................................... 26 
Visit 2: Study Exit Visit ................................................................................................................ 27 
11 STUDY ASSESSMENTS ............................................................................................................ 29 
Demographic Data ........................................................................................................................ 29 
Abbreviated Medical History ....................................................................................................... 29 
ICD Interrogation and Report Generation .................................................................................... 29 
BORG Comfort Scale ................................................................................................................... 29 
Wearability Assessment ............................................................................................................... 29 
Concomitant Medical Devices and Equipment ............................................................................ 29 
Clinical Laboratory Tests ............................................................................................................. 30 
Evaluation of Adverse Events ...................................................................................................... 30 

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Device Usability Survey ............................................................................................................... 30 
12 STATISTICAL OVERVIEW ....................................................................................................... 34 
Data Sources ................................................................................................................................. 34 
Determination of Sample Size ...................................................................................................... 34 
Data sets to be analyzed ................................................................................................................ 34 
Subject Disposition ....................................................................................................................... 35 
Analysis of Demographic and Baseline Data ............................................................................... 35 
Endpoint Analysis ......................................................................................................................... 35 
13 DATA HANDLING AND QUALITY ASSURANCE ................................................................ 39 
Case Report Forms ....................................................................................................................... 39 
Study Monitoring .......................................................................................................................... 39 
Inspection of Records ................................................................................................................... 39 
Study Record Retention ................................................................................................................ 40 
14 STUDY ETHICAL CONSIDERATIONS ................................................................................... 41 
Ethical Conduct of the Study ........................................................................................................ 41 
Informed Consent ......................................................................................................................... 41 
Institutional Review Board ........................................................................................................... 41 
15 ADMINISTRATIVE CONSIDERATIONS ................................................................................ 43 
Confidentiality .............................................................................................................................. 43 
Modification of the Protocol ......................................................................................................... 43 
Protocol Deviations ...................................................................................................................... 43 
Study Reporting Requirements ..................................................................................................... 44 
Financial Disclosure ..................................................................................................................... 44 
Financial Obligations .................................................................................................................... 44 
Investigator Documentation ......................................................................................................... 44 
Clinical Trial Agreement .............................................................................................................. 45 
Policy for Publication and Presentation of Data ........................................................................... 45 
16 INVESTIGATOR AGREEMENT ............................................................................................... 46 
17 BIBLIOGRAPHY ........................................................................................................................ 47 
18 APPENDIX A: SCHEDULE OF EVENTS ................................................................................. 48 

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LIST OF IN-TEXT FIGURES 
Figure 1 ASSURE Cardiac Recovery System ............................................................................................. 16 
 

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5 GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS 
ABBREVIATION 
TERM 
AADE 
Anticipated Adverse Device Effect 
AE 
Adverse Event 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CIED 
Cardiovascular Implantable Electronic Device 
CPAP 
Continuous Positive Airway Pressure (Sleep Apnea Therapy) 
CRF 
Case Report Form 
CRT-D 
Cardiac Resynchronization Therapy Defibrillator 
ECG 
Electrocardiogram 
FDA 
Food and Drug Administration 
GDR 
General Document Record 
ICD 
Implantable Cardioverter-Defibrillator 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
LVAD 
Left Ventricular Assist Device 
LVEF 
Left Ventricular Ejection Fraction 
MCOT 
Mobile Cardiac Outpatient Telemetry 
MI 
Myocardial Infarction 
NSR 
Non-Significant Risk (Medical Device) 
PP 
Per Protocol 
RC 
Research Coordinator 
SAE 
Serious Adverse Event 
SAF 
Safety (set of subjects for statistical analysis) 
SAP 
Statistical Analysis Plan 
SCA 
Sudden Cardiac Arrest 
SID 
Subject Identification Number 
SpO2 
Pulse Oximeter Oxygen Saturation 
SVT 
Supraventricular Tachycardia 
UADE 
Unanticipated Adverse Device Effect 
VF 
Ventricular Fibrillation 
VT 
Ventricular Tachycardia 
WCD 
Wearable Cardioverter Defibrillator 

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6 INTRODUCTION 
Background 
The Wearable Cardioverter-Defibrillator (WCD) is indicated for adult patients who are 
at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate 
candidates for or refuse an implantable defibrillator.   
These patients are defined by two populations.  The first population includes those 
patients for whom there may be optimism for clinical improvement, for example, 
patients soon after revascularization or those with a recent diagnosis of myocardial 
infarction (MI) or cardiomyopathy in whom guideline directed medical therapy is being 
initiated.  The optimal management of these patients during the waiting period before 
ICD implantation is currently unknown.  The second population includes those patients 
who have a clear indication for an ICD but also have a contraindication to immediate 
ICD placement, for example, active infection or unknown prognosis. (Piccini JP)   
The study Sponsor has developed a new wearable defibrillator, the ASSURE WCD, to 
address this need.  This study is part of a comprehensive set of tests 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.         
 
Previous Clinical Studies 
Second Generation Prototypes: 
• Protocol 3322262: Single-center non-randomized study to evaluate 
Electrocardiogram (ECG) signal quality, comfort and usability; 5-day wear 
period; 6 healthy normal adult subjects (Sponsor employees, 4 males, 2 females) 
enrolled; 2 non-serious minor severity adverse events (AEs) observed (skin 
irritation) after five days of wear.  ECG signal analysis and comfort/usability data 
used to improve various aspects of garment and electrode design in the next 
generation prototype. 
• Protocol 3325053: Multi-center (Seattle and Florida) non-randomized study to 
evaluate ECG signal quality, comfort and usability enrolling adult subjects from 
the community with age and body-habitus representative of device intended use; 
5-day wear period; 12 healthy normal adult subjects (8 females, 4 males) 
enrolled; 5 non-serious minor AEs and 1 non-serious moderate severity AE 
observed (all skin irritation) after five days of wear.  The moderate severity AE 
was minor severity skin irritation due to the garment wear that was then 

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exacerbated by the subject scratching the area.  ECG signal analysis and 
comfort/usability data were used to improve various aspects of garment and 
electrode design in the next generation prototype. 
• Protocol 3321770: Single-center (University of Washington Medical Center) 
non-randomized study to evaluate ECG signal quality, comfort and usability 
enrolling adult cardiac subjects with low ejection fraction (≤ 40%), age and 
body-habitus representative of device intended use; 2-day wear period; 50 
subjects enrolled (30 males, 20 females, average age 58, age range 34-90); 1 non-
serious minor severity AE observed (skin irritation) after two days of wear.  ECG 
signal analysis and comfort/usability data were used to improve various aspects 
of garment and electrode design in the next generation prototype.  ECG and 
accelerometer signals were used to support Rhythm Analysis Algorithm (RAA) 
development. 
• Protocol 3324914: Usability, non-randomized, study to evaluate comfort of WF2 
prototypes and subject responses to simulated WF2 prototype system notification 
(alert) messages (low critical battery, adjust garment, and therapy) for 48 hours 
in subjects’ home environments. A total of 10 subjects were enrolled from the 
general population (5 females, 5 males, average age 64.8, age range 56-74) each 
received 20 alert messages during the 48-hour study duration. No AEs were 
reported during the 48-hour study duration and subjects responded to simulated 
system notification messages during the day and night. 
 
Third Generation Prototypes:  
• Protocol 3330766: Multi (6)-center non-randomized study to collect ECG and 
accelerometer signals to support RAA development and assess comfort and 
usability; enrolling adult cardiac patients with low ejection fraction, age and 
body-habitus representative of device intended use; 5-day wear period; 117 
subjects enrolled (40 females, 76 males, average age 60.1 age range 30-82).  
Nine (9) AEs were reported that were all related to skin irritation; 8 minor 
severity and 1 originally minor severity that was exacerbated to moderate 
severity after the subject scratched the area of irritation.      
• Protocol 3333597:  Single center (Swedish Sleep Medicine Sleep Lab) 
randomized study to assess subject response time to high priority alerts (shock 
alarms) during one night’s sleep.  Subjects were randomized at enrollment to one 
of 12 simulated alarm scenarios.  12 subjects from the general population were 
enrolled (5 males/ 7 females) with average age of 69 (range 43-73).  24 shock 
alarms were issued (2 to each subject).  Mean response time to shock alarm 

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during sleep was (7.0 + 2.5 seconds).  There was one shock alarm that was 
“missed” (subject failed to respond in 20 seconds or less).  No AEs were 
reported. 
• Protocol 3334121:  Single center randomized study to assess subject response 
time to high priority alerts (shock alarms) during normal daily activities.  
Subjects were randomized to one of three simulated alarm scenarios 
implemented over a 7-day wear period.  20 subjects from the general population 
were enrolled (9 males/11 females) with average age of 57 (range 41-71).  55 
shock alarms were issued.  Mean response time to shock alarm during normal 
daily activities was 13.3 + 10.1 seconds.  There were eleven shock alarms that 
were “missed” (subject failed to respond in 20 seconds or less).  One minor AE 
reported (skin irritation). 
 
Fourth Generation Prototypes:  
• Protocol 3335586: Multicenter (3) non-randomized study to evaluate safety and 
detection performance of the ASSURE wearable cardioverter defibrillator 
(WCD) device during a typical 30-day prescription period; 32 subjects enrolled 
in the US from the general population (16 females, 16 males, average age 61.7, 
age range 40-73).  This was a pilot study for the pivotal clinical study (ACE-
DETECT).  8 AEs were reported in 6 subjects (2 subjects experienced 2 AEs 
each).  7 AEs were related to skin irritation and 1 was scratches from the garment 
seam; All 8 were minor severity. 
 
Study Rationale 
A WCD provides continuous arrhythmia monitoring with detection of potentially fatal 
ventricular arrhythmias and automatic defibrillation.  The ASSURE WCD incorporates 
an automatic Rhythm Analysis Algorithm (RAA) that uses patient ECG to determine if a 
patient should be treated with a defibrillation shock.  The device also provides vibratory, 
audible, and visual alerts to the patient when a shockable rhythm is detected and before a 
shock is delivered.  If the patient is conscious during this “shock alarm”, they will be 
able to defer a shock using a divert button on the WCD. 
Because shockable rhythms occur infrequently in the target population, RAA sensitivity 
to shockable rhythms and specificity to non-shockable rhythms has been validated in the 
final ASSURE device using a robust, statistically-valid dataset of previously acquired 
rhythms. 

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False shock alarms are another important WCD performance metric.  Medical device 
alarms in general have been recognized as a top health technology risk.  Excessive 
alarms, particularly those for conditions that aren’t clinically significant or for conditions 
that could be avoided, such as alarms that result from poor contact between an ECG 
electrode and the patient’s skin, can lead to alarm fatigue and ultimately patient harm 
(ECRI Institute).   In the case of the WCD, excessive alarms also contribute to lack of 
compliance (Duncker T).  The LifeVest® 4000 Operator’s manual (ZOLL Medical 
Corporation) indicates that false alarms occur at a rate of 2.0 per patient week of use 
(one every 3.4 days).  Similarly, high alarm rates are reported in several other published 
and un-published studies of the LifeVest (Dillon K); (Schuhmann CG); (Duncker T); 
(Hucker W).  Signal interference (ECG noise) is reported as the primary cause of false 
alarms.   
 
 

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7 INVESTIGATIONAL DEVICE 
Description 
The WCD used for this study will be controlled by the Sponsor from managed inventory 
designated for clinical evaluations only.  The devices will be production-equivalent 
systems with shock alarms disabled (Shock Alarm Event Markers will be recorded by 
the device for analysis purposes), defibrillation therapy programmed OFF, and detection 
parameters at default settings.  Detection parameter default settings include Ventricular 
Tachycardia (VT) rate threshold at 170 bpm and Ventricular Fibrillation (VF) rate 
threshold at 200 bpm.1   
The ASSURE™ Cardiac Recovery System is comprised of several components: 
• A WCD including a Garment with embedded ECG sensors that is worn on the 
body next to the skin, a Monitor which houses the battery and the graphic user 
interface, Cable Assembly which connects the Garment to the Monitor, and a 
Carry Pack 
• A Charger that allows recharging of the monitor batteries 
• A Tablet that allows the WCD to be programmed via wireless connection to the 
Monitor 
• CareStation™ website which allows users to view WCD data associated with 
study subjects 
• An ASSISTANT™ mobile device that allows data uploads from the WCD to 
CareStation website  
 
The ASSURE Cardiac Recovery System is illustrated in Figure 1. 
                                                 
1 Accuracy of the ASSURE WCD heart rate measurement for tachyarrhythmias is +/- 10% 

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Figure 1 ASSURE Cardiac Recovery System 
 
 
 
 
 
 

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Device Regulatory Classification 
The Sponsor has assessed this as a minimal risk study using a Non-Significant Risk 
Device.  The study will be governed by the abbreviated Investigational Device 
Exemption (IDE) Requirements [21 CFR 812.2(b)].  The rationale for this assessment is 
based on the configuration with shock alarms disabled and shock functionality 
programmed OFF.   
Safety and Accountability 
Risks have been identified through systematic hazard analysis. The Sponsor has 
documented risk mitigation in a controlled Risk Management Report.  Each component 
of the WCD is assigned a unique serial number that is included on the labeling.  
Labeling also includes “CAUTION: Investigational Device.  Limited by Federal (USA) 
law to investigational use”, and the Sponsor’s name and address in accordance with 21 
CFR 812.5.  The Sponsor will maintain tracking records for all system components. 
Sizes and Fitting 
Multiple sizes of the garment will be available for this study.  In addition, there are two 
garment styles: one more suitable for male subjects, and one with support more suitable 
for female subjects.  Subjects will be measured to select an appropriate size, then the 
garment fit will be adjusted while on the subject to ensure it is adequate for reliable data 
collection.  Each subject will be assigned two garments so when they wash one, they can 
continue wearing the system using the other garment.     
Reuse of System Components 
The Garment, which is the component of the system that will come in direct contact with 
the study subject and includes the dry-contact electrodes, and the Carry Pack, will not be 
re-used for other study subjects.  All other components of the system will be cleaned and 
disinfected by the Sponsor and will undergo safety testing before reuse.   
Devices will be stored at ambient room temperature in a secure location.  Access should 
be strictly limited to the Investigators and their designees. Neither the Investigators nor 
any designees may provide devices to any individual not participating in this protocol.   
Device Accountability 
Sites will maintain accurate records of inventory and dates of receipt of all devices.   
For regulatory requirements regarding device accountability, all device accountability 
will be reconciled during study monitoring.  Study devices must be returned to the 
Sponsor according to applicable state and federal regulations. 

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All Study System components returned by the site must be accompanied by a copy of the 
Product Accountability Log for the respective kit dispensed.  No devices or device 
components should be destroyed. 
 
 
  
 
 

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8 INVESTIGATIONAL PLAN 
This is a multicenter single arm open label study enrolling adult patients at risk for 
sudden cardiac arrest. 
Number of Subjects 
At least 130 subjects (maximum 135) will be enrolled with at least 35 of each sex, male 
and female.   
Study Sites 
Approximately 10 sites in the United States are planned to participate in this study, with 
each site enrolling a maximum of 18 subjects. 
Participation Period 
Subjects will wear the device for approximately 30 days.  This period was selected to 
correspond to the WCD prescription period2 while providing sufficient data to test the 
performance hypothesis.     
Study Objectives and Endpoints 
Primary Objective:  To evaluate ambulatory detection performance of the ASSURE 
WCD. 
Primary Endpoint: WCD False Positive Alarm Rate (FPA) calculated as False Alarms 
per subject-day.  
Secondary Objectives:  To evaluate arrhythmia detection performance and safety of the 
ASSURE WCD. 
Secondary Endpoints: Summary of WCD True Positive Detections and Missed Events 
(False Negative Detections), estimated inappropriate shock rate, and summary of 
adverse events determined to be at least possibly related to the device. 
 
                                                 
2 Medicare classifies the WCD as capped rental Durable Medical Equipment (DME) with a monthly 
payment.  A Written Order Prior to Delivery (WOPD) is required to initiate the prescription, and 
continued use requires documentation justifying continued medical need such as by a prescription refill or 
completion of Certificate of Medical Necessity (CMN).  The WCD is described by Healthcare Common 
Procedures Code Set (HCPCS) K0606, Automatic external defibrillator, with integrated electrocardiogram 
analysis, garment type. 

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Target Population 
Adult cardiac patients at risk for sudden cardiac arrest 
Eligibility Criteria 
Candidates are eligible for participation if they meet all Inclusion Criteria and none of 
the Exclusion Criteria. 
Inclusion Criteria 
1. Males or females, age ≥ 18 years 
2. Patients with an active Implantable Cardioverter Defibrillator (ICD) 
3. Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year 
(12 months) by echocardiography, nuclear imaging (including MRI), or left 
ventricular angiography  
4. Able and willing to provide written informed consent before undergoing any 
study-related procedures  
Exclusion Criteria 
1. Any condition that by the judgement of the physician investigator precludes the 
subject’s ability to comply with the study requirements, including cognitive 
and/or physical limitations that would prevent the subject from interacting with 
the device as intended 
2. Any known skin allergy or sensitivity to the study garment materials that will be 
next to the skin 
3. Any breached or compromised skin on the upper body that would be exacerbated 
by wearing the study garment 
4. Work with or are frequently around equipment that produces high 
electromagnetic fields, for example magnetic resonance imaging devices, power 
supply facilities, or welding equipment 
5. Any planned surgical or medical procedures during the participation period that 
would require the subject to remove the study device for more than 12 hours 
6. Any planned air travel during the participation period 
7. Pregnancy 
8. Use of mechanical circulatory support, for example Left Ventricular Assist 
Device (LVAD) or Total Artificial Heart 
9. Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D) 

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10. Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient 
telemetry (MCOT), Event Recorder, or in-hospital telemetry. 
11. Use of any electronic medical device that is worn on or near the body requires 
Sponsor approval, other than continuous positive airway pressure (CPAP), 
continuous blood glucose monitor, or pulse oximeter oxygen saturation (SpO2) 
monitor. 
12. Under bust chest circumference greater than 52 inches or less than 28 inches 
13. Current hospital inpatient   
 

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9 GENERAL STUDY PROCEDURES 
Screening 
Research Coordinators (RCs) will work in conjunction with the site investigators to 
identify patients who meet eligibility criteria at their respective site.  Candidates will be 
initially screened either in person or by phone.  For eligible candidates who express 
interest in participating, a Screening and Enrollment Visit will be scheduled (Visit 1).  
These candidates may be provided a copy of the informed consent along with 
supplemental materials that illustrate the device to review prior to Visit 1. 
Enrollment and Screen Failures 
At Visit 1, subject eligibility will be reviewed.  Subjects who are still eligible and have 
provided written informed consent by signing the Informed Consent Form (ICF) will be 
considered for enrollment.  Subjects will be provided a copy of the signed ICF.   
Subjects will be considered enrolled in the study when they have completed training, are 
successfully fitted with a WCD System, the Monitor is connected to the Garment and the 
System is powered ON.  Subjects who are consented but not enrolled per this definition 
will be classified as screen failures.   
Subject Identification Numbers 
Each enrolled subject will be assigned a unique subject identification (SID) number.  
The first three characters of the SID will reflect the study site number (e.g. S01, S02, …, 
S10).  The Sponsor will inform each site of its designated site number before the site is 
opened for enrollment.  The last two digits will be assigned based on the enrollment 
sequence (e.g. the first subject enrolled at each site will be assigned 01) and will be 
separated from the site designation by a hyphen e.g. S01-05 is subject 05 enrolled at site 
01.  This number will be used on the Case Report Form (CRF) and on the CareStation 
website data uploads.  The Sponsor will not collect Protected Health Information that 
would allow specific subject identification (e.g. date of birth, name, initials, medical 
record number) on the CRF or in the WCD system data. 
Unscheduled Visits 
Unscheduled visits may be necessary due to AEs or other reasons.  The Investigator may 
examine a subject as often as is medically necessary while the subject is enrolled in the 
study.  Assessments performed at unscheduled visits are at the discretion of the 
Investigator and will be documented in the CRFs. 
 
 

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Phone Calls 
Research Coordinators will conduct weekly phone interviews with the subjects during 
the participation period to address subject questions, review potential adverse events, 
and review usage.  Unscheduled Study-related phone calls to or from the subjects may 
also occur. 
Subject Withdrawals 
Subjects may be withdrawn from the study for any reason including the following:   
• 
Adverse Events (The Medical Monitor will consult with the Site Investigator) 
• 
Investigator/Sponsor decision to withdraw subject from study 
• 
Subject withdrawal of consent  
Subjects who require temporary hospitalization (less than 72 hours) for non-study related 
complications are not required to withdraw from the study but may interrupt use of the 
WCD during this period at the Investigator’s discretion.   
When a subject is withdrawn from the study, the reason(s) for withdrawal will be 
recorded in the case report form (CRF).  For any subject who withdraws due to an AE, 
the reason for withdrawal must be recorded as an AE.  Whenever possible, all subjects 
who are being withdrawn from the study prematurely will undergo assessments listed for 
the Early Withdrawal visit. Every effort will be made to perform the same procedures at 
an Early Withdrawal Visit as the Study Exit Visit.   
A subject who fails to return for any scheduled visit will be contacted by the site 
personnel with every effort made to have the subject comply with the protocol.  After 
enrollment, if a subject cannot be contacted with a minimum of 3 telephone calls or 
emails over a period of 2 weeks (+/- 4 days) including a certified letter, the reason for 
withdrawal will be recorded as “lost to follow-up”.  If no response is received, the study 
withdrawal date will be documented as the date the certified letter was mailed.  Every 
effort will be made to retrieve all study system components regardless of the reason for 
end of study participation. 
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. 
AEs deemed by the investigator to be at least possibly related to the use of the ASSURE 
WCD 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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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 
ASSURE WCD System to determine if they are reportable to the FDA as Unanticipated 
Adverse Device Effects (UADEs) per the definition in Section 11.  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 ASSURE WCD System to verify relatedness and the 
Serious classification. 
Endpoint Review Committee 
An independent panel of board-certified electrophysiologists (physicians not 
participating as clinical investigators in the clinical study) will review all episodes 
recorded by the ASSURE WCD and/or the subject’s ICD in accordance with the 
Endpoint Review Committee (ERC) Charter for ASSURE WCD Clinical Evaluation - 
Detection and Safety Study (ACE-DETECT) (3334131).  These annotations will then be 
used in the statistical analysis to classify the episodes to calculate the study outcome 
measures. 
Replacements 
Subjects who are withdrawn from the study will not be replaced. 
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.  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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10 STUDY VISIT PROCEDURES 
The Schedule of Events is presented in Appendix A.  A detailed description of 
assessments performed at each study visit is presented below. 
Visit 1 (Day 0): Screening and Enrollment 
The ASSURE System Training Manual provides detailed instructions for WCD fitting, 
programming, and System power ON. The following process will be followed at Visit 1.   
• Review eligibility criteria 
• Explain the purpose and conduct of the study visits to the subject, answer the 
subject’s questions, and obtain written informed consent. This consent process 
can be performed in advance of Visit 1 at the discretion of the site Investigator.  
• Provide the subject with a copy of the signed informed consent 
• Obtain demographic data 
• Collect ICD Baseline Documentation:   
o Perform a full interrogation of the ICD on the Day of enrollment prior to 
WCD garment fitting. 
o Synchronize the ICD internal clock to the current time and time zone. 
o If current programmed parameters do not include detection as low as 150 
bpm, the Sponsor requests that a monitoring zone at 150 bpm be 
programmed at the approval of the subject’s physician. (ICD data will be 
used to identify WCD Missed Events (False Negative Detections)). 
o Print the ICD report as part of the source documentation.  The report shall 
include the programmed parameters and arrhythmic episode history. 
• Obtain abbreviated limited medical history as specified in the Case Report Form 
(CRF). 
• Perform Wearability Assessment as specified in the CRF.  If there is any 
question regarding skin condition e.g. eczema, the site investigator shall use 
medical judgement to determine if it disqualifies the subject from participating. 
• Obtain urine pregnancy test for women of childbearing potential.  If positive, 
subject is ineligible to participate. 
• Perform subject training, including overview of study procedures, hands-on 
assembly and disassembly of the garment and cable assembly, use and care of the 

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WCD, and review of manuals.  Sponsor representative(s) may be available to 
assist.  
• Have the subject complete the BORG Comfort Scale before they are fit with the 
Garment.  This provides a baseline comfort level to which the follow up BORG 
Scale scores (obtained at Visit 2 after the subject has worn the WCD) can be 
compared. 
• Fit Garment to subject in accordance with the sizing chart and instructions 
provided in the System Training Manual.  Subjects with an under bust chest 
circumference greater than 52 inches or less than 28 inches are not eligible to be 
enrolled. 
• Photograph Garment fit (torso only, not subject’s head) from both lateral views, 
the anterior view and the posterior view.  
• Set up the WCD including subject ID entry, and synchronization of the WCD 
internal clock to the current time and time zone. VT/VF detection parameters will 
remain at default settings.  (Refer to the System Training Manual). 
• Register the study subject on the CareStation remote monitoring website (Add 
New Patient) using their study subject ID number. 
• Verify Garment fit per System Training Manual using the tablet.  Save tablet 
screen images of the Patient Management, Device Status and WCD Settings 
screens including the ECG signals. 
• Schedule subject to return for follow up (Visit 2)  
• Notify the subject that they will receive phone calls on Days 7 +/- 2, 14 +/-2, 
21+/- 2, and 28 +/- 2 during which they can ask questions, and during which they 
will be asked about usage (how long they have been wearing the system), and if 
they experienced any discomfort or injury.  Schedule these weekly phone calls 
with the subject. 
 
Weekly Phone Calls to Study Subject 
On each of Day 7 +/- 2, Day 14 +/- 2, Day 21 +/- 2, and Day 28 +/- 2 the site RC will 
call the study subject.  In preparation for the call, the RC will review daily usage using 
the CareStation website and will record the usage data in the CRF. 
• Record subject questions and responses in the CRF, noting any questions that 
require additional follow up and when the subject was called again with the 
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• Record subject’s explanation for any usage less than 22 hours per day3 since the 
previous call. 
• Ask the subject if they have experienced any discomfort or injury during the 
previous week.  If yes, and the investigator determines that the symptoms are at 
least possibly related to use of the system, record as an AE in the CRF and gather 
supporting documentation as appropriate, e.g. description, photograph. 
 
Visit 2: Study Exit Visit 
At Visit 2 the following will be performed: 
• Photograph garment fit (torso only) from both lateral views, the anterior view 
and the posterior view. 
• Remove the Garment.  
• Record WCD System Return (all components). 
• Perform Wearability Assessment after system removal as indicated in the CRF. 
• Ask the subject if they have experienced any discomfort or injury since the last 
phone call.  If yes, and the investigator determines that the symptoms are at least 
possibly related to use of the device, record as an AE in the CRF. 
• Have the subject complete the follow up BORG Comfort Scale. 
• Have the subject complete the Usability Survey. 
• Record subject explanation for usage less than 22 hours per day since the last 
weekly phone call.  
• Obtain ICD summary report via the ICD remote management system or direct 
interrogation (model number, current programmed parameters, episode detail and 
any stored electrograms that are available from all new episodes recorded since 
Visit 1).   De-identify and label with subject ID. 
• Release the subject from the Visit.  
 
 
 
                                                 
3 Average WCD wear time reported in WEARIT-II Registry Trial (Kutyifa V) 

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Following the Study Visit: 
• Follow up requirements for subjects with ongoing AEs are specified in Section 
11. 
• If follow-up is needed after the Study Exit visit, it should occur as an 
unscheduled visit at the Investigator’s discretion. 

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11 STUDY ASSESSMENTS 
This section describes the study assessments.  For timing of study assessments, see the 
Schedule of Events (Appendix A).   
Demographic Data 
Demographic data, such as age, sex, race, and ethnicity will be collected on the CRF 
Abbreviated Medical History 
An abbreviated medical history as specified in the CRF, including but not limited to 
cardiac diagnosis and skin allergies will be obtained for each subject at screening and 
updated any time the Investigator learns of information that might affect the subject’s 
eligibility to continue participation in the study or to identify AEs. 
ICD Interrogation and Report Generation 
ICD Interrogation at Visit 1 (collect Baseline ICD Documentation via direct 
interrogation) and at Visit 2 (Obtain ICD summary report via the ICD remote 
management system or direct interrogation) must be done by qualified site personnel.  
BORG Comfort Scale 
Subjects will be asked by the research coordinator at baseline and again at the follow up 
visit to locate and grade the severity of any discomfort they experience on their upper 
body.  This will be recorded on a BORG comfort scale/map as specified in CRFs. 
Wearability Assessment 
A Wearability Assessment (as specified in the CRF), including a review of skin 
abnormalities on the upper body and/or musculoskeletal conditions, and measurement of 
height and weight, will be performed by study personnel.  Abnormal findings at Visit 1 
will be used to reassess eligibility.  If the subject is enrolled, then the findings will be 
recorded in the CRFs as baseline conditions.  The Wearability Assessment will also be 
performed at Visit 2 after the System has been removed.  Height will not be measured or 
recorded at Visit 2.  Abnormal findings that were not present at baseline or have 
worsened from baseline and are determined by the investigator to be at least possibly 
related to use of the WCD will be recorded in the CRFs as AEs.   
Concomitant Medical Devices and Equipment 
Use of allowed concomitant medical devices and durable medical equipment will be 
recorded in the CRFs (e.g. CPAP, walker, wheelchair). 

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Clinical Laboratory Tests 
Pregnancy testing by urinalysis will be performed for women of child bearing potential 
to verify eligibility prior to enrollment.  Test sticks will be provided by the Sponsor. 
Evaluation of Adverse Events 
Adverse events (AEs) as defined below will be monitored continuously during the study 
from the time the subject is considered enrolled through resolution.   Subjects will be 
instructed to report all AEs during the study, and study personnel will interview the 
subjects regarding new AEs during each weekly phone call follow up.  AEs may be 
reported by the subject, discovered by Investigator questioning, or detected through 
physical examination or other means at the study exit visit.  
Device Usability Survey 
A device Usability Survey will be administered at Visit 2. 
 
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 ASSURE WCD System. 
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 
o 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. 
Anticipated Adverse Device Effects (AADE) are those events related to the use of the 
device that are reasonably expected to occur as a result of the subject’s participation in 

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the study. The following are AADEs based on results from the series of previous 
feasibility studies listed in Section 6 and the system engineering hazard analysis: 
• Mild to moderate skin irritation 
• Muscle Strain 
• Emotional discomfort e.g. anxiety, uncomfortable or claustrophobic feelings 
• Fall Injury 
• Bruising 
• Pinched Fingers 
• Shoulder discomfort  
• Skin Infection (bacterial or yeast) 
• ICD System Infection  
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 device, 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 according to: 
• Whether the event is serious (SAE); 
• The severity of the event (mild, moderate, severe); and 
• The relationship of the event to device use (possibly, probably, or definitely 
related)  
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 

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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 or other therapies. 
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 e.g. mild eczema, and AEs identified at Visit 1 following enrollment 
will be documented during the Wearability Assessment.  Baseline conditions are not 
considered adverse events unless the condition worsens because of study device use.  
 
Adverse Event Reporting Procedures 
SAEs deemed at least possibly related to the use of the ASSURE WCD system will 
reviewed by the investigator and will be recorded on the CRF.  The following 
information about each AE will be collected: description, severity, onset and resolution 
dates, seriousness, relationship to study device, action taken, and outcome.   
Upon awareness of a SAE, the study site must enter the data into the eCRF within 2-3 
business 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. 

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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 ASSURE WCD 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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12 STATISTICAL OVERVIEW 
Data Sources 
Outcome measures for the primary and secondary endpoints will be obtained by board-
certified electrophysiologist review of Episodes recorded during the study period by the 
subject’s ICD and/or the ASSURE WCD per the definitions and instructions identified 
in the Endpoint Review Committee (ERC) Charter for ASSURE WCD Clinical 
Evaluation - Detection and Safety Study (ACE-DETECT) (3334131).  Cumulative wear 
time, which is also required to calculate the primary endpoint is recorded by the 
ASSURE WCD as “Usage” data and accessible via the CareStation website.  The 
estimated inappropriate shock rate will be calculated as the product of the False Positive 
Alarm Rate (primary outcome measure) and the missed shock alarm rate obtained from 
prior usability studies (described in Section 6) conducted by the sponsor. 
Determination of Sample Size 
The sample size for this study is determined based on the primary endpoint.   
Approximately 130 subjects will be enrolled. It is anticipated that 10 sites will 
participate and that a maximum of 18 subjects will be enrolled at each site.  This sample 
size will provide approximately 90% power, at a significance level of 2.5%, to detect a 
difference between the study false alarm rate and the comparator rate if the true false 
alarm rate for the study device is at least 50% lower than the comparator rate. Power was 
calculated using the R statistical package. The comparator rate was chosen to be 0.29 
false alarms per subject-day (one alarm every 3.43 days), which is the performance 
reported for the currently marketed ZOLL LifeVest® Model 30004.  A more detailed 
description of this calculation is provided in the Statistical Analysis Plan (SAP) 
(3338311). 
Data sets to be analyzed 
The primary and secondary endpoints will be analyzed using the Intent-to-Treat (ITT) 
and Per-Protocol (PP) sets of subjects, and all safety variables will be analyzed using the 
Safety (SAF) set of subjects.  These data sets are defined below.  Additional data sets 
may be defined in the Statistical Analysis Plan (SAP). 
                                                 
4 LifeVest Model 3000 Clinical Study (as reported in LifeVest 4000 operator’s manual pg. 7-5.) 

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• The ITT set of subjects will include the data from all enrolled subjects.  No 
subjects will be excluded from this data set for any reason (e.g., protocol 
deviation, study device not used, etc.).   
• The PP set of subjects will include all subjects enrolled who met the eligibility 
criteria and were appropriately fitted with a WCD (correct Garment size based on 
the sizing chart in the ASSURE System Training Manual).  The determination of 
subjects excluded from the PP set will be made prior to locking the final 
database. 
• The SAF set of subjects will include all subjects who used the device for at least 
two hours.  No subjects (or data) will be excluded from this data set because of 
protocol deviations that occur during the study. 
Subject Disposition 
Subject disposition including the number of subjects enrolled and number of subjects 
completing the study (and completing each study visit) 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 withdrawals and the reasons for 
withdrawal will also be summarized. 
Analysis of Demographic and Baseline Data 
Subject demographic and baseline data will be summarized by treatment arm for the ITT 
set of subjects.  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. 
Endpoint Analysis 
It is planned that 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.  Further details of 
the statistical methods will be included in the Statistical Analysis Plan (SAP). 
The primary endpoint in this study will be based on the assessment of performance in 
comparison to published performance for a comparative currently marketed device.   
The endpoint analyses will be performed after all subjects have either completed the 
final visit or withdrawn early from the study, the study database has been cleaned, 
verified and locked, and adjudication/reconciliation of all Episodes is complete as 
specified in the Episode Annotation Protocol for ASSURE WCD Clinical Evaluation - 
Detection and Safety Study ACE - DETECT (GDR 3334131).   

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Alarm Definitions (for the Primary Endpoint) 
When initial arrhythmia detection criteria are met, the ASSURE WCD opens an Episode  
and begins storage of ECG signals.  If the rhythm is sustained for the confirmation 
period, a Shock Alarm Event Marker is recorded.  Each Shock Alarm Event Marker will 
be reviewed and annotated per the definitions and instructions in the Endpoint Review 
Committee (ERC) Charter for ASSURE WCD Clinical Evaluation - Detection and Safety 
Study (ACE-DETECT) (3334131).  Each Shock Alarm Event Marker will be classified 
for the primary endpoint as follows: 
• True Positive Alarm: The presence of a WCD Shock Alarm Event Marker 
within a recorded Episode where the Shock Alarm has been annotated as: 
o Rhythm Type VT/VF with HR ≥ 153 bpm (170 bpm - 10%) 
 
• False Positive Alarm: The presence of a WCD Shock Alarm Event Marker 
within a recorded Episode where the Shock Alarm has been annotated as: 
o Rhythm Type Other   
OR 
o Rhythm Type Uncertain (presumed non-shockable)   
OR 
o Rhythm Type VT/VF with HR < 153 bpm (170 bpm - 10%) 
 
Episode Detection (for the secondary Endpoint) 
All WCD Episodes, and ICD Episodes for which there is not a corresponding WCD 
Episode, will be reviewed and annotated per the definitions and instructions in the 
Endpoint Review Committee (ERC) Charter for ASSURE WCD Clinical Evaluation - 
Detection and Safety Study (ACE-DETECT) (3334131).  These annotation results will be 
used to classify the detections according to the following definitions: 
• True Positive Detection:  A WCD recorded Episode (with or without a Shock 
Alarm Event Marker) annotated as Rhythm Type VT/VF with HR ≥ 153 bpm 
(170 - 10%) 
• Missed Event (False Negative Detection): An Episode recorded by the ICD but 
not by the WCD when it is confirmed that the WCD was being worn, and where 

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the ICD Episode is annotated as Rhythm Type VT/VF with HR ≥ 187 bpm (170 
+ 10%) and Duration ≥ 20 seconds.  
 
Analysis of Primary Endpoint 
The primary endpoint analysis will be a one-sided test with significance level 0.025 of 
the null hypothesis H0 that the WCD False Positive Alarm Rate for the study device is 
equal to or greater than the comparator rate. The alternative hypothesis H1 is that the 
study device False Positive Alarm Rate is lower than the comparator rate. 
A random effects Poisson regression model will be fitted with the number of false 
alarms for each subject as the outcome variable. An additional random effects Poisson 
regression model will be fit including subject characteristics (including age, sex, height 
and weight) as covariates. Model assumptions will be checked, and a sensitivity analysis 
will be performed using the bootstrap if substantive violations of model assumptions are 
suspected.    Further details of the statistical methods will be included in the SAP. 
 
Analysis of Secondary Endpoints 
Secondary endpoints are exploratory and do not have specific performance criteria 
requirements.  
Summary of WCD True Positive Detections and Missed Events (False Negative 
Detections) 
Shockable (VT/VF) events are estimated to occur at a rate of 24 per 100 patient-years 
based on reported appropriate shock and non-sustained VT rates in contemporary ICD 
trials5.  Based on this, we estimate approximately two shockable events during the study.  
While all ASSURE WCD devices will be programmed to nominal settings during the 
study, ICD detection schemes and programmed parameters including rate threshold and 
duration will differ across the study population.  This may be due to a variety of factors 
including but not limited to manufacturer, model, physician preference and unique 
subject conditions.  Due to these differences, it is anticipated that all shockable events 
may not be simultaneously detected by the ICD and the ASSURE WCD.  For example, it 
is foreseeable that the ICD may miss lower rate shockable rhythms if the ICD is 
programmed to a high rate cutoff (e.g. VF>200 bpm).  It is also foreseeable that the 
                                                 
5 MADIT-RIT, ADVANCE III, ALTITUDE REDUCES  

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WCD may miss rhythms that are treated quickly by the ICD (e.g. anti-tachycardia pacing 
programmed) and are not sustained long enough to fulfill WCD detection criteria. 
Given the anticipated low incidence of shockable events, the incidence of True Positive 
Detections and Missed Events for each adjudicated Episode will be summarized. 
Estimated Inappropriate Shock Rate 
An estimate of the inappropriate shock rate will be calculated as the product of the WCD 
False Positive Alarm Rate (the Primary Outcome measure of this study) and the Missed 
Shock Alarm Rate.  The Missed Shock Alarm Rate was derived from two prior studies 
during which high priority alarms (shock alarms) were delivered randomly to study 
subjects.  A “Missed Shock Alarm” was one during which the subject failed to respond 
to the shock alarm within 20 seconds following alarm activation.  Data was obtained 
both during sleep (GDR 3333597 ASSURE UISim Sleep Study) and during normal daily 
activities (GDR 3334121 ASSURE UISim 7-day study).    
 
Adverse Events 
AEs will be summarized using the SAF subject set.  Separate summaries of AEs at least 
possibly related to device use and by severity (as reported by the Investigator and 
reviewed by the Medical Monitor) will be prepared.  UADEs will also be summarized.  
AEs leading to withdrawal from the study will be listed and tabulated. 
Subgroup Analysis 
Subgroup analyses are exploratory and will be specified in the Statistical Analysis Plan. 
                                                                                                                                                                              

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13 DATA HANDLING AND QUALITY ASSURANCE 
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, ECG strips, and photographs. 
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 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 site 
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 Case Report Form against source documents at the 
clinical site. 
All aspects of the study will be carefully monitored by the Sponsor or its designee for 
compliance with applicable government regulations. 
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. 

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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 ICF for the study.  Care should be taken to ensure that 
such records are not shared with any person or for any purpose not described by the ICF.  
Furthermore, the CRF 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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14 STUDY ETHICAL CONSIDERATIONS 
Ethical Conduct of the Study 
The Investigator agrees that the study will be conducted according to the applicable FDA 
regulations 21CFR 812.2(b).  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 unusual or non-
routine procedure that involves risk to the subject.  An ICF template may 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 study device.  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.  This consent process can be performed in 
advance of Visit 1 at the discretion of the site Investigator. 
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. 

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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 supply the Sponsor or its designee written documentation of 
continued review of the study. 
The Investigator will notify the Sponsor or Sponsor representative within 5 working 
days of withdrawal of IRB approval or if device use occurs without prior subject 
informed consent. 

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15 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.  Important deviations related to study inclusion or 
exclusion criteria, conduct of the trial, subject management or subject assessment should 
be documented.  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 
• Subjects who receive an excluded concomitant therapy or treatment 
Other protocol deviations to be considered include non-adherence to the protocol that 
results in a significant additional risk to the subject. 
The Investigator must document and explain any protocol deviation in the subject’s 
source documentation.  The IRB should be notified of important protocol deviations in a 
timely manner.  Protocol deviations should be reported to the IRB periodically, 
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 
21CFR812.2(b) 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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16 INVESTIGATOR AGREEMENT 
I agree to conduct the study as outlined in the protocol entitled, “ASSURE WCD 
Clinical Evaluation - Detection and Safety Study (ACE-DETECT)”, and in accordance 
with 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 study 
ethical considerations (Section 14) and administrative considerations (Section 15). 
 
 
 
Principal Investigator’s Name 
 
 
 
 
 
Principal Investigator’s Signature 
 
 
Date 
 

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17 BIBLIOGRAPHY 
Dillon K, et al. "Evaluation of the effectiveness of a wearable cardioverter 
defibrillator detection algorithm." Journal of Electrocardiology (2010): 43; 63-67. 
Duncker D, et al. "Long-term "real life" high-volume wearable 
cardioverter/defibrillator program - Single center experience of 255 patients covering 
more than 50 patient-years." CARDIOSTIM/EUROPACE (2016). 
Duncker T, et al. "Risk for ventricular fibrillation in peripartum cardiomyopathy with 
severely reduced left ventricular function - value of the wearable cardioverter 
defibrillator." European Journal of Heart Failure (2014): 116(12); 1331-6. 
ECRI Institute. "Top 10 Health Techn oligy Hazards for 2014." Health Devices 
(2013): 42(11). 
Hucker W, et al. "Real World Experience with Wearable Cardioverter Defibrillators." 
European Heart Journal (2015): 36 (abstract supplement), 1031. 
Kutyifa V, Moss A, Klein H et al. "Use of the Wearable Cardioverter Defibrillator in 
High-Risk Cardiac Patients." Circulation (2015): 132:1613-1619. 
Piccini JP, et al. "Wearable Cardioverter-Defibrillation Therapy for the Prevention of 
Sudden Cardiac Death." Circulation (2016 Apr 26): 133(17); 1715-27. 
Schuhmann CG, et al. "Experience with the wearable cardioverter defibrillator 
(WCD) in high risk patients from a German single center cohort." San Francisco: 
HRS, 2016. 
ZOLL Medical Corporation. LifeVest Model 4000 Operator's Manual. Z Medical 
Corporation, 2015. 
 
 

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18 APPENDIX A: 
SCHEDULE OF EVENTS 
Assessment 
Visit 1 (Day 0) 
Screening and 
Enrollment 
Weekly 
Phone 
Calls 
Visit 2 
Study Exit 
Early 
Withdrawal 
Visit6 
Study Day 
± window (days) 
0 
Days 7, 14, 
21, and 28 
each +/-2 
Day 30 
+5/-0 
 
Informed Consent 
X 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
Demographics 
X 
 
 
 
Collect ICD Baseline Documentation 
X 
X 
X 
X 
Synchronize the ICD Internal Clock to Current Time 
X 
 
 
 
Abbreviated Medical History 
X 
 
X 
X 
Wearability Assessment7 
X 
 
X 
X 
BORG Comfort Scale7 
X 
 
X 
X 
Urine Pregnancy Test (as required) 
X 
 
 
 
Subject Training on WCD 
X 
 
 
 
Fit, Program and Initiate Device Use 
X 
 
 
 
Photograph Garment Fit (torso only) – both lateral 
views, anterior and posterior views 
X 
 
X 
X 
Set up WCD per System Training Manual 
• Subject ID entry 
• Time zone setting and Synchronization of 
internal clock to current time 
• Leave VT/VF detection criteria at default 
X 
 
 
 
Verify Garment Fit 
• Refer to System Training Manual 
• Save Tablet screen images of device status 
screen and WCD Settings  
X 
 
 
 
Schedule Visit 2 and Weekly Calls with Subject  
X 
 
 
 
Review Usage on CareStation  
• Record explanations for any daily usage less 
than 22 hours  
 
X 
X 
X 
Obtain ICD Report for all new Episodes since Visit 
1 
 
 
X 
X 
Adverse Events (at least possibly device-related) 
X 
X 
X 
X 
Retrieve all WCD System Components 
 
 
X 
X 
Device Usability Survey 
 
 
X 
X 
 
                                                 
6 If the subject is withdrawn early, schedule as soon as possible following the time the study device use is 
stopped. 
7 Perform before the Garment is fitted at Visit 1, and after the Garment is removed at Visit 2 or the Early 
Withdrawal Visit.