Jewel Electrophysiology (EP) Lab Study
Phase: NA
Conditions: Sudden Cardiac Arrest
Sponsor: Element Science, Inc.

 
Confidential 
 
 
 
 
 
 
 
 
 
 
Clinical Investigational Plan 
 
Jewel Electrophysiology (EP) Lab Study 
(ES-1 and ES-2 models) 
 
Protocol Number: PR-2038, Revision 6.0 
NCT Number: NCT05490459 
 
24 March 2021 
 
 
 
Element Science, Inc. 
200 Kansas Street, Suite 210 
San Francisco, CA 94103 
 
 
 
 
 
 
 
 
CONFIDENTIAL:  The clinical investigational plan contains confidential information for 
use by the principal investigators and their designated representatives participating in this 
clinical investigation. It should be held confidential and maintained in a secure location. It 
should not be copied or made available for review by any unauthorized person or firm. 

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Title: Jewel Electrophysiology (EP) Lab Study 
Clinical Investigation Medical 
Device: 
Jewel Electrophysiology (EP) Lab System 
Device Classification: 
IIb (European Union) 
Version: 
PR-2038, Rev. 6.0 
Date: 
24 March 2021 
Principal Investigator: 
Prof Petr Neužil  
Na Homolce Hospital 
Roentgenova 2 
Prague, Czech Republic 
Sponsor: 
Element Science, Inc. 
200 Kansas Street, Suite 210 
San Francisco, CA 94103 
USA 
Sponsor’s Representative: 
High Tech Med Consult, .s. r. o. 
ID:  28443221, 
155 00 Prague 5; Frimlova 1322/4e;  
Czech Republic 
Acting by: Štěpán Královec 
 
 
 

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1. SYNOPSIS OF THE CLINICAL INVESTIGATION 
Sponsor  
Element Science, Inc. 
Name of 
Product 
Jewel Electrophysiology (EP) Lab System 
Title 
Jewel Electrophysiology (EP) Lab Study 
Study Design 
This single center, prospective, single arm study will be conducted in the 
European Union. The sample size for the study is a maximum of 24 
subjects. The study design will allow for continuous enrollment of eligible 
subjects until the sample size is met for the treatment analysis per the 
statistical analysis plan. 
 
The study will enroll subjects who are scheduled for a standard EP 
procedure where life-threatening VT or VF may spontaneously occur or 
may be induced. 
Primary 
Objective 
The primary objective of this study is to demonstrate safety and clinical 
effectiveness of the Jewel EP Lab System. The Jewel EP Lab System will 
be used to deliver a single transthoracic defibrillation shock to terminate 
life-threatening VT or VF. 
Primary 
Endpoint 
Primary Endpoint:  The primary effectiveness endpoint will evaluate the 
percent of successful terminations of life-threatening VT or VF in subjects 
who are treated with the Jewel EP Lab System.  
Safety 
Endpoint 
Safety Endpoint:  Descriptive statistics of safety outcomes will be reported 
to ensure that device safety performance is clinically meaningful. All 
adverse events (AEs) and serious adverse events (SAEs) during the acute 
procedure will be tabulated and presented along with the duration, severity, 
and relatedness to the Jewel EP Lab System. The proportion of subjects 
experiencing an AE or SAE will also be presented. No formal safety 
analyses will be performed due to the fact that the sample size does not 
allow for a powered safety endpoint. 
Study 
Participants 
Subjects must meet the following inclusion/exclusion criteria to be eligible 
for the study: 
 
Inclusion Criteria 
1. Subjects of both genders of at least 18 years of age. 
2. Subjects who are scheduled for a standard EP clinical procedure where 
fast VT or VF may spontaneously occur or may be induced. 
 
Exclusion Criteria 
1. Subjects who may require sterile access to the right upper pectoral or 
lower left torso regions during the planned EP procedure. 
2. Subjects who have taken amiodarone in the past 3 months. 
3. Subjects with an existing unipolar pacemaker.  
4. Subjects who exhibit a left ventricular ejection fraction (LVEF) less 
than 20% (as assessed by techniques such as echocardiography, 

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magnetic resonance imaging, or radionuclide angiography) within the 
last 6 months. 
5. Subjects who have been diagnosed with heart failure (Class IV) or 
experienced an acute heart failure exacerbation within the previous 30 
days. 
6. Subjects who exhibit unstable angina. 
7. Subjects with atrial fibrillation with contraindication to anticoagulation 
or improper anticoagulation management. 
8. Subjects who are participating in an investigational study of a drug, 
biologic, or device not currently approved for marketing. 
9. Subjects who are allergic to or have had a known adverse reaction to 
medical adhesives. 
10. Subjects who have active skin breakdown, erythema, or other signs of 
infection in the pectoral or torso regions where the study device is 
applied. 
11. Subjects with a lower abdomen circumference of less than 68.5 cm or 
greater than 142 cm. 
12. Females who are pregnant or breastfeeding, or planning to be pregnant 
in the next 12 months. 
13. Subjects who cannot provide or have diminished capacity to provide 
informed consent. 
14. Any condition that an Investigator believes would interfere with the 
intent of the study or is not in the best interest of the patient. 
15. Any patient that according to the Declaration of Helsinki is unsuitable 
for enrollment. 
 
Note: Subjects with an active implanted device, such as a pacemaker, ICD, or 
a subcutaneous-ICD, are not excluded in the eligibility criteria, but the 
Investigator may choose to screen out subjects where the active device or 
clinical procedure may interfere with the intent of the study. 
Study Device 
 
The Jewel System is patch-wearable cardioverter defibrillator (P-WCD) 
applied directly to a patient’s torso in an anterior-apical monitoring vector.  
 
The Jewel EP Lab System consists of a Jewel (ES-1, ES-2) System 
modified with the addition of a Controller Box to allow the operator to 
manually charge and manually administer a defibrillation shock. All other 
elements of the Adhesive Electrode Patches are identical to the Jewel (ES-
1, ES-2) System. 
Procedure 
The study device is intended to be used in conjunction with a standard EP 
clinical procedure. The Jewel EP Lab System will be used to terminate the 
first spontaneous or induced life-threatening episode of VT or VF. As an 
added safety precaution, rescue defibrillator pads will be placed on the 
subject in the anterior-posterior position and connected to a rescue 
defibrillator. 
 
 

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TABLE OF CONTENTS 
 
1. 
SYNOPSIS OF THE CLINICAL INVESTIGATION .............................................................................................. 2 
2. 
LIST OF ABBREVIATIONS ........................................................................................................................... 5 
3. 
INTRODUCTION ....................................................................................................................................... 6 
3.1. 
SUDDEN CARDIAC DEATH .................................................................................................................................... 6 
3.2. 
DEVICE DESCRIPTION: JEWEL SYSTEM .................................................................................................................... 6 
3.3. 
DEVICE DESCRIPTION: JEWEL EP LAB SYSTEM ....................................................................................................... 10 
3.4. 
PRIOR CLINICAL EXPERIENCE WITH THE JEWEL AND JEWEL EP LAB SYSTEMS ............................................................... 10 
3.5. 
RISKS AND BENEFITS OF THE JEWEL EP LAB SYSTEM ............................................................................................... 10 
4. 
STUDY OBJECTIVE .................................................................................................................................. 11 
5. 
STUDY PURPOSE .................................................................................................................................... 11 
6. 
STUDY DESIGN ....................................................................................................................................... 13 
6.1. 
PRIMARY EFFICACY ENDPOINT ............................................................................................................................ 13 
6.2. 
PRIMARY SAFETY ENDPOINT .............................................................................................................................. 13 
7. 
STUDY POPULATION .............................................................................................................................. 14 
7.1. 
PATIENT INCLUSION/EXCLUSION CRITERIA ............................................................................................................ 14 
8. 
STUDY ACTIVITIES .................................................................................................................................. 15 
8.1. 
SUBJECT ENROLLMENT ..................................................................................................................................... 15 
8.2. 
STUDY PROCEDURE .......................................................................................................................................... 16 
8.3. 
FOLLOW-UP .................................................................................................................................................... 18 
9. 
SUBJECT REMOVAL FROM STUDY ........................................................................................................... 18 
10. 
ASSESSMENT OF SAFETY..................................................................................................................... 19 
10.1. 
SAFETY DEFINITIONS ........................................................................................................................................ 19 
10.2. 
REPORTING OF ADVERSE EVENTS ........................................................................................................................ 20 
10.3. 
FOLLOW-UP OF PATIENTS AFTER ADVERSE EVENTS / SERIOUS ADVERSE EVENTS ......................................................... 21 
11. 
STATISTICS ......................................................................................................................................... 22 
11.1. 
STATISTICAL ANALYSIS AND SAMPLE SIZE RATIONALE ............................................................................................. 22 
12. 
ADMINISTRATIVE CONSIDERATIONS ................................................................................................... 25 
12.1. 
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE ...................................................................................... 25 
12.2. 
INDEPENDENT ETHICS COMMITTEE (IEC) APPROVAL .............................................................................................. 25 
12.3. 
ETHICAL CONDUCT OF THE STUDY ....................................................................................................................... 25 
12.4. 
ADHERENCE TO PROTOCOL ................................................................................................................................ 25 
12.5. 
PATIENT CONFIDENTIALITY ................................................................................................................................ 25 
13. 
STUDY MONITORING ......................................................................................................................... 26 
13.1. 
TRAINING ....................................................................................................................................................... 26 
13.2. 
ACCOUNTABILITY OF THE JEWEL EP LAB SYSTEM COMPONENTS ............................................................................... 26 
13.3. 
CASE REPORT FORMS AND STUDY RECORDS ......................................................................................................... 26 
13.4. 
PROTOCOL DEVIATIONS .................................................................................................................................... 27 
13.5. 
AMENDMENTS ................................................................................................................................................ 27 
13.6. 
ACCESS TO SOURCE DOCUMENTATION ................................................................................................................ 27 
13.7. 
RETENTION OF DATA ........................................................................................................................................ 28 
14. 
SUPPLEMENTS ................................................................................................................................... 29 
14.1. 
INVESTIGATOR’S AGREEMENT ............................................................................................................................ 29 
 

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2. LIST OF ABBREVIATIONS 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AED 
Automated External Defibrillator 
CABG 
Coronary Artery Bypass Graft 
CMS 
Centers for Medicare and Medicaid Services 
CRF 
Case Report Form  
DD 
Device Deficiency 
DME 
Durable Medical Equipment 
ECG 
Electrocardiogram 
EP 
Electrophysiology 
EU 
European Union 
FDA 
Food and Drug Administration 
ICD 
Implantable Cardioverter Defibrillator 
IEC 
Independent Ethics Committee 
ISO 
International Organization for Standardization 
ITT 
Intent to Treat 
LVEF 
Left Ventricular Ejection Fraction 
MI 
Myocardial Infarction 
NYHA 
New York Heart Association 
PCI 
Percutaneous Coronary Intervention 
PIC 
Patient Informed Consent 
P-WCD 
Patch-Wearable Cardioverter Defibrillator 
RCT 
Randomized Controlled Trial 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SCD 
Sudden Cardiac Death 
S-ICD 
Subcutaneous Implantable Cardioverter Defibrillator 
SOP 
Standard Operating Procedure 
TTI 
Transthoracic Impedance 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
VF 
Ventricular Fibrillation 
VT 
Ventricular Tachycardia 
WCD 
Wearable Cardioverter Defibrillator 
 
 
 

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3. INTRODUCTION 
3.1. SUDDEN CARDIAC DEATH 
Sudden Cardiac Death (SCD) is sudden, unexpected death caused by the abrupt loss of heart function, 
and is one of the largest causes of natural death in Europe, leading to 275,000 adult deaths each year.1 
SCD is most often caused by abnormal heart rhythms, called arrhythmias, which prevent the heart 
from adequately pumping blood to the body. Ventricular Fibrillation (VF) is an erratic, disorganized 
firing of impulses from the ventricles and is the most common life-threatening arrhythmia.2 
Ventricular Tachycardia (VT) occurs when the heart’s ventricles rapidly contract due to improper 
electrical activity and can also be potentially life threatening.  
 
While the Implantable Cardioverter Defibrillator (ICD) is typically implanted for long-term 
prevention of SCD in high-risk populations, there are temporary periods of time when ICD 
implantation is commonly deferred. Examples include the initial 40 days after myocardial infarction 
(MI), the initial 90 days after percutaneous coronary intervention (PCI) or coronary artery bypass 
grafting (CABG), or after ICD explantation. The Wearable Cardioverter Defibrillator (WCD) has 
become a viable option to treat temporary periods of elevated risk for SCD. Patients are typically 
prescribed to wear a WCD 24 hours a day, 7 days a week, for 40 to 90 days or longer, until a medical 
decision is made on whether to implant an ICD.3 
3.2. DEVICE DESCRIPTION: JEWEL SYSTEM 
Element Science, Inc. is developing the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) 
System (“Jewel System”) for patients who are at risk of SCD to improve the comfort and convenience 
of a WCD by focusing on developing a patient-centric design. The Jewel System continuously 
monitors a patient’s cardiac rhythm and, in the event that a patient experiences a life-threatening 
episode of VT (greater than ~200 beats per minute) or VF, delivers a therapeutic shock to convert a 
patient’s rhythm out of the detected VT or VF. The device used in this study is a modified version of 
the Jewel System. 
 
The study includes both the ES-1 model and the ES-2 model of the Jewel System. The ES-1 and ES-
2 models, together referred to as the Jewel family, have identical functionality while incorporating 
device improvements and meeting Durable Medical Equipment (DME) requirements specified by 
the United States Centers for Medicare and Medicaid Services for reimbursement (Defibrillator 
Unit of the ES-2 model is now reusable). The Jewel EP Lab System utilized in this study consists of 
a Jewel (ES-1, ES-2) modified with the addition of a Controller Box to allow the operator to manually 
administer a defibrillation shock.  All other elements of the Adhesive Electrode Patches are identical 
to the Jewel (ES-1, ES-2) System. 
 
 
 
 
 
1 European Resuscitation Council Guidelines for Resuscitation 2010 Section 10. Resuscitation. 2010; 81: 1445-
1451. 
2 “Sudden Cardiac Death (Sudden Cardiac Arrest) | Cleveland Clinic." Sudden Cardiac Death (Sudden Cardiac 
Arrest) | Cleveland Clinic. Cleveland Clinic, 1 May 2015. Web. 08 Jan. 2016. 
3 Chung MK, Szymkiewicz SJ, et. al. “Aggregate national experience with the wearable cardioverter-
defibrillator: event rates, compliance, and survival”. J Am Coll Cardiol. 2010; 56: 194–203. 

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ES-1 Model of the Jewel EP Lab System (“Jewel”) 
The ES-1 model of the Jewel System includes the following three components: Upper Adhesive 
Electrode Patch, Monitoring and Defibrillation Unit with Lower Adhesive Electrode Patch, and 
Connection Cable. A schematic of the system is shown in Figure 3.1 and a brief description of each 
component is outlined in Table 3.1. 
 
 
 
 
Figure 3.1:  Schematic of Jewel (ES-1) System Components 
 
Table 3.1:  ES-1 Model of the Jewel System Component Descriptions 
Jewel System Component 
Description 
Upper Adhesive Electrode 
Patch 
Conformable adhesive patch containing ECG electrodes and a 
defibrillation electrode. 
Monitoring and 
Defibrillation Unit with 
Lower Adhesive Electrode 
Patch 
Conformable adhesive patch containing ECG electrodes and a 
defibrillation electrode.  
 
All electronics are contained within the Monitoring and 
Defibrillation Unit, which is integrated with the Lower 
Adhesive Electrode Patch. 
 
Control Buttons are located on the exterior of the Monitoring 
and Defibrillation Unit. 
Connection Cable 
Multi-conductor cable assembly connecting the Upper 
Adhesive Electrode Patch to the Monitoring and Defibrillation 
Unit with Lower Adhesive Electrode Patch. 
 
 
 

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ES-2 Model of the Jewel EP Lab System (“Jewel”) 
The ES-2 model of the Jewel System is composed of the following three components: disposable 
Upper Adhesive Electrode Patch, a reusable Monitoring and Defibrillation Unit (MDU) attached to a 
disposable Lower Adhesive Electrode Patch with permanently attached disposable Battery Unit, and 
the attached Connection Cable. A schematic of the ES-2 is shown in Figure 3.2 and a description is 
contained in Table 3.2. 
 
Table 3.2: ES-2 Model of Jewel System Component Descriptions 
Jewel System Component 
Description 
Upper Adhesive Electrode 
Patch 
Conformable adhesive patch containing ECG electrodes and a 
defibrillation electrode. 
Monitoring and 
Defibrillation Unit with 
Lower Adhesive Electrode 
Patch 
Conformable adhesive patch containing ECG electrodes and a 
defibrillation electrode.  
 
All electronics are contained within the Monitoring and 
Defibrillation Unit, which is integrated with the Lower 
Adhesive Electrode Patch. 
 
Control Buttons are located on the exterior of the Monitoring 
and Defibrillation Unit. 
Connection Cable 
Multi-conductor cable assembly connecting the Upper 
Adhesive Electrode Patch to the Monitoring and Defibrillation 
Unit with Lower Adhesive Electrode Patch. 
 
 
Figure 3.2: Schematic of the Jewel (ES-2) System Components 
 
 
 
Upper Adhesive Electrode Patch 
Connection Cable 
Monitoring & 
Defibrillation Unit 
with Lower 
Adhesive Electrode 
Patch and Battery 
Unit 
Control Buttons 

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Jewel Accessories (ES-1, ES-2) 
The Jewel System is packaged with accessories to aid in the application and removal of the Jewel 
System. The Skin Preparation Accessories aid in cleaning the torso area prior to application of the 
Adhesive Patches. A Placement Accessory ensures the Adhesive Electrode Patches are aligned 
correctly on the subject’s torso. Removal Accessories are provided to aid in removing the Adhesive 
Electrode Patches and cleaning the skin area. 
 
The Adhesive Electrode Patches are intended to be applied to an adult patient in an anterior-apical 
monitoring vector configuration. The Upper Adhesive Electrode Patch is applied to the skin above the 
right pectoral muscle, and the Lower Adhesive Electrode Patch is applied such that the defibrillation 
pad area is located along the left mid-axillary line. Figure 3.2 is a depiction of the Jewel System 
applied to a patient. 
 
 
Figure 3.2:  Jewel (ES-1, ES-2) System Applied to a Patient’s Torso 
 
The MADIT-RIT study results demonstrated a reduction in inappropriate therapy and all-cause 
mortality when ICDs were programmed to deliver therapy for tachyarrhythmias of 200 bpm and 
higher.4 The Jewel System algorithm was designed with the MADIT-RIT rate cut-off as a guide for 
determining if a rhythm is life-threatening and requires therapy. The Jewel System does not allow the 
physician to program the device to alternate heart rate detection thresholds. 
 
The Jewel System monitors a patient’s ECG through five (5) electrodes located on the Adhesive 
Electrode Patches. The Jewel System employs a proprietary algorithm to detect and classify fast VT 
or VF that is deemed to be life-threatening (“shockable”) versus cardiac rhythms that are non-life 
threatening (“non-shockable”). In the event of a shockable rhythm, the Jewel System firmware 
initiates the charge cycle of the capacitors, and in parallel, the Jewel System will initiate an alarm 
sequence to alert the patient that the device is preparing to deliver a shock. If the patient is conscious, 
the patient is instructed to press the Control Buttons to stop the alarms and prevent the delivery of the 
shock. If the patient does not respond, and the shockable rhythm continues, the Jewel System will 
continue to alarm the patient and also give a verbal warning to bystanders that a shock will be 
delivered. The Jewel System delivers the initial therapeutic shock with a fixed energy of 
approximately 150 joules using a biphasic truncated exponential defibrillation waveform using a 
constant energy pulse that is adjusted based on the transthoracic impedance (TTI) of the patient at the 
time of therapy delivery. Using a cardioversion algorithm, the Jewel System will attempt to cardiovert 
the rhythm and synchronize the shock with the R-peak of the QRS complex. This automatic 
synchronization delivers a cardioversion shock to a patient if R-peaks are detected, suggesting that the 
 
 
4 Moss AJ, Schuger C, Beck CA, et al. Reduction in inappropriate therapy and mortality through ICD  
programming. N Engl J Med 2012;367:2275-83. DOI: 10.1056/NEJMoa1211107 
 

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rhythm is a life-threatening VT. If the cardioversion algorithm is not able to identify a regular R-peak 
during the ventricular arrhythmia, the Jewel System will deliver an asynchronous defibrillation shock. 
After the initial shock of approximately 150 joules, if the Jewel System continues to detect a 
shockable rhythm, the Jewel System will re-initiate the alarm sequence and continue to deliver a 
salvo of up to four (4) additional shocks of approximately 162 joules, totaling five (5) consecutive 
shocks (150, 162, 162, 162, 162 joules). 
 
The Jewel System is a Class III medical device in the United States and a Class IIb medical device in 
the European Union (EU). 
 
3.3. DEVICE DESCRIPTION: JEWEL EP LAB SYSTEM 
The Jewel EP Lab System delivers the same biphasic truncated exponential waveform as the Jewel 
System. The waveform parameters utilized by the Jewel EP Lab System are similar to other 
commercially-approved external defibrillators. 
 
The Jewel EP Lab System consists of a Jewel System modified with the addition of a Controller Box. 
The Controller Box allows the operator to manually charge the Jewel System capacitors as well as 
manually administer a defibrillation shock. This minimizes the safety risk to the patient by limiting 
the VT or VF to a relatively short time period (less than 20-30 seconds).  
 
The Control Buttons on the Controller Box which allow the clinicians to charge the capacitors and 
deliver the shock are unique to the Jewel EP Lab System. Since the user will control the timing of the 
shock delivery using the Controller Box, the shock will not be automatically synchronized to the R-
peak of the ECG complex using the cardioversion algorithm that is integrated into the Jewel System. 
Since the shock is not controlled by the Jewel System, the TTI measurement used to determine the 
energy waveform is taken within 1 second of when the capacitors are fully charged.  
 
Additionally, the Jewel EP Lab System contains a lower strength hydrocolloid adhesive in the Upper 
and Lower Adhesive Electrode Patches. The reduced peel strength of the hydrocolloid adhesive 
allows for easy peel-off of the Adhesive Electrode Patches after the short-term wear duration in the 
EP lab procedure. The regular strength hydrocolloid adhesive used in the Jewel System is only 
located in non-defibrillation areas to allow for an 8 day wear duration. Following the same geometry, 
the Jewel EP Lab System hydrocolloid does not cover any part of the ECG sensing or defibrillation 
electrodes, and therefore will not have any impact on the defibrillation area during the procedure.  
 
The Jewel EP Lab System Instructions for Use contains a thorough description of the product's 
preparation and administration procedures. 
 
The ES-2 model of the Jewel EP Lab System will be used as the study device for new subjects 
enrolled in the Jewel EP Lab Study. 
3.4. PRIOR CLINICAL EXPERIENCE WITH THE JEWEL AND JEWEL EP LAB SYSTEMS 
The Jewel System and the Jewel EP Lab System have both been investigated in animal models to 
characterize the safety of external defibrillation therapy. In addition, the full array of relevant 
biocompatibility tests were performed in accordance with ISO 10993. A complete summary of 
preclinical information regarding the Jewel EP Lab System is available in the Investigator’s 
Brochure. 
3.5. RISKS AND BENEFITS OF THE JEWEL EP LAB SYSTEM 
The Jewel EP Lab System will be used for investigational purposes only. It is not intended for 
commercial use. The study device will be used for external defibrillation during a standard EP 
procedure. A detailed Risk Analysis has been completed and the risk to benefit ratio has been 
determined to be acceptable for use in a clinical investigational study. 

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4. STUDY OBJECTIVE 
The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel EP 
Lab System, utilizing either the ES-1 or the ES-2 model of the Jewel EP Lab System. The Jewel EP 
Lab System will be used to deliver a single transthoracic defibrillation shock to terminate life-
threatening VT or VF to patients undergoing a cardiac EP procedure.  
5. STUDY PURPOSE 
The time to defibrillation is the single most critical determinant of survival in SCD. Survival rates 
after VF decrease approximately seven to ten percent with every minute that defibrillation is delayed.5 
While rapid deﬁbrillation with an Automated External Defibrillator (AED) by nonmedical personnel 
can improve survival after out-of-hospital cardiac arrest, the time period between arrest and 
successful resuscitation must be short and the cardiac arrest must be witnessed. The development of a 
wearable cardioverter deﬁbrillator has provided a new therapy option for patients who are at high risk 
of SCD and may require a defibrillation shock without the assistance from a bystander. 
 
The Jewel System is an automatic external defibrillator which monitors patients at risk for SCD and 
provides a therapeutic shock if needed. The Jewel System is intended to be worn at home or in the 
hospital during temporary periods of time when ICD implantation is commonly deferred. 
 
To date, ZOLL is the sole manufacturer of a commercial product approved as a wearable automated 
external defibrillator. The ZOLL LifeVest WCD is currently available in the United States, Europe, 
Australia, Israel, Japan, and Singapore. 
 
The clinical efficacy of external defibrillation shock waveforms used in the ZOLL LifeVest WCD 
and other AEDs has been studied routinely in the controlled environment of the EP lab. For example, 
with the replacement of monophasic damped sine waveforms with lower energy biphasic truncated 
exponential waveforms, clinical efficacy was compared by measuring first shock success rate in 
patients undergoing electrophysiologic testing.6 With the ZOLL LifeVest WCD, the clinical efficacy 
was also evaluated as part of a routine EP procedure in which ten (10) patients were induced into VF 
and the LifeVest was used to deliver a single defibrillation shock.7 In this study, special WCD units 
were used that were manually charged and discharged by the physician to terminate the VF episode in 
a relatively short time period (mean duration of 32 seconds per episode). 
 
Similar to the ZOLL LifeVest and AEDs, the Jewel System is designed to deliver a fixed energy of 
approximately 150 joules using a biphasic truncated exponential waveform that is adjusted based on 
the transthoracic impedance of the patient. The purpose of this clinical study is to demonstrate the 
safety and effectiveness of the Jewel EP Lab System to deliver a single transthoracic defibrillation 
shock to terminate life-threatening VT or VF. 
 
The study is planned to be conducted in standard clinical cases, such as an EP study or an ablation 
case, in which life-threatening VT or VF may spontaneously occur or be induced. As with similar EP 
lab studies, the duration of life-threatening VT or VF will be limited to a relatively short time period 
(less than 20-30 seconds) to minimize the safety risk to the patient since the duration of life-
threatening  VT or VF has been shown to be inversely proportional to the success of defibrillation 
 
 
5 American Heart Association. 2005 American Heart Association Guidelines for Cardiopulmonary 
Resuscitation and Emergency Cardiovascular Care. Circulation, Supplement 2005. 
6 Bain et.al. Multicenter study if principles-based waveforms for external defibrillation. Annals of Emergency 
Medicine, Jan 2011: 37:1, 5-12. 
7 Auricchio, A. et.al. “Clinical Efficacy of the Wearable Cardioverter-Defibrillator in Acutely Terminating 
Episodes of Ventricular Fibrillation.” Amer J Cardiol. 1998; 81: 1253-1256. 

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therapy.8,9 Unlike the Jewel EP Lab System, the Jewel System is designed for ambulatory patients and 
therefore if the system detects a shockable rhythm, the firmware initiates the alarm sequence, 
allowing a conscious patient to have time to respond and press the Control Buttons to prevent 
delivery of a shock (approximately 50-60 seconds from the initial detection of the shockable rhythm). 
Although this is acceptable for an out-of-hospital event, the Jewel EP Lab System is a derivative of 
the Jewel System designed for the EP lab environment to allow the clinical user to manually charge 
the capacitors and trigger the delivery of the defibrillation shock at any time during the procedure. 
The Jewel EP Lab System does not require waiting for the algorithm to detect and classify a 
shockable rhythm. This ensures that the clinical user has full control of the delivery and timing of the 
therapeutic shock in order to avoid a prolongation of the response time during the acute EP lab 
procedure. 
 
In this study, the EP lab procedure is a standard clinical procedure that follows the standard of care at 
the hospital facility. The clinical presentation of life-threatening VT or VF and the clinical guidelines 
for defibrillation do not differ between European or US clinical sites. 
 
The results of the VEST trial, a randomized controlled trial (RCT) of over 2,300 subjects comparing 
the ZOLL LifeVest to Guideline Directed Medical Therapy, were reported at the American College of 
Cardiology Conference in March 2018, and in the New England Journal of Medicine on 27 
September 2018.10 In this RCT, there were a total of 21 appropriate shocks, of which 13 were 
converted with the first shock and 8 of which required ≥2 shocks (38%). This translates into a 62% 
first shock success rate.11 
 
 
 
 
8 Windecker, S et.al. The influence of ventricular fibrillation duration on defibrillation efficacy using biphasic 
waveforms in humans. Journal of the American College of Cardiology, Volume 33, Issue 1, January 1999, 33-
38. 
9 Winkle, R et.al. Effect of duration of VF on defibrillation efficacy in humans. Circulation, Vol 81, No 5, May 
1990, 1477-1481. 
10 Jeffrey E Olgin et al., “Wearable Cardioverter–Defibrillator after Myocardial Infarction,” N Engl j Med, 
2018, 11. 

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6. STUDY DESIGN 
This study is a single center, prospective, single arm, non-randomized, non-blinded feasibility study 
that will be conducted in the European Union. The sample size for the study is a maximum of 24 
subjects.  
 
Eligible subjects will be those scheduled for a standard EP procedure where life-threatening VT or 
VF may spontaneously occur or may be induced. Subjects are excluded if they exhibit a left 
ventricular ejection fraction (LVEF) less than 20%, have been recently diagnosed with heart failure or 
have NYHA Class IV heart failure, have unstable angina or atrial fibrillation with a contra-indication 
to anticoagulation or improper anticoagulation management. The adaptive study design will allow for 
continuous enrollment of eligible subjects until the sample size is met for the treatment analysis per 
the statistical plan. 
 
Patients undergoing a standard EP clinical procedure where life-threatening VT or VF may occur are 
eligible for enrollment in this study. The Jewel EP Lab System will be placed on the subject’s torso in 
the anterior-apical monitoring vector and will be able to deliver an electric shock in the event the 
patient experiences spontaneous or induced VT or VF.  
 
It is anticipated that the study will require 3 months for enrollment and completion as the study does 
not require follow-up after the completion of the EP Lab procedure except in the event of adverse 
events in which case the subject will be followed until resolution. The Sponsor and the Principal 
Investigator will continuously monitor the safety data (including all reported serious adverse events) 
throughout the trial.  
6.1. PRIMARY EFFICACY ENDPOINT 
The primary endpoint will evaluate the percent of successful terminations of life-threatening VT or 
VF in subjects who are enrolled in compliance with the protocol-defined entry criteria and are treated 
with either model of the Jewel EP Lab System. The endpoint will be achieved if the lower confidence 
limit exceeds the performance goal of 62% using a one-sided exact lower 97.4% confidence bound at 
one of three testing points. These conditions ensure that performance will be in line with previously 
published randomized controlled trial results on a relevant comparator, the ZOLL LifeVest, which is 
the only commercially approved WCD in Europe or the United States. A sequential method of testing 
will be used to evaluate conversion success. If the Jewel EP Lab System is NOT used to deliver a 
defibrillation shock during the EP procedure, the subject will not be included in the treatment 
analysis. 
6.2. PRIMARY SAFETY ENDPOINT  
Descriptive statistics of safety outcomes will be reported to ensure that device safety performance is 
clinically meaningful. All adverse events observed during the acute procedure will be tabulated and 
presented along with the duration, severity, and relatedness to the Jewel EP Lab System. The 
proportion of subjects experiencing an AE or SAE will also be presented. No formal safety analyses 
will be performed due to the fact that the sample size does not allow for a powered safety endpoint. 
 
 

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7. STUDY POPULATION 
7.1. PATIENT INCLUSION/EXCLUSION CRITERIA 
The study will only enroll up to 24 subjects that fulfill the eligibility criteria of the investigation. 
Subject participation is voluntary and the study will be conducted in accordance with the Declaration 
of Helsinki. 
 
Inclusion Criteria: 
Candidates for this study must meet all the following criteria: 
1) Subjects of both genders of at least 18 years of age. 
2) Subjects who are scheduled for a standard EP clinical procedure where life-threatening VT or VF 
may spontaneously occur or may be induced. 
 
Exclusion Criteria: 
Candidates will be ineligible for enrollment if any of the following conditions apply: 
1) Subjects who may require sterile access to the right upper pectoral or lower left torso regions 
during the planned EP procedure. 
2) Subjects who have taken amiodarone in the past 3 months. 
3) Subjects with an existing unipolar pacemaker.  
4) Subjects who exhibit a left ventricular ejection fraction (LVEF) less than 20% (as assessed by 
techniques such as echocardiography, magnetic resonance imaging, or radionuclide angiography 
within the last 6 months). 
5) Subjects who have been diagnosed with heart failure (Class IV) or experienced an acute heart 
failure exacerbation within the previous 30 days. 
6) Subjects who exhibit unstable angina. 
7) Subjects with atrial fibrillation with contraindication to anticoagulation or improper 
anticoagulation management. 
8) Subjects who are participating in an investigational study of a drug, biologic, or device not 
currently approved for marketing. 
9) Subjects who are allergic to or have had a known adverse reaction to medical adhesives. 
10) Subjects who have active skin breakdown, erythema, or other signs of infection in the pectoral or 
torso regions where the study device is applied. 
11) Subjects with a lower abdomen circumference of less than 68.5 cm or greater than 142 cm. 
12) Females who are pregnant or breastfeeding, or planning to be pregnant in the next 12 months. 
13) Subjects who cannot provide or have diminished capacity to provide informed consent. 
14) Any condition that an Investigator believes would interfere with the intent of the study or is not in 
the best interest of the patient. 
15) Any patient that according to the Declaration of Helsinki is unsuitable for enrollment. 
 
Note: Subjects with an active implanted device, such as a pacemaker, ICD, or a  
subcutaneous-ICD, are not excluded in the eligibility criteria, but the Investigator may choose to 
screen out subjects where the active device or clinical procedure may interfere with the intent of the 
study. 
 
 

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8. STUDY ACTIVITIES 
The Study Activities are detailed in Table 8.1. 
Table 8.1:  Study Activities 
Study Activity 
Pre-Procedure 
Intra-Procedure 
Post-Procedure 
Informed Consent  
X 
 
 
Screening Visit 
X 
 
 
Medical History/Clinical Status 
X 
 
 
Skin Preparation & Device 
Placement (including photograph) 
 
X 
 
Therapy Delivery 
 
X (if applicable) 
 
Device Removal 
 
X 
 
Adverse Events Assessment 
 
X 
X (if applicable) 
8.1.  
SUBJECT ENROLLMENT 
All patients admitted for an EP lab procedure will be screened for study eligibility. A member of the 
research team will review the patient’s medical history for eligibility. A screening log will be 
maintained by each site and completed for all patients screened.  The screening log will identify the 
reason(s) potential study subjects were not enrolled into the trial. If all inclusion criteria are met and 
no exclusion criteria are present, the patient will be presented with the Ethics Committee-approved 
Patient Informed Consent (PIC). This consent form will comply with all applicable local, state and 
federal regulations governing the protection of human patients. The Investigator must provide the 
Sponsor with a written copy of the PIC that the IEC reviewed, and the IEC approval of the PIC prior 
to enrollment of any subjects. 
 
It is the responsibility of the Investigator to obtain written informed consent from each subject or the 
legally authorized representative of the subject prior to the initiation of any study-related procedures. 
Each prospective study subject must be informed of: 
 
• 
The purpose, procedures, and expected duration of the subject’s participation; 
• 
Potential hazards/risks to the subject; 
• 
Anticipated benefits to the subject or others; 
• 
Disclosure of appropriate alternate procedures/treatments; 
• 
A statement describing the extent, if any, to which confidentiality of records identifying the 
subject will be maintained and notes that the FDA and the Sponsor may inspect the records; 
• 
An explanation of any compensation and an explanation as to whether any medical treatments are 
available if injury occurs and, if so, what they consist of, or where further information may be 
obtained; 
• 
An explanation of whom to contact for answers to questions about the research and research 
subjects’ rights, and whom to contact in the event of a research-related injury to the subject; 
• 
A statement that participation is voluntary, that refusal to participate or withdrawal at any time 
will involve no penalty or loss of benefits; 
• 
A statement that the particular treatment or procedure may involve risks to the subject (or to the 
embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; 
• 
Anticipated circumstances under which the subject’s participation may be terminated by the 
Investigator without regard to the subject’s consent; 
• 
Any additional costs to the subject that may result from participation in the study; 
• 
The consequences of a subject’s decision to withdraw from the research and procedures for 
orderly termination of participation by the subject; and 
• 
The approximate number of subjects involved in the study. 
 
Each subject will be given a signed copy of the Patient Informed Consent. 

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Signed PIC Forms must be retained in the study file by the Investigator, and be available for review 
by the Sponsor and/or regulatory agencies, as applicable. The time and date consent was rendered will 
be documented in the subject’s medical record. 
 
The PIC and any other written information provided to subjects will be revised whenever important 
new information becomes available, or if there is an amendment to the protocol which necessitates a 
change to the content of subject information and/or to the consent form. The Investigator will inform 
the subject of changes in a timely manner, and will ask the subject/patient to confirm his/her 
continuation in the study by signing a revised consent form. Any revised PIC Form and other written 
information provided to subjects must receive IEC, Sponsor, and regulatory agency approval, as 
applicable.  
 
At the Screening visit the subject’s baseline information will be collected, including demographics, 
medical history and cardiac-related test results, and will undergo a basic physical exam.  
8.2. STUDY PROCEDURE  
The study device is intended to be used in conjunction with a standard EP clinical procedure, such as 
an EP study or ablation procedure, where life-threatening VT or VF may spontaneously occur or may 
be induced. Although subjects will undergo a standard EP procedure, it is not anticipated that life-
threatening VT or VF will occur or be induced in all subjects. 
 
The Jewel EP Lab System will be set-up prior to initiation of the EP clinical procedure. The subject’s 
torso will be prepared for the placement of the Jewel EP Lab System. If hair is present, it will be 
trimmed per the hospital’s protocols. The areas where the Adhesive Electrode Patches will be cleaned 
with antiseptic, such as Isopropyl Alcohol prior to being placed on the subject.  
 
The Adhesive Electrode Patches will be placed in the anterior-apical vector, with the upper patch 
located under the clavicle and lateral to the midline and the lower patch placed so that the 3rd/4th 
exterior housing junction is at or posterior to the mid-axillary line. The patches shall be placed by 
aligning the patch and pulling the release liners in order of their number, 1 through 4. After both 
patches have been placed, the time of device placement will be recorded on the Procedure Case 
Report Form (CRF). A photograph will be taken to document device location. The photograph will 
not include the subject’s face. The device will be turned on and the time will be recorded on the 
Procedure CRF.  
 
Hospital-supplied rescue defibrillator pads will be placed on the subject in an anterior-posterior 
position, ensuring a 1-2 centimeter margin between the defibrillation pads and the Adhesive Electrode 
Patches. A hospital-supplied ECG will be used per hospital procedure. The Investigator will continue 
with the planned EP clinical procedure and monitor the subject’s heart rhythms per standard hospital 
protocol.  
 
After the EP clinical procedure commences, the Jewel EP Lab System will be used to terminate the 
spontaneous or induced life-threatening VT or VF.   
 
Prior to the onset of life-threatening VT or VF, the hospital staff will prepare the Jewel EP Lab 
System by initiating the device charge cycle. The user will depress the “CHARGE” button on the 
Controller Box to charge the capacitors for delivery of the defibrillation shock. Charging will take 
approximately 20 seconds during which the Controller Box will display a flashing green “CHARGE” 
light. The rescue defibrillator will also be prepared for use should the Jewel EP Lab System not 
deliver an electrical shock or fail to terminate VT/VF. 
 
Upon completion of charging, the Jewel EP Lab System will display a solid green “CHARGE” light 
on the Controller Box. After the device is charged, the user will be able to manually deliver a 

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defibrillation shock through the Jewel EP Lab System by depressing the “SHOCK” buttons on the 
Controller Box. 
 
Throughout the procedure, the Jewel EP Lab System will continuously monitor the ECG signal, and 
the Controller Box will illuminate the “DETECT” yellow light to notify the user when the algorithm 
has detected life-threatening VT or VF. The detection algorithm continuously analyzes the ECG 
signal in segments of eight seconds and determines whether a shockable rhythm is present in the 
majority of that segment after the entire segment has finished. Based on the timing of the onset of 
VT/VF relative to ECG segments, the algorithm may require up to 8-12 seconds of ECG signal to 
capture a full eight-second segment for determination of a shockable rhythm. If a shockable rhythm is 
detected, the light indicator on the Controller Box will flash a yellow light continuously. If the VT/VF 
is sustained through a second eight-second segment, the light indicator will change to a solid yellow 
light. At any time during this process, irrespective of algorithm determination, the defibrillation shock 
may be delivered using the “SHOCK” buttons on the Jewel EP Lab System. Although the 
performance of the detection algorithm is not a primary endpoint in this study, the status of the 
detection light will be recorded during the case. 
 
In cases where the patient is stable, the VT/VF may be allowed to continue for 20-30 seconds to 
ensure the algorithm has sufficient ECG data to make a rhythm determination over multiple eight-
second segments. The timing of the defibrillation shock is under the discretion of the physician to 
ensure patient safety. In the case where VT/VF is not sustained for the minimum of 8-12 seconds, the 
indicator light on the Controller Box will not illuminate. The ECG data recorded on the Jewel EP Lab 
System will also be analyzed post-procedure to assess the performance of the algorithm. 
 
In the event that the defibrillation shock delivered through the Jewel EP Lab System does not 
successfully terminate the VT/VF, the rescue defibrillator will be used to deliver subsequent 
defibrillation shock(s). 
 
Throughout the clinical procedure, the Jewel EP Lab System will only be used in appropriate cases 
based on physician judgment. 
 
• 
In the case that a defibrillation shock is delivered through the Jewel EP Lab System, the clinical 
procedure will continue as planned. If a subsequent defibrillation shock is required during the 
procedure, the rescue defibrillator will be used. The Jewel EP Lab System will only be employed 
for a single shock during each procedure. In the case that the Jewel EP Lab System is used to 
deliver a defibrillation shock and the subject meets all enrollment criteria, the subject will be 
included in the treatment analysis for the primary endpoint. 
 
• 
In the case that the Jewel EP Lab System is not used to deliver a defibrillation shock during the 
procedure, the subject will not be included in the treatment analysis to meet the sample size 
requirements per the statistical plan. In approximately 30 percent of cases, life-threatening VT or 
VF may not occur or be inducible and therefore an external defibrillation shock would not be 
required.11 In addition, based on physician judgment, the Jewel EP Lab System may not be used 
to provide a defibrillation shock during the procedure. In these cases, the subject will not be 
included in the treatment analysis for the primary endpoint, however, an Intent-to-Treat (ITT) 
analysis will be performed for informational purpose. 
 
At the conclusion of the acute procedure, the Jewel EP Lab System will be removed from the subject 
and the Controller Box will be disconnected from the Adhesive Electrode Patches. The subject will 
exit the study immediately after completion of the EP clinical procedure. 
 
 
11 Krummen, D. et.al. “Rotor Stability Separates Sustained Ventricular Fibrillation from Self-Terminating 
Episodes in Humans.”  J Am Coll Cardiol. 2014; 63: 2712–21. 
 

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8.3. FOLLOW-UP 
No clinical follow-up is required following the acute procedure, and subjects will exit the study 
immediately after completion of the procedure unless an adverse event (AE) is observed during the 
Jewel EP Lab System treatment procedure in which case the subject will be followed until the AE has 
been resolved.  
9. SUBJECT REMOVAL FROM STUDY 
Only subjects that meet all enrollment criteria and have received a defibrillation shock will be 
included in the treatment analysis, however all subjects enrolled, whether or not receiving a 
defibrillation shock, will be included in the reporting of study results.   
 
Overall, if a subject drops out of the study at any time due to an adverse event or for any other cause, 
the reason for discontinuation, the nature of the event, and its clinical course must be fully followed 
and documented.  In the case of an adverse event, the Investigator must strive to follow the subject 
until the adverse event has either resolved, become clinically insignificant, the event is stabilized, or 
the subject is lost to follow-up. 
 
If at any point during the study, the patient withdraws consent or the Investigator assesses that the 
risks to the subject outweigh the benefits of participation in the study, the subject will be 
discontinued. If, during the course of the study, the Investigator feels that, in his/her best clinical 
judgment, the study should be prematurely terminated, he/she will notify the Sponsor and give the 
reason(s) for this decision. If the Sponsor decides, based on data or internal information, that it would 
be prudent to discontinue temporarily or to terminate the study, the Sponsor will inform the 
Investigator of this decision and the reason(s) for the decision. 
 
 

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10. ASSESSMENT OF SAFETY 
The Investigator will carefully monitor each subject throughout the study for possible adverse events. 
All adverse events must be documented on CRFs designed specifically for this purpose and followed 
until either completely resolved or until a stable chronic outcome is determined by the Investigator. 
 
The definitions and procedures for reporting adverse events (AE), serious adverse events (SAE), 
adverse device effects (ADE)/serious adverse device effects (SADE), unanticipated adverse device 
effects (UADE), and device deficiencies (DD) are presented in the sections below. It is of the utmost 
importance that all staff involved in the investigation are familiar with the definitions and procedures. 
10.1. 
SAFETY DEFINITIONS 
Adverse Event (AE) 
An Adverse Event is any unfavorable and unintended sign, symptom, or disease, temporally 
associated with the use of the Jewel EP Lab System, whether or not it is related to the Jewel EP Lab 
System. 
 
No causal relationship with the clinical trial product is implied by the use of the term “Adverse 
Event.” Exacerbations of a pre-existing condition/illness that are defined as a “more frequent 
occurrence” or as “an increase in the severity of the pre-existing conditions” are considered AEs. 
 
Serious Adverse Event (SAE) 
An adverse event is considered “serious” if, in the view of either the Investigator or Sponsor it: 
• 
Results in death; 
• 
Is considered life-threatening (meaning that its occurrence places the subject at immediate risk of 
death. It does not include an adverse event or suspected adverse reaction that, had it occurred in a 
more severe form, might have caused death.); 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization; 
• 
Results in persistent or significant incapacity or disability; or 
• 
Results in a congenital anomaly/birth defect. 
 
Adverse Device Effect /Serious Adverse Device Effect (ADE/SADE) 
An adverse device effect/serious adverse device effect is any AE that is related to the Jewel EP Lab 
System. All ADEs/SADEs are further categorized as anticipated or unanticipated by the Sponsor.  
 
Unanticipated Adverse Device Effect (UADE) 
A UADE is any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death was not previously identified 
in nature, severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects.  
 
Device Deficiency 
A device deficiency is an inadequacy of a medical device related to its identity, quality, durability, 
reliability, safety or performance, such as a malfunction, misuse or use error, and inadequate labeling. 
 
 

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10.2. 
REPORTING OF ADVERSE EVENTS 
Reports of adverse events will be collected throughout the duration of the study for both the ES-1 and 
ES-2 models of the Jewel EP Lab System. Adverse events must be documented on the Adverse Event 
case report form by the Investigator or his/her designee; however, it is the responsibility of the 
Investigator to ensure that all information is correct. 
 
When reporting AEs/SAEs, the Investigator should include the following information: 
1. Description of event (diagnosis) 
2. Onset of event 
3. Duration of event 
4. Severity 
5. Relationship to device 
6. Action taken 
7. Patient outcome 
 
Severity describes the intensity of an event and will be assessed as: 
Mild – The AE does not interfere in a significant manner with the subject’s normal functioning level 
and requires minimal or no treatment. 
Moderate – The AE produces some impairment of function, but is not hazardous to health. 
Severe – The AE produces significant impairment of function or incapacities and/or is a hazard to the 
subject. These events may require systemic therapy or other treatment.  
  
All AEs will be assessed for relationship to the Jewel EP Lab by the Investigator who examines and 
evaluates the participant, based on temporal relationship and his/her clinical judgment. The degree of 
certainty about causality will be graded using the categories below: 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event occurs in a plausible time relationship to use 
of the study device and cannot be explained by concurrent disease or other drugs or chemicals.  
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event occurs within a reasonable time after use of the study device, is 
unlikely to be attributed to concurrent disease or other drugs or chemicals. 
Potentially Related – There is some evidence to suggest a causal relationship, however, other factors 
may have contributed to the event (e.g., the participant’s clinical condition, other concomitant 
events). Although an AE may rate only as “possibly related” soon after discovery, it can be flagged as 
requiring more information and later be upgraded to “probably related” or “definitely related”, as 
appropriate. 
Unlikely to be Related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to use of the study device makes a causal relationship improbable (e.g., the 
event did not occur within a reasonable time after use of the study device) and in which other drugs or 
chemicals or underlying disease provides plausible explanations. 
Not Related – The AE is completely independent of use of the study device, and/or evidence exists 
that the event is definitely related to another etiology. There must be an alternative, definitive etiology 
documented by the clinician.  
 
All SAEs must be reported to the Sponsor within 24 hours of learning about the event, regardless of 
the time that may have elapsed from the time the event occurred. The Sponsor must also receive a 
completed Adverse Event CRF within three (3) working days of the Investigator being notified of the 
event and should include the Investigator’s assessment of the event, action that is required, results of 
any diagnostic tests that were performed, a description of any treatment implemented, a statement of 
the subject’s current clinical status, and the Investigator’s signature and date. Investigators shall 
comply with all local reporting requirements. 
 

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All device deficiencies (ES-1, ES-2) shall be documented and reported to the Sponsor without 
unnecessary delay. 
 
If required, the Sponsor should inform the Competent Authorities about all SAEs and device 
deficiencies that may have led to a SADE associated with the device, as per local requirements. 
 
The Sponsor is responsible for relaying adequate information on all UADEs to all participating 
Investigators. Regulatory authorities will be informed of all UADEs by the Sponsor. The Sponsor is 
also responsible for assessing whether a UADE poses an unreasonable risk to patients if the study is 
continued. 
10.3. 
FOLLOW-UP OF PATIENTS AFTER ADVERSE EVENTS / SERIOUS ADVERSE EVENTS 
In the case that an AE is observed during the Jewel EP Lab System treatment procedure, the subject 
will be followed until the AE is resolved or the Investigator decides that the AE is stable and needs no 
further follow-up. The date when the Investigator considers one of these outcomes to have occurred 
for the AE will be considered the last visit for the subject, and the outcome should be recorded on the 
appropriate case report form. 
 
 

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11. STATISTICS 
11.1. 
STATISTICAL ANALYSIS AND SAMPLE SIZE RATIONALE 
A prospective Statistical Analysis Plan has been developed for this study. Specific information 
regarding the planned statistical analysis is presented below. 
 
The VEST trial was a randomized controlled trial (RCT), the design of which controls for the bias 
inherently present in retrospective registries. VEST reported the real-world LifeVest performance in 
over 2,300 subjects. The results of the VEST trial were presented at the American College of 
Cardiology Conference in March 2018, and were published in the New England Journal of Medicine 
on 27 September 2018. In this RCT, there were a total of 21 appropriate shocks, of which 13 were 
converted with the first shock and 8 of which required ≥2 shocks (38%). This translates into a 62% 
first shock success rate.10 Of the 21 subjects who received an appropriate shock, 15 subjects (71%) 
survived. There were 25 sudden deaths in the LifeVest arm, 9 of which were wearing the LifeVest at 
the time of death, suggesting that there were a fair number of deaths that likely should have been 
prevented through use of the LifeVest.10 Taken together, these RCT data suggest that the true results 
when using the LifeVest are potentially much lower than typically reported in registries.   
 
Prior to the start of the VEST trial, the VEST protocol estimated that WCD conversion success rate 
would be 79.7%. The VEST trial was powered for mortality, not conversion success, so there were no 
power calculations around this endpoint. As the results of the VEST RCT demonstrated a first shock 
conversion success rate of 62%, this first shock conversion success rate for LifeVest will be the 
performance goal for the EP Lab Study, meaning that when the confidence interval is calculated from 
the observed first shock conversion success rate for the Jewel, the Jewel lower confidence bound will 
be greater than 62%, which will mean that the Jewel results are better than LifeVest’s point estimate.  
 
Utilizing the observed 62% first shock conversion success rate seen with the LifeVest in the RCT as 
the EP Lab Study performance goal provides assurance that the performance of the Jewel is aligned to 
the real-world performance of LifeVest. 
 
For the calculation of sample size, this study will use an anticipated first shock conversion success 
rate of 87.5% in the EP Lab Study with a performance goal of 62%, the same as the first shock 
success rate seen in VEST. The performance of the Jewel will be considered acceptable if the lower 
confidence limit exceeds the performance goal of 62% (green line in the graph on page 24).  
 
The sample size for this study is a maximum of 24 subjects. Subjects can be treated with either the 
ES-1 or the ES-2 model of the Jewel EP Lab System, as the devices are representative of each other. 
This sample size is based on a group sequential design measuring the observed proportion of 
successful life-threatening VT or VF terminations. The group sequential design uses a Pocock alpha 
spending function and allows for testing after 12, 18, and 24 subjects are enrolled. The design 
controls the overall Type I error rate at 5%. In line with the Pocock alpha spending function, a one-
sided lower 97.4% exact confidence bound will be calculated using the exact binomial (Clopper-
Pearson) method at each testing point.  
 
 
 

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Primary Endpoint Analysis: 
Upon completion of the Jewel EP Lab Study, all clinical data from both the ES-1 and ES-2 models of 
the Jewel EP Lab System will be pooled, as the devices are representative of each other.  The primary 
endpoint will evaluate the percent of successful terminations of life-threatening VT or VF in subjects 
who are in subjects who are enrolled in compliance with the protocol-defined entry criteria and 
treated with the Jewel EP Lab System (either ES-1 or ES-2 model). 
 
Using the VEST RCT results for the first shock success as a guide, the performance goal of 62% was 
established for the Jewel EP Lab Study. The endpoint will be achieved if the lower confidence limit 
exceeds the performance goal of 62% using a one-sided lower 94.5% exact confidence bound at one 
of the three testing points. 
 
These conditions ensure that performance will be in line with previously published randomized 
controlled trial results on a relevant comparator, the ZOLL LifeVest which, is the only commercially 
approved WCD in Europe or the US. The method for testing the conversion success will follow these 
steps:  
 
1. If after attempting to convert the first 12 subjects, all subjects have been successfully converted 
(100% conversion rate) the trial will be stopped and deemed a success. Otherwise, continue to 
Step 2. 
2. If conversion is less than 100% after 12 total subjects, enroll six (6) additional subjects for a total 
of 18 subjects. If 17 out of the 18 are successfully converted (94.4% conversion rate), or if 16 out 
of the 18 are successfully converted (88.0% conversion rate), the trial will be stopped and deemed 
a success. Otherwise, continue to Step 3. 
3. Enroll the final six (6) subjects for a total of 24 subjects. If after attempting to convert 24 
subjects, 21 of the 24 are successful (87.5% conversion rate), the trial will be deemed a success.  
A 100% conversion rate with 12 subjects results in a one-sided lower 97.4% exact confidence bound 
of approximately 73.7% which exceeds the 62% performance goal.  
 
With a sample size of 18 subjects with 1 failure, the conversion rate is 94.4% with a one-sided lower 
97.4% exact confidence bound of approximately 72.8% which also exceeds the 62% performance 
goal.  
 
With a sample size of 18 subjects with 2 failures, the conversion rate is 88.9% with a one-sided lower 
97.4% exact confidence bound of approximately 65.4% which also exceeds the 62% performance 
goal.  
 
With a sample size of 24 subjects with 3 failures, the conversion rate is 87.5% with a one-sided lower 
97.4% exact confidence bound of approximately 67.8% which also exceeds the 62% performance 
goal.  
 
All of these scenarios result in a successful trial as the one-sided lower 97.4% exact confidence bound 
is above the performance goal of 62%. If at any point during the course of this study there are more 
than three (3) failures to convert a shockable rhythm (life-threatening VT or VF) due to the Jewel, the 
study will be stopped and deemed unsuccessful.  
 
 
 

Element Science, Inc. 
 
Jewel EP Lab Study – Clinical Investigational Plan 
 
 
 
PR-2038, Rev. 6.0, 24 March 2021 
 
 
Confidential 
 
Page 24 of 29 
The graph below summarizes the group sequential study design, conversion success, and results of 
the one-sided lower 97.4% exact confidence bound. 
 
 
 
Overall Type I Error Discussion: 
The group sequential design of the Jewel EP Lab Study is meant to control the overall Type I error 
rate with 90% power. This design uses a Pocock alpha spending approach which controls the overall 
Type I error rate at 5%. The group sequential design of the Jewel EP Lab Study is being used in order 
to reduce the number of subjects put at risk through early stopping rules, while still providing 
sufficient data to demonstrate the effectiveness of the Jewel EP Lab System to successfully convert 
life-threatening VT and VF. Preliminary testing points and alpha expenditures were estimated using 
SAS version 9.3 which employs a normal approximation to designing sequential trials. The alpha 
spent at each testing point was used to determine the confidence level of the exact lower confidence 
bound. These confidence levels were then used to adjust the testing points to accommodate exact 
methods rather than the normal approximation. Simulations of 3000 trials of size 24 were used to 
confirm that the Type I error rate was controlled at the 5% level. 
 
 
VEST 90%
CI
VEST 95%
CI
Jewel
12/12
Jewel
17/18
Jewel
16/18
Jewel
21/24
Observed Success (point
estimate)
62
62
100
94.4
88.9
87.5
Lower CB
45
42
73.7
72.8
65.4
67.8
Upper CB
76
79
Jewel 1st Shock Success Goal
80
80
80
80
62
62
100
94.4
88.9
87.5
20
30
40
50
60
70
80
90
100
Observed Success (point estimate)
Lower CB
Upper CB

Element Science, Inc. 
 
Jewel EP Lab Study – Clinical Investigational Plan 
 
 
 
PR-2038, Rev. 6.0, 24 March 2021 
 
 
Confidential 
 
Page 25 of 29 
12. ADMINISTRATIVE CONSIDERATIONS 
12.1. 
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE 
The Investigator should ensure that all persons assisting with the trial are adequately qualified and 
informed about the protocol, any amendments to the protocol, the study treatments, and their trial-
related duties and functions. The Investigator must maintain a list of sub-investigators and other 
appropriately qualified persons to whom he/she has delegated significant trial-related duties. 
12.2. 
INDEPENDENT ETHICS COMMITTEE (IEC) APPROVAL 
The Investigator will not begin the study until the protocol and PIC have been approved by the IEC. 
As the product is investigational, national health authority approval is also required. The IEC will also 
review and approve all advertisements, if applicable. The IEC approval will be documented in writing 
and sent to the Investigator. The Investigator will forward a copy of the IEC approval document to the 
Sponsor. Any amendments to the protocol must also be approved in writing by the IEC, prior to 
implementation by the Investigator, except where necessary to eliminate an immediate hazard to 
study participants. 
 
The Investigator will submit a progress report to the IEC at intervals as established by the IEC. The 
Investigator will retain a copy of this report in the Investigator’s Site File. 
12.3. 
ETHICAL CONDUCT OF THE STUDY 
This study will be conducted in accordance with EN ISO 14155:2020, applicable local regulations, 
and the ethical principles that have their origin in the Declaration of Helsinki. 
12.4. 
ADHERENCE TO PROTOCOL 
By signing the Investigator Signature Page of this protocol, the Investigator confirms in writing that 
he/she has read, understands and will strictly adhere to the study protocol and will conduct the study 
in accordance with the Investigator Agreement and applicable regulatory requirements. By signing, 
the Investigator commits to ensuring that all site personnel involved in the execution of this study will 
be properly trained to perform their responsibilities prior to their involvement and that all personnel 
will be properly supervised during the course of this study. 
12.5. 
PATIENT CONFIDENTIALITY 
Patient names will not be supplied to the Sponsor. Only the patient identification number will be 
recorded in the CRF, and if the patient name appears on any other document (e.g. source documents), 
it must be redacted on the copy of the document to be supplied to the Sponsor. Study findings will be 
electronically stored in accordance with local data protection laws. The patients will be informed that 
representatives of the Sponsor, IEC, or regulatory authorities may inspect their medical records to 
verify information collected and that all personal information made available for inspection will be 
handled in strictest confidence and in accordance with local data protection laws. 
 
The Investigator will maintain a personal patient identification list (patient numbers with the 
corresponding patient names) to enable records can be identified. 
 
 

Element Science, Inc. 
 
Jewel EP Lab Study – Clinical Investigational Plan 
 
 
 
PR-2038, Rev. 6.0, 24 March 2021 
 
 
Confidential 
 
Page 26 of 29 
13. STUDY MONITORING 
Monitoring visits will be conducted by representatives of the Sponsor in accordance with EN ISO 
14155:2020 and relevant local regulations. The Investigator will permit the Sponsor’s 
representative(s) to make regular study center visits during the study. At each previously arranged 
visit, the Investigator and staff will be expected to cooperate with the Sponsor’s representative(s) for 
the review and verification of protocol compliance, AE/SAE reporting, CRFs, source documents, 
clinical supplies and inventory records, and any additional pertinent records. In addition to the 
monitoring visits, frequent communications (letter, telephone, email and fax) by the Study Monitor 
will ensure that the investigation is conducted according to protocol design and regulatory 
requirements. 
13.1. 
TRAINING 
The Sponsor will provide formal site initiation training for the Jewel EP Lab System procedure prior 
to activating each site. Training will review all critical aspects of study conduct as well as patient 
selection and eligibility, procedure methods, and follow-up required post treatment. On-site training 
will also be provided for patient treatments. The first case will be proctored at all sites and additional 
on-site support will be provided as needed. 
13.2. 
ACCOUNTABILITY OF THE JEWEL EP LAB SYSTEM COMPONENTS 
The Investigator is responsible for maintaining records relating to the receipt, inventory and 
return/destruction of Jewel EP Lab System components. The Investigator may delegate all or part of 
these responsibilities to qualified personnel. 
13.3. 
CASE REPORT FORMS AND STUDY RECORDS 
Electronic CRFs will be used for the collection of clinical data required by the protocol. The Principal 
Investigator is responsible for assuring the accuracy and completeness of all study documentation. 
The study will be monitored to check that all data collected for the study are recorded accurately and 
promptly. All documents and data shall be produced and maintained in a way that assures control and 
traceability. Where relevant, the accuracy of translations shall be guaranteed and documented. The 
Investigator shall assure the accuracy, completeness, legibility, and timeliness of the data reported to 
the Sponsor on the CRFs. Where copies of the original source documents as well as printouts of 
original electronic source documents are retained, these shall be signed and dated by a member of the 
investigation site team with a statement that it is a true reproduction of the original source document. 
 
The data reported on the CRFs shall be derived from the source documents and be consistent with 
these source documents, and any discrepancies shall be explained in writing. The CRFs shall be 
electronically signed and dated by the Investigator or his/her designee(s). Any change or correction to 
the data shall be dated, signed with initials and explained as necessary, and shall not obscure the 
original entry (i.e. an audit trail shall be maintained); this applies to both written and electronic 
changes or corrections. 
 
All clinical trial data will be recorded completely, promptly, and legibly, using indelible black or blue 
ballpoint ink. Errors made on any paper-based document must be corrected by drawing one line 
through the incorrect data, entering the correct data beside the incorrect entry, then initialing and 
dating the correction. Incorrect data should not be obliterated or obscured. The use of pencil, erasable 
ink, or correction fluid on study records is prohibited. All missing data must be explained. For 
instance, if the item was not done, mark “N/D” (or equivalent) should be used. If the item is not 
applicable to an individual case, mark the space “N/A” or equivalent. 
 
Patients are not to be identified by name in the study database or on any study documents to be 
collected by the Sponsor or designee, but must be identified by the unique defined patient identifier. 
 
Data management and handling will be conducted according to an approved Data Management Plan 
in accordance with applicable guidelines and the Sponsor’s standard operating procedures (SOPs). 

Element Science, Inc. 
 
Jewel EP Lab Study – Clinical Investigational Plan 
 
 
 
PR-2038, Rev. 6.0, 24 March 2021 
 
 
Confidential 
 
Page 27 of 29 
Any deviations, i.e. discrepancies and additions from the process defined in the Data Management 
Plan will be described in the investigation specific study report. The subject’s personal data will be 
de-identified and coded as described in the Data Management Plan. 
13.4. 
PROTOCOL DEVIATIONS 
The Investigator will not alter this clinical study protocol without obtaining written agreement from 
the Sponsor. Once the study has started, amendments should be made only in exceptional cases. The 
amendment will become part of the clinical study protocol. 
 
With the exception of an emergency situation, implementation of any change in the protocol that 
affects the safety of the patients, the scope of investigation, or the scientific quality of the study will 
not be permitted until the Sponsor, the Investigator, and the IEC responsible for review and approval 
of the study have reviewed and approved the amendment. 
 
The Investigator will make every effort not to deviate from the protocol. In the event of an 
emergency, the Investigator shall implement any medical procedures deemed appropriate. However, 
all such procedures must have written documentation and be promptly reported to the Sponsor and 
IEC. 
13.5. 
AMENDMENTS 
Protocol modifications to the study may be made only after the approval of the Sponsor. Protocol 
amendments will be created if the changes affect the relative safety of subject, the scope of the 
investigation, the scientific quality of the study, the experimental design, the assessment variables, the 
number of subject treated, or any of the subject selection criteria. 
 
Amendments may be generated only by the Sponsor, and require prospective review and approval by 
the Investigator’s local IEC and the regulatory authorities, as applicable. The Sponsor/Monitor must 
receive IEC and regulatory authority (if applicable) approval/notification before the changes may be 
implemented. 
 
If the protocol amendment changes the information in the PIC, the Investigator will submit an 
amended PIC to IEC for approval. The amended PIC must also be approved by the Sponsor. 
13.6. 
ACCESS TO SOURCE DOCUMENTATION 
The Investigator will prepare and maintain adequate and accurate source documents designed to 
record all observations and other pertinent data for each patient enrolled in the study. The Investigator 
will allow the Sponsor’s representatives, contract designees, and authorized regulatory authority 
inspectors to have direct access to all documents pertaining to the study. 
 
The Investigator agrees that the Sponsor and its employees or agents, the IEC and governmental 
regulatory agencies have the right, from time to time, both during and after termination of this clinical 
study, to monitor, audit and review records relating to the clinical study, including patient medical 
and billing records. The Sponsor may request real time transmittal of some source data during the 
course of the study. Quality Assurance personnel from the Sponsor or its designee may audit the 
clinical trial site and/or study-related materials at any time during the study. 
 
 

Element Science, Inc. 
 
Jewel EP Lab Study – Clinical Investigational Plan 
 
 
 
PR-2038, Rev. 6.0, 24 March 2021 
 
 
Confidential 
 
Page 28 of 29 
13.7. 
RETENTION OF DATA 
A copy of the following documents must be retained by the investigator for at least two years after 
approval of the device, or two years following the completion of the study if marketing approval is 
not pursued, or longer if notified by the Sponsor to do so: 
 
• 
Study protocol; 
• 
Investigator’s Brochure; 
• 
Completed case report forms; 
• 
Source medical records, including original test result reports, to verify all data entered on the case 
report form; 
• 
Adverse event and protocol deviation documentation; 
• 
Investigational device receipt, return, and accountability logs; 
• 
All study related correspondence (including IEC and Sponsor correspondence); 
• 
A copy of the written informed consent for each subject in the clinical trial; and, 
• 
Any other documents pertaining to the conduct of this study. 
 
No study document shall be destroyed without prior written agreement between the Sponsor and the 
Investigator. Should the Investigator wish to assign the study records to another party or to move 
them to another location, the Investigator must notify the Sponsor in writing and obtain written 
approval. 
 
The Investigator will allow representatives of the Sponsor’s monitoring team (and if applicable, the 
FDA and the local regulatory authority) to inspect all study records, CRFs, and corresponding 
portions of the study subjects’ office and/or hospital medical records at regular intervals throughout 
the study. These inspections are for the purpose of verifying the adherence to the protocol, the 
completeness and exactness of the data being entered in the CRFs, and compliance with regulations. 

Element Science, Inc. 
 
Jewel EP Lab Study – Clinical Investigational Plan 
 
 
 
PR-2038, Rev. 6.0, 24 March 2021 
 
 
Confidential 
 
Page 29 of 29 
14. SUPPLEMENTS 
14.1. 
INVESTIGATOR’S AGREEMENT 
Study Title: Jewel Electrophysiology (EP) Lab Study 
 
I have read the attached protocol and agree that it contains all the necessary details for performing 
the study. I will ensure adequate and eligible patients are enrolled into the study. 
 
I will provide copies of the protocol and the clinical information on the product, which was 
furnished to me by the Sponsor, to all members of the study team responsible to me who 
participate in the study. I will discuss this material with them to assure that they are fully 
informed regarding the product and the conduct of the study. 
 
I understand that the study will not be started without the prior written approval of a properly 
constituted IEC. As the product is Investigational, National Health Authority approval is also 
required. No changes will be made to the study protocol. I will submit any informed consent 
modifications in writing to Element Science, Inc. and the IEC. 
 
Written approval will be obtained before any modifications are implemented. I understand the 
protocol and will work according to it and according to the principles of Good Clinical Practice, 
EN ISO 14155:2020 and relevant local regulations. Information developed in this clinical study 
may be disclosed by the Sponsor to other clinical investigators, government health protection 
agencies, foreign or domestic, as required. 
 
Subject confidentiality will be maintained at all times unless disclosure is required by government 
regulation or applicable law. 
 
 
 
 
 
 
Signature of Investigator 
 
Date 
 
 
 
 
 
 
Name of Investigator 
 
Title