Sudden Cardiac ArrestNCT05201495

The Jewel IDE Study

A study testing Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) in people with Sudden Cardiac Arrest, run by Element Science, Inc. at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL") Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sudden Cardiac Arrest
What is being tested?: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 322 participants
Where: 30 sitesUnited States
Study dates: 12 Jan 2022to 10 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients of any gender aged ≥ 18 years.
Patients with either:
a measured LVEF less than or equal to 40% (as assessed by techniques such as, but not limited to, cardiac angiography, echocardiography, magnetic resonance imaging, or radionuclide angiography within the last 30 days prior to enrollment) AND identified as presenting with a diagnosis of an AMI, ischemic cardiomyopathy (includes congestive heart failure: NYHA Class I - III), non- ischemic cardiomyopathy, or myocarditis;
OR
who have a temporary or long-term contraindication to receiving an ICD, who have had an ICD removed, or who refuse an ICD
OR
whose ICD implantation is delayed due to COVID-19 infection or exposure- related risks

Who cannot join

Member of a vulnerable patient population as defined in ISO 14155;
Life expectancy of less than one year, including end-stage heart failure, cancer, or other diagnosed condition;
Patients with an anticipated initial prescription period over 180 days (limitation only to allow timely closure of this clinical trial);
Patients with an advanced directive prohibiting resuscitation;
Existing ICD;
Existing unipolar pacemaker;

Show all 24Show fewer

Existing FDA-cleared or FDA-approved active implantable or body worn medical device(s) that the Sponsor requires to be removed prior to the study but which cannot be removed;
Clinically significant valve disease, including aortic stenosis, mitral stenosis; mitral regurgitation, tricuspid regurgitation, insufficiency of the aortic or pulmonary valves, any of which is likely to require surgery in the next year;
A planned procedure, such as Coronary Artery Bypass Graft, within six (6) months;
End-stage renal disease, or chronic renal failure requiring hemodialysis;
Planned discharge to an institutional setting with an anticipated stay of greater than seven (7) days;
Having a mental, visual, physical, or auditory deficit, that could impair their ability to properly place, remove, or interact with the Jewel System;
Unable to understand English for the purposes of interacting with the device;
Unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, etc.);
Dextrocardia;
Body circumference of less than 27 inches or greater than 56 inches in the intended area of the Belt component of the Placement Accessory;
Participation in an investigational study of a drug, biologic, or device not currently approved for marketing;
Allergic to or have had a known adverse reaction to medical adhesives or hydrocolloids;
Active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the Adhesive Electrode Patches are applied;
Females who are pregnant or breast-feeding, or planning to be pregnant in the next 12 months;
No US-based postal address that can be used to ship and receive study devices and supplies (a Post Office box is not an acceptable address for product shipments).
Patients who, in the opinion of the Investigator, are anticipated to be non-compliant with study instructions;
Unable to provide or have diminished capacity to provide informed consent;
Any condition that an Investigator believes would interfere with the intent of the study or make participation not in the best interest of the patient.

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Emory University
Atlanta, Georgia, 30308
Fuqua Heart Center Piedmont Hospital
Atlanta, Georgia, 30309
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Northwestern University
Chicago, Illinois, 60611
TriHealth Heart Institute Cardiac and Thoracic
Cincinnati, Ohio, 45242
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
NorthShore Medical Group
Evanston, Illinois, 60201
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Parkview Research Center
Fort Wayne, Indiana, 46845
Hartford Hospital
Hartford, Connecticut, 06102
Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52246
University of Mississippi Medical Center
Jackson, Missouri, 39216
St. Bernard's Heart and Vascular
Jonesboro, Arkansas, 72401
Central Baptist Hospital
Lexington, Kentucky, 40503
Cardiology and Medicine Clinic, P.A.
Little Rock, Arkansas, 72204
University of Louisville
Louisville, Kentucky, 40202
ACRC Trials - Hunt - PPDS
McKinney, Texas, 75071
Methodist Le Bonheur
Memphis, Tennessee, 38104
Crystal Run Healthcare - Circuit - PPDS
Middletown, New York, 10941
Saint Thomas Research Institute
Nashville, Tennessee, 37203
Northwell Health
New Hyde Park, New York, 11040
Virginia Cardiovascular Specialists
Richmond, Virginia, 23225
Montefiore Medical Center
The Bronx, New York, 10467
North Mississippi Medical Center
Tupelo, Mississippi, 38801
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20010
Novant Health
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest

The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")

Read the detailed description

Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in patients at high risk for Sudden Cardiac Arrest

Conditions: Sudden Cardiac Arrest
Being tested: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Medical subject headings: Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)Device
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.

Study groups in NCT05201495
Study group	Role	What they receive
Treatment	Experimental	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) Receives: Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

What is being measured

The primary outcome is the main question the study is designed to answer.

Inappropriate Shock Rate
Inappropriate shocks no more than 2.0 inappropriate shocks per 100 patient-months.
Measured: Prescription Period during which each patient wore the Jewel up to 180 days.
Cutaneous Adverse Device Effects
Rate of subjects experiencing clinically significant cutaneous Adverse Device Effects of < 15%
Measured: Prescription Period during which each patient wore the Jewel up to 180 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202210 Nov 2023

First posted21 Jan 2022
Study start12 Jan 2022
Primary completion10 Nov 2023
Study completion10 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sudden Cardiac ArrestStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 322 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05201495
Sponsor's protocol ID: PR-2053
Status last verified: Apr 2026
First submitted: 5 Jan 2022
Last updated: 27 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hummel J, Houmsse M, Tomassoni G, Nair D, Romero J, Hargrove J, Mathews K, Thakkar AB, Ullery S, Eapen ZJ, Kumar UN, Mehran R, Butler J; Jewel IDE Study Investigators. A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest. J Am Coll Cardiol. 2024 Aug 6;84(6):525-536. doi: 10.1016/j.jacc.2024.04.063.
PubMed 39084827

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sudden Cardiac Arrest trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest
ClinicalTrials.gov ID: NCT05201495
Acronym / sponsor ID: PR-2053
Conditions: Sudden Cardiac Arrest
Study type: Interventional
Recruitment status: Completed
Enrolment: 322 participants (actual)
Lead sponsor: Element Science, Inc.Industry (pharma, biotech, devices)
Study start: 12 Jan 2022 (actual)
Primary completion: 10 Nov 2023 (actual)
Study completion: 10 Nov 2023 (actual)
First posted: 21 Jan 2022 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")

Detailed description

Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in patients at high risk for Sudden Cardiac Arrest

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients of any gender aged ≥ 18 years.
Patients with either:
OR
OR

Key exclusion criteria (24 listed)

Member of a vulnerable patient population as defined in ISO 14155;
Life expectancy of less than one year, including end-stage heart failure, cancer, or other diagnosed condition;
Patients with an anticipated initial prescription period over 180 days (limitation only to allow timely closure of this clinical trial);
Patients with an advanced directive prohibiting resuscitation;
Existing ICD;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.	Device	Treatment

Primary outcome

Inappropriate Shock Rate
Time frame: Prescription Period during which each patient wore the Jewel up to 180 days.
Inappropriate shocks no more than 2.0 inappropriate shocks per 100 patient-months.
Cutaneous Adverse Device Effects
Time frame: Prescription Period during which each patient wore the Jewel up to 180 days.
Rate of subjects experiencing clinically significant cutaneous Adverse Device Effects of < 15%

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	322	314

Primary outcome: Inappropriate Shock Rate

Time frame: Prescription Period during which each patient wore the Jewel up to 180 days.. Number. Unit: inappropriate shocks per 100 pt-months

Measure	Study Arm n = 300
Value	0.333

Population analysed: Of the 314 total patients completed, the primary analysis population was comprised of the 300 subjects who completed the study and had available device data contributing to analyzable wear time.

Primary outcome: Cutaneous Adverse Device Effects

Time frame: Prescription Period during which each patient wore the Jewel up to 180 days.. Number. Unit: percentage of participants

Measure	Study Arm n = 314
Value	2.23

Adverse events

Time frame: Prescription Period during which each patient wore the Jewel up to 180 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Arm	0 of 314 (0%)	49 of 314 (15.6%)	0 of 314

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39084827Hummel J, Houmsse M, Tomassoni G, Nair D, Romero J, Hargrove J, Mathews K, Thakkar AB, Ullery S, Eapen ZJ, Kumar UN, Mehran R, Butler J; Jewel IDE Study Investigators. A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest. J Am Coll Cardiol. 2024 Aug 6;84(6):525-536. doi: 10.1016/j.jacc.2024.04.063.
Individual participant dataSharing planned: No

Related trials for Sudden Cardiac Arrest

RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingObservational study
Cardiovascular Pre-participation Screening in Children and Adolescents
Sudden Cardiac Death, Cardiac Arrhythmias
Recruiting
Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta
AAOCA, ACAOS
RecruitingObservational study
Hypertrophic Cardiomyopathy Registry, Biobank and Imaging Data Repository
Hypertrophic Cardiomyopathy, Hypertrophic Obstructive Cardiomyopathy
RecruitingPhase 4
Epinephrine Dose: Optimal Versus Standard Evaluation Trial
Cardiac Arrest, Out-Of-Hospital, Sudden Cardiac Arrest

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javed Butler, M.D. principal investigator

University of Mississippi Medical Center

John Hummel, M.D. principal investigator

Ohio State University

Roxana Mehran, M.D. principal investigator

Icahn School of Medicine at Mount Sinai

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) in people with Sudden Cardiac Arrest, run by Element Science, Inc. at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inappropriate Shock Rate (time frame: Prescription Period during which each patient wore the Jewel up to 180 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201495, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.