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Wearable defibrillator jewel P-WCD tested in 322 High-Risk patients

NCT ID NCT05201495

Disease control Sponsor: Element Science, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a wearable defibrillator called the Jewel P-WCD in 322 adults at high risk for sudden cardiac arrest. The device is designed to automatically deliver a shock to restore normal heart rhythm if a dangerous heart rhythm occurs. The main goals were to see how often the device gave unnecessary shocks and how well the skin tolerated the device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

322 people

The number who actually took part.

Started

Jan 2022

Finished

Nov 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients of any gender aged ≥ 18 years. 2. Patients with either: 1. 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 2. who have a temporary or long-term contraindication to receiving an ICD, who have had an ICD removed, or who refuse an ICD OR 3. whose ICD implantation is delayed due to COVID-19 infection or exposure- related risks Exclusion Criteria: 1. Member of a vulnerable patient population as defined in ISO 14155; 2. Life expectancy of less than one year, including end-stage heart failure, cancer, or other diagnosed condition; 3. Patients with an anticipated initial prescription period over 180 days (limitation only to allow timely closure of this clinical trial); 4. Patients with an advanced directive prohibiting resuscitation; 5. Existing ICD; 6. Existing unipolar pacemaker; 7. 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; 8. 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; 9. A planned procedure, such as Coronary Artery Bypass Graft, within six (6) months; 10. End-stage renal disease, or chronic renal failure requiring hemodialysis; 11. Planned discharge to an institutional setting with an anticipated stay of greater than seven (7) days; 12. Having a mental, visual, physical, or auditory deficit, that could impair their ability to properly place, remove, or interact with the Jewel System; 13. Unable to understand English for the purposes of interacting with the device; 14. Unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, etc.); 15. Dextrocardia; 16. Body circumference of less than 27 inches or greater than 56 inches in the intended area of the Belt component of the Placement Accessory; 17. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing; 18. Allergic to or have had a known adverse reaction to medical adhesives or hydrocolloids; 19. Active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the Adhesive Electrode Patches are applied; 20. Females who are pregnant or breast-feeding, or planning to be pregnant in the next 12 months; 21. 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). 22. Patients who, in the opinion of the Investigator, are anticipated to be non-compliant with study instructions; 23. Unable to provide or have diminished capacity to provide informed consent; 24. 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.

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Conditions

The condition(s) this trial relates to.

Death, Sudden, Cardiac intrinsic cardiomyopathy myocarditis sudden cardiac arrest prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sudden cardiac arrest

Contacts and locations

Locations

  • ACRC Trials - Hunt - PPDS

    McKinney, Texas, 75071, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cardiology and Medicine Clinic, P.A.

    Little Rock, Arkansas, 72204, United States

  • Central Baptist Hospital

    Lexington, Kentucky, 40503, United States

  • Crystal Run Healthcare - Circuit - PPDS

    Middletown, New York, 10941, United States

  • Emory University

    Atlanta, Georgia, 30308, United States

  • Fuqua Heart Center Piedmont Hospital

    Atlanta, Georgia, 30309, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Methodist Hospital

    Houston, Texas, 77030, United States

  • Methodist Le Bonheur

    Memphis, Tennessee, 38104, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • New York Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • NorthShore Medical Group

    Evanston, Illinois, 60201, United States

  • Northwell Health

    New Hyde Park, New York, 11040, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novant Health

    Winston-Salem, North Carolina, 27103, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Parkview Research Center

    Fort Wayne, Indiana, 46845, United States

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37203, United States

  • St. Bernard's Heart and Vascular

    Jonesboro, Arkansas, 72401, United States

  • TriHealth Heart Institute Cardiac and Thoracic

    Cincinnati, Ohio, 45242, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52246, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Mississippi Medical Center

    Jackson, Missouri, 39216, United States

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23225, United States

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