The Jewel IDE Study
A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest
1 other identifier
interventional
322
1 country
30
Brief Summary
The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Typical duration for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2022
CompletedStudy Start
First participant enrolled
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2023
CompletedResults Posted
Study results publicly available
October 15, 2024
CompletedApril 27, 2026
April 1, 2026
1.8 years
January 5, 2022
August 1, 2024
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Inappropriate Shock Rate
Inappropriate shocks no more than 2.0 inappropriate shocks per 100 patient-months.
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%
Prescription Period during which each patient wore the Jewel up to 180 days.
Study Arms (1)
Treatment
EXPERIMENTALJewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Interventions
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.
Eligibility Criteria
You may qualify if:
- 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;
- who have a temporary or long-term contraindication to receiving an ICD, who have had an ICD removed, or who refuse an ICD
- whose ICD implantation is delayed due to COVID-19 infection or exposure- related risks
You may not qualify if:
- 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;
- 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;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
St. Bernard's Heart and Vascular
Jonesboro, Arkansas, 72401, United States
Cardiology and Medicine Clinic, P.A.
Little Rock, Arkansas, 72204, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20010, United States
Emory University
Atlanta, Georgia, 30308, United States
Fuqua Heart Center Piedmont Hospital
Atlanta, Georgia, 30309, United States
Northwestern University
Chicago, Illinois, 60611, United States
NorthShore Medical Group
Evanston, Illinois, 60201, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52246, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
University of Mississippi Medical Center
Jackson, Missouri, 39216, United States
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Crystal Run Healthcare - Circuit - PPDS
Middletown, New York, 10941, United States
Northwell Health
New Hyde Park, New York, 11040, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Novant Health
Winston-Salem, North Carolina, 27103, United States
TriHealth Heart Institute Cardiac and Thoracic
Cincinnati, Ohio, 45242, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Methodist Le Bonheur
Memphis, Tennessee, 38104, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37203, United States
Methodist Hospital
Houston, Texas, 77030, United States
ACRC Trials - Hunt - PPDS
McKinney, Texas, 75071, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, 23225, United States
Related Publications (1)
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.
PMID: 39084827DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Zubin Eapen, MD; Michael McSweeney
- Organization
- Element Science, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Javed Butler, M.D.
University of Mississippi Medical Center
- PRINCIPAL INVESTIGATOR
John Hummel, M.D.
Ohio State University
- PRINCIPAL INVESTIGATOR
Roxana Mehran, M.D.
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2022
First Posted
January 21, 2022
Study Start
January 12, 2022
Primary Completion
November 10, 2023
Study Completion
November 10, 2023
Last Updated
April 27, 2026
Results First Posted
October 15, 2024
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share