The Jewel IDE Study

NCT ID: NCT05201495

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2023-11-10

Brief Summary

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

Conditions

Sudden Cardiac Arrest

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Group Type: EXPERIMENTAL

Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Intervention Type: DEVICE

Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Element Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javed Butler, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

John Hummel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Roxana Mehran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

St. Bernard's Heart and Vascular

Jonesboro, Arkansas, United States

Cardiology and Medicine Clinic, P.A.

Little Rock, Arkansas, United States

Hartford Hospital

Hartford, Connecticut, United States

MedStar Georgetown University Hospital

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

Emory University

Atlanta, Georgia, United States

Fuqua Heart Center Piedmont Hospital

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

NorthShore Medical Group

Evanston, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Central Baptist Hospital

Lexington, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

University of Mississippi Medical Center

Jackson, Missouri, United States

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Crystal Run Healthcare - Circuit - PPDS

Middletown, New York, United States

Northwell Health

New Hyde Park, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Novant Health

Winston-Salem, North Carolina, United States

TriHealth Heart Institute Cardiac and Thoracic

Cincinnati, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Methodist Le Bonheur

Memphis, Tennessee, United States

Saint Thomas Research Institute

Nashville, Tennessee, United States

Methodist Hospital

Houston, Texas, United States

ACRC Trials - Hunt - PPDS

McKinney, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Virginia Cardiovascular Specialists

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39084827 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PR-2053

Identifier Type: -

Identifier Source: org_study_id