The Jewel IDE Study

Sudden Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201495
• Other study ID #: PR-2053
• Status: Completed
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: November 10, 2023

Study information

• Verified date: February 2024
• Source: Element Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Cardiac Arrest

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Fuqua Heart Center Piedmont Hospital	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	New York Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	Northwestern University	Chicago	Illinois
United States	TriHealth Heart Institute Cardiac and Thoracic	Cincinnati	Ohio
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	NorthShore Medical Group	Evanston	Illinois
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Hartford Hospital	Hartford	Connecticut
United States	Methodist Hospital	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Missouri
United States	St. Bernard's Heart and Vascular	Jonesboro	Arkansas
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Cardiology and Medicine Clinic, P.A.	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	ACRC Trials - Hunt - PPDS	McKinney	Texas
United States	Methodist Le Bonheur	Memphis	Tennessee
United States	Crystal Run Healthcare - Circuit - PPDS	Middletown	New York
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	Northwell Health	New Hyde Park	New York
United States	Virginia Cardiovascular Specialists	Richmond	Virginia
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Novant Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Element Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inappropriate Shock Rate	Inappropriate shocks per 100 patient-months	Prescription Period (~40 to 90 days, anticipated)
Primary	Cutaneous Adverse Device Effects	Rate of subjects experiencing clinically significant cutaneous Adverse Device Effects	Prescription Period (~40 to 90 days, anticipated)