The Jewel IDE Study

Not Applicable

Completed

• Conditions: Sudden Cardiac Arrest
• Interventions: Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

• Registration Number: NCT05201495
• Lead Sponsor: Element Science, Inc.

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

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-07
• Study Start: 2022-01-12
• Study First Posted: 2022-01-21
• Primary Completion: 2023-11-10
• Study Completion: 2023-11-10
• Results First Submitted: 2024-08-01
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Results First Posted: 2024-10-15
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Primary Outcome Measures

Name	Time	Method
Inappropriate Shock Rate	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	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%

Trial Locations

Locations (30)

Fuqua Heart Center Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

North Mississippi Medical Center; 🇺🇸 Tupelo, Mississippi, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Methodist Hospital; 🇺🇸 Houston, Texas, United States

St. Bernard's Heart and Vascular; 🇺🇸 Jonesboro, Arkansas, United States

Cardiology and Medicine Clinic, P.A.; 🇺🇸 Little Rock, Arkansas, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Parkview Research Center; 🇺🇸 Fort Wayne, Indiana, United States

Central Baptist Hospital; 🇺🇸 Lexington, Kentucky, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Crystal Run Healthcare - Circuit - PPDS; 🇺🇸 Middletown, New York, United States

New York Presbyterian Brooklyn Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Missouri, United States

Northwell Health; 🇺🇸 New Hyde Park, New York, United States

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Methodist Le Bonheur; 🇺🇸 Memphis, Tennessee, United States

ACRC Trials - Hunt - PPDS; 🇺🇸 McKinney, Texas, United States

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

NorthShore Medical Group; 🇺🇸 Evanston, Illinois, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

TriHealth Heart Institute Cardiac and Thoracic; 🇺🇸 Cincinnati, Ohio, United States

Novant Health; 🇺🇸 Winston-Salem, North Carolina, United States

Saint Thomas Research Institute; 🇺🇸 Nashville, Tennessee, United States

Virginia Cardiovascular Specialists; 🇺🇸 Richmond, Virginia, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States