Clinical trial NCT05201495: The Jewel IDE Study
Official title: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Arrest
Lead sponsor: Element Science, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Inappropriate Shock Rate
timeFrame: Prescription Period during which each patient wore the Jewel up to 180 days.
measure: Cutaneous Adverse Device Effects
timeFrame: Prescription Period during which each patient wore the Jewel up to 180 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: St. Bernard's Heart and Vascular
state: Arkansas
city: Little Rock
country: United States
facility: Cardiology and Medicine Clinic, P.A.
state: Arkansas
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Fuqua Heart Center Piedmont Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore Medical Group
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Presbyterian Brooklyn Methodist Hospital
state: New York
city: Middletown
country: United States
facility: Crystal Run Healthcare - Circuit - PPDS
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Winston-Salem
country: United States
facility: Novant Health
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth Heart Institute Cardiac and Thoracic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Memphis
country: United States
facility: Methodist Le Bonheur
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: McKinney
country: United States
facility: ACRC Trials - Hunt - PPDS
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
Study officials:
affiliation: University of Mississippi Medical Center
name: Javed Butler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: John Hummel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Roxana Mehran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: