The Jewel IDE Study

• ClinicalTrials.gov Identifier: NCT05201495
• Recruitment Status: Recruiting
• First Posted: January 21, 2022
• Last Update Posted: May 31, 2022
• Sponsor: Element Science, Inc.
• Information provided by (Responsible Party): Element Science, Inc.

Tracking Information

• First Submitted Date: January 5, 2022
• First Posted Date: January 21, 2022
• Last Update Posted Date: May 31, 2022
• Actual Study Start Date: January 12, 2022
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 7, 2022)

• Inappropriate Shock Rate [ Time Frame: Prescription Period (~40 to 90 days, anticipated) ]
  Inappropriate shocks per 100 patient-months
• Cutaneous Adverse Device Effects [ Time Frame: Prescription Period (~40 to 90 days, anticipated) ]
  Rate of subjects experiencing clinically significant cutaneous Adverse Device Effects

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Jewel IDE Study
• Official Title: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.

Study Arms

Experimental: Treatment

Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Intervention: Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 7, 2022): 290
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Zubin Eapen, M.D.; (415) 872-6500; zubin@elementsci.com

Contact: Michael McSweeney; (408) 596-4531; michael@elementsci.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05201495
• Other Study ID Numbers: PR-2053
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Element Science, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Element Science, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Element Science, Inc.
• Verification Date: May 2022