We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

The Jewel IDE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05201495
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : May 31, 2022
Information provided by (Responsible Party):
Element Science, Inc.

Tracking Information
First Submitted Date  ICMJE January 5, 2022
First Posted Date  ICMJE January 21, 2022
Last Update Posted Date May 31, 2022
Actual Study Start Date  ICMJE January 12, 2022
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE The Jewel IDE Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sudden Cardiac Arrest
Intervention  ICMJE 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  ICMJE Experimental: Treatment
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Intervention: Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2022)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;


    2. who have a temporary or long-term contraindication to receiving an ICD, who have had an ICD removed, or who refuse an ICD


    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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zubin Eapen, M.D. (415) 872-6500 zubin@elementsci.com
Contact: Michael McSweeney (408) 596-4531 michael@elementsci.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05201495
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Element Science, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Element Science, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP