CompletedNot Applicable

The Jewel IDE Study

United States322 participantsStarted 2022-01-12

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients of any gender aged ≥ 18 years.
. Patients with either:
. 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;
. who have a temporary or long-term contraindication to receiving an ICD, who have had an ICD removed, or who refuse an ICD
. whose ICD implantation is delayed due to COVID-19 infection or exposure- related risks

Exclusion criteria

. Member of a vulnerable patient population as defined in ISO 14155;
. Life expectancy of less than one year, including end-stage heart failure, cancer, or other diagnosed condition;
. Patients with an anticipated initial prescription period over 180 days (limitation only to allow timely closure of this clinical trial);
. Patients with an advanced directive prohibiting resuscitation;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Inappropriate Shock Rate

Timeframe: Prescription Period during which each patient wore the Jewel up to 180 days.

Cutaneous Adverse Device Effects

Timeframe: Prescription Period during which each patient wore the Jewel up to 180 days.

Trial details

NCT IDNCT05201495

SponsorElement Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-10

Results submitted2024-08-01

View on ClinicalTrials.gov More Sudden Cardiac Arrest trials