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")

Age range18 Years

SexALL

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

✓. 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

✕. 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;
✕. Existing ICD;
✕. Existing unipolar pacemaker;
✕. 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;
✕. 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;

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.

NCT IDNCT05201495

SponsorElement Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-10

Results submitted2024-08-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

✓. 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

✕. 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;
✕. Existing ICD;
✕. Existing unipolar pacemaker;
✕. 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;
✕. 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;