CompletedNot Applicable

Jewel Electrophysiology (EP) Lab Study

Czechia18 participantsStarted 2018-11-27

Plain-language summary

Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.

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.

✓. Subjects of both genders of at least 18 years of age.
✓. Subjects who are scheduled for a standard EP clinical procedure where fast VT or VF may spontaneously occur or may be induced.

✕. Subjects who may require sterile access to the right upper pectoral or lower left torso regions during the planned EP procedure.
✕. Subjects who have taken amiodarone in the past 3 months.
✕. Subjects with an existing unipolar pacemaker.
✕. Subjects who exhibit a left ventricular ejection fraction (LVEF) less than 20% (as assessed by techniques such as echocardiography, magnetic resonance imaging, or radionuclide angiography) within the last 6 months.
✕. Subjects who have been diagnosed with heart failure (Class IV) or experienced an acute heart failure exacerbation within the previous 30 days.
✕. Subjects who exhibit unstable angina.
✕. Subjects with atrial fibrillation with contraindication to anticoagulation or improper anticoagulation management.
✕. Subjects who are participating in an investigational study of a drug, biologic, or device not currently approved for marketing.

Clinical Effectiveness of the Jewel

Timeframe: Immediately following defibrillation with the study device.

NCT IDNCT05490459

SponsorElement Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-07

Results submitted2024-09-04