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.

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

. 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.

Exclusion criteria

. 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.

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

Clinical Effectiveness of the Jewel

Timeframe: Immediately following defibrillation with the study device.

Trial details

NCT IDNCT05490459

SponsorElement Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-07

Results submitted2024-09-04

View on ClinicalTrials.gov More Sudden Cardiac Arrest trials