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Jewel Electrophysiology (EP) Lab Study | Clinical Trials | Clareo Health

COMPLETEDNA

Jewel Electrophysiology (EP) Lab Study

NCT05490459•Element Science, Inc.

Summary

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

Detailed Description

The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel, using a single transthoracic defibrillation shock to terminate life-threatening VT or VF.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Subjects who may require sterile access to the right upper pectoral or lower left torso regions during the planned EP procedure.
•2. Subjects who have taken amiodarone in the past 3 months.
•3. Subjects with an existing unipolar pacemaker.
•4. 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.
•5. Subjects who have been diagnosed with heart failure (Class IV) or experienced an acute heart failure exacerbation within the previous 30 days.
•6. Subjects who exhibit unstable angina.
•7. Subjects with atrial fibrillation with contraindication to anticoagulation or improper anticoagulation management.
•8. Subjects who are participating in an investigational study of a drug, biologic, or device not currently approved for marketing.
•9. Subjects who are allergic to or have had a known adverse reaction to medical adhesives.
•10. Subjects who have active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the study device is applied.
+5 more criteria

Locations (1)

Nemocnice Na Homolce Hospital

Prague, Czechia

Key Dates

Start Date

November 27, 2018

Primary Completion Date

October 7, 2021

Completion Date

April 17, 2024

Last Updated

January 6, 2025

Enrollment

ACTUAL participants

Conditions

Sudden Cardiac Arrest

Interventions

Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

DEVICE

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Sudden Cardiac Arrest

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ENROLLING_BY_INVITATION

Hearts in Rhythm Organization (HiRO)National Registry and Bio Bank

NCT04189822

Sudden Cardiac ArrestSudden Arrhythmic Death Syndrome+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Jewel Electrophysiology (EP) Lab Study

Inclusion Criteria

Exclusion Criteria

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