Jewel Electrophysiology (EP) Lab Study | Clinical Trial

Key information

Conditions

Sudden Cardiac Arrest Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemocnice Na Homolce Hospital

Prague, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
Subjects who are allergic to or have had a known adverse reaction to medical adhesives.
Subjects who have active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the study device is applied.
Subjects with a lower abdomen circumference of less than 68.5 cm or greater than 142 cm.
Females who are pregnant or breastfeeding, or planning to be pregnant in the next 12 months.
Subjects who cannot provide or have diminished capacity to provide informed consent.
Any condition that an Investigator believes would interfere with the intent of the study or is not in the best interest of the patient.
Any patient that according to the Declaration of Helsinki is unsuitable for enrollment.

Treatment and study plan

Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Device

Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.

Primary outcomes

Clinical Effectiveness of the Jewel

Time frame: Immediately following defibrillation with the study device.

The count of participants with successful single shock terminations of life-threatening VT or VF. (The endpoint would be achieved if the lower confidence limit exceeds the performance goal of 62% using a one-sided exact lower 97.4% confidence bound at one of three testing points.)

Sponsors and collaborators

Lead sponsor

Element Science, Inc.

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2024
First posted: Aug 5, 2022
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed