Jewel Electrophysiology (EP) Lab Study

NCT05490459 | Completed Results

• 1 other identifier: PR-2038
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sudden Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Clinical Effectiveness of the Jewel

  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.)

  Immediately following defibrillation with the study device.

Study Arms (1)

Treatment

EXPERIMENTAL

Safety and Effectiveness

Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Interventions

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Element Science, Inc.: lead

Study Sites (1)

Nemocnice Na Homolce Hospital

Prague, Czechia

Location

Related Publications (1)

• Chovanec M, Petru J, Hala P, Kralovec S, Thakkar AB, Mathews K, Dinger M, Ullery S, Eapen ZJ, Kumar UN, Neuzil P. First human safety and effectiveness study of defibrillation with a novel patch wearable cardioverter-defibrillator. Europace. 2024 Jul 2;26(7):euae189. doi: 10.1093/europace/euae189.

  PMID: 39001864 RESULT

Related Links

• Europace

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Zubin Eapen, MD; Michael McSweeney
• Organization: Element Science, Inc.

zubin@elementsci.com; michael@elementsci.com

(415) 872-6500; (408) 596-4531

Study Officials

• Prof. Petr Neužil, MD, PhD, FESC

  Nemocnice na Homolce Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 5, 2022
• Study Start: November 27, 2018
• Primary Completion: October 7, 2021
• Study Completion: April 17, 2024
• Last Updated: April 27, 2026
• Results First Posted: January 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)