Jewel Electrophysiology (EP) Lab Study

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Sudden Cardiac Arrest
• Intervention / Treatment: Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Detailed Description

The objective of this study is to demonstrate the safety and clinical effectiveness of the Jewel EP Lab System in terminating life-threatening VT or VF with a single transthoracic defibrillation shock.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Nemocnice Na Homolce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
11. Subjects with a lower abdomen circumference of less than 68.5 cm or greater than 142 cm.
12. Females who are pregnant or breastfeeding, or planning to be pregnant in the next 12 months.
13. Subjects who cannot provide or have diminished capacity to provide informed consent.
14. Any condition that an Investigator believes would interfere with the intent of the study or is not in the best interest of the patient.
15. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)	Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD); Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Effectiveness of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)	Percent of successful terminations of life-threatening VT or VF	Immediately following defibrillation with the study device

Collaborators and Investigators

• Sponsor: Element Science, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: PR-2038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No