Jewel Electrophysiology (EP) Lab Study

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Treatment
    • Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Element Science, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Prof. Petr Neužil, MD, PhD, FESC, Principal Investigator, Nemocnice na Homolce Hospital

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