Jewel Electrophysiology (EP) Lab Study

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

Detailed Description
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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.

Official Title
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Jewel Electrophysiology (EP) Lab Study

Conditions
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Sudden Cardiac Arrest

Intervention / Treatment
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* Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |