ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

Study Overview
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Brief Summary
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A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients

Detailed Description
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The objective of this study is to evaluate Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) conversion efficacy in adult human subjects using the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform.

Official Title
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ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)

Conditions
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Death, Sudden, Cardiac

Intervention / Treatment
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* Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, age ≥ 18 years Able and willing to provide written informed consent before undergoing any study-related procedures Scheduled for any of the following procedures: Electrophysiology study for induction of ventricular arrhythmias Non-invasive electrophysiology testing using an existing implantable defibrillator Implantable cardioverter-defibrillator (ICD) replacement procedure during which induction of a ventricular arrhythmia is planned Ablation of ventricular tachycardia (patients undergoing ventricular tachycardia ablation in which only a substrate modification approach is planned, with no intention of inducing a ventricular arrhythmia, should not be included) Exclusion Criteria: Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements Pregnancy Use of mechanical circulatory support (e.g. Left Ventricular Assist Device, Total Artificial Heart, intraaortic balloon pump or Impella) Documented nonchronic cardiac thrombus Atrial fibrillation or atrial flutter without therapeutic systemic anticoagulation Critical aortic stenosis Unstable coronary artery disease (CAD) Recent stroke or transient ischemic attack (TIA) Hemodynamic instability Currently implanted Boston Scientific S-ICD (due to location of implant relative to test system) Unstable angina New York Heart Association (NYHA) Class IV Left Ventricular Ejection Fraction (LVEF) < 20% Any medical condition that by the judgement of the physician investigator, patient participation in this study is not in the best interest of the patient History of difficulty of ventricular arrhythmia induction Amiodarone use within 3 months before the study procedure

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
Interventional Model Description: Multicenter single arm open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enrolled Subjects<br>Adult subjects who met eligibility criteria and provided written informed consent to participate | Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system<br>* defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative first and second shock VT/VF conversion rate | The ratio of the number of subjects with successful (first or second shock) arrhythmia conversion using the Test System to the number of total inductions attempted with shocks delivered by the Test System. A successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first or second shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF). | Through study procedure completion, average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First shock VT/VF conversion rate | The ratio of the number of subjects with successful (first shock) arrhythmia conversion using the Test System to the number of total inductions attempted with shocks delivered by the Test System. A successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF). | Through study procedure completion, average of 2 hours |