ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

Not Applicable

Completed

Interventions: Device: Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system

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

Detailed Description: 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.

Recruitment & Eligibility

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:
1. Electrophysiology study for induction of ventricular arrhythmias
2. Non-invasive electrophysiology testing using an existing implantable defibrillator
3. Implantable cardioverter-defibrillator (ICD) replacement procedure during which induction of a ventricular arrhythmia is planned
4. 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

Arm && Interventions

Group	Intervention	Description
Enrolled Subjects	Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system	Adult subjects who met eligibility criteria and provided written informed consent to participate

Primary Outcome Measures

Name	Time	Method
Cumulative First and Second Shock VT/VF Conversion Rate	Through study procedure completion, average of 2 hours	The number of subjects with successful (first or second shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted using 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).

Secondary Outcome Measures

Name	Time	Method
First Shock VT/VF Conversion Rate	Through study procedure completion, average of 2 hours	The number of subjects with successful (first shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted with using 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).

Locations (4): University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Institute for Research and Innovation MultiCare Health System
🇺🇸
Tacoma, Washington, United States
Washington University St Louis
🇺🇸
Saint Louis, Missouri, United States
Alaska Cardiovascular Research Foundation, Inc.
🇺🇸
Anchorage, Alaska, United States