A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator
Alaska Cardiovascular Research Foundation, Inc.
Anchorage, Alaska, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University St Louis
St Louis, Missouri, United States
Institute for Research and Innovation MultiCare Health System
Tacoma, Washington, United States
Cumulative First and Second Shock VT/VF Conversion Rate
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).
Time frame: Through study procedure completion, average of 2 hours
First Shock VT/VF Conversion Rate
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).
Time frame: Through study procedure completion, average of 2 hours
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