A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD). A total of 130 adult subjects at risk for sudden cardiac arrest but otherwise protected by an Implantable Cardioverter Defibrillator (ICD) will be enrolled at 10 clinical sites in the United States. Subjects will wear the device for approximately 30 days during normal daily activities including sleep. The WCD shock alarms and shock functionality will be disabled. Shock Alarm Event Markers are recorded by the WCD and will be used for analysis of the primary outcome measure. All episodes recorded by the ASSURE WCD and/or the subject's ICD will be reviewed by independent clinical experts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
130
WCD with shock alarms and shock functionality disabled
Alaska Cardiovascular Research Foundation
Anchorage, Alaska, United States
Heart Clinic of Hammond, LA
Hammond, Louisiana, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
WCD False Positive Alarm Rate
False Shock Alarms per patient day
Time frame: 30 days
WCD True Positive Detections
WCD recorded episodes annotated as VT or VF
Time frame: 30 days
WCD Missed Events
WCD False Negative Detections
Time frame: 30 days
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University of Michigan
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Mayo Clinic
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St Louis, Missouri, United States
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University of Washington Medical Center
Seattle, Washington, United States
Institute for Research and Innovation MultiCare Health System
Tacoma, Washington, United States