ASSURE WCD Clinical Evaluation - Detection and Safety Study

Study Overview
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Brief Summary
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A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).

Detailed Description
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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.

Official Title
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ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)

Conditions
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Cardiac Arrest, Sudden

Intervention / Treatment
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* Device: ASSURE™ Wearable Cardioverter Defibrillator (WCD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, age ≥ 18 years Patients with an active Implantable Cardioverter Defibrillator (ICD) Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography Able and willing to provide written informed consent before undergoing any study-related procedures Exclusion Criteria: Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements, including cognitive and/or physical limitations that would prevent the subject from interacting with the device as intended Any known skin allergy or sensitivity to the study garment materials that will be next to the skin Any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment Any planned surgical or medical procedures during the participation period that would require the subject to remove the study device for more than 12 hours Any planned air travel during the participation period Pregnancy Use of mechanical circulatory support, including but not limited to Left Ventricular Assist Device (LVAD) or Total Artificial Heart Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D) Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry Use of any electronic medical device that is worn on or near the body requires Sponsor approval, other than continuous positive airway pressure (CPAP), continuous blood glucose monitor, or pulse oximeter oxygen saturation (SpO2) monitor. Under bust chest circumference greater than 52 inches or less than 28 inches Current hospital inpatient

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter single arm open label evaluation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD) | Device: ASSURE™ Wearable Cardioverter Defibrillator (WCD)<br>* WCD with shock alarms and shock functionality disabled<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WCD False Positive Alarm Rate | False Shock Alarms per patient day | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WCD True Positive Detections | WCD recorded episodes annotated as VT or VF | 30 days | 
| WCD Missed Events | WCD False Negative Detections | 30 days |