ASSURE WCD Clinical Evaluation - Detection and Safety Study

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.

Inclusion Criteria:

1. Males or females, age ≥ 18 years

2. Patients with an active Implantable Cardioverter Defibrillator (ICD)

3. Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12
months) by echocardiography, nuclear imaging (including MRI), or left ventricular
angiography

4. Able and willing to provide written informed consent before undergoing any
study-related procedures

Exclusion Criteria:

1. 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

2. Any known skin allergy or sensitivity to the study garment materials that will be next
to the skin

3. Any breached or compromised skin on the upper body that would be exacerbated by
wearing the study garment

4. Work with or are frequently around equipment that produces high electromagnetic
fields, for example magnetic resonance imaging devices, power supply facilities, or
welding equipment

5. 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

6. Any planned air travel during the participation period

7. Pregnancy

8. Use of mechanical circulatory support, including but not limited to Left Ventricular
Assist Device (LVAD) or Total Artificial Heart

9. Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D)

10. Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry
(MCOT), Event Recorder, or in-hospital telemetry

11. 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.

12. Under bust chest circumference greater than 52 inches or less than 28 inches

13. Current hospital inpatient