NCT03887052

ASSURE WCD Clinical Evaluation - Detection and Safety Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Kestra Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cardiac Arrest, Sudden

Interventions

Type	Name	Description
DEVICE	ASSURE™ Wearable Cardioverter Defibrillator (WCD)	WCD with shock alarms and shock functionality disabled

Timeline

• Start date: 2019-03-20
• Primary completion: 2019-06-18
• Completion: 2019-06-18
• First posted: 2019-03-22
• Last updated: 2024-03-12
• Results posted: 2023-10-26

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study