ASSURE WCD Clinical Evaluation - Detection and Safety Study

Not Applicable

Completed

• Conditions: Cardiac Arrest, Sudden
• Interventions: Device: ASSURE™ Wearable Cardioverter Defibrillator (WCD)

• Registration Number: NCT03887052
• Lead Sponsor: Kestra Medical Technologies, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-19
• Study Start: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Primary Completion: 2019-06-18
• Study Completion: 2019-06-18
• Disposition First Submitted: 2020-05-06
• Results First Submitted: 2022-03-25
• Results First Submitted QC: 2023-10-02
• Results First Posted: 2023-10-26
• Disposition First Posted: 2023-10-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm	ASSURE™ Wearable Cardioverter Defibrillator (WCD)	Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD)

Primary Outcome Measures

Name	Time	Method
WCD False Positive Alarm Rate	30 days	False Shock Alarms per patient day

Secondary Outcome Measures

Name	Time	Method
WCD True Positive Detections	30 days	WCD recorded episodes annotated as VT or VF
WCD Missed Events	30 days	WCD False Negative Detections

Trial Locations

Locations (10)

Cooper University Health Care; 🇺🇸 Camden, New Jersey, United States

Alaska Cardiovascular Research Foundation; 🇺🇸 Anchorage, Alaska, United States

Heart Clinic of Hammond, LA; 🇺🇸 Hammond, Louisiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington Adventist Hospital; 🇺🇸 Takoma Park, Maryland, United States

Washington University St Louis; 🇺🇸 Saint Louis, Missouri, United States

Toledo ProMedica Hospital; 🇺🇸 Toledo, Ohio, United States

Institute for Research and Innovation MultiCare Health System; 🇺🇸 Tacoma, Washington, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States