Clinical trial NCT03887052: ASSURE WCD Clinical Evaluation - Detection and Safety Study
Official title: ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest, Sudden
Lead sponsor: Kestra Medical Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Regulatory and Clinical Research Institute Inc
First posted: 2019-03-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter single arm open label evaluation
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: WCD False Positive Alarm Rate
timeFrame: 30 days
Secondary outcomes:
measure: WCD True Positive Detections
timeFrame: 30 days
measure: WCD Missed Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Cardiovascular Research Foundation
state: Alaska
city: Hammond
country: United States
facility: Heart Clinic of Hammond, LA
state: Louisiana
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University St Louis
state: Missouri
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
city: Toledo
country: United States
facility: Toledo ProMedica Hospital
state: Ohio
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Tacoma
country: United States
facility: Institute for Research and Innovation MultiCare Health System
state: Washington
Study officials:
affiliation: University of Washington Medical Center, Seattle
name: Jeanne E. Poole, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poole JE, Gleva MJ, Birgersdotter-Green U, Branch KRH, Doshi RN, Salam T, Crawford TC, Willcox ME, Sridhar AM, Mikdadi G, Beinart SC, Cha YM, Russo AM, Rowbotham RK, Sullivan J, Gustavson LM, Kivilaid K. A wearable cardioverter defibrillator with a low false alarm rate. J Cardiovasc Electrophysiol. 2022 May;33(5):831-842. doi: 10.1111/jce.15417. Epub 2022 Feb 28.