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

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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest, Sudden
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Cardiovascular Research Foundation
  • Louisiana
    • Hammond, Louisiana, United States, 70403
      • Heart Clinic of Hammond, LA
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University St Louis
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Health Care
  • Ohio
    • Toledo, Ohio, United States, 43615
      • Toledo ProMedica Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Tacoma, Washington, United States, 98405
      • Institute for Research and Innovation MultiCare Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kestra Medical Technologies, Inc.
• Collaborators: Regulatory and Clinical Research Institute Inc
• Investigators: Principal Investigator: Jeanne E. Poole, MD, University of Washington Medical Center, Seattle

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): June 18, 2019

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: 3324582_B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No