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

Primary Purpose

Cardiac Arrest, Sudden

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASSURE™ Wearable Cardioverter Defibrillator (WCD)
Sponsored by
Kestra Medical Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrest, Sudden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Cardiovascular Research Foundation
  • Heart Clinic of Hammond, LA
  • Washington Adventist Hospital
  • University of Michigan
  • Mayo Clinic
  • Washington University St Louis
  • Cooper University Health Care
  • Toledo ProMedica Hospital
  • University of Washington Medical Center
  • Institute for Research and Innovation MultiCare Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm

Arm Description

Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD)

Outcomes

Primary Outcome Measures

WCD False Positive Alarm Rate
False Shock Alarms per patient day

Secondary Outcome Measures

WCD True Positive Detections
WCD recorded episodes annotated as VT or VF
WCD Missed Events
WCD False Negative Detections
Estimated WCD Inappropriate Shock Rate
Product of the WCD False Positive Alarm Rate and the missed Shock Alarm Rate
Adverse Events
Those at least possibly related to use of the WCD

Full Information

First Posted
March 19, 2019
Last Updated
September 1, 2020
Sponsor
Kestra Medical Technologies, Inc.
Collaborators
Regulatory and Clinical Research Institute Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03887052
Brief Title
ASSURE WCD Clinical Evaluation - Detection and Safety Study
Acronym
ACE-DETECT
Official Title
ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
June 18, 2019 (Actual)
Study Completion Date
June 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kestra Medical Technologies, Inc.
Collaborators
Regulatory and Clinical Research Institute Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Sudden

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter single arm open label evaluation
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Adult cardiac patients at risk for sudden cardiac arrest otherwise protected with an Implantable Cardioverter Defibrillator (ICD)
Intervention Type
Device
Intervention Name(s)
ASSURE™ Wearable Cardioverter Defibrillator (WCD)
Intervention Description
WCD with shock alarms and shock functionality disabled
Primary Outcome Measure Information:
Title
WCD False Positive Alarm Rate
Description
False Shock Alarms per patient day
Time Frame
30 days
Secondary Outcome Measure Information:
Title
WCD True Positive Detections
Description
WCD recorded episodes annotated as VT or VF
Time Frame
30 days
Title
WCD Missed Events
Description
WCD False Negative Detections
Time Frame
30 days
Title
Estimated WCD Inappropriate Shock Rate
Description
Product of the WCD False Positive Alarm Rate and the missed Shock Alarm Rate
Time Frame
30 days
Title
Adverse Events
Description
Those at least possibly related to use of the WCD
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females, age ≥ 18 years Patients with an active Implantable Cardioverter Defibrillator (ICD) Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography Able and willing to provide written informed consent before undergoing any study-related procedures Exclusion Criteria: 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 Any known skin allergy or sensitivity to the study garment materials that will be next to the skin Any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment 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 Any planned air travel during the participation period Pregnancy Use of mechanical circulatory support, including but not limited to Left Ventricular Assist Device (LVAD) or Total Artificial Heart Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D) Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry 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. Under bust chest circumference greater than 52 inches or less than 28 inches Current hospital inpatient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne E. Poole, MD
Organizational Affiliation
University of Washington Medical Center, Seattle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Cardiovascular Research Foundation
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Heart Clinic of Hammond, LA
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper University Health Care
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Toledo ProMedica Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Institute for Research and Innovation MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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ASSURE WCD Clinical Evaluation - Detection and Safety Study

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