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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887052
Recruitment Status : Active, not recruiting
First Posted : March 22, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Regulatory and Clinical Research Institute Inc
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Cardiac Arrest, Sudden Device: ASSURE™ Wearable Cardioverter Defibrillator (WCD) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter single arm open label evaluation
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 15, 2020

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




Primary Outcome Measures :
  1. WCD False Positive Alarm Rate [ Time Frame: 30 days ]
    False Shock Alarms per patient day


Secondary Outcome Measures :
  1. WCD True Positive Detections [ Time Frame: 30 days ]
    WCD recorded episodes annotated as VT or VF

  2. WCD Missed Events [ Time Frame: 30 days ]
    WCD False Negative Detections

  3. Estimated WCD Inappropriate Shock Rate [ Time Frame: 30 days ]
    Product of the WCD False Positive Alarm Rate and the missed Shock Alarm Rate

  4. Adverse Events [ Time Frame: 30 days ]
    Those at least possibly related to use of the WCD



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887052


Locations
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United States, Alaska
Alaska Cardiovascular Research Foundation
Anchorage, Alaska, United States, 99508
United States, Louisiana
Heart Clinic of Hammond, LA
Hammond, Louisiana, United States, 70403
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University St Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper University Health Care
Camden, New Jersey, United States, 08103
United States, Ohio
Toledo ProMedica Hospital
Toledo, Ohio, United States, 43615
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Institute for Research and Innovation MultiCare Health System
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Kestra Medical Technologies, Inc.
Regulatory and Clinical Research Institute Inc
Investigators
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Principal Investigator: Jeanne E. Poole, MD University of Washington Medical Center, Seattle

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Responsible Party: Kestra Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03887052    
Other Study ID Numbers: 3324582_B
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes