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ACAB: Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

Sponsor
Zoll Medical Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04292405
Collaborator
(none)
60
Enrollment
1
Location
38.2
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder.

Condition or Disease Intervention/Treatment Phase
  • Device: Wearable Cardioverter Defibrillator

Detailed Description

Single arm, prospective, non significant risk device study to evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) compared with the CABs data simultaneously recorded by an acoustic cardiography recorder, the AUDICOR AM device.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
Actual Study Start Date :
Jan 23, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Heart Failure Patients

Simultaneous recordings of cardiac acoustic biomarkers (CABs) by the Wearable Cardioverter Defibrillator and the AUDICOR AM

Device: Wearable Cardioverter Defibrillator
Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.
Other Names:
  • AUDICOR AM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CABs comparison [2 hours]

      Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 18 years of age or older

    • heart failure or a history of heart failure

    • ischemic or non-ischemic cardiomyopathy

    • ejection Fraction less than or equal to 40% as measured within the last 6 months

    Exclusion Criteria:

    • implanted left ventricular assist device

    • pacemaker dependency

    • currently hospitalized

    • atrial fibrillation on their last ECG or having an irregularly irregular pulse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MAYO Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Zoll Medical Corporation

    Investigators

    • Study Director: Mike Osz, Director, Clinical Operations, ZOLL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zoll Medical Corporation
    ClinicalTrials.gov Identifier:
    NCT04292405
    Other Study ID Numbers:
    • 90d0214
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Feb 22, 2022