Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Zoll Medical Corporation
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Updated on 19 February 2024
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ejection fraction
cardiomyopathy

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.

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.

Details
Condition Heart failure, Heart failure, Heart disease, Heart disease
Age 18years - 100years
Treatment Wearable Cardioverter Defibrillator
Clinical Study IdentifierNCT04292405
SponsorZoll Medical Corporation
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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