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Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

Recruiting
18 years and older
All
Phase N/A

Overview

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.

Eligibility

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

Study details
    Heart failure
    Heart failure
    Heart disease
    Heart disease

NCT04292405

Zoll Medical Corporation

16 February 2024

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