Heart Failure Clinical Trial
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
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.
Full 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 Criteria
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
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