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

ZOLL Medical

Status: Terminated

Conditions: Heart Failure

Treatments: Device: Wearable Cardioverter Defibrillator

Study type: Observational

Funder types: Industry

Identifiers

NCT04292405

90d0214

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Heart Failure Patients

Description:

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

Treatment:

Device: Wearable Cardioverter Defibrillator