Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04292405

Acronym

ACAB

Enrollment

Registered

2020-03-03

Start date

2020-01-23

Completion date

2025-09-30

Last updated

2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

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.

Interventions

DEVICEWearable Cardioverter Defibrillator

Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
CABs comparison	2 hours	Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026