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NCT04292405 Clinical Trial

Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

Heart Failure Clinical Trial

— ACAB  

Official title:
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04292405
Other study ID # 90d0214
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 23, 2020
Est. completion date May 31, 2024

Study information
Verified date August 2023
Source Zoll Medical Corporation
Contact Jennifer D Dean, MS
Phone 4129683333
Email jdean@zoll.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date May 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States MAYO Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary CABs comparison Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared 2 hours
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