Status:
TERMINATED
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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 C...
Eligibility Criteria
Inclusion
- 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
- implanted left ventricular assist device
- pacemaker dependency
- currently hospitalized
- atrial fibrillation on their last ECG or having an irregularly irregular pulse
Key Trial Info
Start Date :
January 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04292405
Start Date
January 23 2020
End Date
September 30 2025
Last Update
October 30 2025
Active Locations (1)
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1
MAYO Clinic
Rochester, Minnesota, United States, 55905