Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
Recruiting
- Conditions
- Heart Failure
- Interventions
- Device: Wearable Cardioverter Defibrillator
- Registration Number
- NCT04292405
- Lead Sponsor
- Zoll Medical Corporation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Heart Failure Patients Wearable Cardioverter Defibrillator Simultaneous recordings of cardiac acoustic biomarkers (CABs) by the Wearable Cardioverter Defibrillator and the AUDICOR AM
- Primary Outcome Measures
Name Time Method CABs comparison 2 hours Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MAYO Clinic
🇺🇸Rochester, Minnesota, United States