ACAB: Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Heart Failure Patients Simultaneous recordings of cardiac acoustic biomarkers (CABs) by the Wearable Cardioverter Defibrillator and the AUDICOR AM |
Device: Wearable Cardioverter Defibrillator
Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.
Other Names:
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Outcome Measures
Primary Outcome Measures
- CABs comparison [2 hours]
Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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heart failure or a history of heart failure
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ischemic or non-ischemic cardiomyopathy
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ejection Fraction less than or equal to 40% as measured within the last 6 months
Exclusion Criteria:
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implanted left ventricular assist device
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pacemaker dependency
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currently hospitalized
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atrial fibrillation on their last ECG or having an irregularly irregular pulse
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | MAYO Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Zoll Medical Corporation
Investigators
- Study Director: Mike Osz, Director, Clinical Operations, ZOLL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 90d0214