Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study
Completed · Not applicable
Conditions studied: Heart Failure
In brief
A prospective, validation study to evaluate the data accuracy of heart sounds recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD). These data will be compared with the heart sounds data recorded by an FDA-cleared device AUDICOR AM device.
Key facts
- Study ID
- NCT02825966
- Run by
- Zoll Medical Corporation
- People needed
- 35
- Starts
- 2016-02-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2020-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and female volunteers who are able to fit in the WCD garment (26 to 56 inches measured circumferentially at the level of the xiphoid process).
- Included in this group are at least five healthy subjects with a self-reported history of heart failure.
- The subject must be 18 years of age or older on the day of screening, with at least 7 subjects 40 years of age or older on the day of screening.
You may not qualify if…
- Mental, visual, physical, literacy, and auditory limitations that prevent interaction with the WCD equipment.
- Any acute medical conditions that prevent the following maneuvers: lying on back, lying on the right and left side, standing, sitting, and/ or leaning forward when sitting.
- Any self-reported shortness of breath, fatigue, swelling of feet, ankles, or legs, and/or chest pain
- Employees or family members of the sponsor.
- Unable or unwilling to provide written informed consent.
Where it is running
- MedPace Phase 1 Clinic — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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