N/A
Completed N=35
Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study
Source: ClinicalTrials.gov NCT02825966 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System. — 95.88; 96.98; 98.25 ms — p=< 0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System. |
95.88; 96.98; 98.25 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02825966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.