Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study
NCT02825966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2020-12-02
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.
Conditions
Interventions
- DEVICE
-
AUDICOR then LifeVest then AUDICOR
Wearable Cardioverter Defibrillator to record acoustic cardiograph signals.
Sponsors & Collaborators
-
Zoll Medical Corporation
lead INDUSTRY
Principal Investigators
-
Steve Szymkiewicz, MD · VP Medical Affairs
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2016-03-31
- Completion
- 2016-03-31
Countries
- United States
Study Locations
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