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

Study results available
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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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02825966 on ClinicalTrials.gov