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Vivio AS (Aortic Stenosis) Detection Study

NCT04066634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-08-02

No results posted yet for this study

Summary

Evaluate the sensitivity and specificity of the Vivio System when used as an aid in the identification of heart sounds associated with severe aortic stenosis.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Vivio System

The Vivio Analysis Software is an analysis software that assists in identifying suspected systolic murmurs associated with aortic stenosis. The Vivio Analysis Software is used with the Vivio System, a non-invasive device used for the detection and amplification of sounds from the heart and arteries.

Sponsors & Collaborators

  • Avicena LLC

    lead INDUSTRY

Principal Investigators

  • Sean Brady, JD · Avicena LLC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2019-10-29
Completion
2019-10-29
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04066634 on ClinicalTrials.gov