Vivio AS (Aortic Stenosis) Detection Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

Prospective, non-randomized, multi-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 3 sites. Up to 10 roll-in subjects per site. Enrolled subjects will undergo: Vivio data capture, Eko stethoscope capture of heart sounds, Standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel. Recorded sounds from the FDA-approved Eko stethoscope will be presented to an independent expert physician review panel blinded to Vivio and TTE results, to compare diagnosis of severe AS using Eko (auscultation) vs. Vivio (algorithms). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04066634
Study type	Interventional
Source	Avicena LLC
Contact
Status	Completed
Phase	N/A
Start date	April 2, 2019
Completion date	October 29, 2019

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