NCT04066634

Vivio AS (Aortic Stenosis) Detection Study

Assessment of the Vivio System as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Avicena LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-02
• Primary completion: 2019-10-29
• Completion: 2019-10-29
• First posted: 2019-08-26
• Last updated: 2021-08-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study