NCT04068402

Vivio AS (Aortic Stenosis) Algorithm Optimization Study

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Avicena LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis

Detailed description

Prospective, non-randomized, single-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 1 site Enrolled subjects will undergo: Vivio system data capture, standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Vivio System	The Vivio System is an electronic auscultatory device and optical sensor, plus software application intended to provide support to the physician in the evaluation of heart sounds in patients. The product will analyze the acoustic signals of the heart and signals from a captured arterial (carotid) waveform. The analysis procedure will identify and analyze specific heart sounds and arterial waveform features captured by the Vivio device, to devise a scoring system for severe aortic stenosis.

Timeline

• Start date: 2019-06-27
• Primary completion: 2019-08-31
• Completion: 2019-10-30
• First posted: 2019-08-28
• Last updated: 2022-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study