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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04310046` - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial	N/A
Completed	`NCT03332745` - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting	`NCT06008080` - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting	`NCT06055751` - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting	`NCT04815785` - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis	N/A
Terminated	`NCT02202434` - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement	N/A
Recruiting	`NCT03029026` - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting	`NCT02903420` - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)	N/A
Completed	`NCT02629328` - CardioCel Tri-leaflet Repair Study	N/A
Completed	`NCT02306226` - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Completed	`NCT01676727` - ADVANCE Direct Aortic Study
Withdrawn	`NCT01648309` - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation	N/A
Completed	`NCT01422044` - Risk Prediction in Aortic Stenosis	N/A
Withdrawn	`NCT00774657` - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography	N/A
Terminated	`NCT00535899` - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)	N/A
Terminated	`NCT05070130` - OpSens PRIME CLASS
Completed	`NCT03314857` - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population	N/A
Completed	`NCT04157920` - Impact of Predilatation Between Self-expanding Valves	N/A
Enrolling by invitation	`NCT06212050` - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting	`NCT05893082` - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR	N/A