Vivio AS (Aortic Stenosis) Algorithm Optimization Study

Avicena

Status

Withdrawn

Conditions

Aortic Stenosis

Treatments

Device: Vivio System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04068402

VS-001-AO

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult subjects (21 years of age or older).
Referred for transthoracic echocardiography by physician/primary care provider/cardiologist.
Willing and able to participate in all study evaluations and allow access to medical testing and records.
Ability to understand and sign an informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.

Exclusion criteria

Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support.
Need for bedside echocardiogram (inpatient).
Prosthetic device previously implanted at aortic valve position.
Inability to palpate carotid pulse
History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).
History of significant carotid artery disease or treatment (surgery, stenting, > 50% stenosis in both left and right carotid artery).
Open skin lesions at target site of Vivio examination.