Vivio AS (Aortic Stenosis) Detection Study
Vivio AS (Aortic Stenosis) Detection Study
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.
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).
Inclusion Criteria:

 1. Adult subjects (21 years of age or older).

 2. Referred for transthoracic echocardiography by physician/primary care
 provider/cardiologist.

 3. Willing and able to participate in all study evaluations and allow access to medical
 testing and records.

 4. Signed informed consent or have a legally authorized representative who provides
 informed consent on behalf of the subject.

 Exclusion Criteria:

 1. Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical
 circulatory support.

 2. Need for bedside echocardiogram (inpatient).

 3. Prosthetic device previously implanted at aortic valve position.

 4. Inability to palpate carotid pulse (e.g. due to severe obesity)

 5. History of carotid sinus hypersensitivity (i.e. fainting in response to touching or
 positioning the neck).

 6. History of carotid artery disease or treatment (e.g. unstable carotid plaques that
 might rupture upon massage or endarterectomy).

 7. Open skin lesions at target site of electronic stethoscope/Vivio device examination.