Brief Title
Vivio AS (Aortic Stenosis) Detection Study
Official Title
Assessment of the Vivio System as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
Brief 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).
Study Type
Interventional
Primary Outcome
Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System
Secondary Outcome
Secondary Endpoint 1 - Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.
Condition
Aortic Stenosis
Intervention
Vivio System
Study Arms / Comparison Groups
Assist in Diagnosis
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
200
Start Date
April 2, 2019
Completion Date
October 29, 2019
Primary Completion Date
October 29, 2019
Eligibility Criteria
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.
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Sean Brady, JD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04066634
Organization ID
VS-001-AS
Responsible Party
Sponsor
Study Sponsor
Avicena LLC
Study Sponsor
Sean Brady, JD, Study Director, Avicena LLC
Verification Date
January 2021