Clinical trial NCT04066634: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Avicena LLC
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System
timeFrame: 48 Hours
Secondary outcomes:
measure: Secondary Endpoint 1 - Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.
timeFrame: 48 Hours
measure: Secondary Endpoint 2 - Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.
timeFrame: 48 Hours
measure: Secondary Endpoint 3 - Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).
timeFrame: 48 Hours
measure: Secondary Endpoint 4 - Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe).
timeFrame: 48 Hours
Other outcomes:
measure: Ancillary Endpoint - Incidence of Adverse Events
timeFrame: 48 Hours
Locations:
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Avicena LLC
name: Sean Brady, JD
role: STUDY_DIRECTOR
References: