Vivio AS (Aortic Stenosis) Detection Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-02

Study Completion Date

2019-10-29

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Assist in Diagnosis

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.

Group Type EXPERIMENTAL

Vivio System

Intervention Type DEVICE

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.

Interventions

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Vivio System

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.

Intervention Type DEVICE

Other Intervention Names

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Electronic stethoscope

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes