Vivio AS (Aortic Stenosis) Algorithm Optimization Study

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Optimization of the Vivio System Algorithm as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: Vivio System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Vivio System<br>* The Vivio System is an electronic auscultatory device and optical sensor, plus software application intended to provide support to the physician in the evaluation of heart sounds in patients. The product will analyze the acoustic signals of the heart and signals from a captured arterial (carotid) waveform. The analysis procedure will identify and analyze specific heart sounds and arterial waveform features captured by the Vivio device, to devise a scoring system for severe aortic stenosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint - Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis. | Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study | Incidence of Adverse Events: Summary of all reported adverse events during the study. Events will be summarized by seriousness (e.g. serious vs. non-serious), attribution (e.g. device vs. procedure vs. comorbidity) based upon site reported data. | 48 hours |