Vivio AS (Aortic Stenosis) Algorithm Optimization Study

NCT ID: NCT04068402

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-27
• Study Completion Date: 2019-10-30

Brief Summary

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

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

Conditions

Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Vivio System

Intervention Type: DEVICE

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.

Interventions

Vivio System

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.

Intervention Type: DEVICE

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. 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

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

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

6. History of significant carotid artery disease or treatment (surgery, stenting, > 50% stenosis in both left and right carotid artery).

7. Open skin lesions at target site of Vivio examination.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avicena LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Brady, JD

Role: STUDY_DIRECTOR

Avicena LLC

Locations

Spectrum Health

Grand Rapids, Michigan, United States

Countries

United States

Other Identifiers

VS-001-AO

Identifier Type: -

Identifier Source: org_study_id