Vivio AS (Aortic Stenosis) Algorithm Optimization Study

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04068402
• Other study ID #: VS-001-AO
• Status: Withdrawn
• Phase: N/A
• Start date: June 27, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2021
• Source: Avicena LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Avicena LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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