Vivio AS (Aortic Stenosis) Algorithm Optimization Study

Not Applicable

Withdrawn

• Conditions: Aortic Stenosis
• Interventions: Device: Vivio System

• Registration Number: NCT04068402
• Lead Sponsor: Avicena LLC

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

Study Timeline

• Study Start: 2019-06-27
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-28
• Primary Completion: 2019-08-31
• Study Completion: 2019-10-30
• Status Verified: 2021-01
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Vivio System	-

Primary Outcome Measures

Name	Time	Method
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.	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study	48 hours	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.

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States