Vivio AS (Aortic Stenosis) Algorithm Optimization Study

NCT04068402 | Withdrawn FDA Device

• 1 other identifier: VS-001-AO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study

  48 hours

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Vivio System

Interventions

Vivio System 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.

Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avicena LLC: lead

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Sean Brady, JD

  Avicena LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking required
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 28, 2019
• Study Start: June 27, 2019
• Primary Completion: August 31, 2019
• Study Completion: October 30, 2019
• Last Updated: July 20, 2022

Record last verified: 2021-01

Locations

US (1)