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Rapid Non-invasive Detection of Aortic Stenosis

NCT04024566 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-07-20

No results posted yet for this study

Summary

Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.

Conditions

  • Heart Valve Diseases
  • Aortic Valve Disease
  • Heart Murmurs

Interventions

DEVICE

Vivio System

Optical/sensor tonometer applied to the neck over the carotid pulse (bilateral)

Sponsors & Collaborators

  • Avicena LLC

    lead INDUSTRY

Principal Investigators

  • Sean Brady, JD · Chief Executive Officer

Eligibility

Min Age
60 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-14
Primary Completion
2022-07-18
Completion
2022-07-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04024566 on ClinicalTrials.gov