Rapid Non-invasive Detection of Aortic Stenosis

NCT04024566 | Withdrawn

• 1 other identifier: AS20192
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

echocardiography

Outcome Measures

Primary Outcomes (1)

• Optimized algorithm for diagnosis of AS

  Data collected in this study will be analyzed by multiple mathematical approaches to develop an optimized algorithm for detection of severe AS

  2 years

Secondary Outcomes (1)

• Positive predictive value (PPV) of Vivio in the diagnosis of severe AS

  2 years

Interventions

Vivio System DEVICE

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

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe, symptomatic AS incidence increases with age, so that most patients do not experience symptoms until after age 60. For this reason, to enrich for the population of patients with potential AS, subjects over age 65 will be studied.

You may qualify if:

• Adult subjects \>60 years of age
• Ability to understand and sign informed consent
• Willingness to undergo study protocol (in Pasadena CA)

You may not qualify if:

• Inability to provide informed consent
• History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck)
• History of significant or symptomatic carotid artery disease, or carotid artery stenting or surgery
• History of aortic valve surgery or transcatheter aortic valve replacement
• Absent carotid pulse on initial examination (inability to palpate the carotid pulse)
• Open skin lesions at the site of Vivio application/examination
• Presence of a carotid bruit on examination

Sponsors & Collaborators

• Avicena LLC: lead

Study Sites (1)

Avicena

Pasadena, California, 91105, United States

Location

Related Publications (1)

• Ahmed AK, Garberich R, Gossl M, Tindell L, Williams K, Dennis S, Bae R, Soraja P. A novel method of non-invasive screening for patients with aortic stenosis. JACC March 12, 2019, 73 (9 Supplement 1) 1995; DOI:10.1016/S0735-1097(19)32601-4

  BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Disease; Heart Murmurs

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sean Brady, JD

  Chief Executive Officer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: August 14, 2019
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: July 20, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)