Rapid Non-invasive Detection of Aortic Stenosis
Withdrawn before enrolling
Conditions studied: Heart Valve Diseases, Aortic Valve Disease, Heart Murmurs
In brief
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.
Key facts
- Study ID
- NCT04024566
- Run by
- Ventric Health, LLC
- People needed
- 0
- Starts
- 2019-08-14
- Expected to finish
- 2022-07-18
- Last updated by the study team
- 2022-07-20
Who can join
Age: 60 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Avicena — Pasadena, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.