Clinical trial NCT04024566: Rapid Non-invasive Detection of Aortic Stenosis
Official title: Aortic Stenosis Screening Using the Avicena Vivio System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Valve Diseases
Aortic Valve Disease
Heart Murmurs
Keywords: echocardiography
Lead sponsor: Avicena LLC
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The study proposed here is a research study to develop the Vivio system for diagnosis of severe AS. The data gathered in this study will be used to optimize the Avicena software algorithm used to make the diagnosis of AS.

The Vivio device is an optical-type tonometer that operates based on capturing the vibrations of the skin due to the arterial pulse pressure wave as it propagates through the underlying carotid vessel. When applied to the neck over the subject's carotid pulse, an arterial waveform (pressure tracing) and heart sounds are sensed, and sent to an iPad using Bluetooth, then sent to Avicena for analysis.

After informed consent subjects will undergo a brief cardiac-focused history and examination. All subjects will have bilateral exams with the Vivio (\~5 minutes each) conducted by a study doctor or nurse, and a standard clinical resting TTE conducted by a certified technician. The entire study visit should take 1.5 hours, and there is no follow up.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Optimized algorithm for diagnosis of AS
timeFrame: 2 years
Secondary outcomes:
measure: Positive predictive value (PPV) of Vivio in the diagnosis of severe AS
timeFrame: 2 years
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Avicena
state: California
Study officials:
affiliation: Chief Executive Officer
name: Sean Brady, JD
role: STUDY_DIRECTOR
References:
citation: 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