Rapid Non-invasive Detection of Aortic Stenosis

Aortic Stenosis Screening Using the Avicena Vivio System

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.

Study Overview

• Status: Withdrawn
• Conditions: Aortic Valve Disease; Heart Valve Diseases; Heart Murmurs
• Intervention / Treatment: Device: Vivio System

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Avicena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value (PPV) of Vivio in the diagnosis of severe AS	PPV for detecting AS by Vivio compared to PPV for 2D TTE	2 years

Collaborators and Investigators

• Sponsor: Avicena LLC
• Investigators: Study Director: Sean Brady, JD, Chief Executive Officer

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: echocardiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Heart Valve Diseases; Aortic Valve Disease; Heart Murmurs
• Other Study ID Numbers: AS20192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No