Rapid Non-invasive Detection of Aortic Stenosis

Aortic Valve Disease Clinical Trial

Official title:

Aortic Stenosis Screening Using the Avicena Vivio System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04024566
• Other study ID #: AS20192
• Status: Withdrawn
• Start date: August 14, 2019
• Est. completion date: July 18, 2022

Study information

• Verified date: July 2021
• Source: Avicena LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Heart Murmurs
• Heart Valve Diseases

Intervention

Device:
• Vivio System
Optical/sensor tonometer applied to the neck over the carotid pulse (bilateral)

Locations

Country	Name	City	State
United States	Avicena	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Avicena LLC

Country where clinical trial is conducted

United States, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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