Rapid Non-invasive Detection of Aortic Stenosis

Sponsor
Avicena LLC (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04024566
Collaborator
(none)
0
1
35.1
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
Aortic Stenosis Screening Using the Avicena Vivio System
Actual Study Start Date :
Aug 14, 2019
Actual Primary Completion Date :
Jul 18, 2022
Actual Study Completion Date :
Jul 18, 2022

Outcome Measures

Primary Outcome Measures

  1. Optimized algorithm for diagnosis of AS [2 years]

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

Secondary Outcome Measures

  1. Positive predictive value (PPV) of Vivio in the diagnosis of severe AS [2 years]

    PPV for detecting AS by Vivio compared to PPV for 2D TTE

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 95 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Avicena Pasadena California United States 91105

Sponsors and Collaborators

  • Avicena LLC

Investigators

  • Study Director: Sean Brady, JD, Chief Executive Officer

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Avicena LLC
ClinicalTrials.gov Identifier:
NCT04024566
Other Study ID Numbers:
  • AS20192
First Posted:
Jul 18, 2019
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Avicena LLC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022