Status:
WITHDRAWN
Rapid Non-invasive Detection of Aortic Stenosis
Lead Sponsor:
Avicena LLC
Conditions:
Heart Valve Diseases
Aortic Valve Disease
Eligibility:
All Genders
60-95 years
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...
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...
Eligibility Criteria
Inclusion
- Adult subjects \>60 years of age
- Ability to understand and sign informed consent
- Willingness to undergo study protocol (in Pasadena CA)
Exclusion
- 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
Key Trial Info
Start Date :
August 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 18 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04024566
Start Date
August 14 2019
End Date
July 18 2022
Last Update
July 20 2022
Active Locations (1)
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1
Avicena
Pasadena, California, United States, 91105