Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-30 @ 12:50 AM
Study NCT ID:
NCT04024566
Status:
WITHDRAWN
Last Update Posted:
2022-07-20
First Post:
2019-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Non-invasive Detection of Aortic Stenosis
Sponsor:
Avicena LLC
Organization:
Study Overview
Official Title:
Aortic Stenosis Screening Using the Avicena Vivio System
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company changed strategic direction in Oct 2019 (staff changes; no one at company who participated in this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: