What is the Purpose of this Study?
This study focuses on individuals who have aortic valve stenosis and are scheduled to undergo a transcatheter aortic valve replacement (TAVR) procedure. The purpose of the study is to examine whether the use of the Sentinel device significantly reduces the risk of stroke (≤72 hours) after TAVR. Sentinel is approved for commercial use during TAVR in the U.S.; the device is used to capture and remove embolic debris (plaque that breaks away from an artery or valve and floats in the bloodstream) during TAVR procedures in order to reduce injury to the brain. Participants will be randomly assigned to one of two study groups. One group will receive the usual TAVR procedure with the Sentinel System, and the other group will receive the usual TAVR procedure without the Sentinel System.
Eligibility
- Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access
- Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.
- Subject (or legal representative) provides written informed consent.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
PROTECTED TAVR: Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement