Sentinel System Transcatheter Aortic Valve Replacement Study
PROTECTED TAVR: Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement
This study enrolls adults with aortic valve stenosis. The purpose of this study is to show whether using Sentinel, a medical device to collect debris,
reduces the risk of stroke after transcatheter aortic valve replacement (TAVR).
After having the TAVR procedure to replace the aortic valve there is a risk for stroke. Research has shown that a majority of stroke risk is because the device used to do the procedure, a catheter, may knock debris off blood vessel walls during the procedure. Sentinel is designed to capture this debris (like tissue, calcium, blood clots or foreign body material) during TAVR. It may reduce the risk of stroke associated with catheter based replacement of aortic valves. In this study, you will be randomly selected (like the flip of a coin) to have your TAVR procedure with or without the Sentinel System. You will be in this study while you are in the hospital, and we will follow up with you after if you suffer a stroke. Study takes place at Kaleida Health and Gates Vascular Institute.
The objective of this study is to demonstrate that use of the SentinelCerebral Protection System significantly reduces the risk of periproceduralstroke (?72 hours) after transcatheter aortic valvereplacement (TAVR). Site For Boston Scientific PROTECTED TAVR
Adults ages 18+.
Diagnosed with severe aortic valve stenosis.
Scheduled to undergo a transcatheter aortic valve replacement (TAVR).
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