Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement

Brief description of study

The purpose of this study is to show whether the use of Sentinel significantly reduces the risk of stroke (=72 hours) after TAVR. A TAVR procedure to replace the aortic valve carries risks including the potential for stroke. Research has shown that a majority of stroke risk is attributed to catheters (hollow tubes inserted into the body for medical purposes, including TAVR procedure) that have the potential to knock debris off vessel walls as they are delivered to the heart. Sentinel® Cerebral Protection System (Sentinel) is designed to capture embolic debris (examples include tissue, calcium, blood clot or foreign body material) during TAVR and has the potential to reduce the risk of stroke associated with catheter based replacement of aortic valves.

Clinical Study Identifier: s20-00220 Identifier: NCT04149535
Principal Investigator: Richard K Schwartz.

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