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First received: May 15, 2023

Clinical Trial: The PROTEMBO Trial

Study Status: NOT_YET_RECRUITING

Recruit Status: NOT_YET_RECRUITING

Condition: Severe Aortic Valve Stenosis

Study Type: INTERVENTIONAL


Official Title: Cerebral Protection in Transcatheter Aortic Valve Replacement: The PROTEMBO Trial

Brief Summary: The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and the Sentinel device) in subjects with severe symptomatic native aortic valve stenosis indicated undergoing a TAVR procedure.

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