Last updated on January 2019

The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation


Brief description of study

The Keystone Heart TriGuard HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation.

The objective of the study is to assess the safety and efficacy of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI.

Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuard) with transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve implantation.

Clinical Study Identifier: NCT02536196

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