The TriGuard HDH device 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.~To assess the safety, efficacy, and performance of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with patients undergoing unprotected TAVI.~Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms:~Intervention - TAVI with the TriGuard HDH embolic deflection device~Control - standard unprotected TAVI
A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.