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The primary safety outcome was met compared with the performance goal (21.8% vs. 35%, P  0.0001). The primary hierarchical efficacy endpoint was not met (mean efficacy score, higher is better -5.3 ± 99.8 TG vs. 11.8 ± 96.4 control, P = 0.31). Covert central nervous system injury was numerically lower with TG both in-hospital (46.1% vs. 60.3%, P = 0.0698) and at 5 days (61.7 vs. 76.2%, P = 0.054) compared with controls. REFLECT I demonstrated that TG cerebral protection during TAVR was safe in comparison with historical TAVR