EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis (EARLY TAVR) | SCAI

EARLY TAVR is a strategy trial for patients with severe asymptomatic aortic stenosis. They will be randomized 1:1 to early TAVR via a transfemoral approach with an Edwards Sapien device versus clinical surveillance with deferred TAVR when symptoms develop. Key inclusion criteria include age ≥65, suitable transfemoral access, and negative treadmill stress test. Bicuspid valves with suitable anatomy are included. The study is planned for 1109 subjects and anticipates completed enrollment by December 2021. The primary outcome is a composite endpoint of all cause-death, stroke, and unplanned cardiovascular hospitalization in 2 years.

All Editors: Jared M. O'Leary, MD. 

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