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.
TAVR UNLOAD is a strategy trial for patients with moderate aortic stenosis, left ventricular dysfunction (EF 20- 50%) and heart failure symptoms. Eligible patients will be randomized to immediate TAVR via a transfemoral approach versus clinical surveillance with deferred TAVR when the aortic stenosis becomes severe. Key inclusion criteria include BNP > 200 pg/mL (or NT-proBNP > 900 pg/mL) or a heart failure hospitalization within 2 years, stable guideline-directed medical therapy, and anatomy suitable for transfemoral TAVR with an Edwards Sapien device. The study is planned for 300 subjects and anticipates completed enrollment by December 2021. The primary outcomes are all-cause death, disabling stroke, hospitalizations for heart failure or valve disease, and change in KCCQ in 12-months.