Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis: EARLY TAVR trial

General Information Age Group Adults Status Active Protocol Number 17-2779 Background Information Prospective, randomized, controlled, multi-center study Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or CS. Patients will be stratified by whether or not they are able to perform a treadmill stress test. In addition, patients who are screened for enrollment but have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable. Offered At Inova Fairfax Hospital 3300 Gallows Road Falls Church, VA 22042 Principal Investigator Shahram Yazdani, MD Eric Sarin, MD Eligibility Information 65 years of age or older at time of randomization Severe aortic stenosis defined as: Aortic valve area (AVA) ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 AND Peak jet velocity ≥ 4.0 m/s or Mean gradient ≥ 40 mmHg Patient is asymptomatic LV ejection fraction ≥ 50% Ineligibility Information Patient is symptomatic Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication Evidence of an acute myocardial infarction ≤ 30 days before randomization Stroke or transient ischemic attack (TIA) within 90 days of randomization Renal insufficiency Severe lung disease History of cirrhosis or any active liver disease Contact Information Contact Name Diana McLean Contact Phone 703-776-8051 Contact Email Send Email