Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
This clinical trial is a 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 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
- Aortic Stenosis
- Heart Diseases
- Eligible Ages
- Over 65 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Severe aortic stenosis
- Patient is asymptomatic
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.
- Patient is symptomatic.
- Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
- Aortic valve is a unicuspid, bicuspid with unfavorable features for TAVR or is non-calcified.
- Severe aortic regurgitation (>3+).
- Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
|Transcatheter aortic valve replacement (TAVR) arm will have intervention with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV.||
- Edwards Lifesciences
Study ContactElizabeth Lau, PhD