This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
This is a prospective, randomized, controlled, multicenter study. Patients will be randomized 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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
901
Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
All-cause death, all stroke, and unplanned cardiovascular hospitalization
The number of patients that have any of these conditions
Time frame: When all patients have reached 2-year follow-up
Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points
The number of patients that meet all of these criteria
Time frame: 2 years
Left Ventricular Health
Echocardiographic measurements that will assess the health of the left ventricle
Time frame: 2 years
Change in Left Ventricular Ejection Fraction (LVEF)
The average change in LVEF from baseline
Time frame: 2 years
New onset atrial fibrillation
The number of patients that develop this condition
Time frame: When all patients have reached 2-year follow-up
Death or disabling stroke
The number of patients that have any of these conditions
Time frame: When all patients have reached 2-year follow-up
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