The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk.
This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
583
Patients with TAVR implantation
The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate
The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).
Time frame: 30 Days
Number of Participants With Major Vascular Complications
The rate of major vascular complications at 30 days post implantation
Time frame: 30 Days
Number of Participants With Aortic Insufficiency at 30 Days
The proportion of patients with aortic insufficiency ≥ moderate at 30 days.
Time frame: 30 Days
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