The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery. To assure that patients with an STS score ≥ 4% have been selected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,032
Operable Group with SAPIEN XT
Control Group
All-cause Death or Disabling Stroke to Two Years
All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
Time frame: 2 Years
Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
The number of days the patients are alive and out of the hospital.
Time frame: 2 years
Total Aortic Regurgitation (AR) at 2 Years
Total aortic regurgitation was assessed by the core lab as "Grade 0" = None, "Grade 1+" = Trace, "Grade 2+" = Mild, "Grade 3+" = Moderate and "Grade 4+" = Severe. Total regurgitation at two year was analyzed in the valve implant population.
Time frame: 2 years
6MWT Change From Baseline
Six Minute Walk Test change from baseline to 2 years
Time frame: Baseline and 2 years
NYHA Classification at 2 Years
New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
Time frame: 2 years
Effective Orifice Area (EOA)
Time frame: 2 years
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