The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable). Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
560
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
Time frame: 1 Year
NYHA Classification - Change From Baseline
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: Baseline and 1 Year
Total Aortic Regurgitation - Change From Baseline
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 one year was analyzed in the valve implant population.
Time frame: 1 Year
Effective Orifice Area - Change From Baseline
Time frame: 1 Year
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