To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
197
Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
Time frame: 30-day
Number of Participants With Mortality From Any Cause
Cardiovascular cause is also included
Time frame: 30 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Scripps Green Hospital
La Jolla, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mercy General Hospital
Sacramento, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Hospital
Denver, Colorado, United States
Washington Hospital Center (WHC)
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
University of Miami
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
...and 37 more locations