This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
St. Paul's Hospital
Vancouver, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada
Procedural Success
The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: * Mortality * Conversion to surgery * Moderate or severe paravalvular regurgitation
Time frame: Day 0
Major Vascular Complications
Number of patients with major vascular complications
Time frame: Discharge, expected to be within 1-5 days post-procedure]
Valve Migration or Embolization
Number of patients with valve migration or embolization
Time frame: Discharge, expected to be within 1-5 days post-procedure]
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Kings Hospital
London, United Kingdom
St. Thomas Hospital
London, United Kingdom