Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at intermediate risk for standard aortic valve replacement. Patient data will be entered into the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year follow-up through CMS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,822
Transcatheter aortic valve replacement
Death
Number of deaths
Time frame: 30 days
Death
Number of deaths
Time frame: 1 year
Stroke
Number of participants with stroke
Time frame: 30 days
Stroke
Number of participants with stroke
Time frame: 1 year
Aortic Valve Reintervention
Number of participants with aortic valve reintervention
Time frame: 30 days
Aortic Valve Reintervention
Number of participants with aortic valve reintervention
Time frame: 1 year
Annular Dissection
Number of participants with annular dissection
Time frame: 30 days
Aortic Dissection
Number of participants with aortic dissection
Time frame: 30 days
Major Access Vascular Site Complication
Number of participants with major vascular complications
Time frame: 30 days
Unplanned Vascular Surgery or Intervention
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Scripps Green Hospital
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford Hospital and Clinics
Palo Alto, California, United States
Mercy General Hospital
Sacramento, California, United States
University of Colorado Hospital
Denver, Colorado, United States
Washington Hospital Center DC
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
...and 46 more locations
Number of participants with unplanned vascular surgery or intervention
Time frame: 30 days
Retroperitoneal Bleeds
Number of participants with retroperitoneal bleed
Time frame: 30 days
Gastrointestinal Bleed
Number of participants with gastrointestinal bleeding
Time frame: 30 days
Genitourinary Bleed
Number of participants with genitourinary bleeding
Time frame: 30 days
Bleeding at Access Site
Number of participants with bleeding at the access site
Time frame: 30 days