This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
TAVR with the Edwards CENTERA THV System
Cedars-Sinai Medical Center
Los Angeles, California, United States
All-cause Death
Number of participants that died
Time frame: 1 year
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Stanford University Medical Center
Stanford, California, United States
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, United States
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Washington D.C., District of Columbia, United States
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Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana, United States
University of Kansas Health System
Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
...and 13 more locations