The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
The study is a multi-centre, randomized trial that will sequentially enroll up to 500 eligible patients in each group from up to 10 participating study centres internationally to test the hypothesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
857
On-X Heart valve replacement
SJM Heart valve replacement
Thromboembolisms
Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Southern California Permanente Medical Group
Los Angeles, California, United States
Kaiser Foundation Hospital
Honolulu, Hawaii, United States
Washington University - St Louis
St Louis, Missouri, United States
Christian Hospital Northeast
St Louis, Missouri, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
...and 18 more locations