Prospective Randomized On-X Versus SJM Evaluation Trial
- Conditions
- Heart Valve Disease
- Registration Number
- NCT00639782
- Lead Sponsor
- On-X Life Technologies, Inc.
- Brief Summary
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 857
- The patient requires an isolated mitral or isolated aortic valve replacement. (Patients undergoing coronary artery bypass and / or concomitant repair of mitral or tricuspid valves are eligible.)
- The patient is a candidate for receipt of a mechanical heart valve.
- The patient (or legal guardian) has signed a study-specific informed consent form agreeing to the randomization, data collection and follow-up requirements.
- The patient can be having a re-operative procedure, so long as the previous prosthetic valve is explanted and the patient does not become a double valve implantation patient.
- The patient is not a candidate to receive a mechanical heart valve.
- The patient already has a prosthetic valve other than the valve(s) being replaced at this time.
- The patient requires a tricuspid valve replacement.
- The patient is enrolled in another investigative study or trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Thromboembolisms 5 years Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Southern California Permanente Medical Group
🇺🇸Los Angeles, California, United States
Kaiser Foundation Hospital
🇺🇸Honolulu, Hawaii, United States
Washington University - St Louis
🇺🇸Saint Louis, Missouri, United States
Christian Hospital Northeast
🇺🇸Saint 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
Scroll for more (18 remaining)Southern California Permanente Medical Group🇺🇸Los Angeles, California, United States