Status:
COMPLETED
Prospective Randomized On-X Versus SJM Evaluation Trial
Lead Sponsor:
On-X Life Technologies, Inc.
Conditions:
Heart Valve Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
857 Patients enrolled
Trial Details
Trial ID
NCT00639782
Start Date
July 1 2003
End Date
May 1 2021
Last Update
May 25 2021
Active Locations (28)
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1
Southern California Permanente Medical Group
Los Angeles, California, United States, 91101
2
Kaiser Foundation Hospital
Honolulu, Hawaii, United States, 96817
3
Washington University - St Louis
St Louis, Missouri, United States, 63110
4
Christian Hospital Northeast
St Louis, Missouri, United States, 63136