Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
On-X Life Technologies, Inc.
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. 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.)
2. The patient is a candidate for receipt of a mechanical heart valve.
3. The patient (or legal guardian) has signed a study-specific informed consent form agreeing to the randomization, data collection and follow-up requirements.
4. 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.
You may not be if
1. The patient is not a candidate to receive a mechanical heart valve.
2. The patient already has a prosthetic valve other than the valve(s) being replaced at this time.
3. The patient requires a tricuspid valve replacement.
4. The patient is enrolled in another investigative study or trial.
