CompletedNot Applicable

Prospective Randomized On-X Versus SJM Evaluation Trial

United States857 participantsStarted 2003-07

Plain-language summary

The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

Thromboembolisms

Timeframe: 5 years

NCT IDNCT00639782

SponsorOn-X Life Technologies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-01