Prospective Randomized On-X Versus SJM Evaluation Trial (PROSE)

On-X Life Technologies

Status

Completed

Conditions

Heart Valve Disease

Treatments

Device: SJM Heart valve replacement

Device: On-X Heart valve replacement

Study type

Interventional

Funder types

Industry

Identifiers

NCT00639782

ONXSJM1

Details and patient eligibility

About

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

Full 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.

Enrollment

857 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.