Prospective Randomized On-X Versus SJM Evaluation Trial

Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00639782

Acronym

PROSE

Enrollment

857

Registered

2008-03-20

Start date

2003-07-31

Completion date

2021-05-01

Last updated

2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Disease

Keywords

thromboembolism, mechanical heart valves, randomized

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.

Interventions

DEVICEOn-X Heart valve replacement

On-X Heart valve replacement

DEVICESJM Heart valve replacement

SJM Heart valve replacement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Thromboembolisms	5 years	Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.

Countries

Australia, Canada, Germany, India, Netherlands, Norway, South Africa, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026