Prospective Randomized On-X Versus SJM Evaluation Trial

Not Applicable

Completed

• Conditions: Heart Valve Disease

• Registration Number: NCT00639782
• Lead Sponsor: On-X Life Technologies, Inc.

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2008-02-16
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Status Verified: 2021-05
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 857

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (28)

Southern California Permanente Medical Group; 🇺🇸 Los Angeles, California, United States

Kaiser Foundation Hospital; 🇺🇸 Honolulu, Hawaii, United States

Washington University - St Louis; 🇺🇸 Saint Louis, Missouri, United States

Christian Hospital Northeast; 🇺🇸 Saint Louis, Missouri, United States

Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

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