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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.

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
NameTimeMethod
Thromboembolisms5 years

Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.

Secondary Outcome Measures
NameTimeMethod

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

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