Prospective Randomized On-X Versus SJM Evaluation Trial



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:3/17/2019
Start Date:July 2003
End Date:December 2019

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

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

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.

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.
We found this trial at
6
sites
Los Angeles, California 90027
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Los Angeles, CA
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Honolulu, Hawaii 96817
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Honolulu, HI
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Norfolk, VA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Vancouver, British Columbia
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Vancouver,
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