Prospective Randomized On-X Versus SJM Evaluation Trial
Completed · Not applicable
Conditions studied: Heart Valve Disease
In brief
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
Key facts
- Study ID
- NCT00639782
- Run by
- On-X Life Technologies, Inc.
- People needed
- 857
- Starts
- 2003-07-01
- Expected to finish
- 2021-05-01
- Last updated by the study team
- 2021-05-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Southern California Permanente Medical Group — Los Angeles, California, United States
- Kaiser Foundation Hospital — Honolulu, Hawaii, United States
- Washington University - St Louis — St Louis, Missouri, United States
- Christian Hospital Northeast — St 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
- Victoria Heart Institute — Victoria, British Columbia, Canada
- Horizon New Brunswick Heart Centre — Saint John, New Brunswick, Canada
- Jewish General Hospital — Montreal, Quebec, Canada
- Universitats-Herzzentrum Bad Krozingen — Freiburg im Breisgau, Germany
- Universitats-Herzzentrum Freiburg - Medical Center — Freiburg im Breisgau, Germany
- Universitats Klinik Jena — Jena, Germany
- Universitat Klinik Tübingen — Tübingen, Germany
- Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute — Surat, Gujarat, India
- Shri Jaya Deva Institute of Cardiovascular Sciences — Bangalore, Karnataka, India
- Hero Dayanand Medical College and Hospitals — Ludhiana, Punjab, India
- Apollo Hospital Chennai — Chennai, Tamil Nadu, India
- Frontier Lifeline Hospital — Chennai, Tamil Nadu, India
- Apollo Multispecialty Hospitals — Madurai, Tamil Nadu, India
- Banaras Hindu University — Varanasi, Uttar Pradesh, India
- Erasmus Medical Center — Rotterdam, Netherlands
Full record on ClinicalTrials.gov
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