Prospective Randomized On-X Versus SJM Evaluation Trial
- Conditions
- Heart Valve Disease
- Interventions
- Device: SJM Heart valve replacementDevice: On-X Heart valve replacement
- 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
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SJM SJM Heart valve replacement SJM heart valve replacement ONX On-X Heart valve replacement On-X heart Valve Replacement
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Southern California Permanente Medical Group
๐บ๐ธLos Angeles, California, United States
Hospital of the University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States
Royal Prince Alfred Hospital
๐ฆ๐บSydney, New South Wales, Australia
Horizon New Brunswick Heart Centre
๐จ๐ฆSaint John, New Brunswick, Canada
Kaiser Foundation Hospital
๐บ๐ธHonolulu, Hawaii, United States
Universitat Klinik Tรผbingen
๐ฉ๐ชTรผbingen, Germany
Apollo Hospital Chennai
๐ฎ๐ณChennai, Tamil Nadu, India
Apollo Multispecialty Hospitals
๐ฎ๐ณMadurai, Tamil Nadu, India
Universitats Klinik Jena
๐ฉ๐ชJena, Germany
Robert Wood Johnson Medical School
๐บ๐ธNew Brunswick, New Jersey, United States
Universitats-Herzzentrum Freiburg - Medical Center
๐ฉ๐ชFreiburg, Germany
Sahlgrenska University Hospital
๐ธ๐ชGothenburg, Sweden
Frontier Lifeline Hospital
๐ฎ๐ณChennai, Tamil Nadu, India
Groote Schuur Hospital
๐ฟ๐ฆCape Town, South Africa
Washington University - St Louis
๐บ๐ธSaint Louis, Missouri, United States
Christian Hospital Northeast
๐บ๐ธSaint Louis, Missouri, United States
Sentara Norfolk General Hospital
๐บ๐ธNorfolk, Virginia, United States
Universitats-Herzzentrum Bad Krozingen
๐ฉ๐ชFreiburg, Germany
Jewish General Hospital
๐จ๐ฆMontreal, Quebec, Canada
Hero Dayanand Medical College and Hospitals
๐ฎ๐ณLudhiฤna, Punjab, India
St. Paul's Hospital
๐จ๐ฆVancouver, British Columbia, Canada
Banaras Hindu University
๐ฎ๐ณVaranasi, Uttar Pradesh, India
Erasmus Medical Center
๐ณ๐ฑRotterdam, Netherlands
Shri Jaya Deva Institute of Cardiovascular Sciences
๐ฎ๐ณBangalore, Karnataka, India
University of Bergen
๐ณ๐ดBergen, Norway
Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute
๐ฎ๐ณSลซrat, Gujarat, India
Victoria Heart Institute
๐จ๐ฆVictoria, British Columbia, Canada
Vancouver General Hospital
๐จ๐ฆVancouver, British Columbia, Canada