Prospective Randomized On-X Versus SJM Evaluation Trial
NCT ID: NCT00639782
Last Updated: 2021-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
857 participants
INTERVENTIONAL
2003-07-31
2021-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ONX
On-X heart Valve Replacement
On-X Heart valve replacement
On-X Heart valve replacement
SJM
SJM heart valve replacement
SJM Heart valve replacement
SJM Heart valve replacement
Interventions
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On-X Heart valve replacement
On-X Heart valve replacement
SJM Heart valve replacement
SJM Heart valve replacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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On-X Life Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Jamieson, MD
Role: PRINCIPAL_INVESTIGATOR
Vancouver Coastal Health Research Institute
Locations
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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
University of Bergen
Bergen, , Norway
Groote Schuur Hospital
Cape Town, , South Africa
Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Other Identifiers
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ONXSJM1
Identifier Type: -
Identifier Source: org_study_id
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