Prospective Randomized On-X Versus SJM Evaluation Trial (PROSE)
This study is currently recruiting participants.
Verified June 2011 by Medical Carbon Research Institute, LLC
Sponsor:
Medical Carbon Research Institute, LLC
Information provided by (Responsible Party):
Medical Carbon Research Institute, LLC
ClinicalTrials.gov Identifier:
NCT00639782
First received: February 16, 2008
Last updated: March 13, 2013
Last verified: June 2011
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Purpose
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
| Condition | Intervention |
|---|---|
|
Heart Valve Disease |
Device: On-X Heart valve replacement Device: SJM Heart valve replacement |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses |
Resource links provided by NLM:
Further study details as provided by Medical Carbon Research Institute, LLC:
Primary Outcome Measures:
- Thromboembolic events either major or reversible [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ONX
On-X Prosthetic Valve Replacement
|
Device: On-X Heart valve replacement
On-X Heart valve replacement
Other Name: On-X Prosthetic Heart Valve
|
|
Active Comparator: SJM
SJM prosthetic valve replacement
|
Device: SJM Heart valve replacement
SJM Heart valve replacement
Other Name: St. Jude Medical Prosthetic Heart Valve
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639782
Contacts
| Contact: Eric Jamieson, MD | (604) 240-6300 | eric.jamieson@vch.ca |
| Contact: Alanna Dyck | (604) 806-9632 | adyck@providencehealth.bc.ca |
Locations
| United States, California | |
| Southern California Permanente Medical Group | Recruiting |
| Los Angeles, California, United States, 91101 | |
| Contact: Thomas Pfeffer, MD 626-564-3430 thomas.a.pfeffer@kp.org | |
| Principal Investigator: Thomas A Pfeffer, MD | |
| United States, Hawaii | |
| Kaiser Foundation Hospital | Recruiting |
| Honolulu, Hawaii, United States, 96817 | |
| Contact: John C Chen, MD 808-432-4785 john.c.chen@kp.org | |
| Principal Investigator: John C Chen, MD | |
| United States, Missouri | |
| Washington University - St Louis | Active, not recruiting |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Peter Scholz, MD 732-235-7642 scholz@umdnj.edu | |
| Contact: Amelia Sherr, RN 732-235-3526 sherram@umdnj.edu | |
| Principal Investigator: Peter Scholz, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: John S Ikonomidis, MD 843-876-4842 | |
| Contact: Mariann Schultz, RN 843-876-5009 schultxmt@musc.edu | |
| Principal Investigator: John S Ikonomidis, MD | |
| United States, Virginia | |
| Sentara Norfolk General Hospital | Active, not recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Canada, British Columbia | |
| Royal Columbian Hospital | Recruiting |
| New Westminster, British Columbia, Canada, V3R 7P8 | |
| Contact: Robert I Hayden, MD 604-524-9571 | |
| Contact: Katherine Haveman 604-524-9571 khaveman@fct05.com | |
| Principal Investigator: Robert I Hayden, MD | |
| St. Paul's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Eric Jamieson, MD 604-806-8383 wrej@interchange.ubc.ca | |
| Contact: Alanna Dyck 604-806-9632 adyck@providencehealth.bc.ca | |
| Principal Investigator: Eric Jamieson, MD | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Eric Jamieson, MD 604-806-8383 wrej@interchange.ubc.ca | |
| Contact: Alanna Dyck 604-806-9632 adyck@providencehealth.bc.ca | |
| Principal Investigator: Eric Jamieson, MD | |
| Victoria Heart Institute | Recruiting |
| Victoria, British Columbia, Canada, V8R 4R2 | |
| Contact: Lynn Fedoruk, MD 250-595-1884 vhif@vhif.org | |
| Contact: Kim Allen 250-595-1884 | |
| Principal Investigator: Lynn Fedoruk, MD | |
| Canada, Quebec | |
| Jewish General Hospital | Active, not recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, Netherlands, 3000 CA | |
| Contact: A P Kappetein, MD 31 10 703 2150 a.kappetein@erasmusmc.nl | |
| Contact: Leisbeth Duininck 31 10 703 3993 e.duininck@erasmusmc.nl | |
| Principal Investigator: A P Kappetein, MD | |
| Norway | |
| University of Bergen | Recruiting |
| Bergen, Norway, N-5021 | |
| Contact: Rune Haaverstad, MD rune.haaverstad@helse-bergen.no | |
| Contact: Thomas Geisner, MD thomas.geisner@helse-bergen.no | |
| Principal Investigator: Rune Haaverstad, MD | |
| Sub-Investigator: Thomas Geisner, MD | |
| Sweden | |
| Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden, SE41345 | |
| Contact: Lars Wiklund, MD 46 31 41 7991 | |
| Principal Investigator: Lars Wiklund, MD | |
Sponsors and Collaborators
Medical Carbon Research Institute, LLC
Investigators
| Principal Investigator: | Eric Jamieson, MD | University of British Columbia |
More Information
No publications provided
| Responsible Party: | Medical Carbon Research Institute, LLC |
| ClinicalTrials.gov Identifier: | NCT00639782 History of Changes |
| Other Study ID Numbers: | ONXSJM1 |
| Study First Received: | February 16, 2008 |
| Last Updated: | March 13, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Medical Carbon Research Institute, LLC:
|
thromboembolism mechanical heart valves randomized |
Additional relevant MeSH terms:
|
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013