Text Size

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:
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
History of Changes

February 16, 2008
March 13, 2013
July 2003
July 2015   (final data collection date for primary outcome measure)
Thromboembolic events either major or reversible [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639782 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prospective Randomized On-X Versus SJM Evaluation Trial
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Valve Disease
  • Device: On-X Heart valve replacement
    On-X Heart valve replacement
    Other Name: On-X Prosthetic Heart Valve
  • Device: SJM Heart valve replacement
    SJM Heart valve replacement
    Other Name: St. Jude Medical Prosthetic Heart Valve
  • Active Comparator: ONX
    On-X Prosthetic Valve Replacement
    Intervention: Device: On-X Heart valve replacement
  • Active Comparator: SJM
    SJM prosthetic valve replacement
    Intervention: Device: SJM Heart valve replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
October 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Eric Jamieson, MD (604) 240-6300 eric.jamieson@vch.ca
Contact: Alanna Dyck (604) 806-9632 adyck@providencehealth.bc.ca
United States,   Canada,   Netherlands,   Norway,   Sweden
 
NCT00639782
ONXSJM1
Yes
Medical Carbon Research Institute, LLC
Medical Carbon Research Institute, LLC
Not Provided
Principal Investigator: Eric Jamieson, MD University of British Columbia
Medical Carbon Research Institute, LLC
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP