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
  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:

  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.
  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 April 17, 2014