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Prospective Randomized On-X Versus SJM Evaluation Trial (PROSE)

This study is currently recruiting participants.
Verified September 2017 by On-X Life Technologies, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639782
First Posted: March 20, 2008
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
On-X Life Technologies, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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 On-X Life Technologies, Inc.:

Primary Outcome Measures:
  • Thromboembolic events either major or reversible [ Time Frame: 5 years ]

Estimated Enrollment: 1000
Study Start Date: July 2003
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ONX
On-X heart Valve Replacement
Device: On-X Heart valve replacement
On-X Heart valve replacement
Other Name: On-X Prosthetic Heart Valve
Active Comparator: SJM
SJM heart 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639782


Contacts
Contact: Eric Jamieson, MD (604) 240-6300 eric.jamieson@vch.ca
Contact: Alanna Dyck prosecoordinator@gmail.com

Locations
United States, California
Southern California Permanente Medical Group Completed
Los Angeles, California, United States, 91101
United States, Hawaii
Kaiser Foundation Hospital Completed
Honolulu, Hawaii, United States, 96817
United States, Missouri
Washington University - St Louis Completed
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Robert Wood Johnson Medical School Completed
New Brunswick, New Jersey, United States, 08903
United States, Virginia
Sentara Norfolk General Hospital Completed
Norfolk, Virginia, United States, 23507
Canada, British Columbia
St. Paul's Hospital Completed
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver General Hospital Completed
Vancouver, British Columbia, Canada, V5Z 1M9
Victoria Heart Institute Completed
Victoria, British Columbia, Canada, V8R 4R2
Canada, Quebec
Jewish General Hospital Completed
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
On-X Life Technologies, Inc.
Investigators
Principal Investigator: Eric Jamieson, MD University of British Columbia
  More Information

Responsible Party: On-X Life Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00639782     History of Changes
Other Study ID Numbers: ONXSJM1
First Submitted: February 16, 2008
First Posted: March 20, 2008
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by On-X Life Technologies, Inc.:
thromboembolism
mechanical heart valves
randomized

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases