Prospective Randomized On-X Versus SJM Evaluation Trial - Full Text View

Sponsored by:	Medical Carbon Research Institute, LLC
Information provided by:	Medical Carbon Research Institute, LLC
ClinicalTrials.gov Identifier:	NCT00639782

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

MedlinePlus related topics: Heart Valve Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses

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 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ONX: Active Comparator On-X Prosthetic Valve Recipients	Device: On-X Heart valve replacement On-X Heart valve replacement
SJM: Active Comparator SJM prosthetic valve recipients	Device: SJM Heart valve replacement SJM Heart valve replacement

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) 806-8383	wrej@interchange.ubc.ca
Contact: Cindy Bryson	(604) 806-9148	cbryson@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
Canada, British Columbia
St. Paul's Hospital	Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Eric Jamieson, MD 604-806-8383 wrej@interchange.ubc.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
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
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
Canada, Quebec
Jewish General Hospital	Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
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

Responsible Party:	On-X Life Technologies, Inc. ( John L. Ely )
Study ID Numbers:	ONXSJM1
Study First Received:	February 16, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00639782
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Medical Carbon Research Institute, LLC:

thromboembolism
mechanical heart valves
randomized

Study placed in the following topic categories:

Heart Diseases
Thromboembolism
Heart Valve Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009