Clinical trial NCT00639782: Prospective Randomized On-X Versus SJM Evaluation Trial
Official title: Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Disease
Keywords: thromboembolism
mechanical heart valves
randomized
Lead sponsor: On-X Life Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 857
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.

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 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.

Primary outcomes:
measure: Thromboembolisms
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Honolulu
country: United States
facility: Kaiser Foundation Hospital
state: Hawaii
city: Saint Louis
country: United States
facility: Washington University - St Louis
state: Missouri
city: Saint Louis
country: United States
facility: Christian Hospital Northeast
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute
state: British Columbia
city: Saint John
country: Canada
facility: Horizon New Brunswick Heart Centre
state: New Brunswick
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Freiburg
country: Germany
facility: Universitats-Herzzentrum Bad Krozingen
city: Freiburg
country: Germany
facility: Universitats-Herzzentrum Freiburg - Medical Center
city: Jena
country: Germany
facility: Universitats Klinik Jena
city: Tübingen
country: Germany
facility: Universitat Klinik Tübingen
city: Sūrat
country: India
facility: Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute
state: Gujarat
city: Bangalore
country: India
facility: Shri Jaya Deva Institute of Cardiovascular Sciences
state: Karnataka
city: Ludhiāna
country: India
facility: Hero Dayanand Medical College and Hospitals
state: Punjab
city: Chennai
country: India
facility: Apollo Hospital Chennai
state: Tamil Nadu
city: Chennai
country: India
facility: Frontier Lifeline Hospital
state: Tamil Nadu
city: Madurai
country: India
facility: Apollo Multispecialty Hospitals
state: Tamil Nadu
city: Varanasi
country: India
facility: Banaras Hindu University
state: Uttar Pradesh
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Bergen
country: Norway
facility: University of Bergen
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Vancouver Coastal Health Research Institute
name: Eric Jamieson, MD
role: PRINCIPAL_INVESTIGATOR
References: