Prospective Randomized On-X Versus SJM Evaluation Trial

Heart Valve Disease Clinical Trial

— PROSE  

Official title:

Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639782
• Other study ID #: ONXSJM1
• Status: Completed
• Phase: N/A
• Start date: July 2003
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: On-X Life Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 857
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Disease
• Heart Valve Diseases

Intervention

Device:
• On-X Heart valve replacement
On-X Heart valve replacement
• SJM Heart valve replacement
SJM Heart valve replacement

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Horizon New Brunswick Heart Centre	Saint John	New Brunswick
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute	Victoria	British Columbia
Germany	Universitats-Herzzentrum Bad Krozingen	Freiburg
Germany	Universitats-Herzzentrum Freiburg - Medical Center	Freiburg
Germany	Universitats Klinik Jena	Jena
Germany	Universitat Klinik Tübingen	Tübingen
India	Shri Jaya Deva Institute of Cardiovascular Sciences	Bangalore	Karnataka
India	Apollo Hospital Chennai	Chennai	Tamil Nadu
India	Frontier Lifeline Hospital	Chennai	Tamil Nadu
India	Hero Dayanand Medical College and Hospitals	Ludhiana	Punjab
India	Apollo Multispecialty Hospitals	Madurai	Tamil Nadu
India	Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute	Surat	Gujarat
India	Banaras Hindu University	Varanasi	Uttar Pradesh
Netherlands	Erasmus Medical Center	Rotterdam
Norway	University of Bergen	Bergen
South Africa	Groote Schuur Hospital	Cape Town
Sweden	Sahlgrenska University Hospital	Gothenburg
United States	Kaiser Foundation Hospital	Honolulu	Hawaii
United States	Southern California Permanente Medical Group	Los Angeles	California
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Christian Hospital Northeast	Saint Louis	Missouri
United States	Washington University - St Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
On-X Life Technologies, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  India,  Netherlands,  Norway,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboembolisms	Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.	5 years