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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00639782




Registration number
NCT00639782
Ethics application status
Date submitted
16/02/2008
Date registered
20/03/2008
Date last updated
25/05/2021

Titles & IDs
Public title
Prospective Randomized On-X Versus SJM Evaluation Trial
Scientific title
Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
Secondary ID [1] 0 0
ONXSJM1
Universal Trial Number (UTN)
Trial acronym
PROSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Valve Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - On-X Heart valve replacement
Treatment: Devices - SJM Heart valve replacement

Active comparator: ONX - On-X heart Valve Replacement

Active comparator: SJM - SJM heart valve replacement


Treatment: Devices: On-X Heart valve replacement
On-X Heart valve replacement

Treatment: Devices: SJM Heart valve replacement
SJM Heart valve replacement
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Thromboembolisms
Timepoint [1] 0 0
5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2021
Sample size
Target
Accrual to date
Final
857
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
New Brunswick
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Germany
State/province [10] 0 0
Freiburg
Country [11] 0 0
Germany
State/province [11] 0 0
Jena
Country [12] 0 0
Germany
State/province [12] 0 0
Tübingen
Country [13] 0 0
India
State/province [13] 0 0
Gujarat
Country [14] 0 0
India
State/province [14] 0 0
Karnataka
Country [15] 0 0
India
State/province [15] 0 0
Punjab
Country [16] 0 0
India
State/province [16] 0 0
Tamil Nadu
Country [17] 0 0
India
State/province [17] 0 0
Uttar Pradesh
Country [18] 0 0
Netherlands
State/province [18] 0 0
Rotterdam
Country [19] 0 0
Norway
State/province [19] 0 0
Bergen
Country [20] 0 0
South Africa
State/province [20] 0 0
Cape Town
Country [21] 0 0
Sweden
State/province [21] 0 0
Gothenburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
On-X Life Technologies, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
Trial website
https://clinicaltrials.gov/study/NCT00639782
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric Jamieson, MD
Address 0 0
Vancouver Coastal Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00639782