Heart Valve DiseasePROSENCT00639782
Prospective Randomized On-X Versus SJM Evaluation Trial
A study testing On-X Heart valve replacement and SJM Heart valve replacement in people with Heart Valve Disease, run by On-X Life Technologies, Inc. at 28 sites in 9 countries.
Trial summary
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- On-X Heart valve replacement and SJM Heart valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 857 participants
- Where
- 28 sitesin 9 countries
- Study dates
- Jul 2003to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 9 countries.
28 sites in 9 countries
United States7 sites
Kaiser Foundation Hospital
Honolulu, Hawaii, 96817
Southern California Permanente Medical Group
Los Angeles, California, 91101
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University - St Louis
St Louis, Missouri, 63110
Christian Hospital Northeast
St Louis, Missouri, 63136
India7 sites
Shri Jaya Deva Institute of Cardiovascular Sciences
Bangalore, Karnataka, 560 069
Apollo Hospital Chennai
Chennai, Tamil Nadu, 600 006
Frontier Lifeline Hospital
Chennai, Tamil Nadu, 600 101
Hero Dayanand Medical College and Hospitals
Ludhiana, Punjab, 141 001
Apollo Multispecialty Hospitals
Madurai, Tamil Nadu, 625 020
Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute
Surat, Gujarat, 395 001
Banaras Hindu University
Varanasi, Uttar Pradesh, 221 005
Canada5 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Horizon New Brunswick Heart Centre
Saint John, New Brunswick, E2L 4L2
St. Paul's Hospital
Vancouver, British Columbia, V5Z 1M9
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Victoria Heart Institute
Victoria, British Columbia, V8R 4R2
Germany4 sites
Universitats-Herzzentrum Bad Krozingen
Freiburg im Breisgau, 79106
Universitats-Herzzentrum Freiburg - Medical Center
Freiburg im Breisgau, 79106
Universitats Klinik Jena
Jena, 7743
Universitat Klinik Tübingen
Tübingen, 72074
About this study
Official title: Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
Read the 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.
- Conditions
- Heart Valve Disease
- Being tested
- On-X Heart valve replacement, SJM Heart valve replacement
- Keywords
- thromboembolism, mechanical heart valves, randomized
- Medical subject headings
- Heart Valve Diseases, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-X Heart valve replacementDevice
Also called On-X Prosthetic Heart Valve
On-X Heart valve replacement
SJM Heart valve replacementDevice
Also called St. Jude Medical Prosthetic Heart Valve
SJM Heart valve replacement
| Study group | Role | What they receive |
|---|---|---|
| ONX | Active comparator | On-X heart Valve Replacement Receives: Device: On-X Heart valve replacement |
| SJM | Active comparator | SJM heart valve replacement Receives: Device: SJM Heart valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolisms
Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startJul 2003
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 857 participants (actual)
Sponsor and investigators
- Lead sponsor
- On-X Life Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Jamieson, MD, Principal investigator, Vancouver Coastal Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639782
- Sponsor's protocol ID
- ONXSJM1
- Acronym
- PROSE
- Status last verified
- May 2021
- First submitted
- 16 Feb 2008
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
- ClinicalTrials.gov ID
- NCT00639782
- Acronym / sponsor ID
- PROSE / ONXSJM1
- Conditions
- Heart Valve Disease
- Keywords
- thromboembolism, mechanical heart valves, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 857 participants (actual)
- Lead sponsor
- On-X Life Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONX | Active comparator | Device: On-X Heart valve replacementOn-X heart Valve Replacement |
| SJM | Active comparator | Device: SJM Heart valve replacementSJM heart valve replacement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-X Heart valve replacementAlso: On-X Prosthetic Heart ValveOn-X Heart valve replacement | Device | ONX |
| SJM Heart valve replacementAlso: St. Jude Medical Prosthetic Heart ValveSJM Heart valve replacement | Device | SJM |
Primary outcome
Thromboembolisms
Time frame: 5 years
Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
Related trials for Heart Valve Disease
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TRISCEND JAPAN Study
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Jamieson, MD principal investigator
Vancouver Coastal Health Research Institute
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-X Heart valve replacement and SJM Heart valve replacement in people with Heart Valve Disease, run by On-X Life Technologies, Inc. at 28 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, India, Canada, Germany, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolisms (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.