Trials / Completed
CompletedNCT00639782
Prospective Randomized On-X Versus SJM Evaluation Trial
Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 857 (actual)
- Sponsor
- On-X Life Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | On-X Heart valve replacement | On-X Heart valve replacement |
| DEVICE | SJM Heart valve replacement | SJM Heart valve replacement |
Timeline
- Start date
- 2003-07-01
- Primary completion
- 2021-05-01
- Completion
- 2021-05-01
- First posted
- 2008-03-20
- Last updated
- 2021-05-25
Locations
28 sites across 9 countries: United States, Australia, Canada, Germany, India, Netherlands, Norway, South Africa, Sweden
Source: ClinicalTrials.gov record NCT00639782. Inclusion in this directory is not an endorsement.