Bloodclot complications incidence of obstruction due to bloodclot.
Conditions
Interventions
Haert Valve replacement of the Mitral valve or Aortic valve with a mechanical
heart valve prothesis.
Sponsors
On-X Life Technologies, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Isolated mitral - or isolated aortic valve replacement (eligible for coronary artery bypass and / or concomitant repair of mitral of tricuspid valves) 2. Candidate for receipt of mechanical heart valve
Exclusion criteria
Exclusion criteria: Patient is not a candidate to receive a mechanical heart valve Double valve replacement Patient requires tricuspid valve replacement Enrollment in another investigative trial / study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major thromboembolic events during 5 year FU | — |
Secondary
| Measure | Time frame |
|---|---|
| _ | — |
Countries
Netherlands
Outcome results
None listed