Patients with valvular heart disease
Conditions
Interventions
Standard anticoagulation therapy in patients with aortic mechanical heart valve
Low dose anticoagulation therapy (PT-INR 1.3-1.8) in patients with aortic mechanical heart valve
Sponsors
Senko Medical Instrument Mfg. Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are sifficiently ill to warrant replacement of their diseased natural or prosthetic valve, based on standard cardiovascular diagnostic workups. 2. Patients who are in sufficient satisfactory condition to be an average operative risk. 3. Patients who require an isolated aortic, or an isolated mitral valve replacement. 4. Patients who have agreed to return for the required follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant, or planning to become pregnant. 2. Patients who have a major noncardiac terminal disease. 3. Patients with active endocarditis. 4. Patients who require tricuspid valve replacement. 5. Patients who underwent coronary artery bypass surgery and require aspirin therapy. 6. Patients who require antiplatelet therapy. 7. Patients with a previous prosthetic valve, where it is not being replaced by a study valve, or patients requiring multiple valve replacement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the rate of occurrence of valve thrombosis, thromboembolism, bleeding, acitve endocarditis during the study period. Hemolytic potential demonstrated by serum lactate dehydrogenase at 1-year and postoperative hemodynamics (EOA and pressure gradient) will be also assessed. | — |
Countries
Japan
Outcome results
None listed