Mitral regurgitation
Conditions
Sponsors
Sakakibara Heart Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We include patients who meet all of the followings. 1. Diagnosis of mitral regurgitation 2. Mitral valve disease that meets at least one of following conditions and is indicated for surgery (1) Symptomatic acute severe MR (2) Chronic severe MR and NYHA functional class II, III or IV symptoms in the absence of severe LV dysfunction (severe LV dysfunction is defined as ejection fraction less than 0.30). (3) Asymptomatic chronic severe MR with mild to moderate LV dysfunction, ejection fraction 0.30 to 0.60, and/or end-systolic dimension greater than or equal to 40 mm. 3. Advamced mitral valve disease that standard mitral valve repair is difficult for and is unlikely to present durable results for. (must meet at least one of the followings) (1) Redo mitral valve surgery 6 months or longer after the previous mitral valve surgery. (2) Infective endocarditis extending over the anterior and posterior leaflets 4. Written informed consent is obtained from the patient or his/her parental authority. 5. Patient age must be 16 or older and under 70 at the time of consent.
Exclusion criteria
Exclusion criteria: 1. Active malignancy except for in situ cancer 2. Dialysis 3. Participating in other trials 4. Myocardial infarction in the last 6 months 5. Stroke in the last 6 months 6. Previous percutaneous coronary stenting in a month before surgery 7. Concomitant procedures other than tricuspid valve repair, maze operation and pulmonary vein isolation. 8. Severe left ventricular dysfunction (ejection fraction less than 0.30) 9. When excellent outcomes and prognosis are expected with standard prosthetic mitral valve replacement 10. When a principal investigator deems a patient inappropriate as a trial subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual mitral regurgitation two weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Residual and recurrent mitral regurgitation 12 months after surgery, adverse events in 12 months after surgery, and adverse events in 60 months after surgery. | — |
Countries
Japan
Contacts
Public ContactNatsumi Takahashi
Sakakibara Heart Institute Division of Clinical Research
Outcome results
None listed