functional mitral regurgitation
Conditions
Interventions
experimental group:MVR
Sponsors
zhongshan hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age = 18; 2) Functional mitral regurgitation with MR grade = 3+; 3) Life expectancy>12 months; 4) NYHA Grade II~IVa; 5) According to evaluation by the research team, the heart anatomical structure and cardiac condition of the patient is suitable for the implantation treatment and allows the atrial septal puncture. 6) According to evaluation by the research team, the patient is at high-risk or unsuitable for routine surgery, and they are expected to benefit from the transcatheter mitral valve repair 7) Patients who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and are willing to accept relevant examinations and clinical follow-ups
Exclusion criteria
Exclusion criteria: 1. Previous mitral valve surgery or transcatheter mitral valve intervention; 2. Serious structural abnormalities of mitral valve, serious calcification of mitral annulus; 3. Patients with other valvular diseases requiring surgical or interventional treatment; 4. Echocardiography shows the presence of intracardiac masses, thrombi or vegetations; 5. Severe right ventricular dysfunction as evaluated by echocardiography; 6. NYHA cardiac function is classified as IVb or heart failure stage D, or patients is undergoing heart transplantation or waiting for heart transplantation; 7. Received any percutaneous cardiovascular intervention, carotid surgery, cardiac resynchronization therapy (CRT), cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter defibrillator (ICD) within 1 month before procedure; 8. Active gastrointestinal ulcer or gastrointestinal bleeding; 9. Untreated patients who require revascularization due to coronary artery disease and obvious clinical symptoms ; 10. Patients who are unable to tolerate transesophageal echocardiography (TEE) or general anesthesia; 11. Heart failure caused by hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease 12. Severe symptomatic carotid stenosis; 13. Cardiac surgery is planned in the next 12 months; 14. Active endocarditis; 15. Active infection which needs antibiotic treatment; 16. Uncontrollable bleeding or coagulation dysfunction, or those who cannot tolerate anticoagulation and antiplatelet therapy; 17. Patients who are suffering from other disease(s) that may lead to difficulties in evaluation and treatment (such as severe cognitive impairment, mental illness, etc.); 18. Pregnant or lactating women, or women who plan to become pregnant in 12 months; 19. Being involved in any other clinical trial (except those that have no impact on this clinical study according to the judgment of the research team); 20. Patients who are unsuitable for participating in the study judged by the research team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate instrument success rate;achievement ratio of operation; | — |
Countries
China
Contacts
Public ContactDaxin Zhou
zhongshan hospital
Outcome results
None listed