Mitral regurgitation
Conditions
Interventions
Experimental group:Transapical Mitral Valve Repair System
Sponsors
Fuwai Yunnan Cardivascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. Moderate or above (MR>2+) mitral regurgitation confirmed by echocardiography; 3. Anatomically suitable for mitral valve repair, and can tolerate small incision thoracic surgery; 4. NYHA heart function classification II-IV; 5. LVESD = 25%; 6. The independent expert committee of this study believes that surgery is contraindicated or high-risk. The recommended reference standard: surgical valve replacement with STS score >= 8; or surgical valve repair with STS score >= 6; or other risk factors (for example, at least two Indicators of moderate to severe weakness; potential operating disorders; at least major organ dysfunction, which cannot be improved after surgery, etc.); 7. Patients who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and are willing to cooperate in clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with infective endocarditis or rheumatic mitral valve disease, active bacterial endocarditis; 2. Severe mitral valve calcification or mitral valve stenosis; 3. Ultrasound shows a mass, thrombus or vegetation in the heart; 4. Accompanied by moderate or higher aortic valve stenosis or regurgitation; 5. Mitral regurgitation caused by special pathological mechanisms, such as leaflet perforation and leaflet cracks; 6. Hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, systolic pericarditis or other structural heart disease that causes heart failure in the patient, expected dilated cardiomyopathy; 7. Those who have a history of acute myocardial infarction within 30 days before surgery; 8. Those who have undergone heart surgery within 30 days before surgery or those who need heart surgery at the same time, such as PCI surgery, CAGB surgery, heart transplantation, valve surgery, CRT heart resynchronization therapy, ICD implant surgery, etc.; 9. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months; 10. Severe liver and kidney failure; 11. Active infections require simultaneous antibiotic treatment; 12. Severe pulmonary hypertension (pulmonary artery systolic pressure > 70 mmHg); 13. Blood system dysplasia, including granulocytopenia (WBC = 4; 17. Those who are participating in other clinical trials and have not reached the primary endpoint; 18. The subject has a disease that may make it difficult to evaluate and treat (such as cancer, infection, severe metabolic disease, mental illness, etc.); or a subject that the researcher has assessed as unsuitable for the test.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Clinical success rate;Graded improvement of mitral regurgitation;All-cause mortality;incidence of major adverse events; | — |
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Countries
China
Contacts
Public ContactZhang Gejun
Fuwai Yunnan Cardivascular Hospital
Outcome results
None listed