Patients with severe mitral regurgitation were clinically assessed as patients at high risk of surgery.
Conditions
Interventions
Experimental group:Mitral valve replacement
Sponsors
Fuwai Yunnan Cardiovascular Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Mitral regurgitation >= 3+; 2. Age >= 18 years old; 3. Patients at high risk of traditional surgery: death risk of STS mitral valve replacement >= 8%; Or there are 2 or more frailty indexes; Or there are two or more major organ dysfunction that can not be improved after operation; Or combined with other diseases or factors unsuitable for surgery; 4. The investigator assessed anatomical suitability for transapical implantation of MitraFix transcatheter artificial mitral valve system; 5. Patients who can understand the purpose of the trial, voluntarily participate in and sign informed consent, and are willing to accept relevant examination and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Severe mitral stenosis; 2. Severe calcification of mitral leaflet and /or annulus; 3. Presence of cardiac mitral implants 4. Patients with infective endocarditis or suggesting active infection; 5. Complicated with serious untreated coronary artery disease or acute myocardial infarction within 90 days; 6. Patients with severe pulmonary hypertension (pulmonary systolic pressure estimated by ultrasound > 70mmHg) 7. Tricuspid annular systolic displacement (TAPSE) < 12; 8. Severe aortic or tricuspid valve disease requiring surgical intervention; 9. Left ventricular ejection fraction < 30%; 10. The patient is extremely weak and cannot tolerate the transapical approach or is in shock and needs circulatory support; 11. Implantation of coronary stent, CRT, CRT-D or implantable cardioverter defibrillator within 30 days; 12. Patients receiving chronic dialysis; 13. Patients with definite coagulation dysfunction and severe coagulation system diseases; 14. Patients with clear contraindications to the use of anticoagulant drugs; 15. Echocardiography revealed any intracardiac mass, left ventricular or atrial thrombus; 16. There are contraindications in transesophageal ultrasonography; 17. Known allergy to contrast agents, nitinol or bovine products; 18. Life expectancy<12 months; 19. The investigators judged that it was not suitable to establish the transapical approach; 20. Participated in clinical research of other devices or drugs within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| technical success rate;device success rate;operation success rate;evaluation of valve performance;postoperative cardiac function evaluation;quality of life evaluation;six minute walking distance;Major adverse events;Hospitalization for heart failure;Adverse events / serious adverse events;device performance evaluation; | — |
Countries
China
Contacts
Public ContactShengshou Hu
Fuwai Yunnan Cardiovascular Hospital
Outcome results
None listed