Functional Mitral regurgitation
Conditions
Interventions
Group 1 :transcatheter mitral valve repair system
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Severe mitral regurgitation >= 3+ (moderate or above functional mitral regurgitation disease, or with stenosis is included); 2. Age >= 18 years who are not in pregnancy or lactation; 3. Life expectancy > 12 months; 4. Left ventricular end-systolic diameter = 20%; 6. Cardiac function NYHA >= ?; 7. The patient was anatomically suitable for the implantation of the transcatheter mitral valve repair system, and the conditions allowed the femoral vein and the atrial septum; 8. Effective mitral valve orifice area >= 4.0 cm^2; 9. The patient has received standard and adequate medical treatment (GDMT treatment), and the heart failure treatment has been treated for at least 30 days; 10. Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
Exclusion criteria
Exclusion criteria: 1. Previous cardiac mitral valve surgery; 2. Patients with Infective endocarditis or having an active infection; 3. Combined with untreated severe coronary artery disease; 4. Pulmonary hypertension (pulmonary artery systolic pressure > 70 mmHg); 5. Patients with severe right heart failure; 6. Patients are extremely weak and cannot tolerate general anesthesia or are in shock that circulatory support is needed; 7. Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis; 8. Patients receiving chronic dialysis; 9. Patients with clear coagulation dysfunction and severe coagulopathy; 10. Patients with clear contraindications to anticoagulant drugs; 11. Patients with stroke or transient ischemic attack within 30 days; 12. Echocardiography found any intracardiac mass, left ventricle or atrial thrombus; 13. Patients who require surgery or interventional therapy for other valvular lesions; 14. Patients with severe macrovascular lesions requiring surgical treatment; 15. Patients imaging examinations suggest that the anatomy of the heart and valves are inappropriate; 16. Allergic to contrast agents, nickel-titanium memory alloy products; 17. Patients with severe neurological disorders affecting cognitive ability; 18. Patients with severe thoracic deformities; 19. Concomitant severe chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or long-term oral corticosteroids.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Composite rate of all-cause mortality and rehospitalization for heart failure at 30 days, 180 days/1 year/2 to 5 years;Incidence of major adverse events;Quality of life improvement; | — |
Primary
| Measure | Time frame |
|---|---|
| Composite rate of all-cause mortality and rehospitalization for heart failure at 12 month; | — |
Countries
China
Contacts
Public ContactChen Mao
Shanghai NewMed Medical Co., Ltd.
Outcome results
None listed