Mitral Valve
Conditions
Interventions
experimental group:Transcatheter mitral valve repair
Sponsors
Department of Cardiology, West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
70 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with age >= 70 years old, regardless of gender; 2. Patients with moderate to severe mitral regurgitation (3 +) and severe mitral regurgitation (4 +) confirmed by echocardiography; 3. Patients with heart failure who still have symptoms after the best drug treatment recommended by the guidelines; 4. For patients with surgical contraindication or high risk assessed by the heart team (including a surgeon and physician with rich experience in mitral valve surgery), the recommended reference criteria are: STS score of surgical valve replacement >= 8 or STS score of surgical valve repair >= 6, or there are other high-risk factors, such as >= 2 moderate to severe weakness indicators or possible surgical operation obstacles There were more than 2 major organ dysfunction that could not be improved after operation; 5. The anatomical structure is suitable for mitral valve repair surgery and the patients who use the instruments in this study; 6. Patients whose femoral vein access is suitable and atrial septal puncture is feasible after evaluation; 7. Patients with life expectancy >= 12 months; 8. The patients who can understand the purpose of the trial voluntarily participate in and sign the informed consent, and are willing to accept the relevant examination and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients after heart transplantation, mitral valve surgery or transcatheter mitral valve surgery; 2. Patients whose anatomy of leaflet is not suitable for implantation and placement of instruments assessed by clinical team; 3. Patients with severe calcification or defect in the mitral valve capture area; 4. Patients with LVEF less than 20%; 5. Patients with LVESD >= 60mm; 6. Patients with active leaflet length less than 10 mm; 7. Patients whose mitral valve orifice area measured by ultrasound is less than 3.5cm2 or assessed as mitral valve stenosis after implantation of test device; 8. Patients with intracardiac mass, thrombus or neoplasm shown by echocardiography; 9. Patients with severe non mitral valve disease requiring emergency treatment; 10. Patients with severe pulmonary hypertension (pulmonary systolic pressure > 70mmhg); 11. Patients with severe right ventricular dysfunction; 12. Patients with infective endocarditis or suggestive of active infection; rheumatic valvular heart disease; 13. Patients with untreated severe coronary artery stenosis requiring revascularization, or complicated with other cardiovascular diseases requiring surgical treatment; 14. Patients who are extremely weak and unable to tolerate surgery or in shock state and need circulatory support; 15. Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis; or other structural heart diseases leading to heart failure except dilated cardiomyopathy; 16. Patients with renal failure requiring dialysis; 17. Patients with hematological cachexia, including neutropenia (WBC < 3 x 10^9 / L), acute anemia (HB < 90g / L), thrombocytopenia (PLT < 50 x 10^9 / L), bleeding constitution and severe coagulation dysfunction, have clear contraindications for anticoagulant and antiplatelet drugs; 18. Patients with acute myocardial infarction within 4 weeks before operation; 19. Patients with stroke within 90 days before operation; 20. Patients who had undergone coronary intervention, vascular intervention or cardiac surgery within 30 days before operation; 21. Patients with acute peptic ulcer or upper gastrointestinal bleeding within 3 months before operation; 22. Patients with severe symptomatic carotid stenosis (the degree of stenosis was more than 70% by ultrasonography); 23. Patients with diseases that may cause difficulties in evaluation of treatment (such as cancer, infection, severe metabolic diseases, severe nervous system diseases that affect cognitive ability, psychosis, etc.); or special cases that are not suitable for the surgical research related to the instruments of this clinical trial according to the evaluation of the cardiac team of the local trial center; 24. Patients with life expectancy less than 12 months; 25. Patients who participated in clinical trials of any drug and / or medical device within one month before the trial; 26. The researchers judged that patients with poor compliance could not complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 days Procedure success rate ; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital of Sichuan University
Outcome results
None listed