Functional mitral regurgitation
Conditions
Interventions
Control group:Guideline-Directed Medical Therapy
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient is at least 18 years old; 2. Symptomatic functional mitral regurgitation (FMR) caused by ischemic or non-ischemic cardiomyopathy is >= 3+; 3. According to the judgment of the local clinical trial institution's cardiac team, the subject has received adequate treatment in accordance with applicable standards, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure; 4. NYHA New York Heart Function Classification: II - IV; 5. Left ventricular ejection fraction (LVEF) is >= 20% and 150 pg/ml, or the corrected NT-pro BNP > 600 pg/ml; 9. The femoral vein access is assessed to be appropriate and transseptal puncture is feasible; 10. The subject has been informed of the nature of this study, understands the purpose of the clinical trial, voluntarily participates and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The echocardiogram indicates the presence of a mass, thrombus or neoplasm within the heart chambers; 2. The echocardiogram shows severe tethering of the valve leaflets; 3. There are other severe heart valve diseases that require surgical intervention; 4. Post-surgery of mitral valve surgery or mitral valve transcatheter surgery; 5. Hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy, or other structural heart diseases that cause heart failure, excluding dilated cardiomyopathy; 6. Acute heart failure or acute exacerbation of chronic heart failure, with no improvement after treatment of pericardial effusion or pleural effusion; 7. Moderate to severe right heart dysfunction, or elevated pulmonary artery systolic pressure; 8. Acute myocardial infarction within 4 weeks; or untreated severe coronary artery stenosis requiring revascularization; 9. Any cardiovascular interventional surgery within 30 days; or cardiac surgery within 6 months; or cardiac pacemaker treatment or cardiac resynchronization therapy (CRT-P, CRT-D) or implantation of a defibrillator (ICD) within 30 days; or the patient meets the indications for CRT-P, CRT-D or ICD, but has not been implanted; 10. The investigator determines that the subject's femoral vein cannot accommodate a 25F catheter, or there is a contralateral deep vein thrombosis; or the patient's anatomy is not suitable for atrial septal puncture; 11. There are contraindications for transesophageal echocardiography; or contraindications for general anesthesia; 12. End-stage heart failure (ACC/AHA stage D), after heart transplantation or awaiting heart transplantation; 13. Active endocarditis; or active rheumatic heart disease or valve degeneration caused by rheumatic diseases (such as poor compliance, perforation, etc.); 14. Severe chronic obstructive pulmonary disease (COPD) (requiring continuous home oxygen therapy or long-term use of steroid hormone medication); 15. History of cerebrovascular accident (ischemic) within the past 30 days, or severe symptomatic carotid artery stenosis (ultrasound shows a stenosis degree > 70%); or carotid artery stent implantation within 30 days; history of cerebrovascular accident (hemorrhagic) within 6 months; 16. (Estimated) glomerular filtration rate (eGFR) = 4 points; 20. The disease causes difficulties in treatment evaluation (such as cancer, severe metabolic diseases, mental illness, etc.); 21. Pregnant or lactating women; or women planning to get pregnant within the next 12 months; 22. Hemodynamic instability, defined as systolic blood pressure < 90 mmHg without afterload-lowering drugs and accompanied by low perfusion symptoms, or cardiogenic shock; or requiring vasoactive drug treatment; or requiring intra-aortic balloon counterpulsation; or other hemodynamic support devices; 23. Active infection requiring concurrent antibiotic treatment; 24. The subject is currently participating in a trial drug or device study that has not completed the primary endpoint or may interfere with the endpoint of this study; 25. The investigator determines that the patient has poor compliance and cannot complete the study as required; or the researcher considers the subject not suit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success at 12 months after the procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of subjects with post-treatment mitral regurgitation (MR<=2+);Recurrent heart failure (HF) hospitalizations;Proportion of subjects in NYHA NYHA class I or II after treatment;Change in 6 minutes walk test distance;Quality of life improvement;Change in LVEDV from baseline;Acute procedural success;Acute device success; | — |
Countries
China
Contacts
Public ContactJian'an Wang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed