Atrial functional mitral regurgitation
Conditions
Interventions
Control group:Guideline-directed medical therapy (GDMT)
Experimental Group:Transcatheter edge-to-edge repair (TEER) combined with guider-directed medical therapy (GDMT)
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria (all must be met) 1. Age >=18 years old 2. Have symptoms of heart failure 3. The patient had at least one hospitalization history due to heart failure within 12 months prior to inclusion (the reason for the patient's hospitalization was determined by an expert panel composed of doctors specializing in valvular heart disease and heart failure in combination with the patient's hospitalization records) and/or plasma BNP>=300pg/ml or NT-proBNP>=1500pg/ml 4.NYHA cardiac function classification II, III or active grade IV 5.ECL diagnosis: Moderate to severe (3+) and above (4+) AFMR 6. The subjects have received maximally optimized GDMT, including standardized heart rate and rhythm control drug treatment, for at least 3 months 7. The cardiac team assesses a high risk of surgical operation (STS score >=8%) or the existence of surgical contraindications 8. The area of the mitral valve orifice is greater than 4cm^2 9. The anatomy of the atrial septum and femoral vein is suitable for TEER treatment 10. The subjects or their guardians voluntarily abide by all the regulations of this clinical trial, including the possibility of being randomly assigned to a control group, and participate in all necessary postoperative follow-ups, and provide written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria (all must be excluded) 1.Organic lesions of the mitral valve, such as prolapse, flail lesions, thickening of the valve leaflets caused by rheumatic heart valve disease, valve perforation, and valve damage caused by infective endocarditis, etc 2. Myocardial involvement disorders, such as restrictive cardiomyopathy, hypertrophic cardiomyopathy, dilated cardiomyopathy, ischemic cardiomyopathy, infiltrative cardiomyopathy (amyloidosis, hemochromatosis, sarcoidosis, etc.) 3. Pericardial diseases, such as constrictive pericarditis, etc 4. Has undergone mitral valve surgery or transcatheter mitral valve intervention in the past 5. For patients with moderate to severe or more severe other valve diseases, surgical operation or transcatheter interventional treatment is required 6. Acute cerebrovascular disease occurs within 30 days 7. Within 30 days, have undergone other cardiovascular and cerebrovascular surgical operations or interventional treatments, such as CABG, PCI, TAVR, transcatheter carotid artery stent implantation, etc. 8. Severe symptomatic carotid artery stenosis (ultrasound examination shows stenosis > 70%) 9. Hemodynamic instability requires continuous intravenous drug infusion or mechanical assisted circulation therapy; 10. Echocardiography estimated PASP>70mmHg or right heart catheterization measured PVR>3 WOOD 11. Possessing symptoms, signs or echocardiographic evidence of severe right heart failure, such as TAPSE< 15mm or S-wave peak velocity <10cm/s; Chronic renal insufficiency requires long-term hemodialysis treatment 13. Severe liver cirrhosis complicated with esophageal varices 14. Previous heart transplantation 15. Severe COPD requires continuous home oxygen therapy or long-term use of steroid drugs 16. Severe blood system diseases 17. Intracardiac space-occupying lesions or thrombosis diagnosed by echocardiography 18. There are contraindications or high risks for transesophageal echocardiography 19. The quality of echocardiographic images is poor 20. Known to be allergic to or have contraindications to the drugs required during the operation 21. Pregnant or planning to become pregnant within 12 months 22. It is expected that emergency surgery or any elective cardiac surgery may be required for any reason within 12 months 23. The subjects belong to vulnerable groups or have any diseases that would impair their ability to give written informed consent and/or comply with the research procedures 24.Life expectancy caused by non-heart diseases is less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite endpoint defined as all-cause mortality or rehospitalization for heart failure occurring within 12 months ;A composite endpoint of device-related major adverse events at 12 months.; | — |
Secondary
| Measure | Time frame |
|---|---|
| A hierarchical composite endpoint of all-cause mortality or heart failure rehospitalization within 12 months;All-cause mortality within 12 months;The ratio of patients with MR <=1+;Anteroposterior diameter of the left atrium;The ratio of patients with MR <=2+;The ratio of patients with NYHA grade I or II;Left atrial volume index;A 6-minute walk away;KCCQ;The improvement value of NT-proBNP relative to the baseline; | — |
Countries
China
Contacts
Public ContactGuangyuan Song
Beijing Anzhen Hospital Affiliated to Capital Medical University
Outcome results
None listed