Mitral Valve
Conditions
Interventions
experimental group:transapical memoclip system in the treatment of mitral regurgitation
Sponsors
Hefei High-Tech Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, regardless of gender; 2. Moderate and severe mitral insufficiency (MR >= 3 +) with symptoms but unable to operate or high-risk surgery: STS score of valve replacement >= 8, STS score of valve repair >= 6, or other high-risk surgery. For example, there are >= 2 moderate and severe debilitating factors, or there are possible surgical obstacles, or there are >= 2 major organ dysfunction and can not be improved after operation; Or other high-risk factors determined by the local heart team; 3. NYHA functional class II-IV; 4. Left ventricular ejection fraction (LVEF) >= 20%; 5. Anatomically, it is suitable for treatment through transapical memoclip system; 6. Patients who can understand the purpose of the trial, voluntarily participate in and sign informed consent, and are willing to cooperate in clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Echocardiography shows intracardiac mass, thrombus or vegetation; 2. Other serious heart valve diseases requiring surgical intervention; 3. Previous mitral valve surgery or transcatheter mitral interventional therapy; 4. Heart failure caused by hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, invasive cardiomyopathy (such as amyloidosis, hemochromatosis, sarcoidosis, etc.) or any other structural heart disease, except dilated cardiomyopathy of ischemic or non ischemic etiology; 5. Pulmonary artery systolic pressure (PASP) > 70 mmHg; 6. History of acute myocardial infarction or untreated coronary artery disease with clinical significance and requiring revascularization in the past 4 weeks; 7. Any percutaneous cardiac intervention surgery or any implanted cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy cardioverter defibrillator (ICD) (CRT-D) within the past 30 days, or any cardiac surgery within 6 months; 8. Patients contraindicated by transesophageal echocardiography (TEE) or general anesthesia; 9. Patients with end-stage heart failure (ACC / AHA phase d), or previous orthotopic heart transplantation, or planned heart transplantation; 10. Active endocarditis, or active rheumatic heart disease, or valvular degeneration caused by endocarditis or rheumatic disease; 11. Severe chronic obstructive pulmonary disease (COPD) (requiring continuous home oxygen therapy or long-term use of steroid drugs); 12. Cerebrovascular accident or severe carotid stenosis (ultrasound > 70%) in the past 30 days, or carotid stent implantation within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate; | — |
Countries
China
Contacts
Public ContactMei Ju
Hefei High-Tech Cardiovascular Hospital
Outcome results
None listed