Valvular heart disease
Conditions
Interventions
Group 1 :TEER
Sponsors
Department of Cardiology, West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Moderate to severe or severe mitral regurgitation (MR >= 3+) confirmed by echocardiography, including DMR and FMR; 3. NYHA grade II-IV; 4. LVEF >= 20%; 5. For DMR patients, it needs to be evaluated by two or more cardiovascular specialists, who believe that the surgical risk is high (American Society of Thoracic Surgery Risk Scoring System for Adult Cardiac Surgery (STS score), the risk of death from mitral valve repair >= 6% or mitral valve replacement death risk >= 8% (high risk); or there are 2 or more frailty indices (moderate to severe frailty); or there are 2 or more major organ insufficiencies that cannot be improved after surgery; or local heart team comprehensive Assess the patient for other diseases or factors that are not suitable for surgery); 6. For patients with FMR, adequate standard care, including treatment for coronary heart disease, heart failure, mitral regurgitation and other conditions (e.g., coronary revascularization, cardiac resynchronization, and/or steady dose of GDMT) has been performed in accordance with the guidelines, as determined by the local cardiac team; 7. Voluntarily participate in and sign the informed consent form, and are willing to accept relevant examinations and clinical follow-up; 8. Anatomically suitable for mitral valve repair and assessed to be suitable for the use of this research device.
Exclusion criteria
Exclusion criteria: 1. Previous implantation of artificial mitral annuloplasty ring, artificial mitral valve or transcatheter mitral valve surgery; 2. Patients with active infective endocarditis; 3. Echocardiography found any intracardiac mass, left ventricular or atrial thrombus; 4. Severe coronary artery stenosis without surgical or interventional treatment or acute myocardial infarction within 90 days; 5. Combined with tricuspid valve, aortic valve or severe large vessel disease requiring surgical or interventional treatment; 6. Severe pulmonary hypertension (pulmonary artery systolic pressure > 70 mmHg measured by ultrasound or right heart catheterization, if measured at the same time, the result of right heart catheterization shall prevail; 7. Patients with severe right heart insufficiency; 8. Hemodynamic instability, defined as systolic blood pressure 70%); 10. Received transcatheter cardiovascular interventional surgery within 30 days, and received cardiovascular surgery within 180 days; 11. Patients with clear coagulation dysfunction and severe coagulation system diseases, or patients with clear contraindications to the use of anticoagulant drugs; 12. Known hypersensitivity to contrast agents and product components; 13. Patients with severe neurological lesions affecting cognitive ability; 14. The life expectancy of the patient is less than 12 months; 15. Has undergone heart transplantation or has recently been assigned as a heart transplant donor; 16. Participating in interventional clinical research of other devices or drugs; 17. Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrating cardiomyopathy (such as amyloidosis, hemochromatosis), and constrictive pericarditis; 18. Pregnant and lactating women; or women who plan to become pregnant within the next 12 months; Note: Women of childbearing age should take a pregnancy test within 14 days before registration and get a negative result, and take scientific and safe contraceptive measures; 19. Other conditions that the investigator considers inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed