Mitral regurgitation
Conditions
Interventions
Experimental group:Mitral valve ring repair
Sponsors
Department of Cardiology, West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient's age= 18 years old; 2. Moderate-to-severe or greater functional mitral regurgitation (echocardiographic MR= 3+), as assessed by TTE or TEE imaging within 90 days; 3. Surgical patients at high risk of traditional surgery: surgical risk score results or team center surgeon for surgical risk; 4. According to the basic conditions (such as atrial fibrillation, coronary heart disease, etc.), the patients still had heart failure symptoms [New York Heart Association (NYHA) function class II-IV] after at least one month of guidelin-guided medical therapy (GDMT) or other device assisted therapy, and the patient's condition was stable; 5. The echocardiographic measurement of left ventricular ejection fraction (LVEF) > 30%; 6. Research center according to the ultrasonic imaging evaluation of pulmonary artery systolic pressure (PASP)=70 mmHg, such as PASP > 70 mmHg in ultrasound, by right angiographic assessment of PASP = 70 mmHg; 7. Patients can understand and sign informed consent and willing to follow the plan to complete the supervision.
Exclusion criteria
Exclusion criteria: 1. Invasive cardiomyopathy (for example, amyloidosis, hemochromatosis, sarcoidosis, hypertrophic cardiomyopathy, constrictive pericarditis, or in addition to the ischemic and non ischemic etiology of DCM outside of any other cause heart failure of structural heart disease; 2. The patients had a past history of rheumatic heart disease; 3. Patients who had undergone percutaneous coronary intervention, surgical bypass, carotid intervention, or CRT, CRT-D, or implantable defibrillator within the previous 30 days and who had known unstable angina or myocardial infarction within 30 days; 4. The femoral veins of both lower limbs were not suitable for 23Fr sheath access due to lesions or misalignment; 5. There is an obvious mitral valve ring or mitral valve calcification, mitral stenosis; 6. Mitral valve anatomical abnormalities such as flail-like leaflet movement or leaflet perforation may interfere with proper access, anchoring, and/or entry of the L-clip system; 7. Patients who were hemodynamically unstable (systolic blood pressure 70 mmHg; 9. An echocardiogram showed an intracardiac mass, thrombus, or vegetation; 10. Combined with surgical indications of vascular disease; 11. Contraindications were examined by the TEE; 12. Active systemic infection, including active infective endocarditis; 13. Untreatable allergic reactions to or contraindications to any of the following: aspirin and clopidogrel and ticlopidine (dual antiplatelet therapy) or heparin and bivalirudin, or warfarin leading to intolerance to intraoperative anticoagulation or postoperative antiplatelet therapy; Or nickel titanium alloy, nickel and titanium) or contrast allergy or taboo; 14. Severe aortic-valve disease (stenosis or regurgitation) requiring intervention or cardiac surgery planned for any reason within the next month; 15. TIA within 30 days, or previous stroke with permanent disability (mRS > 2); 16. Hemorrhagic disorders or hypercoagulable states; 17. Pregnant or lactating subjects; 18. Life expectancy in patients with less than 12 months; 19. Within 30 days before signing the informed consent to participate in any other clinical trials and not out of the group, or within 30 days prior to participate in any implant test (except registered sex research), or the future 1 month has plans to participate in other clinical trials; 20. Other circumstances that the investigator deemed inappropriate for participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of device implantation;Incidence of all-cause death and HF readmission at 1 month after surgery;Surgical success rate;Grading of the severity of mitral regurgitation;Improvement rate of mitral regurgitation degree;Left ventricular ejection fraction;Regurgitant volume;Effective regurgitant orifice area;Transvalvular Mitral Mean Pressure Gradient; | — |
Countries
China
Contacts
Public ContactMao Chen
West China Hospital, Sichuan University
Outcome results
None listed