Moderate and severe mitral regurgitation (MR=3+)
Conditions
Interventions
Experimental group:Transcatheter mitral annulus plasty
Sponsors
Zibo Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. =18 years old; 2. Moderate to severe or above functional mitral regurgitation due to mitral band dilation assessed by core lab based on TTE or TEE within 90 days (echocardiographic MR= 3+) ; 3. Patients with high risk of traditional surgical operations:Surgical risk score results or the Center's team of physicians determined that surgery is high-risk; 4. Symptoms of heart failure after one month of GDMT or other device-assisted therapy [NYHA cardiac function Class II to ?]; 5. In the case of atrial fibrillation, coronary artery disease, left ventricular dysfunction, and heart failure, subjects should have received GDMT and be stable; 6. LVEF) assessed by echocardiography =20%; 7.LVESD assessed by echocardiography =70mm; 8. PASP =70 mmHg; 9. Anatomic and otherwise assessed by core lab team as suitable for treating with L-ClipTM Transcatheter Annuloplasty System; 10. The patient is able to understand and sign the ICF and willing to follow the protocol.
Exclusion criteria
Exclusion criteria: 1. Severe right heart failure assessed by core lab based on echocardiographic ; 2. Invasive cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic cardiomyopathy, constrictive pericarditis, or any other structural heart disease that causes heart failure other than dilated cardiomyopathy of ischemic or non-ischemic origin; 3. Previous history of rheumatic heart disease; 4. Patients who underwent percutaneous coronary intervention, surgical bypass, or carotid artery intervention, or CRT, CRT-D, or implantable defibrillator within 30 days had known unstable angina or myocardial infarction within 30 days; 5. Femoral veins of lower limbs are not suitable for 23Fr sheath tube approach due to lesions or misshapiness,femoral intervention is conjunctured; 6. The core lab evaluation shows obvious mitral ring or mitral lobe calcification and mitral stenosis; 7. LVEF = 20% and LVEDD > 80mm assessed by core lab based on TTE; 8. Mitral valve anatomical abnormalities may affect the correct approach, anchoring, and/or entry of the L-clip system,such as flail movement or perforation; 9. Hemodynamic instability (systolic blood pressure 70 mmHg based on echocardiography or right heart catheterization; 11. Echocardiography indicated intracardiac mass, thrombus or growth; 12. Aortic valve, tricuspid valve or other severe large vascular lesions with surgical indications; 13. Contraindications to atrial septal puncture, such as anatomical unsuitable; 14. TEE contraindication or baseline TEE failed; 15. Any previous or other (non-L-clip implantation) scheduled mitral band repair or replacement (surgical or interventional) operation; 16. Active systemic infections, including active endocarditis; 17. Any allergic reaction or contraindication of below: aspirin and clopidogrel and ticlopidine (dual antiplatelet drug) or heparin and bivaludine, or warfarin resulting in intolerance to intraoperative anticoagulant or postoperative antiplatelet therapy regimens; Or Nitinol (nickel and titanium) or contrast media allergy or contraindication; 18. Other severe valvular diseases (stenosis and regurgitation) requiring intervention, or heart surgery plan within the next one month; 19. TIA within 30 days, or previous stroke with permanent disability (mRS > 2 points) ; 20. Hemorrhagic disease or hypercoagulability; 21. Pregnant or lactating subjects; 22. Life expectancy less than 12 months; 23. ICF signed within 30 days participating in any other clinical trial and stiell in following visit, or participating in any clinical trials of interventional devices (exclude registration study) within 30 days, or planning to participate in any other clinical trial within the next 12 months; 24.Other conditions deemed inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate;Mitral regurgitation severity classification;Improvement rate of mitral regurgitation severity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of implantation;success rate of operation;Incidence of all-cause death and heart failure admission 1 month after surgery; | — |
Countries
China
Contacts
Public ContactBo Li
Zibo Central Hospital
Outcome results
None listed