Mitral valve regurgitation
Conditions
Interventions
Experimental group:Novel Morphology Classification Guided Mitral Valve Transcatheter Edge-to-Edge Repair for Patients with Commissural Degenerative Mitral Regurgitation
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Moderate-to-severe (3+) or severe (4+) commissural degenerative mitral regurgitation (DMR), as determined by an independent Echocardiographic Core Laboratory (ECL) using standardized echocardiographic assessments; multiple etiologies are acceptable, but the primary mechanism of mitral regurgitation must be degenerative; 3. Symptomatic heart failure corresponding to New York Heart Association (NYHA) functional class II, III, or IV; or asymptomatic but with evidence of cardiac dysfunction, such as left ventricular end-systolic diameter (LVESD) >= 40 mm; 4. Presence of atrial septum and mitral valve anatomy suitable for transcatheter edge-to-edge repair, as confirmed by the ECL and the multidisciplinary heart team; 5. The subject or legal representative voluntarily agrees to comply with all study requirements, participate in all necessary postprocedural follow-up visits, and has signed the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Degenerative mitral regurgitation (DMR) not involving the commissural regions; 2. Mitral regurgitation caused by non-degenerative primary valve diseases, such as leaflet thickening or perforation due to rheumatic heart disease or infective endocarditis; 3. Moderate or greater functional MR (>=2+ central MR) outside the commissural region, due to leaflet malcoaptation; 4. Presence of myocardial diseases such as restrictive cardiomyopathy, hypertrophic cardiomyopathy, dilated cardiomyopathy, ischemic cardiomyopathy, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.); 5. History of mitral valve surgery or transcatheter mitral valve interventions; 6. Presence of moderate-to-severe (3+) or severe (4+) valvular disease involving other valves requiring surgical or transcatheter intervention; 7. Acute cerebrovascular event within 30 days; 8. Undergoing other cardiac or cerebrovascular surgeries/interventions within 30 days, including CABG, PCI, TAVR, or transcatheter carotid stenting; 9. Severe symptomatic carotid artery stenosis, with ultrasound-confirmed stenosis >70%; 10. Hemodynamic instability requiring continuous intravenous medications or mechanical circulatory support; 11. Estimated pulmonary artery systolic pressure (PASP) >70 mmHg by echocardiography, or pulmonary vascular resistance (PVR) >3 Wood units by right heart catheterization; 12. Evidence of severe right heart failure, including symptoms/signs or echocardiographic findings such as TAPSE <15 mm or peak tricuspid annular S' velocity <10 cm/s; 13. Severe liver cirrhosis with esophageal varices; 14. History of heart transplantation; 15. Severe hematologic disorders; 16. Intracardiac masses or thrombi identified by echocardiography; 17. Contraindications or high risk for transesophageal echocardiography (TEE); 18. Poor TEE image quality; 19. Known allergy or contraindication to any agents used during the procedure; 20. Current pregnancy or planned pregnancy within 12 months; 21. Planned or anticipated need for emergency or elective cardiac surgery for any reason within 12 months; 22. Life expectancy less than 12 months due to non-cardiac causes; 23. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary effectiveness endpoint: Proportion of subjects with mild or less MR (<=1+), without MV replacement, and without recurrent MV intervention (surgical or percutaneous) from the time of index procedure through 12 months ;Primary safety endpoint: Composite endpoint of all-cause mortality, stroke, myocardial infarction, cardiac hospitalization, or nonelective cardiovascular surgery for device-related complications at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effective endpoint: The success rate of TEER is defined as no operative death, no surgical treatment, or reintervention related to device implantation or vascular access. ;Secondary effective endpoint: The success rate of device implantation is defined as successful device implantation 30 days after TEER, no MR (>=2+), no TEER-related mitral stenosis (mitral valve gradient >= 5 mm Hg or effective regurgitant orifice area <1.5 cm^2), no death and stroke, and no nonelective cardiac surgery due to device-related complications;Secondary effective endpoint: Proportion of surviving patients with mild or less MR (<=1+) at 30 days and 6 months after surgery;Secondary effective endpoint: Proportion of surviving patients with moderate or less MR (<=2+) at 30 days, 6 months, and 12 months after surgery;Secondary effective endpoint: Hierarchical composite endpoint of death and recurrent HF hospitalization within 12 months after surgery;Secondary effective endpoint: Recurrent HF hospitalization within 12 months after surgery;Secondary safety endpoint: Composite endpoint at 12 months, Including SLDA; Device embolization; Endocarditis requiring surgery; Mitral stenosis requiring surgery; LVAD implant; Heart transplant; Any device-related complication requiring nonelective cardiovascular surgery;Secondary safety endpoint: Incidence of mitral chordae tendineae entanglement during TEER;Secondary effective endpoint: All-cause mortality within 12 months after surgery;Secondary effective endpoint: Improvement of 6-minute walking distance from baseline at 12 months;Secondary effective endpoint: Improvement of KCCQ compared with baseline at 12 months;Secondary effective endpoint: Proportion of NYHA functional class I or II subjects at 30 days, 6 months, and 12 months after surgery ;Secondary effective endpoint: Change in LVEDV from baseline to 12 months; | — |
Countries
China
Contacts
Public ContactGuangyuan Song
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed