Degenerative Mitral regurgitation
Conditions
Interventions
Single Group:Transcatheter Mitral Valve Repair
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical Criteria: (1) Severe mitral regurgitation>=3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included); (2) Age>=70 years; or patients who are 60~70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or cannot tolerate traditional thoracotomy; (3) The patient's life expectancy was > 12 months; (4) Left ventricular ejection fraction >=30%; (5) As assessed by a multidisciplinary cardiac team (at least two cardiac surgeons/one cardiologist), patients who are at extremely high-risk or unsuitable for routine mitral valve surgery with evaluation; (6) Patients who understand the purpose of the trial and volunteer to participate, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups; 2. Anatomy Criteria: (1) The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation); (2) The width of the mitral valve prolapsed area is =2mm, effective length of anterior and posterior leaflets>1cm (conforming to EVEREST II recommended mitral valve interventional edge-to-edge repair standards); (3) Effective mitral valve orifice area>= 4.0cm2; (4) No obvious calcification of the mitral valve annulus and valve leaflets; (5) The patient's anatomical conditions allow transseptal approach.
Exclusion criteria
Exclusion criteria: 1. Previous history of mitral valve surgery; 2. Patients with infective endocarditis or suggestive of active infection; 3. Patients with mitral regurgitation caused by simple mitral stenosis; 4. Complicated with severe coronary artery disease without effective treatment; 5. Patients with pulmonary arterial hypertension (pulmonary arterial systolic blood pressure > 70mmHg); 6. Patients with severe right ventricular insufficiency; 7. The patient was extremely weak and could not tolerate general anesthesia or was in shock and needed circulatory support; 8. Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis; 9. Patients receiving chronic dialysis; 10. Patients with definite coagulopathy and severe coagulopathy; 11. Patients with definite contraindications of anticoagulant drugs; 12. Patients with stroke or transient ischemic attack within 30 days; 13. Echocardiography revealed any intracardiac mass, left ventricular or atrial thrombus; 14. Patients with other valvular diseases requiring surgery or interventional treatment; 15. Patients with severe macrovascular lesions requiring surgical treatment; 16. Patients with unsuitable heart and valve anatomy indicated by imaging examination; 17. Known to be allergic to contrast agent and nickel-titanium memory alloy products; 18. Patients with severe neurological lesions affecting cognitive ability; 19. Patients with severe thoracic malformations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of product at 12 month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of product at 30 days/180 days/2 to 5 years;Rate of Cardiovascular related mortality at 30 days/180 days/1 year/2 to 5 years;Rate of Severe adverse events at 30 days//180 days/1 year/2 to 5 years (including death, stroke, myocardial infarction, reoperation, instrumental non-selective cardiovascular surgery, renal failure, and adverse events related to transfemoral vein septal approach surgery, etc.);Quality of life Improvement at 30 days/180 days/1 year/2 to 5 years; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed