This is a prospective, multi-center, single-arm study to assess the safety and effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement system in the treatment of moderate to severe or severe degenerative mitral regurgitation and to provide the clinical evidence for product registration in China or other countries
Subject has symptomatic, moderate-to-severe or severe, degenerative mitral regurgitation(MR≥3+);
NYHA functional class≥ II;
Heart team agrees that patient is unsuitable for treatment with conventional mitral valve surgery or transcatheter mitral valve edge-to-edge repair；
Subjects age ≥65 years old;
None
Single group
Microport CardioFlow Mitral Valve Replacement System
DevicePatients will undergo transcatheter mitral valve replacement using Microport CardioFlow Mitral Valve Replacement System. The device is delivered via a transapical approach under the guidance of medical imaging equipment; the valve product loaded within the delivery system is advanced to the mitral annulus and released, thereby replacing the native mitral valve with pathological changes in function or anatomy.
Rate of cumulative all-cause mortality at 12 months post-procedure
Rate of cumulative all-cause mortality at 30 days, 6 months and 2-5 years post procedure
Rate of heart failure rehospitalization at 30 days, 6 months and 2-5 years post procedure
Rate of disabling and non-disabling stroke at 30 days, 6 months, 12 months and 2-5 years post procedure
Rate of myocardial infarction at 30 days, 6 months, 12 months and 2-5 years post procedure
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