CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation

Subjects must meet all of the following criteria to be included in the study:

• 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;
• Subjects willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits;
• Subjects anatomically suitable for the transcatheter mitral valve implantation

Subjects will be excluded from the study if any of the following conditions are present：

• Left ventricular ejection fraction (LVEF)<30%；
• Left ventricular end diastolic diameter (LVEDD)>7.5cm；
• Cardiac echography evidence of intracardiac mass, thrombus, or vegetation；
• Severe tricuspid regurgitation with severe right ventricular dysfunction or any tricuspid valve disease requiring surgery or transcatheter intervention；
• Aortic valve diseases requiring surgery or transcatheter intervention；
• Any prohibitive mitral annular calcification(annulus to the leaflet) interferes the expansion of the device；
• Prior surgical treatment of mitral valve；
• Therapeutic cardiac surgical or interventional procedure within 30 days prior to the index procedure；
• End-stage heart failure requiring left ventricular assist device or cardiac transplantation
• Subjects with severe major vascular disease requiring surgical intervention or with aortic dissection
• Need for emergent surgery
• Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis
• Mitral valve pathological anatomy，LVOT anatomy, left atrial or ventricle anatomy not applicable for the investigational device implantation；
• Concurrent medical condition with a life expectancy of less than 12 months
• Evidence of an acute myocardial infarction or untreated clinically significant coronary artery disease requiring revascularization within 30 days of enrollment.
• Recent cerebrovascular events(ischemic or hemorrhage stroke, not including TIA) within 3 months of enrollment
• Severe carotid stenosis( > 70%, both sides of carotid artery)
• Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated；
• Active endocarditis or active other infection
• Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months
• Subject refuses the blood transfusion;
• Known hypersensitivity or contraindication to nitinol (titanium or nickel),bovine product, PET(Polyethylene terephthalate), contrast media; Inability to tolerate anti-platelet or anticoagulants therapy; Contraindicated for transesophageal echocardiography (TEE)
• Condition that prevents transapical access, such as chest malformation, ventricular aneurysm, apical thinning
• Subjects with rheumatic mitral stenosis
• Acute exacerbation of chronic obstructive pulmonary disease
• Per heart team assessment, conditions that not suitable for transcatheter mitral valve replacement
• Severe disabling Alzheimer's disease
• Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint