Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China

Inclusion Criteria: Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process; Age ≥ 18 years old; Moderate-severe or severe mitral regurgitation (≥3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation. Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery. Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV; Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System. Exclusion Criteria: Patients had any stroke/TIA within 30 days; Patients with severe symptomatic bilateral carotid stenosis (>70% stenosis on non-invasive imaging); Patients with active infection requiring antibiotic therapy; Patients with active ulcer or gastrointestinal bleeding within the past 3 months; Patients with history of coagulopathy or refuse future blood transfusion; Patients unable to undergo transesophageal echocardiography (TEE); Patients who are pregnant or breastfeeding, or planning to have children within 12 months; Patients who are unable to adhere to the follow-up schedule and complete the examination; Patients enrolled in other clinical studies and within the follow-up period; Patients with known allergies to device components or contrast agents; Patients unable to receive anticoagulant or antiplatelet therapy; Patients with a life expectancy of less than 12 months due to non-cardiac disease; Patients requiring emergency surgical treatment; Patients scheduled for cardiac surgery within 12 months; Patients with an inappropriate mitral annulus or leaflet size (<30 mm and >45 mm); Patients with moderate or above mitral stenosis; Flail mitral leaflets, or moderate to severe mitral valve prolapse; Patients with severe hepatic or renal insufficiency; Patients with severe calcification of the mitral annulus and/or mitral leaflets; Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device; Patients had acute myocardial infarction (MI) (Q-wave MI, or non-Q-wave MI, with CK-MB twice the normal and/or T-MB) within the past 1 month; Patients with untreated symptomatic coronary lesions requiring revascularization; Patients with untreated severe aortic stenosis and severe aortic regurgitation; Patients with aortic valve prosthesis; Patients with severe tricuspid valve lesions requiring surgical intervention; Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly; LVEF < 30%; LVEDD > 70 mm; Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm; Hypertrophic obstructive cardiomyopathy (HOCM); Patients with active or recent (within 3 months) endocarditis; Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) > 70 mmHg) Patients with hypotension (systolic blood pressure <90 mmHg) occurring within 7 days or mechanical hemodynamic support.