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

To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.

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.