The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation

Inclusion Criteria: Age ≥ 18 years; Patients with symptomatic FMR due to ischemic or non-ischemic cardiomyopathy with moderate-severe or greater mitral regurgitation (MR ≥ 3+) confirmed by echocardiography; Patients that have undergone adequate treatment, including treatment for conditions such as coronary artery disease, left ventricular dysfunction, heart failure, and mitral regurgitation (e.g., coronary revascularization, cardiac resynchronization therapy, and/or guideline-directed medication therapy (GDMT) at a stable dose), as judged by the local hospital heart team; Note: Any change in GDMT with ≥ 100% increase or ≥ 50% decrease in dose is considered "unstable". NYHA cardiac function classification ≥ Class II; Left ventricular ejection Fraction (LVEF) ≥ 20%; Left ventricular end systolic diameter (LVESD) ≤ 70 mm; At least one hospitalization for heart failure in the past 12 months and/or after adequate treatment, corrected BNP >150 pg/ml or corrected NT-proBNP > 600 pg/ml (correction method: If the patient has a body mass index (BMI) ≥ 20 kg/m2, BNP or NT-proBNP decreases by 4% for each 1 kg/m2 increase); Subjects with mitral valves anatomically suitable for mitral valve repair using this investigational device; Subjects who fully understand the trial protocol and purpose, voluntarily participate in the trial and sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups. Exclusion Criteria: A history of mitral valve surgery or combined valvular disease requiring surgical or interventional treatment; Active rheumatic heart disease, infective endocarditis;dian Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis), constrictive pericarditis; Left intracardiac masses, bulges, thrombi and/or mitral valve leaflets, tendinopathy indicated by imaging; Severe chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or long-term steroid hormone medication; Severe right heart insufficiency or pulmonary hypertension (pulmonary artery systolic pressure > 70 mmHg measured by ultrasound or right heart catheter; if measured at the same time, the right heart catheter measurement shall prevail); Patients who have had an acute myocardial infarction, stroke/transient ischemic attack (TIA) and/or gastrointestinal bleeding within 30 days; Patients who have undergone any transcatheter cardiovascular intervention, carotid artery surgery, pacemaker implantation, cardiac resynchronization therapy (CRT-P, CRT-D) or implantable cardioverter defibrillator (ICD) within 30 days, or cardiovascular surgery within 180 days; Hemodynamic instability, with systolic blood pressure < 90 mmHg in the absence of afterload-reducing drugs, or cardiogenic shock or the need for vasoactive drugs, intra-aortic balloon pump, left ventricular assist devices, etc.; Patients with known bleeding disorders, coagulation disorders, and/or clear contraindications to the use of anticoagulants and antiplatelet agents; Known hypersensitivity to product composition; Patients with clear contraindications to transesophageal echocardiography, contraindications to tracheal intubation, and/or the presence of contraindications to general anesthesia; Modified Rakin score ≥ 4; Patients with a life expectancy of < 12 months or who have undergone a heart transplant or are scheduled to have a heart transplant within 12 months after surgery; Patients who are enrolled in other drug or device clinical trials and have not completed follow-up of the primary endpoint; Pregnant or breastfeeding women or those planning to become pregnant within the next 12 months; Other conditions that the investigator considers inappropriate to participate in this clinical study.