Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation

Exclusion Criteria

• •1. The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;
• •2. The presence of other severe heart valve diseases requiring surgical intervention;
• •3. Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral regurgitation by the valve clip. The assessment is based on transesophageal echocardiographic (TEE) mitral valve evaluation within 180 days prior to the subject's registration and includes:
• •1. inability of the valve clips to hold sufficient active leaflets;
• •2. lack of primary and secondary tendon support in the clamping area;
• •3. significant evidence of calcification in the clamping area;
• •4. significant fissures in the clamping area;
• •4. Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valve leaflet changes resulting from endocarditis or rheumatic heart disease;
• •5. Severe right ventricular insufficiency (e.g. with symptoms of bilateral lower limb edema with increased jugular venous pressure and hepatomegaly); or pulmonary hypertension (pulmonary artery systolic pressure PASA \> 70 mmHg as measured by echocardiography);
• •6. Patients who have had an acute coronary syndrome within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization;
• •7. Patients with any cardiovascular intervention, cardiac surgery, cardiac resynchronization therapy (CRT, CRT-D), implantation of a buried cardioverter-defibrillator (ICD), etc. within 30 days; or have planned one of these procedures;
• •8. Patients underwent mitral valve surgery or mitral transcatheter valve surgery before, or have a left atrial appendage occluder device inside；
• •9. Patients with end-stage heart failure (ACC/AHA stage D), or after cardiac transplantation, or awaiting cardiac transplantation;
• •10. Patients who are hemodynamically unstable, defined as systolic blood pressure \<90 mmHg without postload-reducing drugs, or in cardiogenic shock; or are requiring intra-aortic balloon counterpulsation, or other hemodynamic support drugs or devices;
• •11. Patients requiring emergency or urgent surgery for any reason;
• •12. Patients' femoral vein cannot accommodate a 22F catheter or overlaying ipsilateral deep venous thrombosis, as assessed by the investigator, or are anatomically unsuitable for atrial septum puncture; \[13
• •13. Patients with active infection requiring concurrent antibiotic treatment; in the case of temporary disease, antibiotics must be discontinued for at least 14 days before enrollment;
• •14. Patients with a history of any cerebrovascular accident within 30 days; or a severe symptomatic carotid stenosis (carotid ultrasound suggesting \>70% stenosis);
• •15. Modified Rankin Scale score ≥ 4 (see Annex IV);
• •16. Patients with a history of acute peptic ulcer or gastrointestinal bleeding within 3 months;
• •17. Patients with hematological cachexia, including granulocytopenia (WBC \<3 x 109/L), anemia (HB \< 90 g/L), thrombocytopenia (PLT \<50 x 109/L), bleeding disorders, and coagulopathy; or the presence of contraindications to antiplatelet or anticoagulant medication;
• •18. Patients with a contraindication to transesophageal echocardiography; or a contraindication to general anesthesia；
• •19. Patients with severe chronic obstructive pulmonary disease (COPD) requiring long-term steroids or continuous home oxygen therapy；
• •20. Patients with severe hepatic or renal insufficiency (ALT, AST, creatinine \> 2 times the upper limit of normal values)；
• •21. Pregnant or lactating women, or those with a birth plan within 12 months；
• •22. Patients with known hypersensitivity to device components or contrast media；
• •23. Patients enrolled in another clinical study and within the follow-up period；
• •24. Patients with a disease that would make the evaluation of treatment difficult (e.g. cancer, infection, severe metabolic disease, psychiatric disease, etc.); or patients with a life expectancy shorter than 12 months；
• •25. Patients whose compliance is assessed by the investigator to be poor and are unable to comply with the follow-up schedule and complete the examination; or other situations in which the investigator considers the issue to be unsuitable for participation in the study.