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

Inclusion Criteria:

1. Patients who volunteer to participate and sign an informed consent form, understandthe purpose of the clinical trial and are able to cooperate throughout the trialprocess;

2. An age ≥ 18 years;

3. Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days andtransesophageal echocardiogram (TEE) obtained within 180 days to determine thepresence of symptomatic moderate-severe or severe degenerative mitral regurgitation (defined as mitral regurgitation grade ≥3+);

4. Patients' New York Heart Association (NYHA) cardiac function classification (seeAppendix II) in grades II, III, or non-ambulatory grade IV；

5. Patients' left ventricular ejection fraction LVEF ≥ 20%;

6. Patients considered to be at high surgical risk by the multidisciplinary cardiacteam ;

7. Patients are anatomically suitable for mitral valve repair and suitable for thedevice under this study as assessed by the multidisciplinary cardiac team;

Elements include, however, are not constrained to the following:

1. Mitral valve orifice area ≥ 4.0 cm2;

2. Left ventricular end-systolic dimension (LVESD) ≤ 60 mm;

3. The primary regurgitant bundle is a non-conjunctive regurgitant bundle and if thesecondary regurgitant bundle is present, must be clinically insignificant;

4. Transeptal puncture and femoral venipuncture are feasible; The recommended referencecriteria for high surgical risk are: an STS score of ≥8 for surgical valvereplacement (see Appendix III) or an STS score of ≥6 for surgical valve repair, orthe existence of other high-risk factors, such as the presence of other high-riskelements such as the presence of ≥ 2 warning signs of moderate-severe frailty or thepresence of feasible surgical operative limitations or the presence of ≥ 2 mainorgans dysfunctions that cannot be elevated postoperatively or other surgicalhigh-risk factors that are genuinely existing in the judgment of the independentcardiac surgeon in this study.

Exclusion Criteria:

1. The presence of intra-cardiac space occupancy, thrombus, or bulky organisms asindicated 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 positioningon the leaflet, or prevent adequate reduction of mitral regurgitation by the valveclip. The assessment is based on transesophageal echocardiographic (TEE) mitralvalve evaluation within 180 days prior to the subject's registration and includes:

4. inability of the valve clips to hold sufficient active leaflets;

5. lack of primary and secondary tendon support in the clamping area;

6. significant evidence of calcification in the clamping area;

7. significant fissures in the clamping area;

8. Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valveleaflet changes resulting from endocarditis or rheumatic heart disease;

9. Severe right ventricular insufficiency (e.g. with symptoms of bilateral lower limbedema with increased jugular venous pressure and hepatomegaly); or pulmonaryhypertension (pulmonary artery systolic pressure PASA > 70 mmHg as measured byechocardiography);

10. Patients who have had an acute coronary syndrome within 4 weeks, or untreated severecoronary artery stenosis requiring revascularization;

11. Patients with any cardiovascular intervention, cardiac surgery, cardiacresynchronization therapy (CRT, CRT-D), implantation of a buriedcardioverter-defibrillator (ICD), etc. within 30 days; or have planned one of theseprocedures;

12. Patients underwent mitral valve surgery or mitral transcatheter valve surgerybefore, or have a left atrial appendage occluder device inside；

13. Patients with end-stage heart failure (ACC/AHA stage D), or after cardiactransplantation, or awaiting cardiac transplantation;

14. Patients who are hemodynamically unstable, defined as systolic blood pressure <90mmHg without postload-reducing drugs, or in cardiogenic shock; or are requiringintra-aortic balloon counterpulsation, or other hemodynamic support drugs ordevices;

15. Patients requiring emergency or urgent surgery for any reason;

16. Patients' femoral vein cannot accommodate a 22F catheter or overlaying ipsilateraldeep venous thrombosis, as assessed by the investigator, or are anatomicallyunsuitable for atrial septum puncture; [13

17. Patients with active infection requiring concurrent antibiotic treatment; in thecase of temporary disease, antibiotics must be discontinued for at least 14 daysbefore enrollment;

18. Patients with a history of any cerebrovascular accident within 30 days; or a severesymptomatic carotid stenosis (carotid ultrasound suggesting >70% stenosis);

19. Modified Rankin Scale score ≥ 4 (see Annex IV);

20. Patients with a history of acute peptic ulcer or gastrointestinal bleeding within 3months;

21. Patients with hematological cachexia, including granulocytopenia (WBC <3 x 109/L),anemia (HB < 90 g/L), thrombocytopenia (PLT <50 x 109/L), bleeding disorders, andcoagulopathy; or the presence of contraindications to antiplatelet or anticoagulantmedication;

22. Patients with a contraindication to transesophageal echocardiography; or acontraindication to general anesthesia；

23. Patients with severe chronic obstructive pulmonary disease (COPD) requiringlong-term steroids or continuous home oxygen therapy；

24. Patients with severe hepatic or renal insufficiency (ALT, AST, creatinine > 2 timesthe upper limit of normal values)；

25. Pregnant or lactating women, or those with a birth plan within 12 months；

26. Patients with known hypersensitivity to device components or contrast media；

27. Patients enrolled in another clinical study and within the follow-up period；

28. Patients with a disease that would make the evaluation of treatment difficult (e.g.cancer, infection, severe metabolic disease, psychiatric disease, etc.); or patientswith a life expectancy shorter than 12 months；

29. Patients whose compliance is assessed by the investigator to be poor and are unableto comply with the follow-up schedule and complete the examination; or othersituations in which the investigator considers the issue to be unsuitable forparticipation in the study.