SQ-Kyrin TMVr FIM Study

Inclusion Criteria:

1. Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitationdisease);
2. Patients with high or prohibitive risk for conventional open thoracic surgery asdefined by STS risk scoring result; subjects who are judged as not tolerating mitralvalve surgery due to STS procedural mortality risk ≥ 8% for mitral valve replacementor presence of any of the following risk factors:
3. Porcelain aorta or active ascending aortic atheroma
4. Prior radiation therapy to mediastinum
5. History of mediastinitis
6. Left ventricular ejection fraction (LVEF) < 40%
7. Presence of unobstructed coronary artery bypass graft
8. History of 2 or more cardiothoracic surgeries
9. Liver cirrhosis
10. Other surgical risk factors
11. Degenerated MR patients, or functional MR patients who have receivedguideline-directed medical therapy (GDMT therapy)
12. Age ≥ 18 years, male or female;
13. Patients who are at extremely high risk or not suitable for conventional mitral valvesurgery, as assessed by a multidisciplinary heart team (including at least one cardiacsurgeon and one cardiologist);
14. Anatomically suitable for transcatheter mitral valve repair by edge-to-edge techniqueand can be treated by the SQ-Kyrin device;
15. Patients who can understand the objectives of the trial, volunteer to participate inthe study, sign the informed consent form, and are willing to receive relatedexaminations and clinical follow-up.

Exclusion Criteria:

1. History of cardiac and mitral valve surgeries;
2. Infective endocarditis or evidence of active infection;
3. Mitral valve stenosis;
4. Severe uncontrolled coronary artery disease;
5. Pulmonary artery hypertension (systolic pulmonary artery pressure > 70 mmHg);
6. Severe right cardiac insufficiency;
7. LVEF < 30%;
8. Cardiac function of NYHA Class IV;
9. Patient is extremely week to tolerate surgery under general anesthesia, or in a shockstate indicating circulatory support;
10. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
11. Chronic dialysis;
12. Definite coagulation disorder and severe coagulation system diseases;
13. Clear contraindications for use of anticoagulants;
14. Cerebral stroke or transient ischemic attack in the past 30 days;
15. Any cardiac mass, left ventricular or atrial thrombosis identified byechocardiography;
16. Other valve diseases that requiring surgery or intervention;
17. Severe macrovascular disease requiring surgical treatment;
18. Treatment-naive carotid artery stenosis > 70%;
19. Imaging evidence of inappropriate cardiac and valve anatomy;
20. Known hypersensitivity to contrast media, and nickel-titanium memory alloy products;
21. Severe nervous system disorder compromising the cognitive ability;
22. Life expectancy < 12 months;
23. Severe thorax deformity;
24. Pregnant and lactating women.