Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System

Inclusion Criteria: 1. Age ≥60, male or female; 2. patients with severe or above secondary tricuspid regurgitation (TR≥4+) (secondary tricuspid regurgitation: tricuspid regurgitation caused by right atrial lesions, right ventricular cardiomyopathy, right ventricular myocardial infarction, left ventricular valvular disease, congenital heart disease and other diseases); 3. A multidisciplinary cardiac team (at least 2 doctors) consisting of cardiovascular physicians, cardiovascular surgeons, radiologists, anesthesiologists, etc., considered the subject to be at high risk for surgery and expected to benefit from tricuspid valve repair; 4. Left ventricular ejection fraction LVEF≥40%; 5. The subject voluntarily participates in the clinical trial and agrees or his/her guardian agrees to sign the informed consent. 6. Tricuspid regurgitation symptoms, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites; 7. NYHA grade 2 to 4; 8. Patients who received tricuspid valve optimal drug therapy for ≥ 30 days were in stable condition; 9. In the case of the following diseases: mitral regurgitation, atrial fibrillation, coronary disease and heart failure, drug treatment should be ≥ 30 days or ≥ 30 days after instrumental treatment and the patient's condition is stable. Exclusion Criteria: 1. patients with primary tricuspid regurgitation; 2. Patients with systolic pulmonary artery pressure ≥55 mmHg; 3. Patients with tricuspid valve or annuloplasty or tricuspid related procedure; 4. Patients with posterior tricuspid annulus calcification; 5. Evidence of mass, thrombosis or vegetations in the heart, jugular vein and superior vena cava; 6. patients with moderate or higher aortic stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation; 7. patients with severely uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); 8. Percutaneous coronary intervention within 1 month; 9. myocardial infarction or known unstable angina within 1 month; 10. Cerebrovascular accident within the past 3 months; 11. patients with active endocarditis or active rheumatic heart disease; 12. Patients with coagulation dysfunction, hypercoagulability or anemia (hemoglobin \< 90 g/L); 13. patients with acute infection or other severe infection; 14. Patients with active peptic ulcer or active gastrointestinal bleeding; 15. severe end-stage diseases (such as malignant tumor, severe lung disease, liver disease, renal failure) with a life expectancy of less than one year; 16. Patients with known allergies or contraindications to the raw materials or drugs (such as antiplatelet drugs and anticoagulants) of the test products; 17. Persons addicted to alcohol, drugs or drugs; 18. Patients with cognitive impairment; 19. patients with histories of epilepsy or mental illness; 20. Participate in any other clinical trial (other than a registry study) within 30 days prior to signing the informed consent; 21. have a previous implantation of a pacemaker or defibrillator, or plan to implant a pacemaker or defibrillator; 22. Tricuspid stenosis; 23. Ebstain syndrome; 24. The anatomy of tricuspid annulus could not be assessed by TEE and TTE; 25. Hemodynamic instability; 26. chronic dialysis patients; 27. women who are pregnant during pregnancy, breast-feeding or during the clinical study; 28. Other conditions that the investigator considers inappropriate for participation in the clinical trial.