A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of the Transcatheter Tricuspid Valvuloplasty System in Patients With Severe or Above Tricuspid Regurgitation

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 disease, right ventricular cardiomyopathy, right ventricular myocardial infarction, left heart valve disease, congenital heart disease and other diseases); (3) A multidisciplinary cardiac team consisting of cardiovascular physicians, cardiovascular surgeons, imaging physicians, anesthesiologists, and at least 2 physicians considered the subjects to be at high risk for surgical procedures, i.e., EuroScore II was greater than 3.0%; (4) Left ventricular ejection fraction LVEF≥30%; (5) The subject voluntarily participates in the clinical trial and agrees or his guardian agrees to sign the informed consent; (6) Symptoms of tricuspid regurgitation, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites; (7) NYHA Grades 2 to 4, including Grades 2 and 4; (8) The optimal drug treatment for tricuspid valve ≥ 30 days and the patient's state was stable; (9) Patients with mitral regurgitation, atrial fibrillation, coronary artery disease, and heart failure should be treated for ≥ 30 days with medication or ≥ 30 days after instrument therapy and in stable condition.

Exclusion Criteria:

1. Patients with pure organic (i.e. primary) tricuspid regurgitation;
2. Patients with pulmonary artery systolic blood pressure ≥60 mmHg;
3. Patients with tricuspid valve prosthesis or plastic ring, or patients with tricuspid valve-related surgery;
4. Patients with retrotricuspid annulus calcification;
5. Evidence of intracardiac, jugular and superior vena cava masses, thrombus or growths;
6. Patients with more than moderate aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation;
7. Patients with severe 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 the previous 1 month;
10. cerebrovascular accidents occurred within the previous 3 months;
11. Patients with active endocarditis or active rheumatic heart disease;
12. Patients with coagulopathy, hypercoagulability or anemia (hemoglobin \< 90 g/L);
13. Patients in the acute infection stage or other severe infections;
14. Patients with active peptic ulcer or active gastrointestinal bleeding;
15. severe end-stage diseases (such as malignant tumors, severe lung diseases, liver diseases, renal failure) with a life expectancy of less than 1 year;
16. Patients with known allergy or contraindications to the raw material or drug (e.g. antiplatelet drugs, anticoagulants) of the test product;
17. persons addicted to alcohol, drugs or drugs;
18. Patients with cognitive impairment;
19. A history of epilepsy or mental illness with primary and persistent seizures and poor drug control;
20. Participate in any other clinical trial (other than a registered study) within 30 days prior to signing the informed consent;
21. have had a pacemaker (other than a leadless pacemaker) or a defibrillator implanted in the past, or plan to have a pacemaker (other than a leadless pacemaker) or a defibrillator implanted;
22. tricuspid stenosis;
23. Ebstain syndrome;
24. esophageal esophageal echocardiography (TEE) and Trans thoracic echocardiography (TTE) were not esophageal esophageal tricuspid ring anatomy;
25. Hemodynamic instability;
26. Patients with chronic dialysis;
27. Women who have planned to become pregnant during pregnancy, lactation or clinical study;
28. Other conditions for which the investigator considers it inappropriate to participate in the clinical trial.