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

Inclusion Criteria: 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: Patients with pure organic (i.e. primary) tricuspid regurgitation; Patients with pulmonary artery systolic blood pressure ≥60 mmHg; Patients with tricuspid valve prosthesis or plastic ring, or patients with tricuspid valve-related surgery; Patients with retrotricuspid annulus calcification; Evidence of intracardiac, jugular and superior vena cava masses, thrombus or growths; Patients with more than moderate aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation; Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); Percutaneous coronary intervention within 1 month; Myocardial infarction or known unstable angina within the previous 1 month; cerebrovascular accidents occurred within the previous 3 months; Patients with active endocarditis or active rheumatic heart disease; Patients with coagulopathy, hypercoagulability or anemia (hemoglobin < 90 g/L); Patients in the acute infection stage or other severe infections; Patients with active peptic ulcer or active gastrointestinal bleeding; severe end-stage diseases (such as malignant tumors, severe lung diseases, liver diseases, renal failure) with a life expectancy of less than 1 year; Patients with known allergy or contraindications to the raw material or drug (e.g. antiplatelet drugs, anticoagulants) of the test product; persons addicted to alcohol, drugs or drugs; Patients with cognitive impairment; A history of epilepsy or mental illness with primary and persistent seizures and poor drug control; Participate in any other clinical trial (other than a registered study) within 30 days prior to signing the informed consent; 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; tricuspid stenosis; Ebstain syndrome; esophageal esophageal echocardiography (TEE) and Trans thoracic echocardiography (TTE) were not esophageal esophageal tricuspid ring anatomy; Hemodynamic instability; Patients with chronic dialysis; Women who have planned to become pregnant during pregnancy, lactation or clinical study; Other conditions for which the investigator considers it inappropriate to participate in the clinical trial.