A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.

Inclusion criteria

• ✓. Age ≥ 18 years, male or female;
• ✓. Patients with severe or greater tricuspid regurgitation (TR ≥ 4+) judged by the local study team to have received adequate treatment according to applicable standards and remained stable for at least 30 days (TR grading to be determined by the core laboratory);
• ✓. The multidisciplinary heart team (comprising cardiologists, cardiovascular surgeons, imaging specialists, anesthesiologists, etc., with at least 2 physicians) judges that the subject is at moderate or high surgical risk (Tri-Score ≥ 4.0) and is expected to benefit from tricuspid edge-to-edge repair;
• ✓. Left ventricular ejection fraction (LVEF) ≥ 20%;
• ✓. Presence of symptoms attributable to tricuspid regurgitation (e.g., chest distress, dyspnea, shortness of breath, lower extremity edema, ascites), or asymptomatic subjects with right ventricular dilation or impaired right ventricular function (as determined by the core laboratory);
• ✓. Impaired right ventricular function is defined as: tricuspid annular plane systolic excursion (TAPSE) \< 17 mm or fractional area change (FAC) \< 35%.
• ✓. Subject voluntarily agrees to participate in the clinical trial and provides written informed consent, or consent is provided by the subject's legal representative.

Exclusion criteria