A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Tricuspid Valve Clipping Systems in Patients With Severe or Greater Tricuspid Regurgitation.
The transcatheter tricuspid valve clipping system is specially designed for the treatment of tricuspid regurgitation. Under the guidance of ultrasound and DSA imaging, the investigational device is advanced into the right ventricle via a femoral or jugular venous puncture approach. The clipping component grasps the edges of the dysfunctional valve leaflets (usually unable to close properly), thereby reducing the area of the tricuspid orifice that fails to coapt normally, achieving minimally invasive treatment of tricuspid regurgitation.
• 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);
• Adequate treatment is defined as:
• Oral diuretic therapy for tricuspid regurgitation at a stable dose for at least 30 days; Guideline-directed medical therapy for heart failure (if applicable) according to heart failure subtype with different ejection fractions, at a stable dose for at least 30 days; For subjects with mitral regurgitation (MR ≥ 3+), atrial fibrillation, or coronary artery disease: medical therapy for ≥ 30 days, or ≥ 30 days post device-based therapy with stable clinical status.
• Stable dose is defined as: dose increase ≤ 100% or dose reduction ≤ 50%.
• 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%.
• NYHA functional class II to IV, inclusive;
• Subject voluntarily agrees to participate in the clinical trial and provides written informed consent, or consent is provided by the subject's legal representative.