A Prospective, Multicenter, Stratified Randomized Controlled, Non-Inferiority Clinical Trial to Evaluate the Safety and Efficacy of the Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used. The experimental group will utilize the Structural Heart Surgery Assist System, while the control group will undergo manual TEER (e.g., MitraClip G4).
• Age ≥18 years, regardless of gender.
• Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE), with planned transcatheter edge-to-edge repair (TEER):
• For degenerative mitral regurgitation (DMR):
⁃ Deemed high-risk for surgical intervention by the heart team:STS score ≥8% for mitral valve replacement (MVR) mortality risk; ≥6% for mitral valve repair mortality risk; OR presence of ≥2 frailty indices (moderate-to-severe frailty); OR anatomical/technical barriers to surgery; OR ≥2 major organ dysfunctions unlikely to improve postoperatively; OR other high-risk factors per heart team assessment.OR patient declines surgery.
• For functional mitral regurgitation (FMR):
⁃ Persistent heart failure symptoms (NYHA Class III/IVa) despite guidelines directed medical therapy (GDMT), revascularization, or cardiac resynchronization therapy (CRT) for 1-3 months.
⁃ ≥1 hospitalization for heart failure within the past 12 months and/or BNP \>150 pg/mL or NT-proBNP \>600 pg/mL.
⁃ Left ventricular ejection fraction (LVEF) ≥20% and ≤50%, with left ventricular end-systolic diameter (LVESD) ≤70 mm.
• Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant).
• Volunteerly provides informed consent, understands the trial objectives, and agrees to comply with follow-up.