Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

Inclusion criteria

• 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.

Exclusion criteria

• Rheumatic mitral valve disease.
• Uncorrected active infection.
• Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
• Intracardiac mass, thrombus, or vegetation on echocardiography.
• Severe right heart dysfunction (e.g., lower extremity edema with elevated jugular venous pressure and hepatomegaly) or severe pulmonary hypertension (echocardiographic systolic pulmonary artery pressure >70 mmHg).
• Severe left heart dysfunction (LVEF <20%).
• Acute myocardial infarction (AMI) within 30 days prior to the procedure.
• Recent CABG, PCI, or TAVR within 30 days prior to the procedure.
• Planned tricuspid/aortic valve or major vascular intervention within 30 days post-procedure.
• Prior surgical or transcatheter mitral valve repair/replacement.
• Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impeding catheter advancement.
• Stroke/TIA within 30 days or severe carotid stenosis (>70% by ultrasound).
• Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictive pericarditis, or active endocarditis.
• Hemodynamic instability: Systolic blood pressure <90 mmHg without afterload-reducing agents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) or hemodynamic support.
• Implanted pacemaker, CRT, or ICD within 30 days prior to the procedure.
• End-stage heart failure (ACC/AHA Stage D), post-heart transplant, or listed for transplant.
• Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplatelet agents, or anesthesia, allergy to mitralclip materials (nickel/titanium, cobalt, chromium, polyester), severe contrast allergy precludes intervention.
• Pregnant or breastfeeding.
• Participation in other clinical trials (drug/device) without meeting primary endpoints.
• Other contraindications per investigator judgment.