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

Exclusion Criteria

• •1. Rheumatic mitral valve disease.
• •2. Uncorrected active infection.
• •3. Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
• •4. Intracardiac mass, thrombus, or vegetation on echocardiography.
• •5. 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).
• •6. Severe left heart dysfunction (LVEF \<20%).
• •7. Acute myocardial infarction (AMI) within 30 days prior to the procedure.
• •8. Recent CABG, PCI, or TAVR within 30 days prior to the procedure.
• •9. Planned tricuspid/aortic valve or major vascular intervention within 30 days post-procedure.
• •10. Prior surgical or transcatheter mitral valve repair/replacement.
• •11. Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impeding catheter advancement.
• •12. Stroke/TIA within 30 days or severe carotid stenosis (\>70% by ultrasound).
• •13. Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictive pericarditis, or active endocarditis.
• •14. Hemodynamic instability: Systolic blood pressure \<90 mmHg without afterload-reducing agents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) or hemodynamic support.
• •15. Implanted pacemaker, CRT, or ICD within 30 days prior to the procedure.
• •16. End-stage heart failure (ACC/AHA Stage D), post-heart transplant, or listed for transplant.
• •17. Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplatelet agents, or anesthesia, allergy to mitralclip materials (nickel/titanium, cobalt, chromium, polyester), severe contrast allergy precludes intervention.
• •18. Pregnant or breastfeeding.
• •19. Participation in other clinical trials (drug/device) without meeting primary endpoints.
• •20. Other contraindications per investigator judgment.