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

Inclusion Criteria:

1. Age ≥18 years, regardless of gender.

2. Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed bytransthoracic and/or transesophageal echocardiography (TTE/TEE), with plannedtranscatheter edge-to-edge repair (TEER): For degenerative mitral regurgitation (DMR):

-Deemed high-risk for surgical intervention by the heart team:STS score ≥8% formitral valve replacement (MVR) mortality risk; ≥6% for mitral valve repair mortalityrisk; OR presence of ≥2 frailty indices (moderate-to-severe frailty); ORanatomical/technical barriers to surgery; OR ≥2 major organ dysfunctions unlikely toimprove postoperatively; OR other high-risk factors per heart team assessment.ORpatient declines surgery. For functional mitral regurgitation (FMR):

• Persistent heart failure symptoms (NYHA Class III/IVa) despite guidelinesdirected medical therapy (GDMT), revascularization, or cardiacresynchronization therapy (CRT) for 1-3 months.

• ≥1 hospitalization for heart failure within the past 12 months and/or BNP >150pg/mL or NT-proBNP >600 pg/mL.

• Left ventricular ejection fraction (LVEF) ≥20% and ≤50%, with left ventricularend-systolic diameter (LVESD) ≤70 mm.

3. Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant).

4. Volunteerly provides informed consent, understands the trial objectives, and agreesto comply with follow-up.

Exclusion Criteria:

1. Rheumatic mitral valve disease.

2. Uncorrected active infection.

3. Severe calcification or thickening in the clip coaptation zone, rendering TEERanatomically unsuitable.

4. Intracardiac mass, thrombus, or vegetation on echocardiography.

5. Severe right heart dysfunction (e.g., lower extremity edema with elevated jugularvenous 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 dayspost-procedure.

10. Prior surgical or transcatheter mitral valve repair/replacement.

11. Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impedingcatheter advancement.

12. Stroke/TIA within 30 days or severe carotid stenosis (>70% by ultrasound).

13. Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrativecardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictivepericarditis, or active endocarditis.

14. Hemodynamic instability: Systolic blood pressure <90 mmHg without afterload-reducingagents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) orhemodynamic 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 fortransplant.

17. Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplateletagents, 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 primaryendpoints.

20. Other contraindications per investigator judgment.