Highlights:
The pivotal trial enrolled 130 patients (including 10 roll-in patients), all of whom were at high surgical risk with symptomatic moderate-to- severe or severe primary mitral regurgitation (MR).
Technical success rate was 96.9%, and device success rate at 30 days reached 93.1%.
3. Echocardiographic follow-up demonstrated significant MR reduction, with 96.12% of ppaatt i ieennttss maintaining MR ≤2+ at one-year follow-up. Marked i m p r o v e m e n t i n c a r d i a c function was observed, with 95.45% of patients achieving NYHA Class I/II at 1 year.
4. At 1-year follow-up, the all- cause mortality rate was only 3.1%, and the device-related adverse event rate was 3.1%. No cases of device locking failure, clip embolization, or myocardium infarction were reported.
