Highlights:
1. The reported results were derived from a single-center feasibility trial and 7 participating centers in the multi-center confirmatory clinical study. All 22 enrolled patients have moderate-to-severe or severe mitral regurgitation (MR)
2. Technical success rate was 95.45%, and Average hospital stay was only 8 days post-procedure. 90.91% of patients showed no paravalvular leakage (PVL). No cases of left ventricular outflow tract obstruction (LVOTO ), conversion to surgery or in-hospital death.
3. At 30-day follow-up, 100% of patients achieved MR reduction to ≤1+, demonstrating significant regurgitation improvement. The 30-day follow-up data also demonstrated marked cardiac function recovery, with the proportion of patients in NYHA Class III-IV decreasing significantly from 72.73% to 31.82%, while 9.09% of subjects showed remarkable improvement to NYHA Class I.
4. The safety profile at 30-day post-procedure showed 0 incidence of LVOTO, valve thrombosis, mitral valve reintervention, valve embolism, severe renal injury, or vascular complications.
