Novel Transcatheter Edge-to-Edge Repair System for High-Risk Primary Mitral Regurgitation

BACKGROUND: Transcatheter edge-to-edge repair (TEER) is established for severe primary mitral regurgitation (MR), but robust clinical data in Asian populations are limited. OBJECTIVES: This study aimed to evaluate the safety and efficacy of the novel Neonova TEER system in high-risk Chinese patients with symptomatic, moderate-to-severe or severe primary MR. METHODS: This prospective, multicenter, single-arm, performance-goal pivotal trial enrolled 123 patients from 23 Chinese centers (April 2022 to March 2024). Eligible patients had symptomatic primary MR (≥3+) and high surgical risk. The primary efficacy endpoint was treatment success at 1 year (freedom from mortality, mitral valve surgery, and MR >2+) compared with a 60% performance goal. Follow-up extended to 2 years. RESULTS: Event-free survival at 1 year was 92.68%, exceeding the target value, and remained 84.55% at 2 years. The proportion of patients with MR ≤2+ was 96.61% at 1 year and 95.41% at 2 years. Immediate procedural success was 98.37%. The proportion of patients in NYHA functional class I/II improved from 0% at baseline to 94.92% at 1 year, sustained at 92.52% at 2 years. Significant left ventricular reverse remodeling occurred. The composite major adverse event rate was 8.13% at 1 year, with all-cause mortality at 2.44%. All-cause mortality at 2-year follow-up was only 4.07%. CONCLUSIONS: The novel TEER system demonstrates excellent safety and efficacy for high-risk primary MR patients, achieving high event-free survival and sustained clinical and echocardiographic improvements through 2 years. It offers a reliable, minimally invasive alternative to conventional surgery.