Novel Transcatheter Edge-to-Edge Repair System for High-Risk Primary Mitral Regurgitation: 2-Year Pivotal Trial...

Transcatheter edge-to-edge repair (TEER) is established for severe primary mitral regurgitation (MR), but robust clinical data in Asian populations are limited.

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.

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.

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%.

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.