ArticleJACC. Asia2026
Novel Transcatheter Edge-to-Edge Repair System for High-Risk Primary Mitral Regurgitation: 2-Year Pivotal Trial Outcomes.
Article in JACC. Asia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- More to Come: What Can We Expect From the Newcomer in Transcatheter Mitral Edge-to-Edge Repair?JACC. Asia · 2026Article
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTranscatheter edge-to-edge repair (TEER) is established for severe primary mitral regurgitation (MR), but robust clinical data in Asian populations are limited.
objectivesThis 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.
methodsThis 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.
resultsEvent-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%.
conclusionsThe 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.
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