ArticleJACC. Asia2026
Novel Transcatheter Edge-to-Edge Repair System for Degenerative Mitral Regurgitation: 1-Year Outcomes.
Article in JACC. Asia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05655897 (A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System for the Treatment of Moderate-severe or Severe Degenerative Mitral Regurgitation With Single-arm Objective Performance Criteria), which is not on this 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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A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System for the Treatment of Moderate-severe or Severe Degenerative Mitral Regurgitation With Single-arm Objective Performance Criteria
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1 citing paper in PubMed.
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22 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundFor patients with severe degenerative mitral regurgitation (DMR) at prohibitive or high surgical risk, transcatheter edge-to-edge repair (TEER) has become an effective alternative. The GeminiOne is a novel TEER device featuring a unique groove-cam mechanism.
objectivesThis study reports the primary, secondary, and 1-year outcomes of the GeminiOne-DMR (Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation) trial.
methodsA total of 120 patients with prohibitive surgical risk and DMR grade ≥3+ were enrolled and evaluated by an independent echocardiography core laboratory and a clinical event committee. The primary endpoint was clinical success, defined as freedom from all-cause mortality, mitral valve reintervention, and mitral regurgitation >2+ at 1-year follow-up.
resultsAt 1 year, the clinical success rate was 89.84% ± 2.78% (95% CI: 84.56%-95.46%), meeting the prespecified primary efficacy endpoint. The rates of freedom from 1-year all-cause mortality, major adverse events, mitral valve reintervention, and heart failure hospitalization were 97.48% ± 1.35%, 91.61% ± 2.54%, 98.31% ± 1.02%, and 94.00% ± 2.20%, respectively. Mitral regurgitation ≤2+ was achieved in 92.24% of patients at 1 year. Significant improvements were observed in functional and quality-of-life outcomes, with the proportion of patients classified as NYHA funcional class I/II increasing from 23.33% at baseline to 94.74% at 1 year (P < 0.001), and Kansas City Cardiomyopathy Questionnaire scores also improving significantly from baseline to 1 year (P < 0.001).
conclusionsThis trial demonstrated the initial safety and efficacy of the GeminiOne TEER system for treating significant symptomatic DMR in patients at prohibitive or high surgical risk. (Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation; NCT05655897).
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