Novel Transcatheter Edge-to-Edge Repair System for Degenerative Mitral Regurgitation

BACKGROUND: For 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. OBJECTIVES: This 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. METHODS: A 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. RESULTS: At 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). CONCLUSIONS: This 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).