Early Safety and Feasibility Study of a Novel Transcatheter Aortic Valve With Polymeric Leaflets

BACKGROUND: Transcatheter aortic valve replacement is a promising alternative treatment for patients with severe aortic stenosis (AS), but uncertainties remain regarding its long-term durability. OBJECTIVES: This study aimed to evaluate the safety and feasibility of Sikelia transcatheter heart valve with polymeric leaflets in AS. METHODS: In this first-in-human, prospective, nonrandomized, single-arm, multicenter study, patients with severe symptomatic AS eligible for the novel valve were recruited. Clinical outcomes and hemodynamic performance were reported at discharge and 30-day, 6-month, and 1-year follow-up. RESULTS: ) and mean pressure gradient (6.33 ± 2.54 mm Hg vs 47.50 ± 13.82 mm Hg) improved substantially, so did those in bicuspid patients (all P < 0.001). No moderate/severe paravalvular leakage was recorded, and computed tomography scans revealed no evidence of subclinical leaflet thrombosis during follow-up. After discharge, no patients reported death, stroke, new pacemakers, or valve-related reintervention. CONCLUSIONS: The preliminary outcomes of the novel transcatheter heart valve demonstrated a favorable hemodynamic performance with an acceptable safety profile at 1 year. Long-term follow-up is warranted to assess its durability in treating patients with AS.