Lesion Durability of the Second Generation Pentaspline Pulsed Field Ablation Catheter NAVIGATE-PF Phase 2 Results

BACKGROUND: Remapping studies have evaluated chronic lesion durability of the first-generation pentaspline pulsed field ablation (PFA) catheter that did not have integrated electroanatomical mapping. By invasive remapping, this first-in-human study evaluated the durability of lesions facilitated by the integration of the navigation-enabled pentaspline PFA catheter and mapping system in patients with atrial fibrillation. METHODS: The NAVIGATE-PF Phase 2 trial evaluated the second-generation, mapping-integrated pentaspline PFA catheter. Lesion durability was assessed by invasive remapping 60 days post index procedure. RESULTS: After index ablation in 20 patients with the pentaspline PFA catheter, remaps were performed 60 days later in 17 patients, demonstrating a high rate of lesion durability in the pulmonary veins (95%) and posterior wall (86%). CONCLUSIONS: By facilitating real-time visualization of catheter positioning and acute lesion estimation through tags, the second-generation map-and-ablate pentaspline PFA catheter and integrated mapping system may enhance procedural success. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06175234.