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Lesion Durability of the Second Generation Pentaspline Pulsed Field Ablation Catheter NAVIGATE-PF Phase 2 Results
Vivek Y Reddy1,2, Jan Petru1, Moritoshi Funasako1
1Homolka Hospital, Prague, Czech Republic (V.Y.R., J.P., M.F., P.N.).
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.
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