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.