Efficacy and Safety of Hexaspline Pulsed Field Ablation for Atrial Fibrillation
Results from the PLEASE-AF Study
Background: Pulsed field ablation (PFA) is a promising non-thermal treatment for atrial fibrillation (AF), but its effects on Asian/Chinese populations are not well understood.
Study Objective: To assess the 12-month efficacy and safety of a multi-electrode hexaspline PFA catheter in treating predominantly Asian/Chinese patients with drug-refractory paroxysmal AF.
Methods: The study involved 143 patients who underwent pulmonary vein isolation (PVI) using the hexaspline PFA catheter. Follow-up at 3, 6, and 12 months included various examinations to assess treatment success and safety.
Results: All pulmonary veins were successfully isolated in 100% of patients, with an 86.7% success rate in achieving 12-month freedom from recurrent atrial arrhythmias. Only one patient (0.7%) developed a minor pericardial effusion that did not require intervention.
Conclusion: The hexaspline PFA catheter showed universal acute PVI, excellent safety, and promising long-term efficacy in treating paroxysmal AF in an Asian/Chinese population.
Clinical Trial Registration
ClinicalTrials.gov Identifier: NCT05114954
PMID: 39082709 | DOI: 10.1093/europace/euae174
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