A randomized controlled trial of two pulsed field ablation systems for paroxysmal atrial fibrillation: the DUAL-PULSE trial rationale and design.

Background: The energy source for atrial fibrillation (AF) catheter ablation is shifting from thermal energy to pulsed field ablation (PFA), introducing several systems with distinct pulse settings and catheter designs. This study aims to compare the efficacy and safety of two PFA systems: the PulseSelect™ and FARAPULSE™ PFA systems.

Methods: The DUAL-PULSE trial is a multicenter, prospective, open-label, randomized controlled trial conducted at eight centers across Japan (UMIN000056534). A total of 180 patients undergoing an index ablation for paroxysmal AF will be enrolled. They will be randomly assigned in a 1:1 ratio to either the PulseSelect™ or FARAPULSE™ group using permuted block randomization. The study was approved by the Institutional Review Boards at all centers.

Results: The primary endpoint is the one-year atrial arrhythmia recurrence-free rate, defined as the proportion of patients remaining free from any atrial arrhythmia lasting ≥ 30 s without antiarrhythmic drug use after a 90-day blanking period. Secondary endpoints include the one-year procedure-related adverse event rate, defined as the proportion of patients experiencing any procedure-related complications, biomarkers of myocardial injury, PFA-related hemolysis, and changes in the sinus rate during a one-year follow-up. The silent cerebral ischemic event rate in patients undergoing brain magnetic resonance imaging post-procedure will be evaluated as an exploratory endpoint.

Conclusion: The DUAL-PULSE trial is a multicenter, prospective, open-label, randomized controlled trial that will directly compare the efficacy and safety of the two PFA systems. This study will provide a better understanding of the advantages and limitations of each system.