Whitesburg

Researchers are conducting a global, multi-center, non-randomized observational trial to evaluate the PulseSelect™ PFA System in adults with recurrent symptomatic paroxysmal or persistent atrial fibrillation who have not responded to at least one Class I or III antiarrhythmic drug. The study aims to observe safety and effectiveness outcomes over a 36-month period following the ablation procedure. Participants will undergo an ablation procedure using the commercially available PulseSelect™ PFA System according to each hospital's standard of care. After the procedure, study visits are scheduled at 3, 6, 12, 24, and 36 months, with required 24-hour Holter monitoring at 6, 12, 24, and 36 months to assess heart rhythm. During the study, researchers will track freedom from atrial fibrillation and monitor for any device or procedure-related adverse events, especially within the first 6 months post-ablation. Participants will be followed for up to 36 months to evaluate long-term outcomes and safety of the PulseSelect™ PFA System.