Pulsed-field Ablation Versus Sham Ablation to Treat Atrial Fibrillation A Randomized Study Comparing Catheter Ablation and Sham Procedure for AF

What this Trial Is About

Researchers are evaluating the effectiveness of catheter ablation using pulsed-field ablation (PFA) compared to a sham ablation procedure in adults with symptomatic paroxysmal or persistent atrial fibrillation (AF). This phase 3, single-blind, multicenter, prospective randomized study aims to determine if catheter ablation leads to greater freedom from recurrent AF or related arrhythmias and improved quality of life at six months post-procedure. The study excludes patients with certain heart conditions and those who have had prior AF ablations. Sixty participants will be randomly assigned to one of two groups: one receiving an electrophysiology (EP) study followed by PFA pulmonary vein isolation using a specialized catheter, and the other receiving an EP study followed by a sham procedure involving anesthesia but no ablation. Before randomization, all patients undergo an EP study to exclude other arrhythmias. The treatment group receives catheter ablation under sedation, while the control group receives anesthesia alone. After the procedure, patients are monitored in hospital and discharged the next day. Participants will be followed for at least six months, with regular in-person visits at months 2, 3, 6, and 12, and phone assessments at months 1, 4, 5, and 9. Evaluations include ECG monitoring with implantable loop recorders, quality of life questionnaires, anxiety and depression scales, and safety assessments. The main outcomes measured are freedom from AF recurrence and quality of life improvements at six months, with additional monitoring of arrhythmia burden, hospitalizations, and complications throughout the study period.

Pulsed-field Ablation Vs. Sham Ablation to Treat AF