Pulsed-field Ablation vs. Sham Ablation to Treat AF

The study is planned as a single-blind, multicenter, prospective, randomized study. Subjects will be randomized 1:1 to either: (i) EP study + PFA, or (ii) EP study + Sham ablation control.After informed consent is obtained, an implantable loop recorder (ILR) will be implanted within seven days, and an EP study will be scheduled for 30±5 days after ILR implantation.Patients in both groups will first undergo an EP study to rule out a concealed AV bypass tract and supraventricular tachycardia (SVT). Patients will not be randomized if SVT or concealed AV bypass tract is found during the EP study. Once an SVT or bypass tract is excluded, randomization will be performed. Patients randomized to Ablation will undergo PVI using the commercially-available pentaspline PFA catheter (Farawave, Farapulse-BSCI Inc). Patients randomized to the Sham-ablation Control group will simply receive propofol anesthesia for ~20-30 min.Primary endpoints will be assessed six months after the procedure.ECGs will be monitored using implantable ECG monitors (ILR) in all patients. There will be two co-primary endpoints (assessed at six months):Freedom from recurrent AF/AT/AFL (post blanking, two months): assessed both as time-to first recurrence, and AF burden at six months post-ablationQuality of life according to the Atrial Fibrillation Effect on QualiTy of life (AFEQT) score at six months post ablation (or at cross-over for Early Exits); compared between groups

Inclusion Criteria:Age >18 yearsParoxysmal or Persistent Atrial Fibrillation (but not long-standing Persistent AF)Baseline AFEQT score ≤ 50Exclusion Criteria:any prior AF ablation procedure (or left atrial ablation procedure)untreated arrhythmias (e.g., atrial flutter, SVT, VT, frequent PVCs)long-standing Persistent AF episodes (any continuous episodes lasting > 1 year)left atrium size > 55 mmhypertrophic cardiomyopathyvalve disease (any aortic stenosis, moderate or severe mitral regurgitation)permanent AFleft ventricular ejection fraction < 35%moderate or severe pulmonary hypertension (sPAP ≥ 30 mm Hg)history of tachycardia-induced cardiomyopathysymptomatic coronary artery diseasepregnancypresence of an artificial valvelife expectancy of less than two years