Pulsed-field ablation (PFA) is a novel, non-thermal method for the treatment of atrial fibrillation (AF). It uses short, high-voltage electrical pulses to selectively ablate cardiomyocytes. PFA has demonstrated a high safety profile with reduced complication rates compared to thermal ablation.
Thermal ablation of parasympathetic ganglia during conventional pulmonary vein isolation (PVI) may improve long-term procedural outcomes by reducing AF recurrence. However, due to its non-thermal nature, PFA may not significantly affect cardiac autonomic innervation, which could be clinically relevant in vagally mediated AF or tachycardia-bradycardia syndrome.
This randomized study compares two strategies: (1) PFA-only PVI, and (2) PFA combined with selective thermal ablation (radiofrequency energy) of the superior paraseptal parasympathetic ganglion. The primary objective is to evaluate whether adjunctive thermal ablation improves clinical outcomes and reduces intraprocedural bradyarrhythmic events.
Age ≥18 years
Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring
Willingness and ability to provide written informed consent
Life expectancy >1 year
Persistent AF lasting >7 days or long-standing AF >1 year
Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes
Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography
Clinically significant coexisting arrhythmias other than AF
Parallel
Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation
Procedure/SurgeryPulmonary vein isolation is performed via transseptal access to the left atrium using a point-by-point bipolar pulsed-field ablation catheter
Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion
Procedure/SurgeryTargeted application of radiofrequency energy at the anterior aspect of the right superior pulmonary vein, corresponding to the anatomical location of the superior paraseptal parasympathetic ganglion.
Recurrence of atrial fibrillation
Any symptomatic or asymptomatic episode of atrial fibrillation lasting \>30 seconds, confirmed by ECG or Holter monitoring.
Intraprocedural bradyarrhythmic episodes
Number of Participants with periprocedural occurrence of bradyarrhythmias lasting \>10 seconds that require atropine administration or temporary pacing.
Requirement for intraprocedural cardioversion
Number of Participants with periprocedural need for electrical cardioversion to terminate atrial fibrillation episodes during the procedure.
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