About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation
- Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion