Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Joseph's Centre, Poland

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

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators