Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation Using Point-by-Point Bipolar Pulsed Field Ablation Combined With Thermal Ablation of the Superior Paraseptal Parasympathetic Ganglion Region

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
St. Joseph's Heart Rhythm Center
RECRUITING
Rzeszów
Contact Information
Primary
Piotr Futyma, MD, PhD
piotr.futyma@gmail.com
+48 17 858 19 00
Backup
Łukasz Zarębski, MD
lukasz.zarebski@interia.pl
+48 17 858 19 00
Time Frame
Start Date: 2025-05-26
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 20
Treatments
Experimental: PFA with selective thermal ganglion ablation
Participants will undergo pulmonary vein isolation using a point-by-point bipolar pulsed-field ablation. In addition, selective thermal ablation using radiofrequency energy will be performed at the anterior aspect of the right superior pulmonary vein, corresponding to the anatomical region of the superior paraseptal parasympathetic ganglion.
Active_comparator: Standard PFA pulmonary vein isolation
Participants will undergo pulmonary vein isolation using the same point-by-point bipolar PFA system without any additional thermal applications.
Related Therapeutic Areas
Sponsors
Leads: St. Joseph's Centre, Poland

This content was sourced from clinicaltrials.gov