Heart Rhythm Procedure Combining Pulsed Field and Radiofrequency Ablation in Atrial Fibrillation
Tests pulsed field ablation with added heat ablation in adults with paroxysmal atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
Key facts
- Where
- Rzeszów, PolandSee the site
Where in Poland
- St. Joseph's Heart Rhythm CenterRzeszów, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Joseph's Centre, Poland
- Trial code
- NCT07171463
- Record updated
- 12 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Previous AF or atrial flutter ablation; Prior closure of atrial septal defect or left atrial appendage; Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes; Clinically significant coexisting arrhythmias other than AF; Significant valvular heart disease or valve prosthesis; Chronic heart failure NYHA class III/IV; History of pericarditis; Congenital heart disease; Coagulopathy or bleeding disorders; History of organ transplantation; Severe pulmonary disease; Active malignancy; Significant infection; Psychiatric disorders preventing study participation; Persistent AF lasting >7 days or long-standing AF >1 year; Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography; Atrial myxoma; Implanted pacemaker or defibrillator; Contraindications to oral anticoagulation; Contraindications to CT or MRI; Pregnancy or breastfeeding; Body Mass Index >30; Estimated Glomerular Filtration Rate <30 mL/min/1.73 m²; Life expectancy <1 year; Refusal or inability to provide informed consent.