RecruitingNot ApplicableNCT07171463

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

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

Sponsor

St. Joseph's Centre, Poland

Enrollment

20 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (Paroxysmal)

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria25

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
Significant valvular heart disease or valve prosthesis
Chronic heart failure NYHA class III/IV
Previous AF or atrial flutter ablation
Prior closure of atrial septal defect or left atrial appendage
Atrial myxoma
Implanted pacemaker or defibrillator
History of pericarditis
Congenital heart disease
Coagulopathy or bleeding disorders
Contraindications to oral anticoagulation
Contraindications to CT or MRI
Pregnancy or breastfeeding
Body Mass Index \>30
History of organ transplantation
Severe pulmonary disease
Estimated Glomerular Filtration Rate \<30 mL/min/1.73 m²
Active malignancy
Significant infection
Life expectancy \<1 year
Psychiatric disorders preventing study participation
Refusal or inability to provide informed consent

Interventions

PROCEDUREPulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation

Pulmonary vein isolation is performed via transseptal access to the left atrium using a point-by-point bipolar pulsed-field ablation catheter

PROCEDURESelective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion

Targeted 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.