RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years - Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring - Willingness and ability to provide written willing to sign a consent form - Life expectancy \>1 year Who Should NOT Join This Trial: - 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * 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

Treatments Being Tested

PROCEDURE

Pulmonary 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

PROCEDURE

Selective 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.

Locations (1)

St. Joseph's Heart Rhythm Center

Rzeszów, Podkarpackie Voivodeship, Poland