Atrial Fibrillation (Paroxysmal)
Conditions
Keywords
Atrial fibrillation, Pulsed Field Ablation, Cardioneuroablation
Brief 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.
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.
Sponsors
St. Joseph's Centre, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial fibrillation | 12 months post-procedure | Any symptomatic or asymptomatic episode of atrial fibrillation lasting \>30 seconds, confirmed by ECG or Holter monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraprocedural bradyarrhythmic episodes | During ablation procedure | Number of Participants with periprocedural occurrence of bradyarrhythmias lasting \>10 seconds that require atropine administration or temporary pacing. |
| Requirement for intraprocedural cardioversion | During ablation procedure | Number of Participants with periprocedural need for electrical cardioversion to terminate atrial fibrillation episodes during the procedure. |
Countries
Poland
Contacts
Primary ContactPiotr Futyma, MD, PhD
Backup ContactŁukasz Zarębski, MD
Outcome results
None listed