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

Plain Language Summary

Simplified for easier understanding

This study is testing a combined heart procedure for people with paroxysmal atrial fibrillation (AF) — the kind that comes and goes. It combines pulsed field ablation (a newer energy-based technique to fix abnormal heart rhythm) with a nerve ablation procedure to reduce the triggers of AF. Researchers want to see if this dual approach works better than ablation alone. **You may be eligible if...** - You are 18 or older with documented paroxysmal AF (episodes lasting at least 30 seconds) - You are otherwise healthy enough for the procedure **You may NOT be eligible if...** - Your AF has been continuous for more than 7 days or ongoing for over a year - Your AF is caused by thyroid disease, electrolyte imbalance, or alcohol use - Your left atrium (heart chamber) is enlarged - You have a pacemaker or defibrillator implanted - You have had a prior AF ablation or heart surgery involving the left atrium - You have significant valve disease, severe heart failure, severe lung disease, or active cancer - Your BMI is above 30 - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.