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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation (Paroxysmal)

• Registration Number: NCT07171463
• Lead Sponsor: St. Joseph's Centre, Poland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-26
• Study First Submitted: 2025-08-29
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-07
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

St. Joseph's Heart Rhythm Center; 🇵🇱 Rzeszów, Podkarpackie Voivodeship, Poland