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NCT Number: NCT07171463

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

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.

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Key information

Conditions

Atrial Fibrillation (Paroxysmal) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion

Procedure

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.

Primary outcomes

  1. Recurrence of atrial fibrillation

    Time frame: 12 months post-procedure

    Any symptomatic or asymptomatic episode of atrial fibrillation lasting >30 seconds, confirmed by ECG or Holter monitoring.

Secondary outcomes

  1. Intraprocedural bradyarrhythmic episodes

    Time frame: During ablation procedure

    Number of Participants with periprocedural occurrence of bradyarrhythmias lasting >10 seconds that require atropine administration or temporary pacing.

  2. Requirement for intraprocedural cardioversion

    Time frame: During ablation procedure

    Number of Participants with periprocedural need for electrical cardioversion to terminate atrial fibrillation episodes during the procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Futyma, MD, PhD

CONTACT

[email protected]

+48 17 858 19 00

Łukasz Zarębski, MD

CONTACT

[email protected]

+48 17 858 19 00

Sponsors and collaborators

Lead sponsor

St. Joseph's Centre, Poland

Other

Registry information

Official study title

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

Acronym: PFACNA-AF

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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