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

NCT07171463 | Recruiting

• 1 other identifier: 12/2025/B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (Paroxysmal)

Keywords

Atrial fibrillation; Pulsed Field Ablation; Cardioneuroablation

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial fibrillation

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

  12 months post-procedure

Secondary Outcomes (2)

• Intraprocedural bradyarrhythmic episodes

  During ablation procedure

• Requirement for intraprocedural cardioversion

  During ablation procedure

Study Arms (2)

PFA with selective thermal ganglion ablation

EXPERIMENTAL

Participants will undergo pulmonary vein isolation using a point-by-point bipolar pulsed-field ablation. In addition, selective thermal ablation using radiofrequency energy will be performed at the anterior aspect of the right superior pulmonary vein, corresponding to the anatomical region of the superior paraseptal parasympathetic ganglion.

Procedure: Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation; Procedure: Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion

Standard PFA pulmonary vein isolation

ACTIVE COMPARATOR

Participants will undergo pulmonary vein isolation using the same point-by-point bipolar PFA system without any additional thermal applications.

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

Interventions

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

PFA with selective thermal ganglion ablation; Standard PFA pulmonary vein isolation

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.

PFA with selective thermal ganglion ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Centre, Poland: lead

Study Sites (1)

St. Joseph's Heart Rhythm Center

Rzeszów, Podkarpackie Voivodeship, 35-623, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Piotr Futyma, MD, PhD

CONTACT

+48 17 858 19 00; piotr.futyma@gmail.com

Łukasz Zarębski, MD

CONTACT

+48 17 858 19 00; lukasz.zarebski@interia.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 12, 2025
• Study Start: May 26, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

PL (1)