Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
NCT ID: NCT07171463
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-05-26
2026-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PFA with selective thermal ganglion ablation
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.
Pulmonary 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
Selective 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.
Standard PFA pulmonary vein isolation
Participants will undergo pulmonary vein isolation using the same point-by-point bipolar PFA system without any additional thermal applications.
Pulmonary 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
Interventions
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Pulmonary 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
Selective 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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St. Joseph's Centre, Poland
OTHER
Responsible Party
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Łukasz Zarębski
MD
Locations
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St. Joseph's Heart Rhythm Center
Rzeszów, Podkarpackie Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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12/2025/B
Identifier Type: -
Identifier Source: org_study_id
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