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

RecruitingNAAges 18 Years - anyAllSt. Joseph's Centre, Poland
NCT07171463 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Pulmonary Vein Isolation using Point-by-Point Bipolar Pulsed-Field Ablation
  • Selective Radiofrequency Ablation of the Superior Paraseptal Parasympathetic Ganglion
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Where

1 site
St. Joseph's Heart Rhythm Center
Rzeszów, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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