Pulsed-field pulmonary vein isolation with optional radiofrequency nerve-targeting for paroxysmal atrial fibrillation
Official 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
Run by St. Joseph's Centre, Poland · NCT07171463 · Data updated 2026-11-12
This trial tests whether adding selective radiofrequency ablation of a parasympathetic ganglion to pulsed-field pulmonary vein isolation helps adults with paroxysmal atrial fibrillation have fewer recurrences and fewer bradyarrhythmic events.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | St. Joseph's Centre, Poland Academic / other |
| Locations | 1 site (Rzeszów, Podkarpackie Voivodeship) |
| Status | Recruiting |
| Started | May 26, 2025 |
| Main results expected | September 30, 2025 |
| Study ends | September 30, 2026 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT07171463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with documented paroxysmal atrial fibrillation, suitable cardiac anatomy (left atrial diameter <45 mm), no prior AF ablation, and the ability to provide informed consent are ideal candidates.
✕Probably not a fit
Patients with persistent or long-standing AF, prior AF/atrial flutter ablation, implanted pacemakers/defibrillators, large left atria (≥45 mm), significant heart failure, or other listed exclusions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, single-center trial compares two approaches for pulmonary vein isolation in adults with paroxysmal atrial fibrillation: pulsed-field ablation (PFA) alone versus PFA combined with selective radiofrequency (RF) ablation of the superior paraseptal parasympathetic ganglion. PFA is a non-thermal technique that selectively targets cardiomyocytes and has shown a favorable safety profile, while RF ganglion ablation is intended to modify autonomic inputs that may contribute to AF recurrence or intraprocedural bradyarrhythmias. Participants meeting inclusion criteria are randomized to one of the two procedural strategies and followed for clinical outcomes including AF recurrence and procedure-related bradyarrhythmic events. The trial is conducted at St. Joseph's Heart Rhythm Center in Rzeszów, Poland.
Why it matters
Potential benefit: If successful, the combined approach could lower AF recurrence and reduce bradyarrhythmic complications for some patients undergoing PVI.
How similar studies have gone: Pulsed-field ablation has shown promising safety and efficacy for pulmonary vein isolation, while thermal ganglionated plexus ablation has had mixed results in prior studies, making this combined approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
St. Joseph's Heart Rhythm Center
Rzeszów, Podkarpackie Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Piotr Futyma, MD, PhD
- Email: piotr.futyma@gmail.com
- Phone: +48 17 858 19 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.