Actively Recruiting
Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
Led by St. Joseph's Centre, Poland · Updated on 2025-09-12
20
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Documented paroxysmal atrial fibrillation lasting at least 30 seconds on ECG or Holter monitoring
- Willing and able to provide written informed consent
- Life expectancy greater than 1 year
You will not qualify if you...
- Persistent atrial fibrillation lasting more than 7 days or long-standing atrial fibrillation over 1 year
- Secondary atrial fibrillation caused by electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes
- Left atrial diameter greater than 45 mm on echocardiography
- Significant arrhythmias other than atrial fibrillation
- Significant valvular heart disease or valve prosthesis
- Chronic heart failure NYHA class III or IV
- Previous atrial fibrillation or flutter ablation
- Prior closure of atrial septal defect or left atrial appendage
- Atrial myxoma
- Implanted pacemaker or defibrillator
- History of pericarditis
- Congenital heart disease
- Blood clotting or bleeding disorders
- Contraindications to oral anticoagulants
- Contraindications to CT or MRI scans
- Pregnancy or breastfeeding
- Body Mass Index over 30
- History of organ transplantation
- Severe lung disease
- Severe kidney impairment (eGFR less than 30 mL/min/1.73 m²)
- Active cancer
- Significant infection
- Life expectancy less than 1 year
- Psychiatric disorders preventing study participation
- Refusal or inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Joseph's Heart Rhythm Center
Rzeszów, Podkarpackie Voivodeship, Poland, 35-623
Actively Recruiting
Research Team
P
Piotr Futyma, MD, PhD
CONTACT
Ł
Łukasz Zarębski, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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