Status:
RECRUITING
Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
Lead Sponsor:
St. Joseph's Centre, Poland
Conditions:
Atrial Fibrillation (Paroxysmal)
Eligibility:
All Genders
18+ years
Phase:
NA
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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07171463
Start Date
May 26 2025
End Date
September 30 2026
Last Update
September 12 2025
Active Locations (1)
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1
St. Joseph's Heart Rhythm Center
Rzeszów, Podkarpackie Voivodeship, Poland, 35-623