NCT07171463Recruiting
Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 Aug 2025
- Start date
- 26 May 2025
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- St. Joseph's Centre, Poland
- Diseases
- Atrial fibrillation
- NCT number
- NCT07171463
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 26 May 2025 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous AF or atrial flutter ablation
- Prior closure of atrial septal defect or left atrial appendage
Other illness
- Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes
- Clinically significant coexisting arrhythmias other than AF
- Significant valvular heart disease or valve prosthesis
- Chronic heart failure NYHA class III/IV
- History of pericarditis
- Congenital heart disease
- Coagulopathy or bleeding disorders
- History of organ transplantation
- Severe pulmonary disease
- Active malignancy
- Significant infection
- Psychiatric disorders preventing study participation
Other
- Persistent AF lasting \>7 days or long-standing AF \>1 year
- Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography
- Atrial myxoma
- Implanted pacemaker or defibrillator
- Contraindications to oral anticoagulation
- Contraindications to CT or MRI
- Pregnancy or breastfeeding
- Body Mass Index \>30
- Estimated Glomerular Filtration Rate \<30 mL/min/1.73 m²
- Life expectancy \<1 year
- Refusal or inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Joseph's Heart Rhythm Center Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.