Pulsed field versus radiofrequency approaches to change vagal nerve effects during pulmonary vein isolation for paroxysmal AF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study compares three point-by-point pulmonary vein isolation approaches: pulsed field (PF) only, a hybrid PF posterior/RF anterior approach, and RF-only as the control. Heart rate variability (HRV) will be used as a surrogate marker of ganglionated plexi and measured before and 24 hours after the procedure, while troponin and S100B biomarkers are sampled before and 20 minutes after ablation. Participants are followed for 12 months with 24-hour Holter ECGs at 3, 6, and 12 months to monitor rhythm outcomes and longer-term autonomic effects. The trial enrolls adults with symptomatic paroxysmal AF suitable for catheter ablation and excludes those with prior left atrial ablation, recent MI, severe LV dysfunction, intracardiac thrombus or implanted cardiac metal devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset
* Age range: 18-70 years
* Willing and capable of providing informed consent
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

* Previously diagnosed Persistent AF (\> 7 days in duration)
* Previous LA ablation
* Previous cardiac surgery
* Myocardial Infarction within the previous 3 months
* Severely compromised Left Ventricular Ejection Fraction (LVEF\<40%)
* Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
* Acute illness, active systemic infection, or sepsis
* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
* Severe mitral regurgitation
* Woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation

Where it's running

• OLV Hospital
  Aalst, Belgium, Belgium Recruiting

Study contacts

• Principal investigator: Tom De Potter, MD — Cardiovascular Research Center Aalst
• Study coordinator: Chiara Valeriano, MD
• Email: chiara.valeriano91@gmail.com
• Phone: +34 697539354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.