Pulsed field versus radiofrequency approaches to change vagal nerve effects during pulmonary vein isolation for paroxysmal AF
A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulse Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
NA · VZW Cardiovascular Research Center Aalst · NCT06647485
This study tests whether pulsed field ablation, alone or combined with radiofrequency, changes vagal nerve activity during pulmonary vein isolation in people with paroxysmal atrial fibrillation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | VZW Cardiovascular Research Center Aalst (other) |
| Locations | 1 site (Aalst, Belgium) |
| Trial ID | NCT06647485 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–70 with symptomatic paroxysmal atrial fibrillation that terminates within seven days, who are eligible for point-by-point pulmonary vein isolation and can complete follow-up testing.
Not a fit: Patients with persistent AF, prior left atrial ablation or cardiac surgery, severe left ventricular dysfunction, intracardiac thrombus, or implanted pacemakers/ICDs (and other listed exclusions) would not be eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could guide ablation strategies that reduce unwanted autonomic effects and improve symptom control for people with paroxysmal AF.
How similar studies have performed: Pulsed field ablation has shown promising safety and efficacy for pulmonary vein isolation in recent studies, but its specific effects on autonomic ganglia and combinations with RF energy are not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aalst, Belgium
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Paroxysmal AF, vagal modulation, ganglionated plexi, pulsed field, dual-energy focal ablation, paroxysmal atrial fibrillation, heart rate variability