Compares pulsed field and radiofrequency heart ablation effects on nerves in atrial fibrillation
Tests pulsed field and combined heart ablation in adults with paroxysmal atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
Key facts
- Where
- Aalst, BelgiumSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with symptomatic paroxysmal atrial fibrillation who are having a pulmonary vein isolation procedure with pulsed field energy, radiofrequency energy, or both.
- Age
- 18-70 years
- Sex
- All sexes can join.
- Disease stage
- Symptomatic paroxysmal atrial fibrillation that stops by itself or with treatment within 7 days of starting.
- Earlier treatment
- Cannot have had a previous left atrium ablation or previous cardiac surgery.
Main reasons for not taking part
- Persistent atrial fibrillation lasting more than 7 days
- Heart attack within the previous 3 months
- Severely reduced heart pumping (LVEF below 40%)
- Pacemaker, ICD or other implanted metal heart device that may interfere with pulsed electric field energy
- Pregnant, breastfeeding or planning pregnancy during the trial
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06647485, who can take part
Where in Belgium
- OLV HospitalAalst, BelgiumContact: Hedwig Batjoens, MScTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- VZW Cardiovascular Research Center Aalst
- Trial code
- NCT06647485
- Record updated
- 10 July 2025
- Original description
The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior/RF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.Read full original descriptionShow less
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
The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior/RF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.
Inclusion: 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: Previously diagnosed Persistent AF (\> 7 days in duration); Previous LA ablation; Previous cardiac surgery; Myocardial Infarction within the previous 3 months; 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; Severely compromised Left Ventricular Ejection Fraction (LVEF\<40%); 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.