NCT06647485Recruiting
Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 15 Oct 2024
- Start date
- Jan 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- VZW Cardiovascular Research Center Aalst
- Diseases
- Atrial fibrillation
- NCT number
- NCT06647485
What you commit to
- Study type: Interventional
- Planned participants: 105
- From Jan 2025 to the primary completion date, Jun 2026
- 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
- Previously diagnosed Persistent AF (\> 7 days in duration)
- Previous LA ablation
- Previous cardiac surgery
- Myocardial Infarction within the previous 3 months
Other illness
- 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
Lab values
- Severely compromised Left Ventricular Ejection Fraction (LVEF\<40%)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · 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 |
|---|---|---|---|
| OLV Hospital Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.