NCT06647485 Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
| NCT ID | NCT06647485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VZW Cardiovascular Research Center Aalst |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-01-29 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 105 participants in total. It began in 2025-01-29 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Tom De Potter, MD
PRINCIPAL INVESTIGATOR
Cardiovascular Research Center Aalst
Frequently Asked Questions
Who can join the NCT06647485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06647485 currently recruiting?
Yes, NCT06647485 is actively recruiting participants. Contact the research team at chiara.valeriano91@gmail.com for enrollment information.
Where is the NCT06647485 trial being conducted?
This trial is being conducted at Aalst, Belgium.
Who is sponsoring the NCT06647485 clinical trial?
NCT06647485 is sponsored by VZW Cardiovascular Research Center Aalst. The principal investigator is Tom De Potter, MD at Cardiovascular Research Center Aalst. The trial plans to enroll 105 participants.
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