Condition: Atrial Fibrillation (AF) · Paroxysmal AF · Sponsor: VZW Cardiovascular Research Center Aalst
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.
This description comes directly from the study's public registry record.
Chiara Valeriano, MD · +34 697539354 · chiara.valeriano91@gmail.com
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| OLV Hospital | Aalst, Belgium, Belgium | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06647485