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.
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
Previously diagnosed Persistent AF (> 7 days in duration)
Previous LA ablation
Previous cardiac surgery
Myocardial Infarction within the previous 3 months
Parallel
PF-only PVI
Procedure/SurgeryIt consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only PF energy for ablation
Hybrid PVI
Procedure/SurgeryIt consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing both PF and RF energy for ablation. Specifically, PF energy is used for the posterior segments and RF energy for the anterior segments of the pulmonary veins
RF-only PVI
Procedure/SurgeryIt consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only RF energy for ablation
Acute HRV variation (PF-only vs. RF-only arm)
It is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the PF-only arm and the control arm (RF-only).
Acute HRV variation (Hybrid vs. RF-only arm)
The secondary endpoint is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the Hybrid arm and the control arm (RF-only)
Acute difference in biomarker release
It measures the change in blood levels of the neuro-biomarker S100B (Δ S100B) and the cardiac injury biomarker Troponin (Δ Troponin), both measured before and immediately (\~ 20 minutes) after the ablation
Atrial arrhythmia recurrences and atrial fibrillation burden
It measures any difference between the study arms in terms of AT/AF/AFL documented recurrences and AF burden during the effective evaluation period (Day 91-Day 365)
Acute difference in resting Heart Rate (HR)
Acute difference in average resting HR (Δ HR: baseline/1-day after ablation) between the investigational arms compared to the control arm
HRV variation across the follow-up period
It measures the HRV change at 3, 6 and 12 months after the ablation procedure to assess the durability of the vagal modulation
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VZW Cardiovascular Research Center Aalst
Lead sponsor
Biosense Webster, Inc.
Collaborator
