Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation

• PF-only PVI (Procedure): It 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): It 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): It 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

Primary outcomes

• Acute HRV variation (PF-only vs. RF-only arm) [from enrolment to the day after the ablation procedure]: 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).

Secondary outcomes

• Acute HRV variation (Hybrid vs. RF-only arm) [from enrolment to the day after the ablation procedure]: 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)

Other outcomes

• Acute difference in biomarker release [Peri-procedural: from procedure start (after groin puncture) to its end (before sheaths removal)]: 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 [from day 91 to day 365 post-ablation]: 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) [from enrolment to the day after the ablation procedure]: 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 [from the first follow-up (3-month) visit until the last one (12-month)]: It measures the HRV change at 3, 6 and 12 months after the ablation procedure to assess the durability of the vagal modulation

Sex: All, ages: 18 Years to 70 Years

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

• Tom De Potter, MD, Principal investigator, Cardiovascular Research Center Aalst