NCT06647485

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: VZW Cardiovascular Research Center Aalst · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation (AF)
• Paroxysmal AF

Interventions

Type	Name	Description
PROCEDURE	PF-only PVI	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
PROCEDURE	Hybrid PVI	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
PROCEDURE	RF-only PVI	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

Timeline

• Start date: 2025-01-29
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-10-17
• Last updated: 2025-07-10

Locations

1 site across 1 country: Belgium