RecruitingNot ApplicableNCT06647485

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

Sponsor

VZW Cardiovascular Research Center Aalst

Enrollment

105 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Paroxysmal AF

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

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 Criteria10

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

Interventions

PROCEDUREPF-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

PROCEDUREHybrid 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

PROCEDURERF-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