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

Plain Language Summary

Simplified for easier understanding

This study is evaluating how pulsed field ablation (PFA) — a newer type of procedure that uses electrical pulses to treat atrial fibrillation (an irregular heart rhythm) — affects the autonomic nervous system, which controls the heart's rate and rhythm automatically. **You may be eligible if...** - You are between 18 and 70 years old - You have symptomatic paroxysmal atrial fibrillation (episodes that stop on their own or with treatment within 7 days) - You have not had a prior atrial fibrillation ablation or cardiac surgery - You are willing to attend all follow-up appointments **You may NOT be eligible if...** - You have persistent AF (episodes lasting more than 7 days) - You have had previous heart surgery or a prior LA ablation procedure - You had a heart attack within the past 3 months - Your heart's pumping function is significantly reduced (ejection fraction below 40%) - You have a pacemaker, defibrillator, or other implanted metal cardiac device - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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