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Recruiting NCT06647485

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

No phase Interventional Atrial Fibrillation (AF) Paroxysmal AF

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PF-only PVI, Hybrid PVI, RF-only PVI.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF), Paroxysmal AF. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Acute HRV variation (PF-only vs. RF-only arm) [Time frame: from enrolment to the day after the ablation procedure]
Secondary outcome measures (1)
  • Acute HRV variation (Hybrid vs. RF-only arm) [Time frame: from enrolment to the day after the ablation procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • OLV Hospital — Aalst

Identifiers

NCT: NCT06647485 · GPfIRE01-BWI-CS-012 · CIV-24-02-046139-RS01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗