Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06647485

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

Led by VZW Cardiovascular Research Center Aalst · Updated on 2025-07-10

105

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

V

VZW Cardiovascular Research Center Aalst

Lead Sponsor

B

Biosense Webster, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

OLV Hospital

Aalst, Belgium, Belgium, 9300

Actively Recruiting

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Research Team

C

Chiara Valeriano, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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