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NCT Number: NCT06647485

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Paroxysmal AF Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-only PVI

Procedure

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

Hybrid PVI

Procedure

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

RF-only PVI

Procedure

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 outcomes

  1. Acute HRV variation (PF-only vs. RF-only arm)

    Time frame: from enrolment to the day after the ablation procedure

    It is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the PF-only arm and the control arm (RF-only).

Secondary outcomes

  1. Acute HRV variation (Hybrid vs. RF-only arm)

    Time frame: from enrolment to the day after the ablation procedure

    The secondary endpoint is the acute difference in the HRV variation (Δ SDNN: baseline/1-day after ablation) between the Hybrid arm and the control arm (RF-only)

Other outcomes

  1. Acute difference in biomarker release

    Time frame: Peri-procedural: from procedure start (after groin puncture) to its end (before sheaths removal)

    It measures the change in blood levels of the neuro-biomarker S100B (Δ S100B) and the cardiac injury biomarker Troponin (Δ Troponin), both measured before and immediately (~ 20 minutes) after the ablation

  2. Atrial arrhythmia recurrences and atrial fibrillation burden

    Time frame: from day 91 to day 365 post-ablation

    It measures any difference between the study arms in terms of AT/AF/AFL documented recurrences and AF burden during the effective evaluation period (Day 91-Day 365)

  3. Acute difference in resting Heart Rate (HR)

    Time frame: from enrolment to the day after the ablation procedure

    Acute difference in average resting HR (Δ HR: baseline/1-day after ablation) between the investigational arms compared to the control arm

  4. HRV variation across the follow-up period

    Time frame: from the first follow-up (3-month) visit until the last one (12-month)

    It measures the HRV change at 3, 6 and 12 months after the ablation procedure to assess the durability of the vagal modulation

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Valeriano, MD

CONTACT

[email protected]

+34 697539354

Sponsors and collaborators

Lead sponsor

VZW Cardiovascular Research Center Aalst

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study 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

Acronym: GPfIRE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 17, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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