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

VZW Cardiovascular Research Center Aalst

Status: Enrolling

Conditions: Paroxysmal AF; Atrial Fibrillation (AF)

Treatments: Procedure: PF-only PVI; Procedure: RF-only PVI; Procedure: Hybrid PVI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06647485

GPfIRE01-BWI-CS-012

CIV-24-02-046139-RS01 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

PF-only

Experimental group

Description:

The PF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only PF energy

Treatment:

Procedure: PF-only PVI

Hybrid (PF posterior/RF anterior)

Experimental group

Description:

The Hybrid arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using both PF and RF energy

Treatment:

Procedure: Hybrid PVI

RF-only

Active Comparator group

Description:

The RF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only RF energy

Treatment:

Procedure: RF-only PVI