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

NCT06647485 | Recruiting

• 2 other identifiers: GPfIRE01-BWI-CS-012CIV-24-02-046139-RS01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF); Paroxysmal AF

Keywords

vagal modulation; ganglionated plexi; pulsed field; dual-energy focal ablation; paroxysmal atrial fibrillation; heart rate variability; pulmonary vein isolation

Outcome Measures

Primary Outcomes (1)

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

  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).

  from enrolment to the day after the ablation procedure

Secondary Outcomes (1)

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

  from enrolment to the day after the ablation procedure

Other Outcomes (4)

• Acute difference in biomarker release

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

• Atrial arrhythmia recurrences and atrial fibrillation burden

  from day 91 to day 365 post-ablation

• Acute difference in resting Heart Rate (HR)

  from enrolment to the day after the ablation procedure

Study Arms (3)

PF-only

EXPERIMENTAL

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

Procedure: PF-only PVI

Hybrid (PF posterior/RF anterior)

EXPERIMENTAL

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

Procedure: Hybrid PVI

RF-only

ACTIVE COMPARATOR

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

Procedure: RF-only PVI

Interventions

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

PF-only

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

Hybrid (PF posterior/RF anterior)

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

RF-only

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VZW Cardiovascular Research Center Aalst: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

OLV Hospital

Aalst, Belgium, 9300, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tom De Potter, MD

  Cardiovascular Research Center Aalst

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Valeriano, MD

CONTACT

+34 697539354; chiara.valeriano91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)