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

NCT ID: NCT06647485

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PF-only

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

Group Type: EXPERIMENTAL

PF-only PVI

Intervention Type: 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 (PF posterior/RF anterior)

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

Group Type: EXPERIMENTAL

Hybrid PVI

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

RF-only PVI

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

VZW Cardiovascular Research Center Aalst

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom De Potter, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Research Center Aalst

Locations

OLV Hospital

Aalst, Belgium, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Chiara Valeriano, MD

Role: CONTACT

chiara.valeriano91@gmail.com

+34 697539354

Facility Contacts

Hedwig Batjoens, MSc

Role: primary

hedwig.batjoens@olvz-aalst.be

+32 53 72 44 49

Other Identifiers

CIV-24-02-046139-RS01

Identifier Type: OTHER

Identifier Source: secondary_id

GPfIRE01-BWI-CS-012

Identifier Type: -

Identifier Source: org_study_id