Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation-2

NCT06160076 | Completed

• 1 other identifier: CHUBX 2023/33
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Catheter ablation using pulmonary vein isolation (PVI) in an established treatment strategy for AF. Pulsed Field Ablation (PFA) is a non-thermal ablation modality which has recently been introduced in clinical practice with the aim of improving PVI efficacy and safety. The aim of this study is to analyse whether PFA generates a lower inflammatory reaction as compared to conventional radiofrequency ablation (RFA).

Conditions

Atrial Fibrillation; Catheter Ablation; Inflammation

Keywords

Atrial Fibrillation; catheter ablation; Inflammation; Pulsed-field ablation

Outcome Measures

Primary Outcomes (5)

• Acute thromboinflammatory response

  Circulating platelet-monocyte complexes (PMC)

  24 hours

• Systemic inflammatory response (IL-6)

  Changes in leukocyte count and circulating levels of IL-6

  24 hours

• Systemic inflammatory response (TNF-α)

  Changes in leukocyte count and circulating levels of TNF-α

  24 hours

• Systemic inflammatory response (CRP)

  Changes in leukocyte count and circulating levels of CRP

  24 hours

• Pericarditis

  Chest pain suggestive of pericarditis assessed using a numeric pain rating scale (0 to 10)

  24 hours

Secondary Outcomes (4)

• Incidence of early arrhythmias

  24 hours

• Analysis of biomarkers (CD40L)

  24 hours

• Analysis of biomarkers (Willebrand)

  24 hours

• Incidence of late atrial arrhythmia recurrence

  6 months

Study Arms (2)

Radiofrequency

Patient with atrial fibrillation ablated per radiofrequency

Device: Radiofrequency

Pulsed electric field

Patient with atrial fibrillation ablated per pulsed electric field

Device: Pulsed electric field

Interventions

Radiofrequency DEVICE

Patient with atrial fibrillation ablated per catheter using radiofrequency energy

Also known as: Catheter ablation per radiofrequency

Radiofrequency

Pulsed electric field DEVICE

Patient with atrial fibrillation ablated per catheter using pulsed electric field

Also known as: Catheter ablation per pulsed electric field

Pulsed electric field

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atrial fibrillation treated by catheter ablation

You may qualify if:

• Age ≥ 18 years
• Patients with paroxysmal AF referred for first-time catheter ablation using PFA or RFA
• Non-opposition to participate

You may not qualify if:

• Age \< 18 years
• Persons under judicial protection (guardianship, guardianship) or deprived of freedom
• Prior left atrial ablation
• Prior cardiac surgery comprising incision of the left atrium
• Prior myocardial infarction or stroke in the previous 30 days
• Acute or chronic inflammatory state: active smoking, auto-immune disease, active tumor disease, myocarditis
• Antiplatelet therapy (e.g. aspirine, clopidogrel) within the 7 last days
• Anti-inflammatory treatment (e.g. glucocorticoids, colchicine, cyclophosphamide, azathioprine, mycophenolic acid, antibodies) within the 7 last days

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Haut-Lévèque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre JAÏS, MD

  University Hospital, Bordeaux

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: December 7, 2023
• Study Start: October 16, 2023
• Primary Completion: October 11, 2024
• Study Completion: April 25, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)