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

Active, not recruiting

• Conditions: Inflammation; Atrial Fibrillation; Catheter Ablation
• Interventions: Device: Radiofrequency; Device: Pulsed electric field

• Registration Number: NCT06160076
• Lead Sponsor: University Hospital, Bordeaux

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).

Detailed Description

Pulmonary vein isolation represents the cornerstone of AF ablation. PFA is a novel non-thermal cardiac ablation modality which is currently studied in clinical trials for the treatment of AF with promising efficacy and safety results. PFA is reported to generate less collateral damage by inducing selective apoptosis of cardiomyocytes, while other structures such as nerves, vessels and oesophageal tissue remain spared. PFA lesions show more organized and homogeneous fibrosis on histopathological study as compared to thermal lesions. In a recent study conducted at Hôpital Haut-Lévêque, PFA was associated with 20% less acute oedema on magnetic resonance imaging. Therefore, PFA may generate a reduced inflammatory reaction which could translate into lower early recurrence rates, less post-procedural chest pain and improved clinical outcomes. Data on the systemic inflammation generated by PFA and RFA is still lacking.

The aim of this study is to analyse the inflammatory reaction after PFA and RFA in patients referred for first-time catheter ablation of paroxysmal AF. For this purpose, established biomarkers of systemic inflammation (leucocytosis, platelet-monocyte-complexes, inflammatory cytokines) will be determined in blood samples collected from patients treated with either PFA or RFA.

The collection of blood samples will be exclusively performed during routine blood drawing at three time points: at the beginning of the procedure (to define baseline values), at the end of the procedure (to measure acute inflammation) and the day following the procedure (to define inflammation occurring within 24 hours). Clinical signs of inflammation (fever, chest pain, pericardial fluid) and early arrhythmia recurrences will also be assessed the day after the ablation. On a routine 6-month follow-up visit, late arrhythmia recurrences will be registered. In a secondary analysis, the thrombogenic and pro-arrhythmogenic potential of both ablation modalities and the predictive value of inflammatory biomarkers for early and late recurrences will be assessed.

Study Timeline

• Study First Submitted: 2023-09-28
• Study Start: 2023-10-16
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-07
• Primary Completion: 2024-10-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Study Completion: 2025-12-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiofrequency	Radiofrequency	Patient with atrial fibrillation ablated per radiofrequency
Pulsed electric field	Pulsed electric field	Patient with atrial fibrillation ablated per pulsed electric field

Primary Outcome Measures

Name	Time	Method
Pericarditis	24 hours	Chest pain suggestive of pericarditis assessed using a numeric pain rating scale (0 to 10)
Acute thromboinflammatory response	24 hours	Circulating platelet-monocyte complexes (PMC)
Systemic inflammatory response (CRP)	24 hours	Changes in leukocyte count and circulating levels of CRP
Systemic inflammatory response (IL-6)	24 hours	Changes in leukocyte count and circulating levels of IL-6
Systemic inflammatory response (TNF-α)	24 hours	Changes in leukocyte count and circulating levels of TNF-α

Secondary Outcome Measures

Name	Time	Method
Incidence of early arrhythmias	24 hours	Incidence of early arrhythmias occurring during the post-operative period on telemetry in PFA vs. RFA
Analysis of biomarkers (Willebrand)	24 hours	Endothelial cell damage: Changes in plasma levels of von Willebrand factor
Incidence of late atrial arrhythmia recurrence	6 months	Atrial fibrillation and/or atrial tachycardia recurrences documented by Holter-ECGs or other wearable devices
Analysis of biomarkers (CD40L)	24 hours	Platelet activation: Changes in plasma levels of soluble CD40L

Trial Locations

Locations (1)

Hôpital Haut-Lévèque; 🇫🇷 Pessac, France