Hôpital Haut-Lévèque
Pessac, 33604, France
NCT Number: NCT06160076
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).
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Notify Me18 year–100 year
All sexes
Observational
Pessac, 33604, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient with atrial fibrillation ablated per catheter using radiofrequency energy
Other names: Catheter ablation per radiofrequency
Patient with atrial fibrillation ablated per catheter using pulsed electric field
Other names: Catheter ablation per pulsed electric field
Time frame: 24 hours
Circulating platelet-monocyte complexes (PMC)
Time frame: 24 hours
Changes in leukocyte count and circulating levels of IL-6
Time frame: 24 hours
Changes in leukocyte count and circulating levels of TNF-α
Time frame: 24 hours
Changes in leukocyte count and circulating levels of CRP
Time frame: 24 hours
Chest pain suggestive of pericarditis assessed using a numeric pain rating scale (0 to 10)
Time frame: 24 hours
Incidence of early arrhythmias occurring during the post-operative period on telemetry in PFA vs. RFA
Time frame: 24 hours
Platelet activation: Changes in plasma levels of soluble CD40L
Time frame: 24 hours
Endothelial cell damage: Changes in plasma levels of von Willebrand factor
Time frame: 6 months
Atrial fibrillation and/or atrial tachycardia recurrences documented by Holter-ECGs or other wearable devices
University Hospital, Bordeaux
Other
Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation of Paroxysmal Atrial Fibrillation-2
Acronym: RIPAF-2
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