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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Inflammatory Response Following  Pulsed Field Ablation  vs. Radiofrequency Ablation of Paroxysmal Atrial Fibrillation-2

Conditions
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Atrial Fibrillation, Catheter Ablation, Inflammation

Intervention / Treatment
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* Device: Radiofrequency
* Device: Pulsed electric field


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiofrequency<br>Patient with atrial fibrillation ablated per radiofrequency | Device: Radiofrequency<br>* Patient with atrial fibrillation ablated per catheter using radiofrequency energy<br>* Other names: Catheter ablation per radiofrequency;|
| Pulsed electric field<br>Patient with atrial fibrillation ablated per pulsed electric field | Device: Pulsed electric field<br>* Patient with atrial fibrillation ablated per catheter using pulsed electric field<br>* Other names: Catheter ablation per pulsed electric field;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, catheter ablation, Inflammation, Pulsed-field ablation