Atrial Fibrillation Clinical Trial
— RIPAF-2Official title:
Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation of Paroxysmal Atrial Fibrillation-2
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).
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 16, 2024 |
Est. primary completion date | April 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Haut-Lévèque | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute thromboinflammatory response | Circulating platelet-monocyte complexes (PMC) | 24 hours | |
Primary | Systemic inflammatory response (IL-6) | Changes in leukocyte count and circulating levels of IL-6 | 24 hours | |
Primary | Systemic inflammatory response (TNF-a) | Changes in leukocyte count and circulating levels of TNF-a | 24 hours | |
Primary | Systemic inflammatory response (CRP) | Changes in leukocyte count and circulating levels of CRP | 24 hours | |
Primary | Pericarditis | Chest pain suggestive of pericarditis assessed using a numeric pain rating scale (0 to 10) | 24 hours | |
Secondary | Incidence of early arrhythmias | Incidence of early arrhythmias occurring during the post-operative period on telemetry in PFA vs. RFA | 24 hours | |
Secondary | Analysis of biomarkers (CD40L) | Platelet activation: Changes in plasma levels of soluble CD40L | 24 hours | |
Secondary | Analysis of biomarkers (Willebrand) | Endothelial cell damage: Changes in plasma levels of von Willebrand factor | 24 hours | |
Secondary | Incidence of late atrial arrhythmia recurrence | Atrial fibrillation and/or atrial tachycardia recurrences documented by Holter-ECGs or other wearable devices | 6 months |
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