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临床试验/NCT06160076
NCT06160076已完成不适用

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

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Pericarditis

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Pericarditis

时间窗: 24 hours

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

Acute thromboinflammatory response

时间窗: 24 hours

Circulating platelet-monocyte complexes (PMC)

Systemic inflammatory response (CRP)

时间窗: 24 hours

Changes in leukocyte count and circulating levels of CRP

Systemic inflammatory response (IL-6)

时间窗: 24 hours

Changes in leukocyte count and circulating levels of IL-6

Systemic inflammatory response (TNF-α)

时间窗: 24 hours

Changes in leukocyte count and circulating levels of TNF-α

次要结局

  • Incidence of early arrhythmias(24 hours)
  • Analysis of biomarkers (Willebrand)(24 hours)
  • Incidence of late atrial arrhythmia recurrence(6 months)
  • Analysis of biomarkers (CD40L)(24 hours)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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