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临床试验/NCT07395089
NCT07395089
尚未招募
不适用

Atrial Remodeling Associated With Pulse-Field Ablation of Atrial Fibrillation: a Computed Tomography Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Difference between baseline and post-ablation LA indexed volume (ml/cm^2)

概览

简要总结

Radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) reduces left atrial (LA) volume post-ablation, a phenomenon termed reverse atrial remodeling, indicative of successful reversal of atrial cardiomyopathy progression. In contrast, pulse field ablation (PFA), a novel non-thermal technology, offers a promising efficacy and safety profile without inducing persistent atrial fibrosis. While RFCA-associated reverse atrial remodeling is well-documented, it remains uncertain whether PFA, operating on a non-thermal paradigm, also promotes this remodeling, which would enhance its physiological relevance in AF treatment. Additionally, RFCA studies show that LA wall thickness at the pulmonary vein (PV) antrum can predict PV reconnection and arrhythmia recurrence, but whether PFA affects LA thinning or enables similar predictions from post-treatment computed tomography (CT) scans is unknown. Moreover, epicardial adipose tissue (EAT), strongly linked to LA abnormalities and AF recurrence, can be quantified via CT, yet the impact of PFA on LA EAT remains unexplored. Finally, PFA's versatility, particularly in isolating the LA posterior wall (LAPW) in non-paroxysmal AF, raises questions about its effect on posterior wall thinning or EAT changes, factors associated with post-ablation recurrence

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

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

入选标准

  • Age≥18 years at the time of AF ablation
  • AF ablation by pulse-field ablation (BOSTON SCIENTIFIC FARAPULSE) or by radiofrequency (any manufacturer) between 2020 and 2024
  • Paroxysmal or non-paroxysmal AF
  • Pre-ablation CT data available and of high quality
  • Post-ablation CT data available and of high quality
  • Post-ablation CT performed 3-months (+- 2 weeks) after AF ablation

排除标准

  • Low quality CT, non-homogeneous contrast agent perfusion
  • Post-ablation CT performed in another center
  • Patients in which pre- and post-ablation CTs do not share common phases
  • Patients who underwent ethanol infusion in the vein of Marshall

研究组 & 干预措施

Pulse-Field Ablation

Radiofrequency Catheter Ablation

结局指标

主要结局

Difference between baseline and post-ablation LA indexed volume (ml/cm^2)

时间窗: Post-procedural (3-months)

次要结局

  • Difference between baseline and post-ablation mean wall thickness, mm(Post-procedural (3-months))
  • Difference between baseline and post-ablation Epicardial adipose tissue , mm^3(Post-procedural (3-months))
  • Difference between baseline and post-ablation left atrial appendage indexed volume, ml/cm^2(Post-procedural (3-months))
  • Difference between baseline and post-ablation left atrial appendage dimensions (long-axis, short-axis, ostium long-axis, ostium short-axis), mm(Post-procedural (3-months))
  • Difference between baseline and post-ablation mean LA wall thickness at the LAPW, mm(Post-procedural (3-months))
  • Difference between baseline and post-ablation epicardial adipose tissue at the PW, mm^3(Post-procedural (3-months))
  • Recurrence of sustained atrial arrhythmia(Post-procedural (3-months))
  • Recurrence of sustained atrial arrhythmia(12 months after procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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