跳至主要内容
临床试验/NCT04218604
NCT04218604已完成不适用

Feasibility and Efficacy of Tailoring Ablation Index to Left Atrial Wall Thickness During Atrial Fibrillation Ablation: The Ablate By-LAW Study

Centro Medico Teknon6 个研究点 分布在 3 个国家目标入组 106 人开始时间: 2020年11月21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
106
试验地点
6
主要终点
Arrhythmia-free survival

研究概览

简要总结

Of all the determinants of lesion creation during atrial fibrillation (AF) ablation, left atrial wall thickness (LAWT), as measured with multi-detector cardiac tomography (MDCT) is one key element that has been evaluated in some retrospective analyses but is not yet used per protocol to modulate the radiofrequency delivery. Adapting ablation index (AI) to LAWT would be very useful in standardising the ablation procedure with parameters fitted to every patient, enabling the development of a personalized approach that will both: i) increase efficacy by performing transmural lesions to prevent the formation of conduction gaps in the initial lesion set, and ii) increase safety by preventing excessive RF delivery on thin wall areas related to procedural complications, such as cardiac perforation or atrio-esophageal fistula. The investigators sought to evaluate the feasibility, safety, efficacy and reproducibility of guiding AF ablation procedures with the integrated MDCT-derived LAWT information.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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.
  • Indication for paroxysmal atrial fibrillation ablation.
  • Signed informed consent.

排除标准

  • Age < 18 years.
  • Pregnancy.
  • Previous AF ablation procedure (REDO).

结局指标

主要结局

Arrhythmia-free survival

时间窗: 1 year

1-year atrial arrhythmia-free survival

次要结局

  • Peri-procedural complications(1 month)
  • Acute procedural outcomes(1 day)
  • REDO outcomes(2 years)

研究者

发起方
Centro Medico Teknon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Berruezo, MD, PhD

Principal investigator, cardiologist, cardiac electrophysiologist

Centro Medico Teknon

研究点 (6)

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