Feasibility and Efficacy of Tailoring Ablation Index to Left Atrial Wall Thickness During Atrial Fibrillation Ablation: The Ablate By-LAW Study
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
- 否
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
Antonio Berruezo, MD, PhD
Principal investigator, cardiologist, cardiac electrophysiologist
Centro Medico Teknon
