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临床试验/NCT06145906
NCT06145906招募中不适用

Application Value of Whole-procedure Optimization for Catheter Ablation of Atrial Fibrillation

Henan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年12月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
AF recurrence

研究概览

简要总结

The success rate of single-procedure atrial arrhythmia-free survival particularly ranged from 40% to 66% in persistent AF ablation. However, The surgical Cox maze III procedure has been established to be an effective curative strategy for AF with an AF-free survival rate of more than 95%. The main reason is the difficulty of creating continuous, transmural, and durable lesions by catheter ablation, especially when the procedure is performed on some complex anatomical structures in which epicardial muscular bundles may serve as components of the reentrant circuits.

The durability of the conduction block is a crucial factor for long-term effective AF ablation since previous studies reported that the reconnected Pulmonary veins contributed to the atrial tachycardia recurrence after persistent AF ablation. In addition, it is possible that the inadequate lesions accidentally produce new arrhythmogenic substrates. Therefore, new and better techniques are always chosen to minimize the reconnection of Pulmonary vein isolation (PVI) and additional ablation.

For paroxysmal AF, the ablation strategy of PVI plus superior vena cava isolation is chosen while PVI, superior vena cava isolation, and linear ablation of linear ablations of the mitral isthmus, roofline and posterior wall line of the left atrium, and cavotricuspid isthmus (CTI) for persistent AF. Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds was regarded as an AF recurrence after a 3-month blanking period. The primary outcome was defined as 12-month atrial arrhythmia-free survival. The secondary outcomes include the block rate of PVI, superior vena cava isolation, and all linear ablations.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Radiofrequency catheter ablation for the first time
  • AF rhythm recorded by ECG

排除标准

  • Thrombosis in left atrium
  • Left ventricular ejection fraction of < 35%
  • Abnormal thyroid function
  • Previous history of AF radiofrequency ablation and CABG
  • Left atrium diameter of > 65 mm or the volume of > 200 ml

结局指标

主要结局

AF recurrence

时间窗: 12 months

Any symptomatic or asymptomatic atrial arrhythmia lasting more than 30 seconds after a 3-month blanking period

次要结局

  • initial block rate(intraoperation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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