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临床试验/NCT01696344
NCT01696344Unknown不适用

Does AF Termination Without Additional Ablation Influence Outcome?

Texas Cardiac Arrhythmia Research Foundation2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
AF recurrence

研究概览

简要总结

This prospective study aims to investigate if termination of atrial fibrillation (AF) after pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in long-standing persistent (LSP) AF, is enough to ensure long-term success.

详细描述

Background: AF is a heterogeneous arrhythmia. At its simplest, it is triggered by rapidly firing foci around pulmonary veins (PV) and can be cured by isolation of PV alone. Evidences suggest that when high frequency of atrial activation is maintained for relatively longer period (as in persistent or long-standing AF), ion channel remodeling changes the electrophysiologic substrate and lead to AF permanence. Therefore, PVAI alone, as anticipated, demonstrates to have limited success rate in persistent and LSP AF and additional ablations beyond PVAI involving substrate modification are advocated by many experts in electrophysiology. However, there is yet no consensus on the ablation strategy for long-standing AF. It is still not clear whether AF termination during ablation could be considered as an ablation endpoint or not, as earlier studies have reported results that are at variance with each other. Some studies have suggested that termination of AF during ablation is associated with reduced recurrence of arrhythmia while others detected no association of AF termination with long-term maintenance of sinus rhythm (SR) in persistent or LSP-AF.Therefore this study aims to examine ablation outcomes in LSP-AF patients with AF termination with or without additional ablation of extra-PV triggers.

Hypothesis

AF termination does not eliminate the need for additional ablations in achieving long-term ablation success in LSP-AF.

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

  • Age ≥ 18 years
  • LSP-AF patients experiencing AF termination during ablation
  • Ability to understand and provide signed informed consent

排除标准

  • Previous left atrial catheter ablation or MAZE procedure in left atrium
  • Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

结局指标

主要结局

AF recurrence

时间窗: 3 years

Any episode of AF/AT longer than 30 seconds will be considered as recurrence. Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Natale

Executive Medical Director, TCAI

Texas Cardiac Arrhythmia Research Foundation

研究点 (2)

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