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临床试验/NCT02238392
NCT02238392已完成不适用

Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial

Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年1月1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
150
试验地点
2
主要终点
Arrhythmia-free survival

研究概览

简要总结

This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.

详细描述

Despite intensive efforts to increase single procedure success rates of pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has not raised beyond 80%. This prospective, randomized study investigates the efficacy of two different procedural endpoints in terms of single-procedure arrhythmia-free outcome.

A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be randomized to two different treatment arms. In group-A patients, PVI will be performed with the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation will be continued by targeting extra-PV AF sources with the desired endpoint of termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to adenosine administration in the attempt to reveal and ablate dormant conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • patients with paroxysmal AF
  • de-novo AF ablation
  • age > 18 years

排除标准

  • persistent AF
  • previous cardioversion

结局指标

主要结局

Arrhythmia-free survival

时间窗: 1 year

arrhythmia-free outcome during 1 year after the procedure

次要结局

  • Recurrence if PV conduction after ablation in PVs with abolished dormant conduction(1 year)

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Rostock

Thomas Rostock, MD

Johannes Gutenberg University Mainz

研究点 (2)

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