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临床试验/NCT01091597
NCT01091597已完成不适用

PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
freedom from atrial fibrillation

研究概览

简要总结

Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.

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

入选标准

  • •Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.

排除标准

  • •Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation

研究组 & 干预措施

usual ablation

Active Comparator

Wide-area circumferential ablation of the pulmonary veins

干预措施: usual PV ablation (Procedure)

Box isolation of the pulmonary veins

Experimental

Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.

干预措施: Box isolation of pulmonary veins (Procedure)

结局指标

主要结局

freedom from atrial fibrillation

时间窗: 3 months following ablation

次要结局

  • safety of Box isolation(3 months following procedure)

研究者

申办方类型
Other

研究点 (1)

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