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临床试验/NCT00180362
NCT00180362已完成4 期

Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary in Patients After Survived Cardiac Arrest? A Prospective Randomised Multi-centre Trial.

Boston Scientific Corporation2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年5月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
2
主要终点
Combined endpoint of major ICD-related adverse events as the primary outcome measure

研究概览

简要总结

The purpose of this study is to evaluate the strategy of implanting an ICD with or without EPS before, during and after ICD-implantation in a randomised controlled trial, using a combined endpoint of major ICD-related adverse events as the primary outcome measure.

详细描述

Usually, EPS before and during ICD-implantation is performed to allow risk stratification, to test serial antiarrhythmic drugs, to find suitable ablation sites in patients with hemo-dynamically stable monomorphic VTs, to exclude supraventricular tachycardias as a cause of cardiac arrest and to help programming detection rate and enhancement criteria in the ICD. However, routine EPS preceeding ICD-implantation exposes the patient to some risk and the health care system to considerable costs. So the question has been raised, whether such testing is still necessary and costseffective, if the indiaction for ICD-implantation is clear on a clinical ground.The purpose of this study is to evaluate the strategy of implanting an ICD with or without EPS before during and after ICD-implantation in a randomised controlled trial, using a combined endpoint of major ICD-related adverse events as the primary outcome measure (see details under "Endpoints"). The results will be viewed against the extra costs and patients´ quality of life both study arms.Secondary outcomes are considered as differences in decisions between the groups and difference of events in the two groups.

研究设计

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

  • structural heart disease and survived cardiac arrest or hemodynamically unstable VT (bpm > 200/min)

排除标准

  • conditions, which make a secondary cause for cardiac arrest probable or are not compatible with a single chamber ICD; co-morbidity, prior ICD PM, or EPS

结局指标

主要结局

Combined endpoint of major ICD-related adverse events as the primary outcome measure

次要结局

  • Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU

研究者

申办方类型
Industry

研究点 (2)

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