NCT00170261已完成4 期
Early Loop-Recorder in Suspected Arrhythmogenic Syncope
Medtronic Cardiac Rhythm and Heart Failure6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Cost of diagnostics per patient until final cardiac diagnosis has been made
研究概览
简要总结
This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes
排除标准
- •Indication for the implantation of a pacemaker
- •Indication for the implantation of an implantable cardioverter defibrillator
- •Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular [LV] outflow stenosis, decompensated heart failure)
- •Contraindication for a diagnostic procedure requested by the study protocol
- •Enrollment in another study
- •Circumstances or comorbidities which do not allow enrollment
结局指标
主要结局
Cost of diagnostics per patient until final cardiac diagnosis has been made
次要结局
- Cost of diagnostics until final diagnosis has been made
- Rate of correct cardiac diagnoses
- Comparison of time needed to make a diagnosis
- Comparison of pre-syncopes and syncopes occuring in both groups after enrollment
研究者
研究点 (6)
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