NCT02044315已完成2 期
Prevention of Inappropriate ICD Shocks
Yuksek Ihtisas Hospital2 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- First total inappropriate therapy
研究概览
简要总结
The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years
- •Cardiomyopathy (ischemic or not)
- •Current accepted indication for ICD implantation
排除标准
- •Previous device implantation
- •Secondary prevention patients
- •Pregnancy,
- •Primary electrical disorders,
- •Patient refusal,
- •<1 year of expected mortality
结局指标
主要结局
First total inappropriate therapy
时间窗: 12 months
Occurence of first total inappropriate therapy at 12-month follow-up
Occurence of first total appropriate therapy at 12-month follow-up
时间窗: 12 months
Occurence of first total appropriate therapy at 12-month follow-up
次要结局
- All-cause mortality(12 months)
- Hospitalization for heart failure(12 months)
研究者
Serkan Cay
Associate Professor
Yuksek Ihtisas Hospital
研究点 (2)
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