NCT00481377终止不适用
Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial
National Institute of Cardiology, Warsaw, Poland2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of appropriate ICD interventions
研究概览
简要总结
The aim of this study is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The patients will be randomized into ablation arm and conventional treatment. Number of appropriate ICD interventions is the primary endpoint of this study. All patients will have control follow-up visits every 3 months. The follow-up will be based on ICD memory.
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
- 否
入选标准
- •Coronary Artery Disease
- •ICD implanted
- •Appropriate ICD intervention during the 3 months prior to enrollment
- •Coronary angiography during the 6 months prior to enrollment
- •Possible revascularization
- •Age over 18 years
- •Signed informed consent
排除标准
- •Age less then 18 years
- •Pregnancy
- •Active participation in other trial
- •Heart failure (NYHA IV)
- •Contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access.
- •Monomorphic, incessant, ventricular tachycardia
- •Revascularization or other cardio-surgical procedure scheduled in the next 6 months
结局指标
主要结局
Number of appropriate ICD interventions
次要结局
- Overall mortality
- Cardiac mortality
- Hospitalization due to arrhythmia or heart failure
- Quality of life
研究者
研究点 (2)
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