NCT01035489Unknown2 期
Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum
Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Echocardiographic reverse remodelling and dyssynchrony
研究概览
简要总结
In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements of reverse remodelling and dyssynchrony.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LVEF < 35%
- •LVEDD > 5.5 cm
- •QRS > 120 ms
- •Optimal medical treatment
- •Both CRT-pacemakers (CRT-P) and CRT combined with ICD (CRT-D)
排除标准
- •Not fulfilling inclusion criteria or not written consensus
结局指标
主要结局
Echocardiographic reverse remodelling and dyssynchrony
时间窗: 3, 6, 12, 18 and 24 months
次要结局
未报告次要终点
研究者
研究点 (2)
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