CT and 3D-Echocardiography Placement of CRT-Leads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Rate of non-responders regarding ejection fraction
研究概览
简要总结
In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.
详细描述
Patients will be allocated to two groups with either
- Guided implantation of the left ventricular lead
- Empirical implantation of the left ventricular lead (current clinical standard)
For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined.
For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC.
In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are:
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
- •Congestive heart failure,
- •Ejection fraction <35%,
- •Complete left bundle branch block >120ms,
- •NYHA II,III or IV
排除标准
- •Patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions;
- •Impaired kidney function (GFR <30ml/min;
- •Pregnant or breastfeeding women
结局指标
主要结局
Rate of non-responders regarding ejection fraction
时间窗: 6 months
次要结局
- rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume(6 months)