Guided Placement of CRT-Leads (EK138/08)
CT and 3D-Echocardiography Placement of CRT-Leads
研究概览
详细说明
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:
- Technical success in placing the electrode in the target vessel.
- Failure due to dislocation during the implantation procedure or phrenic nerve stimulation.
Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
NRW
-
Aachen、NRW、德国、52074
- Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Congestive heart failure,
- Ejection fraction <35%,
- Complete left bundle branch block >120ms,
- NYHA II,III or IV
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:1
guided implantation of the left ventricular lead
|
application of BeutelTM
|
|
安慰剂比较:2
standard implantation of the left ventricular lead
|
standard procedure will be applied but no Beutel TM software
|
|
实验性的:Pilot Group
feasibility of guided placement of CRT-leads in 20 Patients
|
application of BeutelTM to patients data for determination of site of latest contraction
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Rate of non-responders regarding ejection fraction
大体时间:6 months
|
6 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume
大体时间:6 months
|
6 months
|
合作者和调查者
调查人员
- 首席研究员:Christian Knackstedt, MD、RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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