NCT00180557已完成4 期
Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- QRS width
研究概览
简要总结
In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.
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
- •Age < 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient
排除标准
- •Live expectancy < 6 months, pregnancy or women without contraception in birth bearing age, inability or refusal to sign consent form, simultaneous participation in another clinical trial, contraindication for any procedure required during pacemaker implantation, patients who need other pacemaker systems including pacing leads than those required by the protocol, heart failure (LVEF <35%, QRS-Width>150ms), functional (rate dependent) bundle branch bloc
研究组 & 干预措施
Passive fixation lead
Active Comparator
Passive fixation lead was implanted
干预措施: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip (Device)
Active fixation lead
Experimental
Active fixation lead was implanted
干预措施: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip (Device)
结局指标
主要结局
QRS width
Ejection fraction
NYHA class
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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