NCT01897558已完成不适用
Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)
Deutsches Herzzentrum Muenchen7 个研究点 分布在 3 个国家目标入组 290 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 7
- 主要终点
- high-sensitive Troponin T
研究概览
简要总结
Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. Both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. The PACMAN-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.
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
- Single (Participant)
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
- •de-novo implantation of a pacemaker system
排除标准
- •AAI pacing or cardiac resynchronization therapy
- •ICD indication
- •temporary pacing
- •lead revision
- •right ventricular pacing aimed from alternative pacing sites (other than the apex)
- •lead revision
- •severe tricuspid valve regurgitation
- •previous myocardial infarction, coronary intervention, stroke, cardioversion or ablation in the presence of elevated troponin levels
结局指标
主要结局
high-sensitive Troponin T
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (7)
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