NCT00745745已完成不适用
Septal Positioning of Ventricular ICD Leads
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 42
- 主要终点
- Event free survival of RV-ICD-lead related complications
研究概览
简要总结
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.
详细描述
The primary objective of this clinical investigation is to demonstrate that septal positioning of the right ventricular defibrillation lead is not inferior to the apical positioning in terms of safety and efficacy in a population of ICD recipients.
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
- •Signed written informed consent
- •Approved indication for implantation of ICD / CRT-D device
排除标准
- •Preexisting transvenous RV pacemaker or ICD leads
- •Pacemaker dependency without sufficient intrinsic rhythm (≤ 30min-1)
- •Hypertrophic obstructive cardiomyopathy
- •Presence of intra-aortic balloon pump
- •Inotropic drug (not digitalis) necessary for hemodynamic support
- •Inability to perform VF induction testing due to anticipated high risk
- •Condition likely to limit cooperation
- •Unable to give informed consent
- •Pregnancy or planned pregnancy in the next 6 months
- •Patients with planned cardiac surgery within the next 3 months following randomization
- •Patient is currently participating in a clinical investigation that includes an active treatment arm.
- •Acute myocardial infarction within the previous 4 weeks.
研究组 & 干预措施
2
Experimental
Mid-Septal ICD lead placement
干预措施: Device Implantation (Device)
1
Active Comparator
Apical ICD lead placement
干预措施: Device Implantation (Device)
结局指标
主要结局
Event free survival of RV-ICD-lead related complications
时间窗: 3 months after implantation
次要结局
未报告次要终点
研究者
研究点 (42)
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