hs Troponin Release in Relation to Different ICD-Implantation Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Influence of different ICD-implantation strategies on release of high sensitivity Troponin
研究概览
简要总结
Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for sensing and defibrillation capabilities of the ICD system is performed. Modern implantation strategies suggest a non-testing approach because net-benefit of a testing versus a non-testing strategy is questionable and because arrhythmia induction and defibrillation may cause micro damage to the heart.
The study aims to investigate the contribution of different steps in the ICD implantation procedure (implantation of the lead, shock delivery and induced ventricular fibrillation) with respect to their potential damage to the heart measured by high sensitivity (HS) TroponinT.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD-Implantation in patients with coronary artery disease or dilative cardiomyopathy
排除标准
- •Atrial fibrillation with inappropriate anticoagulation
研究组 & 干预措施
ICD implantation only
ICD Implantation without testing of defibrillation threshold testing
干预措施: ICD Implantation without DFT testing (Device)
ICD implantation only
ICD Implantation without testing of defibrillation threshold testing
干预措施: T-wave shock with induction of ventricular fibrillation (Device)
Modified upper limit of vulnerability testing
Modified testing of "upper limit of vulnerability"
干预措施: Upper limit of vulnerability testing (Device)
VF-Induction
traditional VF-induction with T-Wave shock
干预措施: T-wave shock with induction of ventricular fibrillation (Device)
结局指标
主要结局
Influence of different ICD-implantation strategies on release of high sensitivity Troponin
时间窗: 6 hours
次要结局
- Influence of different ICD-implantation strategies on BNP release(6 hours)