NCT02362802已完成不适用
Myocardial Minimal Damage After Rapid Ventricular Pacing
Deutsches Herzzentrum Muenchen2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2014年9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
- 149
- 试验地点
- 2
- 主要终点
- High sensitive Troponin
研究概览
简要总结
This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial tissue with respect to its potential micro damage measured by several myocardial markers, especially by high-sensitive 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
- 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
- •All patients for de-novo implantation of a transvenous ICD (single chamber, dual chamber or cardiac resynchronization tehrapy) with left pectoral device position and planned apical location of the right ventricular defibrillation electrode.
排除标准
- •Resuscitation, cardiac surgical procedure, acute coronary syndrome, acute myocardial infarction, coronary revascularisation, cardioversion or ablation during the past 4 weeks, if baseline high-sensitive Troponin T is elevated
- •Known stenosis of coronary vessels with indication for coronary intervention or operative revascularisation
- •Intracardiac thrombus or general contraindication against ventricular burst stimulation or intraoperative ICD-testing
- •Atypical lead implantation with indication for defibrillation threshold testing by induction of ventricular fibrillation
- •Right sided implantation of ICD
- •Planned electrical cardioversion
- •Lead explantation or -extraction during procedure
- •Redo procedure (except of additional implantation of a right ventricular ICD lead)
- •Present temporary pacemaker electrode
- •ASA >= IV or NYHA IV
- •Cardiogenic shock
- •Pulmonary embolism, cerebrovascular insult or dialysis in the past 4 weeks
- •Lack of consent of patient
- •Minority of patient
结局指标
主要结局
High sensitive Troponin
时间窗: 14-20 hours
次要结局
未报告次要终点
研究者
Adnan Kastrati, MD
PD Dr. med. C. Kolb
Deutsches Herzzentrum Muenchen
研究点 (2)
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