Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- occurrence of sustained VT/VF or ICD therapy
研究概览
简要总结
Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter ablation in patients with nonsustained VT has been not yet clarified. The incidence of appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can result in the prognostic improvement.To suppress ventricular arrhythmias aside from antiarrhythmic agents, catheter ablation has been developed prominently in this decade along with the technological improvement such as irrigated ablation catheters, three-dimensional mapping systems, multi-polar catheters, and image integration system with CT and MRI. The rationale of this trial is to study the efficacy of the eradication of arrhythmogenic substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of the occurrence of sustained VT/VF and ICD therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •left ventricular ejection fraction (TTE or MRI) ≤40%
- •diagnosed ischemic heart disease
- •nonsustained monomorphic VT with more than 5 beats in the record of the implantable cardioverter-defibrillator or in any means of electrocardiogram (ECG) including ECG monitor and holter monitoring
- •ICD implantation with primary preventive indication
排除标准
- •ICD implantation within 2 months
- •previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock
- •no written informed consent
结局指标
主要结局
occurrence of sustained VT/VF or ICD therapy
时间窗: time from randomization to occurrence of any sustained VT/VF within 24 months
occurrence of sustained VT/VF or ICD therapy including ATP and shock
次要结局
- survival free from clinical events(time from randomization to 24 months)
- number of appropriate ICD therapies(time from randomization to 24 months)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Principal Investigator
Heinrich-Heine University, Duesseldorf
