跳至主要内容
临床试验/NCT03147027
NCT03147027Unknown不适用

Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年5月2日最近更新:
适应症

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

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

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Principal Investigator

Heinrich-Heine University, Duesseldorf

研究点 (1)

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