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临床试验/NCT02274168
NCT02274168已完成不适用

Aid of Recording ICD Electrograms During Monomorphic Ventricular Tachycardia Ablation Procedures

Fundación Hospital de Madrid14 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2011年4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
260
试验地点
14
主要终点
Percentage of patients free of VT recurrence

研究概览

简要总结

With the increasing use of implantable cardioverter defibrillators (ICD) for primary prevention in patients with structural heart disease, an increasing number of patients are expected to develop their first episode of monomorphic ventricular tachycardia (VT) after an ICD is in place and the only documentation of the clinical arrhythmia will be the ICD electrogram (EG). The absence of a 12-lead ECG in patients with an ICD and sustained monomorphic VT represents a limitation when performing treatment with radiofrequency (RF) ablation. The analysis of ICD-EG during a RF ablation procedure is expected to provide a reference "model" of VT with clinical expression consisting of the electrical signal of the ICD during VT (which otherwise is not generally possible to obtain in ICD patients). This will allow for a more targeted approach to the substrate of the VT with clinical expression because: 1) if VT is induced by programmed stimulation, one can tell whether it is with clinical expression or not, and 2) if VT is not induced, ventricular pacing could be performed based on the comparative analysis of morphology and activation times of ICD-EG. These approaches will result in improved outcomes of the ablation procedure.

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

入选标准

  • Age 18 years or older
  • Clinical indication for RF catheter ablation
  • Presence of an implanted ICD
  • At least 1 episode of spontaneous sustained monomorphic VT documented with ICD electrogram
  • Presence of structural heart disease
  • Able to obtain signed informed consent and willing to comply with study activity requirements

排除标准

  • It is anticipated that data can not be obtained during follow-up
  • Unwilling or unable to provide informed consent
  • Women who are or may potentially be pregnant
  • Patients who are participating in another clinical trial

结局指标

主要结局

Percentage of patients free of VT recurrence

时间窗: 6 months

次要结局

  • Reduction in number of VT recurrence(6 months)
  • Reduction in the proportion of patients free of recurrence in patients in whom 12-lead ECG of the spontaneous VT is not available and in those in whom hemodinamically tolerated VT is not induced(6 months and total follow-up)
  • Reduction in the proportion of patients free of VT recurrence(6 months)
  • Improvement of spatial resolution of the ICD-EG after information from local ventricular endocardial acceleration is added(6 months)

研究者

发起方
Fundación Hospital de Madrid
申办方类型
Other
责任方
Sponsor

研究点 (14)

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