跳至主要内容
临床试验/NCT04000412
NCT04000412Unknown不适用

A Novel Myocardial Impedance Mapping System for Ablation of Post-infarction Ventricular Arrhytmias in Humans

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年3月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
1
主要终点
Comparative detection of infarct scar by impedance mapping

研究概览

简要总结

Precise identification of the infarct scar is essential for successful catheter ablation of ventricular arrhythmias in patients with chronic myocardial infarction. Voltage mapping of endocardial electrograms is currently used to delineate the necrotic scar but this is influenced by the direction of the activation wave front and is not sensitive enough to differentiate distinct degrees of transmural injury in the scar. Mapping of local myocardial electrical impedance may overcome these limitations.

详细描述

Clinical series: Patients with chronic infarction undergoing catheter ablation of ventricular arrhythmias will be submitted to mapping of both voltage and tissue impedance. Likewise, the accuracy of the two maps identifying the extent and transmurality of the infarction will be assesssed by gadolinium imaging. The impedance system is already constructed and certified for clinical research use.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • More than 18 yearts
  • Chronic myocardial infarction
  • Undergoing ventricular ablation of ventricular arrhythmias

排除标准

  • patients with device not suitable for cardiac magnetic ressonance (CMR)

结局指标

主要结局

Comparative detection of infarct scar by impedance mapping

时间窗: 3 hours

myocardial local impedance will be measured at different sites of the infarct scar and healthy tissue.

Comparative detection of infarct scar by gadolinium enhanced MR imaging

时间窗: 30 minutes

Intensity of gadolinium will be measured at different sites of the infarct scar and healthy tissue.

Comparative detection of infarct scar by voltage mapping

时间窗: 3 hours

Voltage will be measured at different sites of the infarct scar and healthy tissue.

次要结局

未报告次要终点

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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