跳至主要内容
临床试验/NCT05159180
NCT05159180Unknown不适用

Desarrollo de un Nuevo Sistema de Mapeo de Impedancia Para la ablación de Las Arritmias Auriculares en Pacientes

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 15 人开始时间: 2021年12月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
1
主要终点
Comparative detection of atrial scar by voltage mapping

研究概览

简要总结

Precise identification of the atrial fibrosis is essential for successful catheter ablation of atrial arrhythmias in patients with atrial fibrillation. Voltage mapping of endocardial electrograms is currently used to delineate the anatomical substrate, but this is influenced by the direction of the activation wave front and is limited by the patient-specific thresholds. Mapping of local myocardial electrical impedance may overcome these limitations.

详细描述

Clinical series: Patients with atrial arrythmias undergoing catheter ablation of these will be submitted to mapping of both voltage and tissue impedance. Likewise, the accuracy of the two maps identifying the extent of the substrate 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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 85 years.
  • That they understand and sign the informed consent.
  • That they do not present any contraindication.- Pass the exploration and tests prior to bioimpedance measurements.

排除标准

  • Age outside the range described in the inclusion criteria.
  • Subjects who present any type of complication during the procedure.
  • Pregnancy.

结局指标

主要结局

Comparative detection of atrial scar by voltage mapping

时间窗: 30 minutes

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

Comparative detection of atrial scar by impedance mapping

时间窗: 30 minutes

Myocardial local impedance spectroscopy will be measured at different sites of the atrial scar and healthy tissue.

Comparative detection of atrial 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

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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