跳至主要内容
临床试验/NCT05296954
NCT05296954招募中不适用

Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping. Feasibility Study.

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Determine the precise location of the AV node

研究概览

简要总结

The aim of the present work is to analyze the capacity of high resolution mapping systems to determine the precise location of the AV node and peri-nodal slow-conducting pathways, using standard recording parameters, but also off-line additional filter changes and additional techniques (conduction velocities, isochrones and dV/dt). The investigative team plan a prospective monocentric study.

Detailed high resolution mapping of the Koch triangle and neighboring areas will be collected through the RHYTHMIA HDx 3D electro-anatomical mapping system and the multipolar ORION catheter. This sample will consist of 2 groups of patients: the first will include patients referred for AVNRT ablation and the second will include control patients (without AVNRT), referred for another indication requiring similar mapping system. If visualized, position of the slow pathway and AV node will be compared with the ablation areas, which will be set conventionally under fluoroscopy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • Group 1: Patients without heart disease presenting with reciprocal tachycardia by intra-nodal reentry.
  • Group 2: Control subjects, without nodal tachycardia, without heart disease, and admitted for ablation of atrial fibrillation or ventricular extrasystoles on a healthy heart and with a 3D system.

排除标准

  • Presence of underlying structural heart disease or history of atrial ablation or atrial tachycardia
  • Minor or protected patient
  • Patient under guardianship, curatorship or safeguard of justice

研究组 & 干预措施

Group 2

Active Comparator

Without tachycardia

干预措施: high resolution cartography (Procedure)

Group 1

Experimental

Tachycardia

干预措施: high resolution cartography (Procedure)

结局指标

主要结局

Determine the precise location of the AV node

时间窗: 7 months

Determine the precise location of the AV node with off-line additional filter changes and additional techniques (conduction velocities, isochrones and dV/dt).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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