跳至主要内容
临床试验/NCT05508880
NCT05508880Unknown不适用

SIGIL: Signal Interpretation and Analysis In Real Life Cardiac Arrhythmias

National Heart Centre Singapore1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年10月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
The overall objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinicallyindicated EP mapping and ablation procedures.

研究概览

简要总结

This study essentially consists of the prospective collection of mapping data derived from patients undergoing clinically indicated 3D mapping procedures. There is no intervention. The mapping data is used to construct and/or validate new activation mapping algorithms but will not be used to direct clinical treatment of the patient.

详细描述

Cardiac arrhythmias are a common clinical problem in cardiology. Often, such arrhythmias can be effectively and permanently treated through catheter ablation.

A key technology enabling the success of catheter ablation is activation mapping of cardiac arrhythmias. This refers to the construction of maps which depict the sequential activation of the cardiac chamber of interest. It is a fundamental electrophysiology technique, but at the same time, the principles behind activation map construction have not changed for decades.

In brief, the way activation maps are constructed nowadays consists of the following steps:

(i) Sequential acquisition of voltage signals throughout the cardiac chamber of interest, recording both the signal together with the location of the signal in 3D space (ii) Local activation time annotation of each of the acquired signals in relation to a so-called timing reference (iii) Depiction of the annotated activation time graphically as a so-called activation map, through which the mechanism of the arrhythmia can be understood and an appropriate ablation target chosen

Following assignment of the LAT to each individual signal, the map is complete and can be used to discern the arrhythmia circuit to choose an appropriate ablation target.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient undergoing a clinically indicated 3D mapping procedure for a cardiac arrhythmia
  • Ability to provide informed consent

排除标准

  • Patients who cannot provide informed consent will be excluded. Otherwise, there are no specific exclusion criteria.

结局指标

主要结局

The overall objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinicallyindicated EP mapping and ablation procedures.

时间窗: 2 years

This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.

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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