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临床试验/NCT05716581
NCT05716581尚未招募不适用

The Identification of Prognostic Factors for Patients Undergoing Ablation for Atrial Fibrillation

Charles University, Czech Republic0 个研究点目标入组 300 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
AF reoccurrence during follow-up

研究概览

简要总结

The aim of the study is to find factors associated with sinus rhythm maintenance after catheter ablation for atrial fibrillation.

详细描述

Catheter ablation presents the most effective kind of treatment for atrial fibrillation (AF). However, its efficacy is still limited, and AF reoccurs in approx. 30% of patients during the first year after ablation.

Several factors associated with AF recurrences were found, such as dilated left atrium, higher age, or the duration of AF before the ablation. As it was shown, the detailed analysis of the ECG before the ablation could also serve several important factors that could predict AF reoccurrence.

In the study, all participants who will be referred for AF ablation in the study center will be enrolled. Pre-procedural ECG on the day of the ablation (just during the procedure) will be analysed using several methods: 1) spectral analysis (dominant AF frequency will be determined), 2) heart rate variability (for time and frequency domain analysis), 3) vectorcardiography. All ECG recordings will be analyzed using matlab software.

All participants will have regular follow-up checks at 3, 6, and 12 months after ablation including 24-hour Holter recordings. Based on the rhythm presence during the follow-up, participants will be divided in two groups: 1) AF group (patients with AF recurrences) and 2) sinus rhythm (SR) group (patients without AF reoccurrence during follow-up). AF reoccurrence will be determined at a presence of AF or any other atrial tachycardia lasting > 30 sec. The results of pre-procedural ECG analysis will be compared between both groups. Logistic regression will be done to determine optimal combination of parameters associated with AF freedom.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • atrial fibrillation

排除标准

  • absent of informed content

结局指标

主要结局

AF reoccurrence during follow-up

时间窗: 1 year after the ablation

AF freedom will be defined as freedom from atrial fibrillation or any other regular atrial tachycardia lasting \> 30sec. Rhythm monitoring will be done using regular Holter recordings

次要结局

未报告次要终点

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Sponsor

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