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临床试验/NCT03075930
NCT03075930Unknown不适用

A Registry With the Aim to Identify Characteristics of Atrial Conduction and Risk of Recurrence in Patients With Atrial Fibrillation Undergoing Ablation for Atrial Fibrillation

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 1,250 人开始时间: 2017年1月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,250
试验地点
1
主要终点
Recurrence of AF after ablation

研究概览

简要总结

This is a single centre prospective data registry. In this study atrial conduction characteristics of extended surface Electrocardiograms (esECG), biomarkers and genetic analysis will be performed before ablation, before discharge and 3 months after catheter ablation of atrial fibrillation (AF) and compared to routine clinical follow-up data.

The objective of this registry is to establish a data registry of patients undergoing ablation of AF. Supplementary to the routine clinical diagnostic an esECG and an analysis of biomarkers will be performed and compared to clinical and outcome data.

详细描述

Electro anatomical remodelling of the atria due to ageing or structural heart disease leads to AF which in turn leads to cardiac electrical and structural remodelling. In case of advanced remodelling restoration of sinus rhythm (SR) becomes more difficult and the results of catheter ablation are disappointing. Furthermore, there is no valid parameter to predict or diagnose recurrence of AF during SR after successful ablation, so repeated long-term electrocardiogram (ECG) recordings have to be performed to detect asymptomatic AF episodes in particular.

Thus, the rationale to establish a systematic review of patient data in a registry are:

  • Self-termination AF leads to slight, persistent AF leads to more advanced cardiac remodelling, shown in altered atrial conduction properties
  • Early recognition and therapy of AF improves the outcome, thus clinical parameter to predict or diagnose recurrence of AF during SR are desirable Ablation of AF is predominantely performed using standard endocardial transvenous technique of pulmonary veins isolation (PVI) by radiofrequency or cryoballoon ablation. For medical reasons specific ablation techniques like additional ablation lines or an epicardial approach is in discretion of the treating cardiologist. The esECG is measured by signal averaged routine 12-lead ECG with 3-5 supplementary leads before ablation, before discharge and 3 months after ablation. 2 tubes of EDTA plasma will be taken supplementary during routine venous puncture on admission and analysed for biomarkers and common gene variants.

During 5 years every participant receives an esECG before ablation, before discharge and three months after ablation. Routine follow-up data of each participant is included until 12 months of follow-up.

Patients who are included would also undergo a procedure without participation in this study. Risks (complications of procedures) are associated with the procedure and not with participation in the registry. The supplementary diagnostics performed for the registry are comprehensible to clinical routine ECG diagnostics. Extra (study-related) investigations consist of esECG (a signal averaged surface ECG with 3-5 supplementary leads at baseline before ablation), before discharge, and 3 months after ablation, and possibly also a body surface potential map (BSPM). These are always planned together with routine follow-up, no extra visits are necessary. The esECG and BSPM can be compared to regular ECGs, the only additional discomfort might be the number of leads. Furthermore 2 tubes of EDTA plasma blood will be taken supplementary at the routine admission venous puncture for further biomarker and common gene variants analysis.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Documented self-terminating or persistent AF
  • Scheduled for ablation of AF
  • At least 18 years of age, mentally able and willing to give informed consent

排除标准

  • Emergency ablation
  • Serious patient condition before ablation
  • Physically or mentally unable to provide written informed consent
  • Permanent atrial fibrillation

结局指标

主要结局

Recurrence of AF after ablation

时间窗: 12 months

The predictive value for recurrence of AF in patients after ablation of AF based on atrial conduction characteristics in electrocardiographic, -anatomical, biomarker and genetic analysis

次要结局

  • AF characteristics(12 months)
  • ECG AF characteristics(3 months)
  • ECG to BSPM discriminative power(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias D Zink

Principal Investigator

Maastricht University Medical Center

研究点 (1)

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