NCT06061120招募中不适用
Non-invasive Differentiation of Supraventricular Tachyarrhythmias by Questionnaire and High-resolution ECG in the Context of Ablation Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Triggers of supraventricular arrhythmia
研究概览
简要总结
- Questionnaire for supraventricular tachycardia: About history and targeted diagnosis of supraventricular tachycardia
- Extended Signal-averaged ECG for detailed P-Wave analysis and to calculate a virtual atrial electrocardiogram (ECG)
详细描述
- Questionnaire Patient questionnaires on supraventricular tachycardia including atrial fibrillation often refer to the symptoms of the cardiac arrhythmia and the resulting limitations in everyday life. The evaluation of these questionnaires only allows a rough differentiation between the various cardiac arrhythmias. Nevertheless, it is known that supraventricular tachycardias are influenced by the sympathetic and parasympathetic nervous system. For example, tachyarrhythmias can begin or be terminated with a reentry circuit through the atrioventricular (AV) node by Valsalva manoeuvres or some other change in tone of the nervus vagus. For atrioventricular reentrytachycardia (AVNRT) in particular, an increased probability of occurrence in poststress phases has been described, as well as an association with certain behaviours such as positional changes, but also alcohol and drug consumption. To date, there is no systematic questionnaire on the specific triggering and terminating components. All patients referred for ablation of a supraventricular arrhythmia and potentially included in this project will receive a detailed history of the triggering and terminating factors using a structured questionnaire, as well as two validated supraventricular tachycardia questionnaires (5Q-3L and ASTA) to classify the results of our questionnaire.
- Extended ECG A high-resolution and signal-averaged ECG is recorded with a significantly higher resolution than a 12-lead ECG over a period of several minutes. Additional electrode positions are also used in the vicinity of the examined structure, e.g. the left atrium. The signal from several recorded heartbeats is then averaged. This preserves repetitive smallest atrial excitation patterns and changes. In this way, it is possible to find indications of cardiac arrhythmias like atrial fibrillation in the signal-averaged ECG, which were not detectable in a 12-lead ECG.
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
- 否
入选标准
- •Scheduled for ablation of a supraventricular tachycardia (atrial fibrillation, typical atrial flutter, AV nodal reentry tachycardia, accessory pathway)
排除标准
- •Unstable patient with need for intensive medical care
- •Lack of language skills or limited cognitive abilities that prevent a differentiated anamnesis and information.
- •Exclusion criteria for study section Questionnaire:
- •Competing clinically present arrhythmias, including relevant supra- and ventricular extrasystole (>5%/die).
- •Exclusion criteria for study section Extended high-resolution ECG:
- •Previous electrophysiological ablation at the same site for atrial fibrillation.
- •Relevant supra- and ventricular extrasystole (>5%/die).
- •Other clinically present arrhythmias are not excluded if they can be sequentially triggered and ablated (e.g. atrial fibrillation and atrial flutter). Since separate detection is possible with the high-resolution ECG.
- •Implanted active electrical device (e.g. pacemaker, defibrillator, deep brain pacemaker)
- •Allergy to measuring electrodes
结局指标
主要结局
Triggers of supraventricular arrhythmia
时间窗: 2 years
Anamnestic and ECG measured triggers of supra ventricular arrhythmia
次要结局
- P-Wave amplitude(2 years)
- Signal-averaged P-Wave complexity(2 years)
- P-Wave duration(2 years)
- Signal-averaged P-Wave sample entropy(2 years)
- P-Wave PQ time (time mesaured from begin of P-wave to begin of Q-Peak)(2 years)
- Signal-averaged P-Wave shannon entropy(2 years)
- Visualisation of a signal-averaged P-Wave before and after catheter ablation with qualitative review of morphology(2 years)
研究者
Matthias Zink
Dr. med.
RWTH Aachen University
研究点 (1)
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