Non-invasive Differentiation of Supraventricular Tachyarrhythmia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Recording of an extended high-resolution ECG.
- Кому может быть актуально
- Состояния в реестре: Supraventricular Arrhythmia, Atrial Fibrillation. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Non-invasive Differentiation of Supraventricular Tachyarrhythmias by Questionnaire and High-resolution ECG in the Context of Ablation Treatment
Обзор
1. Questionnaire for supraventricular tachycardia: About history and targeted diagnosis of supraventricular tachycardia 2. Extended Signal-averaged ECG for detailed P-Wave analysis and to calculate a virtual atrial electrocardiogram (ECG)
Подробное описание
1. 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. 2. 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.
Вмешательства
- Устройство Recording of an extended high-resolution ECG
Recording of an extended high-resolution ECG
Первичные конечные точки
- Triggers of supraventricular arrhythmia [Срок оценки: 2 years]
Вторичные конечные точки (7)
- P-Wave duration [Срок оценки: 2 years]
- P-Wave amplitude [Срок оценки: 2 years]
- P-Wave PQ time (time mesaured from begin of P-wave to begin of Q-Peak) [Срок оценки: 2 years]
- Signal-averaged P-Wave sample entropy [Срок оценки: 2 years]
- Signal-averaged P-Wave shannon entropy [Срок оценки: 2 years]
- Signal-averaged P-Wave complexity [Срок оценки: 2 years]
- Visualisation of a signal-averaged P-Wave before and after catheter ablation with qualitative review of morphology [Срок оценки: 2 years]
Критерии участия
Критерии включения
- Scheduled for ablation of a supraventricular tachycardia (atrial fibrillation, typical atrial flutter, AV nodal reentry tachycardia, accessory pathway)
- majority
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 1 центр
- RWTH Aachen University — Aachen
Публикации
- Fantazi N, Hermans BJM, Zeemering S, Berbers J, Emrani M, Napp A, Marx N, Gramlich M, Schotten U, Zink MD. Acute effect of cryoballoon pulmonary vein isolation on the signal-averaged P-wave. Front Cardiovasc Med. 2026 Jan 20;12:1728939. doi: 10.3389/fcvm.2025.1728939. eCollection 2025. PMID 41640583
Идентификаторы
NCT: NCT06061120 · CTCA 21-083