Cerebral Embolization During Pulmonary Vein Isolation
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: QMODE intervention, QMODE+ intervention.
- Кому может быть актуально
- Состояния в реестре: Atrial Fibrillation, Ischemic Stroke, Cerebral Microembolism. 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
Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study
Обзор
The goal of the TCD-CA study is to determine the frequency of cerebral embolization during pulmonary vein isolation using continuous transcranial Doppler examination. Different parts of the procedure, different ablation techniques and periprocedural anticoagulation regimes will be compared.
Подробное описание
Pulmonary vein isolation (PVI) is a well-established interventional treatment of patients with atrial fibrillation. Previous studies have shown that catheter-based treatments such as PVI may lead to cerebral ischemia. Cerebral ischemia related to PVI may present with new neurological deficits but may also occur as "silent brain infarction". However, even "silent brain infarctions" are associated with an increased risk of incident dementia and clinically overt new strokes. To date, it remains unclear which procedural steps of PVI are associated with an increased risk of cerebral ischemia.
Cerebral blood flow and microembolic signals can be detected by using transcranial doppler ultrasound (TCD). TCD has been used in clinical routine for many years and is known to be safe in stroke patients. By performing continuous TCD monitoring for microembolic signals during PVI, the aim of this study is therefore to identify, which procedural steps are associated with the occurence of cerebral microemboli. In addition, the investigators aim to compare the frequency of cerebral microemboli in different pulmonary vein isolation techniques, namely high-power with a maximum of up to 50 W (QMODE) and very high power with a maximum of up tp 90 W (QMODE +)
Вмешательства
- Процедура QMODE intervention
Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For standard ablation, a Thermocool Smarttouch SF (Biosense Webster) catheter will be used (50 W, target ablation index of 550). - Процедура QMODE+ intervention
Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For comparison, catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +) will be used.
Первичные конечные точки
- Microembolic Signals (MES) [Срок оценки: during the procedure]
Вторичные конечные точки (5)
- neurological outcome [Срок оценки: at baseline, 0-5 days after pulmonary vein isolation]
- cognitive outcome [Срок оценки: at baseline, 0-5 days after pulmonary vein isolation]
- cerebral infarctions [Срок оценки: at baseline, 0-5 days after pulmonary vein isolation]
- cerebral microbleeds [Срок оценки: at baseline, 0-5 days after pulmonary vein isolation]
- cerebral macrobleeds [Срок оценки: at baseline, 0-5 days after pulmonary vein isolation]
Критерии участия
Критерии включения
- patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin
- age 18 years or older
Критерии исключения
- pregnancy
- patient unable to provide written informed consent
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
- Charité-University Medicine Berlin, Campus Benjamin Franklin — Berlin
Идентификаторы
NCT: NCT05048004 · EA1/215/20