Идёт набор NCT05565209

Left Atrial Appendage Closure Registry of Henri Mondor Hospital

— Наблюдательное Atrial Fibrillation

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: SA brief descriptive name used to refer to the intervention(s) studied.
Кому может быть актуально: Состояния в реестре: 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: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke. Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records. Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.

Вмешательства

Другое SA brief descriptive name used to refer to the intervention(s) studied
Details that can be made public about the intervention

Первичные конечные точки

Frequency of thrombo-embolic events [Срок оценки: 60months of follow-up after the procedure]

Вторичные конечные точки (12)

Efficacy of the procedure [Срок оценки: One hour after the end of the procedure]
Occlusion of the left atrial appendage [Срок оценки: 3 months]
residual peri-device leak [Срок оценки: 3 months]
Percentage of ischemic stroke [Срок оценки: 1 and 5 years after the procedure]
Percentage of transient ischemic attack (TIA) [Срок оценки: 1 and 5 years after the procedure]
Percentage of systemic embolism [Срок оценки: 1 and 5 years after the procedure]
Cardiovascular or unexplained death [Срок оценки: 1 and 5 years after the procedure]
All-cause mortality [Срок оценки: 1 and 5 years after the procedure]
Comparison of the rate of thromboembolic events to expected values [Срок оценки: 1 and 5 years after the procedure]
Rate of complications related or potentially related to the device or the implantation procedure [Срок оценки: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)]
Percentage of pericardial effusion [Срок оценки: Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)]
Percentage of pericardial effusion [Срок оценки: 3 months]

Критерии участия

Критерии включения

Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)