Идёт набор NCT06983613

New Onset of Arrhythmia After Patent Foramen Ovale (PFO) Closure

— Наблюдательное Cardiovascular Diseases

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Cardiovascular Diseases. 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: Чехия
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

New Onset of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure - Na Homolce Hospital

Обзор

Embolic stroke of undetermined source (ESUS) accounts for approximately 25% of all ischemic strokes, with patent foramen ovale (PFO) considered a major mechanism behind ESUS. When specific anatomic criteria are met, transcatheter PFO occlusion is regarded as the gold standard for secondary stroke prevention. However, previous studies have shown that percutaneous PFO closure may increase the risk of new-onset atrial fibrillation and atrial flutter (AF), arrhythmias that elevate the risk of embolic stroke. This raises concerns about performing PFO closure. Indeed, the most common clinically significant complication after catheter-based PFO closure is AF. Available data indicates that AF typically occurs in the early period following occluder implantation, with peak incidence around the 14th day post-closure, followed by a decline after the 45th day. Although AF is considered the most frequent adverse complication after percutaneous PFO occlusion, its incidence remains relatively low, ranging from 3% to 7.4%, depending on the method used for arrhythmia screening, though this remains unclear. In this study, investigators will prospectively monitor patients who have experienced ESUS and are indicated for PFO closure. They will be screened for the occurrence of AF following percutaneous PFO closure using a 3-week ECG Holter monitor (from day 7 to day 28 post-closure) and again 1 week (one year post-closure) after the procedure. The study aims to determine the true incidence of new-onset AF following catheter-based PFO occlusion and to identify the risk factors associated with its development.

Первичные конечные точки

New onset of atrial fibrillation after percutaneous patent foramen ovale closure - Na Homolce Hospital [Срок оценки: 2025-2028]

Вторичные конечные точки (12)

Time to first episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia) . [Срок оценки: 2025-2028]
Number of participants with new stroke or transient ischemic attack during follow up. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]
Risk factor at baseline. [Срок оценки: 2025-2028]

Критерии участия

Критерии включения

Indication for percutaneous closure of patent foramen ovale due to stroke, confirmed through an interdisciplinary meeting between cardiologists and neurologists, in accordance with current guidelines.
Age > 18 years.
Written informed consent.