Идёт набор NCT05963698

The Fourth Left Atrial Appendage Occlusion Study

Без фазы С лечением Atrial Fibrillation Stroke, Ischemic Systemic Embolism

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: WATCHMAN device.
Кому может быть актуально: Состояния в реестре: Atrial Fibrillation, Stroke, Ischemic, Systemic Embolism. 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: США, Бельгия, Канада, Дания, Франция +7
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

The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)

Обзор

LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Подробное описание

LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Вмешательства

Устройство WATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Первичные конечные точки

Ischemic stroke or systemic embolism [Срок оценки: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]

Вторичные конечные точки (6)

All-cause stroke or systemic embolism [Срок оценки: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
All-cause stroke, systemic embolism, or transient ischemic attack (TIA) [Срок оценки: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
Montreal Cognitive Assessment (MoCA) Score [Срок оценки: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
New disabling ischemic strokes [Срок оценки: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
Cardiovascular mortality [Срок оценки: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]
All-cause mortality [Срок оценки: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).]

Критерии участия

Критерии включения

(a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).\]
Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.

Критерии исключения

Age < 18 years
Current left atrial appendage thrombus
Prior left atrial appendage occlusion or removal (surgical or percutaneous)
Prior percutaneous atrial septal defect or patent foramen ovale closure
Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
Planned atrial fibrillation ablation within 90 days of enrollment
Individuals being treated with direct thrombin inhibitors
Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
Anticipated life-expectancy of < 2 years
Patient unable or willing to give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Простое слепое
Основная цель: Лечение

Центры проведения

США · 51 центр

Affinity Hospital dba Grandview Medical Center — Birmingham
Arrhythmia Research Group — Jonesboro
Memorial Health Services — Fountain Valley
Loma Linda University Health — Loma Linda
Southern California Permanente Medical Group — Pasadena
Sutter Valley Hospitals dba Sutter Institute for Medical Research — Sacramento
JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital — Atlantis
St. Vincent's Health System — Jacksonville
… и ещё 43 центра

Канада · 24 центра

University of Calgary — Calgary
Vancouver Coastal Health Authority — Vancouver
St. Boniface Hospital Inc. — Winnipeg
Circulate Cardiac & Vascular Centre (CCVC) — Burlington
Cambridge Cardiac Care Inc. — Cambridge
Hamilton Health Sciences Corp — Hamilton
Research St. Joseph's - Hamilton — Hamilton
Waterloo Wellington Cardiovascular Research Institute (WWCRI) — Kitchener
… и ещё 16 центров

Германия · 18 центров