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Идёт набор NCT06465459

Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure

— 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: LAMBRE device implantation.
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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Официальное название

ESCALLE : Post-marketing Clinical Study of the LambrE System for Left Auricle Closure

Обзор

Atrial fibrillation (AF) is responsible for 15-20% of ischaemic strokes. These events are often caused by thrombus formation in the left atrium. Thromboembolic risk in AF is primarily prevented by oral anticoagulation. However, this drug-based approach has a number of limitations, the most important of which are compliance problems and, above all, the risk of haemorrhagic complications, some of which are potentially serious. Left atrial appendage closure is a therapeutic alternative for the prevention of cardioembolic risk in cases where anticoagulation is clearly contraindicated. The CNEDiMTS opinion of 12 March 2019 defines that the LAMBRE, LIFETCH prosthesis, a device for transcatheter closure of the left atrial appendage, is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a CHA2DS2-VASc score ≥ 4 and a formal and permanent contraindication to anticoagulants (validated by a multidisciplinary committee). LAMBRE prosthesis in France are subject to a review of the results by the CNEDIMTS committee. Among the criteria analysed regarding the efficacy and safety of the device implantation, the result regarding the migration rate of the LAMBRE device will be one of the criteria enabling the Commission to decide on the appropriateness of the renewal of the registration.

Подробное описание

This is a non-interventional, prospective and retrospective national multicentre study.

Вмешательства

  • Процедура LAMBRE device implantation
    LAMBRE device implantation

Первичные конечные точки

  • To assess the incidence of first cardiovascular event in patients implanted with a left atrial closure device. [Срок оценки: during procedure and a follow-up lasting 12 months in a population having had a installation of an Lambre device]
Вторичные конечные точки (12)
  • To evaluate the effectiveness of the device [Срок оценки: end of procedure]
  • To evaluate the effectiveness of the device [Срок оценки: at 3 months after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 3 months after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 3 months after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 3 months after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 1 year after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 1 year after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 1 year after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 1 year after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 1 year after implantation]
  • To evaluate the effectiveness of the device [Срок оценки: at 1 year after implantation]
  • To evaluate the tolerance of the procedure and the device [Срок оценки: at the pre-discharge examination (up to 3 days)]

Критерии участия

Критерии включения

  • Patient requiring a left atrial exclusion procedure according to the recommendations by the CNEDiMTS and HAS using the LAMBRE device
  • Age ≥18 years
  • Patient has been informed of the nature of the study and agrees to participate

Критерии исключения

  • Minor patient
  • Patient refusing to participate in the study or unable to give informed consent (patient under guardianship, curatorship or safeguard of justice)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hôpital Cardiologique de Haut Lévêque — Pessac

Идентификаторы

NCT: NCT06465459 · 2024-A00420-47

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗