Идёт набор NCT05474092

Aeson TAH System - Post-Market Clinical Follow-up Study

— Наблюдательное Heart Failure

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: Aeson Total Artificial Heart.
Кому может быть актуально: Состояния в реестре: Heart Failure. 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

Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting

Обзор

The safety and performance of the Aeson TAH system have been demonstrated for the CE mark approval in December 2020. The purpose of this post-market clinical investigation is to confirm the safety, performance and effectiveness of the Aeson TAH system when used in routine care by surgeons.

Подробное описание

The Primary objective/endpoint is survival rate on the originally implanted Aeson device at 90 days post-implant (H1 \> 64%).

The second objectives/endpoints are:

1. Confirm the performance and safety profile of the device for patients implanted with the Aeson TAH system until being transplanted:

* Survival at 6, 12, 18, and 24-months post-implant, and total support duration before transplantation; * Health status change as measured by NYHA classification, 6MWT and Quality of Life Questionnaire (EQ-5D-5L); * Renal and hepatic function as measured by biological parameters; * Hemocompatibility profile measured by biological parameters and incidence of hemocompatible-related adverse events; * Frequency and Incidence of Serious Adverse events. 2. Assess the effectiveness of device upgrades 3. Confirm the safety profile of the device for patients after being transplanted.

* Survival at 30 days, 6 months, and 12 months post-transplant * Frequency and Incidence of Serious Adverse Event of special interest as graft reject, neurological events, major bleeding.

Вмешательства

Устройство Aeson Total Artificial Heart
Heart Replacement Therapy

Первичные конечные точки

Survival rate [Срок оценки: 90 days post-implant]

Вторичные конечные точки (7)

Survival and total support duration before transplantation [Срок оценки: 6, 12, 18 and 24-months post-implant]
Health status change before transplantation [Срок оценки: 3, 6, 9, 12, 18 and 24-months post-implant]
Functional status change before transplantation [Срок оценки: 3, 6, 9, 12, 18 and 24-months post-implant]
Length of hospital stay and time at home before transplantation [Срок оценки: 3, 6, 9, 12, 18 and 24-months post-implant]
Frequency and Incidence of Serious Adverse events before transplantation [Срок оценки: 3, 6, 9, 12, 18 and 24-months post-implant]
Assess the effectiveness of device upgrades [Срок оценки: Between 3 and 24 months post-implantation, when heart transplant occurred]
Confirm the safety profile of the device after transplantation [Срок оценки: 30 days, 3 months, 6 months, 12 months post-transplantation]

Критерии участия

Критерии включения

Patient is intended to receive an Aeson TAH system according to the IFU indications within standard medical practice
Patient has provided written informed consent using the Ethics Committee approved consent form

Non-inclusion Criteria: