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Набор скоро начнётся NCT07626567

Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO)

— Наблюдательное Aortic Valve Stenosis Postoperative Cognitive Dysfunction (POCD) Delirium - Postoperative Neurocognitive Disorders

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: Aortic Valve Stenosis, Postoperative Cognitive Dysfunction (POCD), Delirium - Postoperative, Neurocognitive Disorders. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant. Heart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated. HVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included. Neurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.

Подробное описание

HVU-NEURO is a prospective single-center observational cohort study conducted at the Kerckhoff-Klinik Bad Nauheim, Germany. The study investigates whether implementation of a structured Heart Valve Unit (HVU) influences neuropsychological outcomes in patients undergoing transcatheter valve therapy.

Approximately 500 consecutive patients undergoing transcatheter valve therapy will be prospectively enrolled during two predefined 6-month observation periods before and after HVU implementation, separated by a 6-month run-in/blanking phase.

Neuropsychological assessments will be performed preinterventionally, at discharge from acute hospital care, and three months after intervention. Postoperative delirium (POD) will be assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC).

The primary endpoint is postoperative cognitive decline (POCD) at discharge from acute hospital care. Secondary endpoints include POCD at three months, postoperative delirium, patient-reported postoperative neurocognitive symptoms, affective symptoms, posttraumatic stress symptoms, and instrumental activities of daily living.

The study aims to improve understanding of neuropsychological outcomes and their integration into modern structured heart valve care pathways.

Первичные конечные точки

  • Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care [Срок оценки: At discharge from acute hospital care (typically within 7 days after intervention)]
Вторичные конечные точки (6)
  • Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months [Срок оценки: 3 months after intervention]
  • Postoperative Delirium [Срок оценки: During intensive care stay (up to 2 days)]
  • Patient-Reported Neurocognitive Symptoms [Срок оценки: 3 months after intervention]
  • Postoperative Affective Symptoms [Срок оценки: 3 months after intervention]
  • Posttraumatic Stress Symptoms [Срок оценки: 3 months after intervention]
  • Instrumental Activities of Daily Living [Срок оценки: 3 months after intervention]

Критерии участия

Критерии включения

  • Severe aortic valve stenosis
  • Indication for transcatheter valve therapy according to current guideline recommendations and/or Heart-Team consensus
  • Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German
  • Age ≥18 years
  • Willingness to participate voluntarily with written informed consent

Критерии исключения

  • Known pregnancy at the time of study inclusion
  • Life expectancy <1 year due to non-cardiac disease
  • Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack \[TIA\], migraine, epilepsy) with acute symptoms that may interfere with data collection

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07626567 · 185/25-HVU-NEURO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗