Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO) (HVU-NEURO)
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Marius Butz, Phd, M.Sc.
- Numer telefonu: +49 6032 9965812
- E-mail: m.butz@kerckhoff-klinik.de
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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Non-HVU Cohort
Patients undergoing transcatheter valve therapy during the predefined 6-month observation period before implementation of the Heart Valve Unit (HVU).
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HVU Implementation Cohort
Patients undergoing transcatheter valve therapy during the 6-month HVU implementation and run-in phase.
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Post-HVU Cohort
Patients undergoing transcatheter valve therapy during the predefined 6-month observation period after implementation of the Heart Valve Unit (HVU).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care
Ramy czasowe: At discharge from acute hospital care (typically within 7 days after intervention)
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Postoperative cognitive decline (POCD) will be assessed using repeated neuropsychological testing covering DSM-5-related cognitive domains and subdomains. POCD is defined as a decline of at least one standard deviation in at least 20% of assessed neurocognitive subdomains compared with baseline assessment. Learning and memory will be assessed using the Montreal Cognitive Assessment (MoCA) word list, including delayed free recall and the Memory Index Score (MIS). Complex attention will be assessed using the Trail Making Test A (TMT-A) for selective attention and the SKT-7 subtest of the Syndrom-Kurztest (SKT) for inhibitory control. Language will be assessed using the Regensburg Verbal Fluency Test (RWT), including semantic and phonemic verbal fluency. Perceptual-motor function will be assessed using the MoCA three-dimensional figure copy task. |
At discharge from acute hospital care (typically within 7 days after intervention)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months
Ramy czasowe: 3 months after intervention
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Postoperative cognitive decline (POCD) will be assessed using repeated neuropsychological testing covering DSM-5-related cognitive domains and subdomains. POCD is defined as a decline of at least one standard deviation in at least 20% of assessed neurocognitive subdomains compared with baseline assessment. Learning and memory will be assessed using the Montreal Cognitive Assessment (MoCA) word list, including delayed free recall and the Memory Index Score (MIS). Complex attention will be assessed using the Trail Making Test A (TMT-A) for selective attention and the SKT-7 subtest of the Syndrom-Kurztest (SKT) for inhibitory control. Language will be assessed using the Regensburg Verbal Fluency Test (RWT), including semantic and phonemic verbal fluency. Perceptual-motor function will be assessed using the MoCA three-dimensional figure copy task. |
3 months after intervention
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Postoperative Delirium
Ramy czasowe: During intensive care stay (up to 2 days)
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Incidence of postoperative delirium assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC).
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During intensive care stay (up to 2 days)
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Patient-Reported Neurocognitive Symptoms
Ramy czasowe: 3 months after intervention
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Patient-reported postoperative neurocognitive symptoms assessed using the Postoperative Neurocognitive Disorder Questionnaire (PNCD-Q).
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3 months after intervention
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Postoperative Affective Symptoms
Ramy czasowe: 3 months after intervention
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Patient-reported affective symptoms assessed using the Postoperative Affective Disorder Questionnaire (PAD-Q).
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3 months after intervention
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Posttraumatic Stress Symptoms
Ramy czasowe: 3 months after intervention
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Posttraumatic stress symptoms assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
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3 months after intervention
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Instrumental Activities of Daily Living
Ramy czasowe: 3 months after intervention
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Functional impairment assessed using Instrumental Activities of Daily Living (IADL).
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3 months after intervention
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Matthias Renker, MD, Campus Kerckhoff, Justus-Liebig-Universität Gießen
- Główny śledczy: Marius Butz, Phd, M.Sc., Campus Kerckhoff, Justus-Liebig-Universität Gießen
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroba zastawki aortalnej
- Objawy neurologiczne
- Choroby Układu Nerwowego
- Choroby układu krążenia
- Zaburzenia psychiczne
- Powikłania pooperacyjne
- Procesy patologiczne
- Choroby serca
- Dezorientacja
- Manifestacje neurobehawioralne
- Zaburzenia poznawcze
- Choroby zastawek serca
- Niedrożność odpływu komorowego
- Delirium
- Zaburzenia funkcji poznawczych
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Pooperacyjne powikłania poznawcze
- Pojawiające się delirium
- Zwężenie zastawki aortalnej
- Zaburzenia neurokognitywne
Inne numery identyfikacyjne badania
- 185/25-HVU-NEURO
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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