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

29 de maio de 2026 atualizado por: Heart and Brain Research Group, Germany

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

500

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Consecutive adult patients undergoing transcatheter valve therapy at the Kerckhoff-Klinik Bad Nauheim, Germany, who meet study eligibility criteria and are treated during predefined observation periods before, during, and after Heart Valve Unit implementation.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Non-HVU Cohort
Patients undergoing transcatheter valve therapy during the predefined 6-month observation period before implementation of the Heart Valve Unit (HVU).
HVU Implementation Cohort
Patients undergoing transcatheter valve therapy during the 6-month HVU implementation and run-in phase.
Post-HVU Cohort
Patients undergoing transcatheter valve therapy during the predefined 6-month observation period after implementation of the Heart Valve Unit (HVU).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care
Prazo: At discharge from acute hospital care (typically within 7 days after intervention)

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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months
Prazo: 3 months after intervention

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
Postoperative Delirium
Prazo: During intensive care stay (up to 2 days)
Incidence of postoperative delirium assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC).
During intensive care stay (up to 2 days)
Patient-Reported Neurocognitive Symptoms
Prazo: 3 months after intervention
Patient-reported postoperative neurocognitive symptoms assessed using the Postoperative Neurocognitive Disorder Questionnaire (PNCD-Q).
3 months after intervention
Postoperative Affective Symptoms
Prazo: 3 months after intervention
Patient-reported affective symptoms assessed using the Postoperative Affective Disorder Questionnaire (PAD-Q).
3 months after intervention
Posttraumatic Stress Symptoms
Prazo: 3 months after intervention
Posttraumatic stress symptoms assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
3 months after intervention
Instrumental Activities of Daily Living
Prazo: 3 months after intervention
Functional impairment assessed using Instrumental Activities of Daily Living (IADL).
3 months after intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Heart and Brain Research Group, Germany

Colaboradores

University of Giessen
Kerckhoff Klinik
University Hospital Giessen and Marburg

Investigadores

  • Investigador principal: Matthias Renker, MD, Campus Kerckhoff, Justus-Liebig-Universität Gießen
  • Investigador principal: Marius Butz, Phd, M.Sc., Campus Kerckhoff, Justus-Liebig-Universität Gießen

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

25 de maio de 2026

Conclusão Primária (Estimado)

1 de novembro de 2027

Conclusão do estudo (Estimado)

1 de fevereiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 185/25-HVU-NEURO

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data (IPD) will not be routinely shared because the study involves pseudonymized clinical and neuropsychological data collected at a single center. Data access is restricted to authorized study personnel in accordance with local data protection regulations and ethical approval requirements.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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