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

NCT07626567 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-06-04

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

  • University of Giessen

    collaborator OTHER

  • University Hospital Giessen and Marburg

    collaborator OTHER

  • Kerckhoff Klinik

    collaborator OTHER

  • Heart and Brain Research Group, Germany

    lead OTHER

Principal Investigators

  • Matthias Renker, MD · Campus Kerckhoff, Justus-Liebig-Universität Gießen

  • Marius Butz, Phd, M.Sc. · Campus Kerckhoff, Justus-Liebig-Universität Gießen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-25
Primary Completion
2027-11-30
Completion
2028-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626567 on ClinicalTrials.gov