Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07626567 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: HVU-NEURO
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07626567
Lead Sponsor Heart and Brain Research Group, Germany
Collaborators: University of Giessen, University Hospital Giessen and Marburg, Kerckhoff Klinik
Conditions
(from sponsor)		 Aortic Valve Stenosis, Postoperative Cognitive Dysfunction (POCD), Delirium - Postoperative, Neurocognitive Disorders
Related terms Aortic Valve Stenosis, Emergence Delirium, Neurocognitive Disorders, Postoperative Cognitive Complications
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov