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

NCT07626567 | Not Yet Recruiting

• 1 other identifier: 185/25-HVU-NEURO
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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; Neurocognitive Disorders; Delirium - Postoperative; Postoperative Cognitive Dysfunction (POCD)

Keywords

TAVI; HVU; Postoperative Cognitive Decline; Postoperative Delirium; Neuropsychology; Transcatheter Aortic Valve Implantation; Intensive Care Delirium Screening Checklist

Outcome Measures

Primary Outcomes (1)

• Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care

  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)

Secondary Outcomes (6)

• Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months

  3 months after intervention

• Postoperative Delirium

  During intensive care stay (up to 2 days)

• Patient-Reported Neurocognitive Symptoms

  3 months after intervention

• Postoperative Affective Symptoms

  3 months after intervention

• Posttraumatic Stress Symptoms

  3 months after intervention

Study Arms (3)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Brain Research Group, Germany: lead
• Kerckhoff Klinik: collaborator
• University of Giessen: collaborator
• University Hospital Giessen and Marburg: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis; Postoperative Cognitive Complications; Emergence Delirium; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Matthias Renker, MD

  Campus Kerckhoff, Justus-Liebig-Universität Gießen

  PRINCIPAL INVESTIGATOR

• Marius Butz, Phd, M.Sc.

  Campus Kerckhoff, Justus-Liebig-Universität Gießen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marius Butz, Phd, M.Sc.

CONTACT

+49 6032 9965812; m.butz@kerckhoff-klinik.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 4, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share