Aortic Valve StenosisHVU-NEURONCT07626567
Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO)
An observational study of Aortic Valve Stenosis and Postoperative Cognitive Dysfunction (POCD), run by Heart and Brain Research Group, Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Postoperative Cognitive Dysfunction (POCD), Delirium - Postoperative
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2026to Feb 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Aortic Valve Stenosis, Postoperative Cognitive Dysfunction (POCD), Delirium - Postoperative, Neurocognitive Disorders
- Keywords
- TAVI, HVU, Postoperative Cognitive Decline, Postoperative Delirium, Neuropsychology, Transcatheter Aortic Valve Implantation, Intensive Care Delirium Screening Checklist
- Medical subject headings
- Aortic Valve Stenosis, Postoperative Cognitive Complications, Emergence Delirium, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 3 months after intervention
Postoperative Delirium
Incidence of postoperative delirium assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC).
Measured: During intensive care stay (up to 2 days)
Patient-Reported Neurocognitive Symptoms
Patient-reported postoperative neurocognitive symptoms assessed using the Postoperative Neurocognitive Disorder Questionnaire (PNCD-Q).
Measured: 3 months after intervention
Postoperative Affective Symptoms
Patient-reported affective symptoms assessed using the Postoperative Affective Disorder Questionnaire (PAD-Q).
Measured: 3 months after intervention
Posttraumatic Stress Symptoms
Posttraumatic stress symptoms assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Measured: 3 months after intervention
Instrumental Activities of Daily Living
Functional impairment assessed using Instrumental Activities of Daily Living (IADL).
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start25 May 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Brain Research Group, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Giessen, University Hospital Giessen and Marburg, Kerckhoff Klinik
- Responsible party
- Sponsor
- Investigators
- Matthias Renker, MD, Principal investigator, Campus Kerckhoff, Justus-Liebig-Universität GießenMarius Butz, Phd, M.Sc., Principal investigator, Campus Kerckhoff, Justus-Liebig-Universität Gießen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626567
- Sponsor's protocol ID
- 185/25-HVU-NEURO
- Acronym
- HVU-NEURO
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.