Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis, Postoperative Cognitive Dysfunction (POCD), Delirium - Postoperative, Neurocognitive Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care [Time frame: At discharge from acute hospital care (typically within 7 days after intervention)]
Secondary outcome measures (6)
- Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months [Time frame: 3 months after intervention]
- Postoperative Delirium [Time frame: During intensive care stay (up to 2 days)]
- Patient-Reported Neurocognitive Symptoms [Time frame: 3 months after intervention]
- Postoperative Affective Symptoms [Time frame: 3 months after intervention]
- Posttraumatic Stress Symptoms [Time frame: 3 months after intervention]
- Instrumental Activities of Daily Living [Time frame: 3 months after intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07626567 · 185/25-HVU-NEURO