[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639710":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":25,"locations":10,"responsibleParty":30,"collaborators":32,"id":39,"slug":10,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":10,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Heart and Brain Research Group, Germany","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Non-HVU Cohort",null,"Patients undergoing transcatheter valve therapy during the predefined 6-month observation period before implementation of the Heart Valve Unit (HVU).",{"label":13,"type":10,"description":14,"interventionNames":10},"HVU Implementation Cohort","Patients undergoing transcatheter valve therapy during the 6-month HVU implementation and run-in phase.",{"label":16,"type":10,"description":17,"interventionNames":10},"Post-HVU Cohort","Patients undergoing transcatheter valve therapy during the predefined 6-month observation period after implementation of the Heart Valve Unit (HVU).",[19,23],{"name":20,"affiliation":21,"role":22},"Matthias Renker, MD","Campus Kerckhoff, Justus-Liebig-Universität Gießen","PRINCIPAL_INVESTIGATOR",{"name":24,"affiliation":21,"role":22},"Marius Butz, Phd, M.Sc.",[26],{"name":24,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+49 6032 9965812","m.butz@kerckhoff-klinik.de",{"type":31,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[33,35,37],{"name":34,"class":6},"University of Giessen",{"name":36,"class":6},"University Hospital Giessen and Marburg",{"name":38,"class":6},"Kerckhoff Klinik","100639710",false,"NCT07626567","Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO)","HVU-NEURO","Inclusion Criteria:\n\n* Severe aortic valve stenosis\n* Indication for transcatheter valve therapy according to current guideline recommendations and\u002For Heart-Team consensus\n* Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German\n* Age ≥18 years\n* Willingness to participate voluntarily with written informed consent\n\nExclusion Criteria:\n\n* Known pregnancy at the time of study inclusion\n* Life expectancy \\\u003C1 year due to non-cardiac disease\n* 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","ALL","18 Years",{"count":48,"type":49},500,"ESTIMATED","OBSERVATIONAL","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.\n\nHeart 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.\n\nHVU-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.\n\nNeurocognitive 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.",[53,54,55,56],"Aortic Valve Stenosis","Postoperative Cognitive Dysfunction (POCD)","Delirium - Postoperative","Neurocognitive Disorders",[58,59,60,61,62,63,64],"TAVI","HVU","Postoperative Cognitive Decline","Postoperative Delirium","Neuropsychology","Transcatheter Aortic Valve Implantation","Intensive Care Delirium Screening Checklist","NOT_YET_RECRUITING","2026-05-29",{"date":68,"type":69},"2026-06-04","ACTUAL",{"date":71,"type":49},"2026-05-25",{"date":73,"type":49},"2028-02",{"name":5,"class":6}]