[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481695":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":18,"enrollmentInfo":88,"targetDuration":18,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","Patients in the intervention arm receive on the day before the implantation of the artificial aortic valve, a virtual reality assisted information. On the day of the implantation the patients are informed about the process via virtual reality assisted information.",[13],"Other: Virtual Reality assisted information",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Patients in the control arm receive no virtual reality assisted information.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Virtual Reality assisted information","Patients in the intervention group receive a VR instructional application in the patient's room the day before TAVI implantation and in the operational suite during TAVI implantation the next day. In this application, the patient is guided through different VR parts that repeat the indication, the procedure, the localities and the post-interventional phase of the implantation with the corresponding safety instructions.",[9],[25],{"name":26,"affiliation":5,"role":27},"Christian Jung, Prof MD PhD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":26,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","+49 211 81","18567","christian.jung@med.uni-duesseldorf.de",{"name":35,"role":30,"phone":31,"phoneExt":36,"email":37},"Raphael Bruno, MD","18800","raphael.bruno@med.uni-duesseldorf.de",[39,58],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie","RECRUITING","Düsseldorf","North Rhine-Westphalia","40225","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],6.77927,51.22319,{"lat":51,"lon":50},[54,57],{"name":55,"role":30,"phone":56,"phoneExt":32,"email":33},"Christian Jung, Prof. MD PhD","+4921181",{"name":35,"role":30,"phone":56,"phoneExt":36,"email":37},{"facility":59,"status":41,"city":60,"state":18,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62","Cologne","50937",{"type":48,"coordinates":63},[64,65],6.95,50.93333,{"lat":65,"lon":64},[68],{"name":69,"role":30,"phone":70,"phoneExt":18,"email":71},"Matti Adam, PD Dr.","+49 221 478-8777","matti.adam@uk-koeln.de",{"type":73,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[75],{"name":76,"class":77},"Edwards Lifesciences","INDUSTRY","100481695","vrap-heart---virtual-reality-assisted-patient-empowerment-for-interventions-in-structural-heart-disease-100481695",false,"NCT05552352","VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease","VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study","VRAP-Heart","Inclusion Criteria:\n\n* High-grade aortic valve stenosis\n* Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI)\n* Existing heart center decision\n* Age ≥ 18 years\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Surgery planned under general anesthesia\n* Language barrier, defined as insufficient language proficiency at the discretion of the investigator to understand the purpose of the trial and follow the VR application.\n* Severe hearing impairment, preventing the patient from understanding the sound of the VR goggles, tested with the VR goggles fitted without using the VRAP-Heart software\n* Severe visual impairment that prevents viewing of the VR modules if it is not possible to use existing visual corrections (contact lenses, glasses) together with the VR glasses in the event of defective vision, tested with the VR goggles fitted without using the VRAP-Heart software\n* Moderately severe or severe dementia syndrome noted in the medical history or identified during the informed consent discussion\n* Known seizure disorder (epilepsy)\n* Positive pregnancy test on inclusion and\u002For pregnancy is present\n* Court ordered placement in an institution\n* Any psychosocial condition that makes compliance with the protocol unlikely","ALL","18 Years",{"count":89,"type":90},300,"ESTIMATED","INTERVENTIONAL",[93],"NA","This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay.",[96],"Severe Aortic Valve Stenosis","2025-08-22",{"date":99,"type":100},"2025-08-28","ACTUAL",{"date":102,"type":100},"2022-10-05",{"date":104,"type":90},"2027-02-28",{"name":5,"class":6},2]