[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557538":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":66,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":10,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Nemocnice AGEL Trinec-Podlesi a.s.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mixed Reality (MR) Assisted MitraClip Group",null,"Patients undergoing MitraClip implantation with the assistance of MR technology, using Hololens 2.0 for three-dimensional visualization of DICOM images to enhance procedural precision and operator spatial awareness.",[13],"Procedure: MitraClip implantation",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard MitraClip Group","Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","MitraClip implantation","The MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.",[9,15],[25],"TEER procedure",[27],{"name":28,"affiliation":29,"role":30},"Otakar Jiravsky, MD","Hospital Agel Trinec-Podlesi","STUDY_DIRECTOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Jan Hecko, Ing, Ph.D.","CONTACT","+420602416905","jan.hecko@npo.agel.cz",{"name":28,"role":34,"phone":38,"phoneExt":10,"email":39},"+420602579193","otakar.jiravsky@npo.agel.cz",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":10,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital AGEL Trinec-Podlesi a.s.","RECRUITING","Třinec","CZ","73961","Czechia",{"type":49,"coordinates":50},"Point",[51,52],18.67078,49.67763,{"lat":52,"lon":51},[55,58,60,62,64],{"name":56,"role":34,"phone":57,"phoneExt":10,"email":39},"Otakar Jiravsky, MD, Phd.","602579193",{"name":33,"role":34,"phone":59,"phoneExt":10,"email":36},"602416905",{"name":61,"role":34,"phone":10,"phoneExt":10,"email":10},"Jan Hečko, Ing., Ph.D",{"name":63,"role":34,"phone":10,"phoneExt":10,"email":10},"Jaroslav Januška, MD, Ph.D.",{"name":65,"role":34,"phone":10,"phoneExt":10,"email":10},"Daniel Preček, Ing",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ing. Jan Hečko","Lead Biomedical Engineer","100557538","mixed-reality-in-mitraclip-implantation-preliminary-case-series-100557538",false,"NCT06539416","Mixed Reality in MitraClip Implantation: Preliminary Case Series","Leveraging Mixed Reality in MitraClip Implantation: a Preliminary Case Series Toward a Pilot Study","MIMIC","Inclusion Criteria:\n\n* Adults aged over 18 years\n* Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation\n* Ability to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Patients with contraindications for MR technology (e.g., MRI incompatibility)\n* Individuals unable to comply with study procedures due to physical or cognitive impairments\n* Pregnant or breastfeeding women","ALL","18 Years",{"count":81,"type":82},14,"ESTIMATED","6 Months","OBSERVATIONAL","The study aims to evaluate the impact of mixed reality (MR) technology, particularly using Hololens 2.0 and specialized software for three-dimensional DICOM image visualization, on MitraClip implantation procedures. This preliminary case series includes a comparative analysis of four MitraClip implantations, assessing procedural efficiency, radiation exposure, and operator stress through both physiological and subjective measures.",[87],"Mitral Regurgitation",[89,90,91,92,93,94],"MitraClip,","MixedReality","Hololens","DICOM","Rendering","Support","2025-01-10",{"date":97,"type":98},"2025-01-13","ACTUAL",{"date":100,"type":98},"2024-08-15",{"date":102,"type":82},"2026-12-30",{"name":5,"class":6},1]