[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557538":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":46,"studyPopulation":47,"armGroups":48,"interventions":58,"overallOfficials":66,"centralContacts":71,"locations":80,"responsibleParty":106,"collaborators":42,"id":110,"slug":42,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":42,"enrollmentInfo":119,"targetDuration":122,"studyType":123,"phases":42,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":83,"whyStopped":42,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Nemocnice AGEL Trinec-Podlesi a.s.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":42},[9,13,17,20,24,27],{"measure":10,"description":11,"timeFrame":12},"Operator stress indicator 1","difference of cortisol levels in mmol\u002Fl","Measured pre-procedure, immediately post-procedure",{"measure":14,"description":15,"timeFrame":16},"Operator stress indicator 2","heart rate variability of operator in BPM","During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.",{"measure":18,"description":19,"timeFrame":16},"Operator stress indicators 3","QTc interval in ms",{"measure":21,"description":22,"timeFrame":23},"Subjective assessments 1","NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales","Administered immediately post-procedure.",{"measure":25,"description":26,"timeFrame":23},"Subjective assessments 2","STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80",{"measure":28,"description":29,"timeFrame":23},"Subjective assessments 3","SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ",[31,35,39],{"measure":32,"description":33,"timeFrame":34},"Procedural efficiency","time of procedure","From the beginning of the MitraClip implantation procedure until the completion of the procedure, measured in real-time, typically ranging from 1 to 3 hours.",{"measure":36,"description":37,"timeFrame":38},"Radiation time exposure","Fluoroscopy Time (in minutes)","From the start of the MitraClip implantation procedure until the end of fluoroscopy use, measured in real-time throughout the duration of the procedure, typically ranging from 30 to 120 minutes.",{"measure":40,"description":41,"timeFrame":38},"Radiation dose exposure","Dose Area Product (DAP) through the procedure in Gy·cm²",null,{"allocation":42,"interventionModel":42,"interventionModelDescription":42,"primaryPurpose":42,"observationalModel":44,"timePerspective":45,"maskingInfo":42},"COHORT","PROSPECTIVE","The advent of mixed reality (MR) technology, especially when integrated with Hololens 2.0 and specialized software for three-dimensional DICOM image visualization, offers promising avenues for enhancing precision and spatial awareness in interventional cardiology procedures. This case series aims to preliminarily evaluate the impact of MR on MitraClip implantation processes, setting the foundation for a comprehensive pilot study.","The study population comprises adult patients aged over 18 who require MitraClip implantation for the treatment of mitral valve regurgitation. These patients are selected from the patient pool at Hospital AGEL Trinec-Podlesi, Trinec, Czechia.",[49,54],{"label":50,"type":42,"description":51,"interventionNames":52},"Mixed Reality (MR) Assisted MitraClip Group","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.",[53],"Procedure: MitraClip implantation",{"label":55,"type":42,"description":56,"interventionNames":57},"Standard MitraClip Group","Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology.",[53],[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"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.",[50,55],[65],"TEER procedure",[67],{"name":68,"affiliation":69,"role":70},"Otakar Jiravsky, MD","Hospital Agel Trinec-Podlesi","STUDY_DIRECTOR",[72,77],{"name":73,"role":74,"phone":75,"phoneExt":42,"email":76},"Jan Hecko, Ing, Ph.D.","CONTACT","+420602416905","jan.hecko@npo.agel.cz",{"name":68,"role":74,"phone":78,"phoneExt":42,"email":79},"+420602579193","otakar.jiravsky@npo.agel.cz",[81],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":42,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Hospital AGEL Trinec-Podlesi a.s.","RECRUITING","Třinec","CZ","73961","Czechia",{"type":89,"coordinates":90},"Point",[91,92],18.67078,49.67763,{"lat":92,"lon":91},[95,98,100,102,104],{"name":96,"role":74,"phone":97,"phoneExt":42,"email":79},"Otakar Jiravsky, MD, Phd.","602579193",{"name":73,"role":74,"phone":99,"phoneExt":42,"email":76},"602416905",{"name":101,"role":74,"phone":42,"phoneExt":42,"email":42},"Jan Hečko, Ing., Ph.D",{"name":103,"role":74,"phone":42,"phoneExt":42,"email":42},"Jaroslav Januška, MD, Ph.D.",{"name":105,"role":74,"phone":42,"phoneExt":42,"email":42},"Daniel Preček, Ing",{"type":107,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Ing. Jan Hečko","Lead Biomedical Engineer","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":120,"type":121},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.",[126],"Mitral Regurgitation",[128,129,130,131,132,133],"MitraClip,","MixedReality","Hololens","DICOM","Rendering","Support","2025-01-10",{"date":136,"type":137},"2025-01-13","ACTUAL",{"date":139,"type":137},"2024-08-15",{"date":141,"type":121},"2026-12-30",{"name":5,"class":6},1]