[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423722":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":54,"collaborators":19,"id":56,"slug":19,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":19,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Treated group","Patients in whom the free margin cusp sizer will be used to measure the free margin of the three leaflets of the aortic valve during aortic valve repair.",[12],"Device: Free Margin Cusp Sizer",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Free Margin Cusp Sizer","The free margin cusp sizer will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Laurent de kerchove","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Laurent de Kerchove, MD, PhD","CONTACT","+32 2 764 41 51","laurent.dekerchove@uclouvain.be",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Corinne Coulon","+32 2 764 6108","corinne.coulon@uclouvain.be",[35],{"facility":36,"status":37,"city":38,"state":19,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Cliniques Universitaires Saint-Luc","RECRUITING","Brussels","1200","Belgium",{"type":42,"coordinates":43},"Point",[44,45],4.34878,50.85045,{"lat":45,"lon":44},[48,51,53],{"name":49,"role":27,"phone":50,"phoneExt":19,"email":29},"Laurent de Kerchove","+3227644151",{"name":31,"role":27,"phone":52,"phoneExt":19,"email":33},"+3227646108",{"name":49,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":55,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100423722",false,"NCT04797572","Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)","CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery","CALIBRATE","Inclusion Criteria:\n\n* Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.\n\nExclusion Criteria:\n\n* Acute aortic dissection;\n* Diffuse aortic valve calcification;\n* AV endocarditis;\n* Bicuspid, unicuspid or quadricuspid aortic valves;\n* Patients under the age of 18 years;\n* Patients above the age of 80 years.","ALL","18 Years","80 Years",{"count":67,"type":68},120,"ESTIMATED","INTERVENTIONAL",[71],"NA","The objective of this study is to investigate safety and performance of the Free Margin Cusp sizer. The device will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length at different stages of the procedure. The patient will be followed for one year clinically (at 1, 2, 6 and 12 months) and by echocardiography (at 6 and 12 months) to assess aortic valve function.",[74,75],"Aortic Valve Regurgitation","Aortic Root Aneurysm",[77,78,79],"aortic valve repair","Valve sparing surgery","Trileaflet aortic valve","2025-05-13",{"date":82,"type":83},"2025-05-16","ACTUAL",{"date":85,"type":83},"2021-03-22",{"date":87,"type":68},"2027-12-30",{"name":5,"class":6},1]