[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590308":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":29,"overallOfficials":35,"centralContacts":39,"locations":44,"responsibleParty":61,"collaborators":17,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":17,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":17,"enrollmentInfo":73,"targetDuration":17,"studyType":76,"phases":17,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":46,"whyStopped":17,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Endeavor Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Mitral leaflet coaptation length.","Direct measurement of mitral leaflet coaptation length performed with the sizer in position, performed in mm using surgical (disposable) ruler.","During surgery, immediately prior to prosthesis implantation.",{"measure":14,"description":15,"timeFrame":16},"Post-procedure, echocardiography measurements - mitral coaptation length.","Indirect measurement of mitral leaflet coaptation length (mm), using standard intraoperative trans-esophageal echocardiography (TEE) images (measurements performed postoperatively based on archived images).","After separation from cardiopulmonary bypass.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","This is a pilot feasibility study of an investigational device. The proposed device is designed to be used as a temporary, disposable tool that will guide final ring size selection during mitral valve repair surgery. This device enables the direct measurement of the mitral valve opening. Currently, sizing tools for mitral annuloplasty ring implantation has provide only a rough estimate. The field of cardiac surgery is in need of a precise technique to accomplish the important task of correctly selecting an annuloplasty ring for implantation.","Patients undergoing mitral valve repair.",[24],{"label":25,"type":17,"description":26,"interventionNames":27},"Annuloplasty ring sizing tool","A single time use of a novel sizing tool for mitral valve repair surgery",[28],"Device: Annuloplasy ring sizing device",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":17},"DEVICE","Annuloplasy ring sizing device","A single time use of a novel sizing tool for mitral valve repair surgery (used ONLY in an observational capacity - this device does NOT influence decision-making during the conduct of the operation in any way).",[25],[36],{"name":37,"affiliation":5,"role":38},"Nikola Dobrilovic, MD","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":17,"email":43},"CONTACT","(847) 570-2868","nikola.dobrilovic@endeavorhealth.org",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Glenview","Illinois","60026","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-87.78784,42.06975,{"lat":56,"lon":55},[59],{"name":37,"role":41,"phone":60,"phoneExt":17,"email":43},"847-570-2868",{"type":38,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Nikola Dobrilovic","MD","100590308","paired-ring-mitral-annuloplasty-ring-sizing-device-100590308",false,"NCT06965725","Paired-Ring Mitral Annuloplasty Ring Sizing Device","Evaluation of a Novel Paired-Ring Mitral Annuloplasty Sizing Method and Device","Inclusion Criteria:\n\n1. All patients scheduled for mitral repair surgery\n2. Age 18 years or older\n\nExclusion Criteria:\n\n1. Adults unable to consent,\n2. Pregnant women and prisoners.\n3. Emergency operations and those patients in whom mitral repair is not performed in a meaningful way, requiring mitral replacement instead, will be excluded.\n4. Presence of acute endocarditis infection during the initial screening process","ALL","18 Years",{"count":74,"type":75},22,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.",[79],"Heart Valve Diseases",[81,82],"Annuloplasty Ring","Sizing methods","2026-09-02",{"date":85,"type":86},"2026-09-04","ACTUAL",{"date":88,"type":86},"2025-07-03",{"date":90,"type":75},"2026-11",{"name":5,"class":6},1]