[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659300":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":13,"interventions":13,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":40,"collaborators":13,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":13,"studyType":55,"phases":13,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":27,"whyStopped":13,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Nakata index evolution and predictive value","Assessment of the Nakata index based on pulmonary artery diameters measured on imaging at different time points (birth, palliative surgery, complete repair), and evaluation of its association with surgical outcomes using predefined thresholds (108 and 160 mm²\u002Fm²).","From birth to complete surgical repair (retrospective data 2010-2024)",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"CASE_ONLY","RETROSPECTIVE","Pediatric patients with Tetralogy of Fallot or related conditions managed surgically in tertiary care centers in Strasbourg and Bordeaux.",[19],{"name":20,"role":21,"phone":22,"phoneExt":13,"email":23},"Laurent Bonnemains, MD, PhD","CONTACT","33 3 88 12 74 99","laurent.bonnemains@chru-strasbourg.fr",[25],{"facility":26,"status":27,"city":28,"state":13,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Service de Pédiatrie 1 - CHU de Strasbourg - France","RECRUITING","Strasbourg","67091","France","FR",{"type":33,"coordinates":34},"Point",[35,36],7.74553,48.58392,{"lat":36,"lon":35},[39],{"name":20,"role":21,"phone":22,"phoneExt":13,"email":23},{"type":41,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659300","volution-of-pulmonary-artery-dimensions-in-tetralogy-of-fallot-100659300",false,"NCT07864129","Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot","SEPT-TOF","Inclusion Criteria:\n\n* Patients aged from birth to less than 18 years\n* Patients operated at Strasbourg or Bordeaux University Hospitals between 01\u002F01\u002F2010 and 31\u002F12\u002F2024\n* Patient (or legal guardians) not opposing the reuse of medical data for research purposes\n\nExclusion Criteria:\n\n* Patient expressing opposition to participation in the study\n* Parents\u002Flegal guardians or minor opposing data reuse\n* Specific clinical forms (VDDI)\n* Absence of subvalvular obstruction and absence of muscular resection","ALL","0 Years","18 Years",{"count":53,"type":54},400,"ESTIMATED","OBSERVATIONAL","Tetralogy of Fallot is the most common cyanotic congenital heart disease. Management strategies vary between primary repair and staged approaches including palliative surgery. The development of pulmonary arteries is a key determinant in surgical decision-making.\n\nThis multicenter retrospective observational study aims to evaluate the evolution of pulmonary artery dimensions using the Nakata index at key stages of patient management (birth, palliative surgery, and complete repair). The goal is to assess its predictive value in optimizing surgical strategy and improving outcomes in patients with Tetralogy of Fallot or pulmonary atresia with ventricular septal defect.",[58,59],"Tetralogy of Fallot (TOF)","Congenital Heart Defects",[61,62,63,64,65],"Tetralogy of Fallot","Pulmonary arteries","Nakata index","Congenital heart disease","Pediatric cardiology","2026-10-01",{"date":68,"type":69},"2026-10-07","ACTUAL",{"date":71,"type":69},"2026-06-18",{"date":73,"type":54},"2027-06-18",{"name":5,"class":6},1]