[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600310":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":30,"locations":39,"responsibleParty":65,"collaborators":67,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":10,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Hospital Universitario 12 de Octubre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retrospective cohort",null,"Retrospective cases that meet all the inclusion criteria and none of the exclusion criteria from 2013 until 2023 will be included for model development. They should be non-intervened cases in order to assess the natural history of the disease.",[13],"Other: No intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Prospective cohort","Prospectively recruited cases will be included when meeting all the inclusion criteria and none of the exclusion ones. This cohort will serve as a validation cohort for the previously developed model. The nature of the study is observational. Clinicians will not be given the result of the model during the study and clinical practice will be routine.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"No intervention","Evaluation of natural history of the disease",[15,9],[24,28],{"name":25,"affiliation":26,"role":27},"Cecilia Villalaín González, MD PhD","Instituto de investigación imas12","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":26,"role":27},"Alberto Galindo Izquierdo, MD PhD",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Cecilia Villalain, MD PhD","CONTACT","+34913908310","cecilia.villalain@salud.madrid.org",{"name":37,"role":33,"phone":34,"phoneExt":10,"email":38},"Alberto Galindo, MD PhD","agalindo@salud.madrid.org",[40,54],{"facility":5,"status":41,"city":42,"state":10,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Madrid","28041","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],-3.70256,40.4165,{"lat":50,"lon":49},[53],{"name":32,"role":33,"phone":10,"phoneExt":10,"email":35},{"facility":55,"status":56,"city":57,"state":10,"zip":10,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":10},"University of Gothenburg","ACTIVE_NOT_RECRUITING","Gothenburg","Sweden","SE",{"type":47,"coordinates":61},[62,63],11.96679,57.70716,{"lat":63,"lon":62},{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[68,71],{"name":69,"class":70},"Instituto de Salud Carlos III","OTHER_GOV",{"name":72,"class":73},"Instituto de investigación Hospital 12 de Octubre","UNKNOWN","100600310","prognostic-model-of-postnatal-circulation-in-pulmonary-atresia-critical-stenosis-with-intact-ventricular-septum-100600310",false,"NCT07095829","Prognostic Model of Postnatal Circulation in Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum","Development and Validation of a Prognostic Model of Postnatal Circulation in Fetuses With a Diagnosis of Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Absence of flow at the pulmonary valve (PA) or presence of thickened and domed. pulmonary valve cusps with a pinhole jet of flow.\n* Doppler evidence of ductal-dependent pulmonary circulation.\n* Intact ventricular septum.\n\nExclusion Criteria:\n\n* Poor imaging windows and incomplete\u002Fpoor quality scan\n* Termination of pregnancy\n* Cases initially included that undergo prenatal pulmonary valvuloplasty later on in pregnancy.\n* Unconfirmed PA-CS\u002FIVS at birth.\n* Functional PA-CS\u002FIVS (Ebstein malformation, monochorionic twins)\n* Any associated cardiac defect except persistent left superior vena cava and aberrant right subclavian artery.\n* Any significant (i.e that might influence outcome) extracardiac anomaly and\u002For known genetic syndromes. Also, if such a condition is present at inclusion but diagnosed only after birth, the case will be retrospectively excluded.","ALL","16 Weeks","28 Weeks",{"count":85,"type":86},150,"ESTIMATED","OBSERVATIONAL","Pulmonary atresia (PA)\u002Fcritical stenosis (CS) with intact ventricular septum (PA\u002FCS-IVS) is a rare congenital heart disease (CHD), that presents heterogeneously. Prognosis is conditioned by the possibility of achieving a primary repair with biventricular circulation (BV) or a one-and-a-half ventricle solution vs. a palliative approach bound to a univentricular (UV) circulation in which both survival and quality of life are significantly impaired. Predicting UV circulation prenatally is still a challenge.\n\nThe aim of this study is: 1\u002F to evaluate the natural history of the disease and develop a prognostic model for the prediction of transplantation-free survival with a biventricular or a one-and-a-half repair at 2 years postnatal age 2\u002F To develop a model to predict the risk of right ventricle dependent coronary circulation 3\u002F To evaluate prenatal and postnatal outcomes in non-intervened fetuses with a confirmed postnatal diagnosis of PA-CS\u002FIVS including Intrauterine death, neonatal\u002FInfant death, number of required postnatal procedures, need for oxygen support, need for cardiac transplantation",[90,91,92],"Pulmonary Atresia With Intact Ventricular Septum","Congenital Heart Disease","Fetal Cardiac Disorder",[94,95,96],"Prognosis","Prenatal diagnosis","Ultrasound","2025-09-08",{"date":99,"type":100},"2025-09-15","ACTUAL",{"date":102,"type":100},"2024-02-01",{"date":104,"type":86},"2029-12-31",{"name":5,"class":6},2]