[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulmonary-atresia-with-intact-ventricular-septum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulmonary-atresia-with-intact-ventricular-septum":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"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":20,"type":21},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",[25,26,27],"Pulmonary Atresia With Intact Ventricular Septum","Congenital Heart Disease","Fetal Cardiac Disorder",[29,30,31],"Prognosis","Prenatal diagnosis","Ultrasound","RECRUITING","2025-09-08",{"date":35,"type":36},"2025-09-15","ACTUAL",{"date":38,"type":36},"2024-02-01",{"date":40,"type":21},"2029-12-31",{"name":42,"class":43},"Hospital Universitario 12 de Octubre","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100510576","a-comparison-of-morbidity-between-patients-with-pulmonary-atresia-with-intact-ventricular-septum-and-uni--or-biventricular-circulation-100510576","NCT05928234","A Comparison of Morbidity Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation","A Longterm Follow-up and Comparison of Morbidity and Heart Health Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation","Inclusion Criteria:\n\n* Individuals born with pulmonary atresia with intact ventricular septum (PA-IVS) who are 15 years or older at the start of the study.\n* Regarding the mortality variable, research subjects who have died after the age of 15 years old will be included.\n\nExclusion Criteria:\n\nIndividuals born with pulmonary atresia with intact ventricular septum who are younger than 15 years old at the start of the study.","15 Years",{"count":53,"type":21},140,"The goal of this observational study is to compare patients with pulmonary atresia with intact ventricular septum (PA-IVS) with univentricular circulation to patients with the same heart defect but that has a biventricular circulation in regards to mortality, quality of life, comorbidity, cardiac function, and work capacity. The main questions the study aims to answer are:\n\n• Do mortality, quality of life, comorbidity, cardiac function, and work capacity differ between patients with PA-IVS who have univentricular and biventricular circulation?\n\nParticipants will be asked to answer a Quality of Life questionnaire. The investigators will also inquire with a sample size of the research subjects (based on place of residence) about their participation in a series of examinations (ergo-spirometry to assess work capacity, transthoracic echocardiogram, magnetic resonance of the heart and blood sampling to assess cardiac function and cardiac health).",[25],"2025-03-25",{"date":58,"type":36},"2025-03-30",{"date":60,"type":36},"2024-07-15",{"date":62,"type":21},"2026-01",{"name":64,"class":65},"Vastra Gotaland Region","OTHER_GOV",1]