[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468929":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":33,"responsibleParty":213,"collaborators":217,"id":222,"slug":223,"hasResults":224,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":224,"sex":230,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":236,"studyType":237,"phases":10,"briefSummary":238,"conditions":239,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},{"fullName":5,"class":6},"Queen Silvia Children's Hospital, Gothenburg, Sweden","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fetal intervention group",null,"Fetuses with aortic valve stenosis satisfying all of the inclusion\u002Fexclusion criteria",[13],"Procedure: Fetal aortic balloon dilatation",{"label":15,"type":10,"description":16,"interventionNames":10},"Fetal non-intervention group","Fetuses with aortic valve stenosis satisfying all of the inclusion\u002Fexclusion criteria which are identical with the criteria in the Fetal intervention group",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"PROCEDURE","Fetal aortic balloon dilatation","Fetal valvuloplasty will be performed as described in Arzt W, Wertaschnigg D, Veit I, Klement F, Gitter R, Tulzer G. Intrauterine aortic valvuloplasty in fetuses with critical aortic stenosis: experience and results of 24 procedures. Ultrasound Obstet Gynecol. 2011;37:689-695. with minor variations between centers involved. Technical success is defined as improved forward flow and\u002For new aortic regurgitation.",[9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Mats Mellander, Dr, Prof","CONTACT","0046705530606","mats.mellander@vgregion.se",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Annika Öhman, Dr, PhD","0046313434568","annika.ohman@vgregion.se",[34,52,66,80,95,109,123,135,147,161,175,189,201],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fetal Cardiovascular Program, University of California San Francisco","RECRUITING","San Francisco","California","94158","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-122.41942,37.77493,{"lat":46,"lon":45},[49],{"name":50,"role":26,"phone":10,"phoneExt":10,"email":51},"Anita Grady, Prof","Anita.Grady@ucsf.edu",{"facility":53,"status":36,"city":54,"state":55,"zip":56,"country":40,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Congenital Heart Collaborative, Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":43,"coordinates":58},[59,60],-82.99879,39.96118,{"lat":60,"lon":59},[63],{"name":64,"role":26,"phone":10,"phoneExt":10,"email":65},"Aimee Armstrong, Prof","ArmstrAimee.Armstrong@nationwidechildrens.org",{"facility":67,"status":36,"city":68,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Kinderherzzentrum Linz","Linz","Austria","AT",{"type":43,"coordinates":72},[73,74],14.28611,48.30639,{"lat":74,"lon":73},[77],{"name":78,"role":26,"phone":10,"phoneExt":10,"email":79},"Andreas Tulzer, Dr","andreastulzer@gmx.at",{"facility":81,"status":36,"city":82,"state":10,"zip":10,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"The Hospital for Sick Children Toronto","Toronto","Canada","CA",{"type":43,"coordinates":86},[87,88],-79.39864,43.70643,{"lat":88,"lon":87},[91,93],{"name":92,"role":26,"phone":10,"phoneExt":10,"email":10},"Edgar Jaeggi, Prof",{"name":94,"role":26,"phone":10,"phoneExt":10,"email":10},"edgar.jaeggi@sickkids.ca",{"facility":96,"status":36,"city":97,"state":10,"zip":10,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Department of Paediatric Cardiology, Helsinki University Children's Hospital","Helsinki","Finland","FI",{"type":43,"coordinates":101},[102,103],24.93545,60.16952,{"lat":103,"lon":102},[106],{"name":107,"role":26,"phone":10,"phoneExt":10,"email":108},"Olli Pitkänen, Prof","Olli.Pitkanen@hus.fi",{"facility":110,"status":36,"city":111,"state":10,"zip":10,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Pediatric Cardiology - University Hospital Bonn","Bonn","Germany","DE",{"type":43,"coordinates":115},[116,117],7.09549,50.73438,{"lat":117,"lon":116},[120],{"name":121,"role":26,"phone":10,"phoneExt":10,"email":122},"Ulrike Herberg, Prof","Ulrike.Herberg@ukbonn.de",{"facility":124,"status":36,"city":125,"state":10,"zip":10,"country":112,"countryCode":113,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Department of Pediatric and Congenital Cardiology, University of Heidelberg","Heidelberg",{"type":43,"coordinates":127},[128,129],8.69079,49.40768,{"lat":129,"lon":128},[132],{"name":133,"role":26,"phone":10,"phoneExt":10,"email":134},"Alexander Kovacevic, Dr","Alexander.Kovacevic@med.uni-heidelberg.de",{"facility":136,"status":36,"city":137,"state":10,"zip":10,"country":112,"countryCode":113,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"University hospital Technical university, mother- and-child center","Munich",{"type":43,"coordinates":139},[140,141],11.57549,48.13743,{"lat":141,"lon":140},[144],{"name":145,"role":26,"phone":10,"phoneExt":10,"email":146},"Renate Oberhoffer, Prof","renate.oberhoffer@tum.de",{"facility":148,"status":36,"city":149,"state":10,"zip":10,"country":150,"countryCode":151,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education.","Warsaw","Poland","PL",{"type":43,"coordinates":153},[154,155],21.01178,52.22977,{"lat":155,"lon":154},[158],{"name":159,"role":26,"phone":10,"phoneExt":10,"email":160},"Agnieszka Grzyb, Dr","agagrzyb@gmail.com",{"facility":162,"status":36,"city":163,"state":10,"zip":10,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre","Madrid","Spain","ES",{"type":43,"coordinates":167},[168,169],-3.70256,40.4165,{"lat":169,"lon":168},[172],{"name":173,"role":26,"phone":10,"phoneExt":10,"email":174},"Alberto Galindo, Prof","agalindo@salud.madrid.org",{"facility":176,"status":36,"city":177,"state":10,"zip":10,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Department of Pediatric Cardiology, Skane University Hospital","Lund","Sweden","SE",{"type":43,"coordinates":181},[182,183],13.19321,55.70584,{"lat":183,"lon":182},[186],{"name":187,"role":26,"phone":10,"phoneExt":10,"email":188},"Petru Liuba","petru.liuba@med.lu.se",{"facility":190,"status":36,"city":191,"state":10,"zip":10,"country":178,"countryCode":179,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Department of pediatric cardiology, Karolinska Institute","Stockholm",{"type":43,"coordinates":193},[194,195],18.06871,59.32938,{"lat":195,"lon":194},[198],{"name":199,"role":26,"phone":10,"phoneExt":10,"email":200},"Gunnar Bergman","Ggunnar.e.bergman@regionstockholm.se",{"facility":202,"status":36,"city":203,"state":10,"zip":10,"country":178,"countryCode":179,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Department of Pediatrics, Umeå University Hospital","Umeå",{"type":43,"coordinates":205},[206,207],20.25972,63.82842,{"lat":207,"lon":206},[210],{"name":211,"role":26,"phone":10,"phoneExt":10,"email":212},"Annika Rydberg","annika.rydberg@umu.se",{"type":214,"investigatorFullName":215,"investigatorTitle":216,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Mats Mellander","Associate professor, Consultant pediatric and fetal cardiology",[218,220],{"name":219,"class":6},"Swedish Heart Lung Foundation",{"name":221,"class":6},"Sahlgrenska University Hospital","100468929","effect-of-fetal-aortic-valvuloplasty-on-outcomes-100468929",false,"NCT05386173","Effect of Fetal Aortic Valvuloplasty on Outcomes","Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort","FASSprosp","Inclusion Criteria:\n\nA. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):\n\n1. Aortic valve stenosis with antegrade flow through the valve\n2. Predominantly left-to-right shunt at the atrial level\n3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels\n4. Qualitatively depressed left ventricular function\n5. Left ventricular end-diastolic diameter Z-score \\> ±0\n6. Left ventricular inlet length in diastole :\n\n   1. Gestational age ≤ 24+6: Z-score \\> ±0\n   2. Gestational age 25+0 to 27+6: Z-score \\> -0.75\n   3. Gestational age ≥ 28+0: Z-score \\> -1.50\n7. Mitral valve diameter in diastole Z-score \\> -2.0\n\nB. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery\n\nExclusion Criteria:\n\n1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta\n2. Any significant (i.e. that might influence outcome) extracardiac anomaly and\u002For known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.","ALL","23 Weeks","31 Weeks",{"count":234,"type":235},200,"ESTIMATED","3 Years","OBSERVATIONAL","In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective.\n\nThe aim of this study is: 1\u002F to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2\u002F to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3\u002F to also describe side effects and risks in fetuses and mothers of the fetal procedure.",[240,241,242,243],"Congenital Heart Disease","Aortic Valve Stenosis","Fetal Cardiac Disorder","Hypoplastic Left Heart Syndrome","2025-03-18",{"date":246,"type":247},"2025-03-21","ACTUAL",{"date":249,"type":247},"2021-01-01",{"date":251,"type":235},"2029-12-31",{"name":5,"class":6},13]