Condition: Congenital Heart Disease · Aortic Valve Stenosis · Fetal Cardiac Disorder · Sponsor: Queen Silvia Children's Hospital, Gothenburg, Sweden
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. The aim of this study is: 1/ 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/ to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3/ to also describe side effects and risks in fetuses and mothers of the fetal procedure.
This description comes directly from the study's public registry record.
Mats Mellander, Dr, Prof · 0046705530606 · mats.mellander@vgregion.se
Annika Öhman, Dr, PhD · 0046313434568 · annika.ohman@vgregion.se
Always discuss trial participation with your own doctor first.
| Fetal Cardiovascular Program, University of California San Francisco | San Francisco, California, United States | Recruiting |
| Congenital Heart Collaborative, Nationwide Children's Hospital | Columbus, Ohio, United States | Recruiting |
| Kinderherzzentrum Linz | Linz, Austria | Recruiting |
| The Hospital for Sick Children Toronto | Toronto, Canada | Recruiting |
| Department of Paediatric Cardiology, Helsinki University Children's Hospital | Helsinki, Finland | Recruiting |
| Pediatric Cardiology - University Hospital Bonn | Bonn, Germany | Recruiting |
| Department of Pediatric and Congenital Cardiology, University of Heidelberg | Heidelberg, Germany | Recruiting |
| University hospital Technical university, mother- and-child center | Munich, Germany | Recruiting |
| Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education. | Warsaw, Poland | Recruiting |
| Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre | Madrid, Spain | Recruiting |
| Department of Pediatric Cardiology, Skane University Hospital | Lund, Sweden | Recruiting |
| Department of pediatric cardiology, Karolinska Institute | Stockholm, Sweden | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05386173