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Effect of Fetal Aortic Valvuloplasty on Outcomes
Sponsor: Queen Silvia Children's Hospital, Gothenburg, Sweden
Summary
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.
Official title: Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
Key Details
Gender
All
Age Range
23 Weeks - 31 Weeks
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2021-01-01
Completion Date
2029-12-31
Last Updated
2025-03-21
Healthy Volunteers
No
Conditions
Interventions
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/or new aortic regurgitation.
Locations (13)
Fetal Cardiovascular Program, University of California San Francisco
San Francisco, California, United States
Congenital Heart Collaborative, Nationwide Children's Hospital
Columbus, Ohio, United States
Kinderherzzentrum Linz
Linz, Austria
The Hospital for Sick Children Toronto
Toronto, Canada
Department of Paediatric Cardiology, Helsinki University Children's Hospital
Helsinki, Finland
Pediatric Cardiology - University Hospital Bonn
Bonn, Germany
Department of Pediatric and Congenital Cardiology, University of Heidelberg
Heidelberg, Germany
University hospital Technical university, mother- and-child center
Munich, Germany
Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education.
Warsaw, Poland
Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre
Madrid, Spain
Department of Pediatric Cardiology, Skane University Hospital
Lund, Sweden
Department of pediatric cardiology, Karolinska Institute
Stockholm, Sweden
Department of Pediatrics, Umeå University Hospital
Umeå, Sweden