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RECRUITING
NCT05386173

Effect of Fetal Aortic Valvuloplasty on Outcomes

Sponsor: Queen Silvia Children's Hospital, Gothenburg, Sweden

View on ClinicalTrials.gov

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

Interventions

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/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