Effect of fetal aortic valvuloplasty on outcomes.
Research type
Research Study
Full title
Effect of fetal aortic valvuloplasty on outcomes. A prospective observational cohort study with a comparison cohort.
IRAS ID
312133
Contact name
Anna Seale
Contact email
Sponsor organisation
Children´s Heart Centre, Queen Silvia Childrens Hospital, Sahlgrenska University Hospital
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ClinicalTrials.gov, NCT05386173
Duration of Study in the UK
5 years, 0 months, 1 days
Research 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.REC name
North West - Preston Research Ethics Committee
REC reference
23/NW/0010
Date of REC Opinion
24 Feb 2023
REC opinion
Further Information Favourable Opinion