FASSprosp
Effect of Fetal Aortic Valvuloplasty on Outcomes
AI Description
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.
- Who can join
- child
- Participants
- 200
- Expected completion
- 2029-12-31
- Funded by
- other
Conditions studied
Aortic Valve Stenosis, Congenital Heart Disease, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
What is being tested
- PROCEDURE: Fetal aortic balloon dilatation
What it measures
- Transplantation-free survival, Transplantation-free survival from fetal diagnosis to 2 years postnatal age with a biventricular circulation without pulmonary hypertension at that time. Absence of pulmonary hypertension is defined as a TR max velocity ≤ 2.8 m/s with no other echocardiographic signs of pulmonary hypertension and/or catheter data showing a mean pulmonary arterial pressure \<25 mmHg., Follow-up from study inclusion during fetal life until 2 years postnatal age
Working with
Sahlgrenska University Hospital, Swedish Heart Lung Foundation
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2025-03-21
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.