Effect of Fetal Aortic Valvuloplasty on Outcomes
Recruiting
Observational Study
Congenital Heart Disease
Aortic Valve Stenosis
Fetal Cardiac Disorder
Hypoplastic Left Heart Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 23 Weeks – 31 Weeks
- Sex
- Any
- Study type
- Observational
- Participants needed
- 200 (estimated)
- Sponsor
- Queen Silvia Children's Hospital, Gothenburg, Sweden · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):
1. Aortic valve stenosis with antegrade flow through the valve
2. Predominantly left-to-right shunt at the atrial level
3. Predominantly …
Contacts