Balloon Treatment for Hypoplastic Left Heart Syndrome
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
Who this trial is looking for
This trial is looking for pregnant individuals with fetuses diagnosed with a severe heart condition known as hypoplastic left heart syndrome. Participants will be evaluated for a special treatment that involves balloon dilation to help improve heart function before birth.
Are You a Good Fit for This Trial?
You may be able to join if
- I have a fetus diagnosed with aortic valve stenosis
- My fetus has a left ventricular diameter score over zero
- I am between 23 and 31 weeks pregnant
- I have access to certain postnatal heart surgeries for my baby
You may not be able to join if
- My fetus has any additional heart defects except for minor ones
- My fetus has a significant other health condition that could affect the outcome
- My fetus has a known chromosomal abnormality
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
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