Fetal Aortic Valvuloplasty for Congenital Heart Disease
This observational study is looking at the effect of fetal aortic balloon dilatation (a procedure where a balloon is used to widen a narrowed aortic valve before birth) on babies born with certain heart conditions. Specifically, it aims to see if this procedure can reduce the risk of a baby developing hypoplastic left heart syndrome (HLHS), a severe condition where the left side of the heart is underdeveloped. Researchers will also investigate if the treatment improves the baby's overall prognosis. You might be able to participate if you are between 23 and 31 weeks pregnant and your baby meets specific heart ultrasound criteria, including a narrowed aortic valve with forward blood flow. The main goal is to see if babies who have this procedure have a better chance of surviving without needing a heart transplant by two years of age. The study status is currently unclear.
- Study design
- This is an observational study with a planned enrollment of 200 participants. It compares the outcomes of babies who receive fetal aortic balloon dilatation to those who do not.
- What's involved
- Participation involves routinely collected pre- and postnatal clinical data and echocardiographic examinations. The number of examinations is not different from standard care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from study inclusion during fetal life until 2 years postnatal age.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effect of Fetal Aortic Valvuloplasty on Outcomes
At a glance
Conditions
Where it's being run
13 sites across 9 statesWho to contact
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What this trial measures
- Transplantation-free survivalFollow-up from study inclusion during fetal life until 2 years postnatal age
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.