Effect of Fetal Aortic Valvuloplasty on Outcomes

Launched by QUEEN SILVIA CHILDREN'S HOSPITAL, GOTHENBURG, SWEDEN · May 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fetal aortic valvuloplasty, which involves using a balloon to widen a narrowed aortic valve in unborn babies. This condition is linked to a serious heart defect known as hypoplastic left heart syndrome (HLHS), where the left side of the heart doesn’t develop properly. The goal of the study is to see if this balloon procedure can help the left ventricle grow better and reduce the chance of the baby being born with HLHS. Researchers also want to understand how this treatment affects the health of both the baby and the mother.

To participate in the trial, pregnant individuals must be carrying a fetus between 23 to 31 weeks gestation and meet certain heart-related criteria identified through ultrasound. Some of these criteria include having a narrowed aortic valve with specific blood flow patterns and a certain level of left ventricular function. Participants will be monitored for any side effects or risks associated with the procedure. The study is currently recruiting, and it welcomes participants of all genders. If you or someone you know might qualify, this trial could provide valuable insights and potentially beneficial outcomes for babies with this serious heart condition.

Gender

ALL

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 retrograde flow in the aortic arch between the first two brachiocephalic vessels
• • 4. Qualitatively depressed left ventricular function
• • 5. Left ventricular end-diastolic diameter Z-score \> ±0
• 6. Left ventricular inlet length in diastole :
• • 1. Gestational age ≤ 24+6: Z-score \> ±0
• • 2. Gestational age 25+0 to 27+6: Z-score \> -0.75
• • 3. Gestational age ≥ 28+0: Z-score \> -1.50
• • 7. Mitral valve diameter in diastole Z-score \> -2.0
• • B. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery
• Exclusion Criteria:
• • 1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
• • 2. Any significant (i.e. that might influence outcome) extracardiac anomaly and/or known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.