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Effect of Fetal Aortic Valvuloplasty on Outcomes

Recruitingn/aAges 23 Weeks - 31 WeeksAllQueen Silvia Children's Hospital, Gothenburg, Swe…
NCT05386173 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 effec

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📋 Eligibility rules (as published)
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.
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What it tests

  • Fetal aortic balloon dilatation
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Where

13 sites
Fetal Cardiovascular Program, University of California San Francisco
San Francisco, United States
Congenital Heart Collaborative, Nationwide Children's Hospital
Columbus, United States
Kinderherzzentrum Linz
Linz, Austria
The Hospital for Sick Children Toronto
Toronto, Canada
Department of Paediatric Cardiology, Helsinki University Children's Hospital
Helsinki, Finland
Pediatric Cardiology - University Hospital Bonn
Bonn, Germany
Department of Pediatric and Congenital Cardiology, University of Heidelberg
Heidelberg, Germany
University hospital Technical university, mother- and-child center
Munich, Germany

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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