Effect of Fetal Aortic Valvuloplasty on Outcomes
Key facts
- Where
- Linz, AustriaSee the site
Where in Austria
- Kinderherzzentrum LinzLinz, AustriaContact: Andreas Tulzer, DrTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Queen Silvia Children's Hospital, Gothenburg, Sweden
- Trial code
- NCT05386173
- Record updated
- 21 March 2025
- Original description
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.Read full original descriptionShow less
Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
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 effects and risks in fetuses and mothers of the fetal procedure.
Inclusion: All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):; Aortic valve stenosis with antegrade flow through the valve; Predominantly left-to-right shunt at the atrial level; Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels; Qualitatively depressed left ventricular function; Left ventricular end-diastolic diameter Z-score > ±0; Left ventricular inlet length in diastole :; Gestational age ≤ 24+6: Z-score > ±0; Gestational age 25+0 to 27+6: Z-score > -0.75; Gestational age ≥ 28+0: Z-score > -1.50; Mitral valve diameter in diastole Z-score > -2.0; 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: Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta; 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.