Effect of Fetal Aortic Valvuloplasty on Outcomes
Key facts
- Who runs it
- Queen Silvia Children's Hospital, Gothenburg, Sweden
- Where
- Helsinki, FinlandSee the siteAlso in 7 other countries, 12 sites
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Jan 2021
- Expected to end
- 31 Dec 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Fetal aortic balloon dilatation
- Record updated
- 21 March 2025
Who can take part
- Age
- 23 weeks to 31 weeks
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Finland
Also in 7 other countries, 12 sites
- Department of Paediatric Cardiology, Helsinki University Children's HospitalHelsinki, FinlandContact: Olli Pitkänen, ProfTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Fetal intervention group
Fetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria
Treatment: Fetal aortic balloon dilatation
- Fetal non-intervention group
Fetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria which are identical with the criteria in the Fetal intervention group
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
- Record updated
- 21 March 2025