NCT05386173 · Queen Silvia Children's Hospital, Gothenburg, Sweden
Effect of Fetal Aortic Valvuloplasty on Outcomes
(FASSprosp)
What this study is about
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.
View original scientific 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. 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.
Interventions
PROCEDURE
Fetal aortic balloon dilatation
Fetal valvuloplasty will be performed as described in Arzt W, Wertaschnigg D, Veit I, Klement F, Gitter R, Tulzer G. Intrauterine aortic valvuloplasty in fetuses with critical aortic stenosis: experience and results of 24 procedures. Ultrasound Obstet Gynecol. 2011;37:689-695. with minor variations between centers involved. Technical success is defined as improved forward flow and/or new aortic regurgitation.
Primary outcome measures
Transplantation-free survival
Time frame: Follow-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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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):
- 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 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
- 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
- San Francisco, California
- Columbus, Ohio
Collaborators
Swedish Heart Lung Foundation, Sahlgrenska University Hospital
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Mar 21, 2025 · Source of record for eligibility and locations