Effect of Fetal Aortic Valvuloplasty on Outcomes
Recruiting now
Conditions studied: Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
In brief
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.
Key facts
- Study ID
- NCT05386173
- Run by
- Queen Silvia Children's Hospital, Gothenburg, Sweden
- People needed
- 200
- Starts
- 2021-01-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2025-03-21
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Fetal Cardiovascular Program, University of California San Francisco — San Francisco, California, United States (enrolling)
- Congenital Heart Collaborative, Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
- Kinderherzzentrum Linz — Linz, Austria (enrolling)
- The Hospital for Sick Children Toronto — Toronto, Canada (enrolling)
- Department of Paediatric Cardiology, Helsinki University Children's Hospital — Helsinki, Finland (enrolling)
- Pediatric Cardiology - University Hospital Bonn — Bonn, Germany (enrolling)
- Department of Pediatric and Congenital Cardiology, University of Heidelberg — Heidelberg, Germany (enrolling)
- University hospital Technical university, mother- and-child center — Munich, Germany (enrolling)
- Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education. — Warsaw, Poland (enrolling)
- Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre — Madrid, Spain (enrolling)
- Department of Pediatric Cardiology, Skane University Hospital — Lund, Sweden (enrolling)
- Department of pediatric cardiology, Karolinska Institute — Stockholm, Sweden (enrolling)
- Department of Pediatrics, Umeå University Hospital — Umeå, Sweden (enrolling)
Full record on ClinicalTrials.gov
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