Evaluating fetal aortic valve balloon dilation for congenital heart defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness of fetal aortic valvuloplasty in treating aortic valve stenosis in fetuses diagnosed with hypoplastic left heart syndrome (HLHS). It will collect and analyze pre- and postnatal clinical data, including echocardiographic examinations, to compare outcomes between fetuses receiving the intervention and those who do not. The study will also investigate potential side effects and risks associated with the procedure for both the fetus and the mother. The decision to perform the balloon dilation is independent of the study protocol, ensuring standard care is maintained for all participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fetal Cardiovascular Program, University of California San Francisco
  San Francisco, California, United States Recruiting
• Congenital Heart Collaborative, Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting
• Kinderherzzentrum Linz
  Linz, Austria Recruiting
• The Hospital for Sick Children Toronto
  Toronto, Canada Recruiting
• Department of Paediatric Cardiology, Helsinki University Children's Hospital
  Helsinki, Finland Recruiting
• Pediatric Cardiology - University Hospital Bonn
  Bonn, Germany Recruiting

Study contacts

• Study coordinator: Mats Mellander, Dr, Prof
• Email: mats.mellander@vgregion.se
• Phone: 0046705530606

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.