Effect of Fetal Aortic Valvuloplasty on Outcomes
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.
Conditions:
🦠 Congenital Heart Disease 🦠 Aortic Valve Stenosis 🦠 Fetal Cardiac Disorder 🦠 Hypoplastic Left Heart Syndrome
πŸ—“οΈ Study Start (Actual) 1 January 2021
πŸ—“οΈ Primary Completion (Estimated) 31 December 2029
βœ… Study Completion (Estimated) 31 December 2029
πŸ‘₯ Enrollment (Estimated) 200
πŸ”¬ Study Type OBSERVATIONAL
πŸ“Š Phase N/A
Locations:
πŸ“ San Francisco, California, United States
πŸ“ Columbus, Ohio, United States
πŸ“ Linz, Austria
πŸ“ Toronto, Canada
πŸ“ Helsinki, Finland
πŸ“ Bonn, Germany
πŸ“ Heidelberg, Germany
πŸ“ Munich, Germany
πŸ“ Warsaw, Poland
πŸ“ Madrid, Spain
πŸ“ Lund, Sweden
πŸ“ Stockholm, Sweden
πŸ“ UmeΓ₯, Sweden

πŸ“‹ Eligibility Criteria

Description

    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 \> Β±0
    • 6. Left ventricular inlet length in diastole :
    • 1. Gestational age ≀ 24+6: Z-score \> Β±0
    • 2. Gestational age 25+0 to 27+6: Z-score \> -0.75
    • 3. Gestational age β‰₯ 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.
Ages Eligible for Study: 23 Weeks to 31 Weeks (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 May 2022
  • First Submitted that Met QC Criteria 18 May 2022
  • First Posted 23 May 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 November 2023
  • Last Update Posted 21 November 2023
  • Last Verified November 2023