Clin2
NCT05386173Possibly a fitRecruiting

Tests fetal aortic valve balloon surgery for severe narrowing

Congenital Heart DiseaseAortic Valve StenosisFetal Cardiac DisorderHypoplastic Left Heart Syndrome

Part of Genetic & congenital, Heart & circulation clinical trials.

This trial studies whether doing a procedure before birth to open a baby’s aortic valve improves outcomes. It compares this approach in a specific group of pregnancies with severe heart flow problems seen on ultrasound.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
200 people
Ages
5 months to 7 months
Study type
Observational

Who can take part

  • The pregnancy must be between 23 weeks 0 days and 31 weeks 6 days based on ultrasound timing
  • Ultrasound must show aortic valve narrowing with forward (antegrade) flow
  • Ultrasound must show a mostly left-to-right leak at the heart’s upper chambers (atrial level)
  • Ultrasound must show mostly backward (retrograde) blood flow in the aortic arch (between the first two head/arm blood vessels)
  • After birth, the baby must be able to receive specific heart surgeries/procedures (aortic valvotomy, plus Ross–Konno and Norwood or hybrid stage-one options)

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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