Effect of Fetal Aortic Valvuloplasty on Outcomes

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.

Conditions

Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome

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Study Overview

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Study Details

Study overview

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.

Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort

Effect of Fetal Aortic Valvuloplasty on Outcomes

Condition
Congenital Heart Disease
Intervention / Treatment

-

Contacts and Locations

San Francisco

Fetal Cardiovascular Program, University of California San Francisco, San Francisco, California, United States, 94158

Columbus

Congenital Heart Collaborative, Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Queen Silvia Children's Hospital, Gothenburg, Sweden,

Study Record Dates

2029-12-31