RECRUITING

Effect of Fetal Aortic Valvuloplasty on Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-01-01
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05386173

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.

Ages Eligible for Study:23 Weeks to 31 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Aortic valve stenosis with antegrade flow through the valve
  2. 2. Predominantly left-to-right shunt at the atrial level
  3. 3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
  4. 4. Qualitatively depressed left ventricular function
  5. 5. Left ventricular end-diastolic diameter Z-score \> ±0
  6. 6. Left ventricular inlet length in diastole :
  7. 1. Gestational age ≤ 24+6: Z-score \> ±0
  8. 2. Gestational age 25+0 to 27+6: Z-score \> -0.75
  9. 3. Gestational age ≥ 28+0: Z-score \> -1.50
  10. 7. Mitral valve diameter in diastole Z-score \> -2.0
  1. 1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
  2. 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.

Contacts and Locations

Study Contact

Mats Mellander, Dr, Prof
CONTACT
0046705530606
mats.mellander@vgregion.se
Annika Öhman, Dr, PhD
CONTACT
0046313434568
annika.ohman@vgregion.se

Study Locations (Sites)

Fetal Cardiovascular Program, University of California San Francisco
San Francisco, California, 94158
United States
Congenital Heart Collaborative, Nationwide Children's Hospital
Columbus, Ohio, 43205
United States

Collaborators and Investigators

Sponsor: Queen Silvia Children's Hospital, Gothenburg, Sweden

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

Study Start Date2021-01-01
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2021-01-01
Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

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