MedTrace Logo

Effect of Fetal Aortic Valvuloplasty on Outcomes

NCT05386173 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-03-21

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Fetal aortic balloon dilatation

Fetal valvuloplasty will be performed as described in Arzt W, Wertaschnigg D, Veit I, Klement F, Gitter R, Tulzer G. Intrauterine aortic valvuloplasty in fetuses with critical aortic stenosis: experience and results of 24 procedures. Ultrasound Obstet Gynecol. 2011;37:689-695. with minor variations between centers involved. Technical success is defined as improved forward flow and/or new aortic regurgitation.

Sponsors & Collaborators

  • Swedish Heart Lung Foundation

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Queen Silvia Children's Hospital, Gothenburg, Sweden

    lead OTHER

Eligibility

Min Age
23 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • United States
  • Austria
  • Canada
  • Finland
  • Germany
  • Poland
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386173 on ClinicalTrials.gov