Effect of Fetal Aortic Valvuloplasty on Outcomes

Part of paid clinical trials in San Francisco, California.

Sponsor
Queen Silvia Children's Hospital, Gothenburg, Sweden
Study ID
NCT05386173
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
23 Weeks - 31 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Fetal aortic balloon dilatation — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2021
Status verified
Mar 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Fetal intervention group
    Fetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria
  • Arm: Fetal non-intervention group
    Fetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria which are identical with the criteria in the Fetal intervention group

Primary Outcome Measure

Transplantation-free survival [ Time Frame: Follow-up from study inclusion during fetal life until 2 years postnatal age ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Fetal Cardiovascular Program, University of California San FranciscoSan FranciscoCalifornia94158
Anita Grady, Prof
[email protected]
Congenital Heart Collaborative, Nationwide Children's HospitalColumbusOhio43205
Aimee Armstrong, Prof
[email protected]

Find similar trials in San Francisco, CA

By research site
Fetal Cardiovascular Program, University of California San Francisco· San Francisco, CACongenital Heart Collaborative, Nationwide Children's Hospital· Columbus, OH

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