Recruiting

Fetal Aortic Valvuloplasty

Sponsor:

Queen Silvia Children's Hospital, Gothenburg, Sweden

Code:

NCT05386173

Conditions

Congenital Heart Disease

Aortic Valve Stenosis

Fetal Cardiac Disorder

Hypoplastic Left Heart Syndrome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Fetal aortic balloon dilatation

Study Details

Brief 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

Congenital Heart Disease

Aortic Valve Stenosis

Fetal Cardiac Disorder

Hypoplastic Left Heart Syndrome

Study ID

NCT05386173

Start date

Jan 1, 2021

Status verified date

Mar, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):

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

B. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery

Exclusion Criteria:

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Fetal intervention group

Fetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mats Mellander, Dr, Prof

0046705530606mats.mellander@vgregion.se

Annika Öhman, Dr, PhD

0046313434568annika.ohman@vgregion.se

Locations

Fetal Cardiovascular Program, University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Anita Grady, Prof

Anita.Grady@ucsf.edu

Congenital Heart Collaborative, Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Aimee Armstrong, Prof

ArmstrAimee.Armstrong@nationwidechildrens.org

The Hospital for Sick Children Toronto

Recruiting

Toronto, Canada

More Information

Sponsor

Queen Silvia Children's Hospital, Gothenburg, Sweden

Last update posted

Mar 21, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen Silvia Children's Hospital, Gothenburg, Sweden on 2025-03-21.