Effect of Fetal Aortic Valvuloplasty on Outcomes

NCT05386173 | Recruiting

• 1 other identifier: FASSprosp
• Study Type: observational
• Target: 200
• Locations: 8 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• Transplantation-free survival

  Transplantation-free survival from fetal diagnosis to 2 years postnatal age with a biventricular circulation without pulmonary hypertension at that time. Absence of pulmonary hypertension is defined as a TR max velocity ≤ 2.8 m/s with no other echocardiographic signs of pulmonary hypertension and/or catheter data showing a mean pulmonary arterial pressure \<25 mmHg.

  Follow-up from study inclusion during fetal life until 2 years postnatal age

Secondary Outcomes (5)

• Intervention-related fetal death

  From the time of fetal intervention until 24 hours after the intervention

• Fetal death not directly related to the intervention

  From 24 hours after fetal intervention until fetal death, up to 20 weeks after study inclusion.

• Maternal complications to fetal intervention procedure

  From time of fetal intervention until 24 hours after the intervention

• Preterm delivery

  From time of fetal intervention until 37 weeks gestational age, maximum 14 weeks

• Fetal left heart growth

  From the date of study inclusion until just before the first postnatal catheter or surgical intervention, or death, whichever comes first, total time frame 7 months

Study Arms (2)

Fetal intervention group

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

Procedure: Fetal aortic balloon dilatation

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 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.

Fetal intervention group

Eligibility Criteria

• Age: 23 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of fetuses and children with aortic valve stenosis and/or hypoplastic left heart syndrome

You may qualify if:

• 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):
• Aortic valve stenosis with antegrade flow through the valve
• Predominantly left-to-right shunt at the atrial level
• Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
• Qualitatively depressed left ventricular function
• Left ventricular end-diastolic diameter Z-score \> ±0
• Left ventricular inlet length in diastole :
• Gestational age ≤ 24+6: Z-score \> ±0
• Gestational age 25+0 to 27+6: Z-score \> -0.75
• Gestational age ≥ 28+0: Z-score \> -1.50
• 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

You may not qualify if:

• Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta

Sponsors & Collaborators

• Queen Silvia Children's Hospital, Gothenburg, Sweden: lead
• Swedish Heart Lung Foundation: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (13)

Fetal Cardiovascular Program, University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Congenital Heart Collaborative, Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Kinderherzzentrum Linz

Linz, Austria

RECRUITING

The Hospital for Sick Children Toronto

Toronto, Canada

RECRUITING

Department of Paediatric Cardiology, Helsinki University Children's Hospital

Helsinki, Finland

RECRUITING

Pediatric Cardiology - University Hospital Bonn

Bonn, Germany

RECRUITING

Department of Pediatric and Congenital Cardiology, University of Heidelberg

Heidelberg, Germany

RECRUITING

University hospital Technical university, mother- and-child center

Munich, Germany

RECRUITING

Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education.

Warsaw, Poland

RECRUITING

Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre

Madrid, Spain

RECRUITING

Department of Pediatric Cardiology, Skane University Hospital

Lund, Sweden

RECRUITING

Department of pediatric cardiology, Karolinska Institute

Stockholm, Sweden

RECRUITING

Department of Pediatrics, Umeå University Hospital

Umeå, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Aortic Valve Stenosis; Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Mats Mellander, Dr, Prof

CONTACT

0046705530606; mats.mellander@vgregion.se

Annika Öhman, Dr, PhD

CONTACT

0046313434568; annika.ohman@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Consultant pediatric and fetal cardiology

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 23, 2022
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); FI (1); SE (3); DE (3); US (2); AU (1); PL (1); CA (1)