Effect of Fetal Aortic Valvuloplasty on Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fetal aortic balloon dilatation.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome. Basic parameters: 23 Weeks — 31 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Canada, Finland, Germany +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
Overview
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.
Detailed description
Routinely collected pre- and postnatal clinical data will be entered into a digital database and echocardiographic examinations will be uploaded to a server. A core lab will measure and analyze all echocardiographic examinations according to protocol. The growth of the left heart structures and the postnatal outcome will be compared between the intervention and non-intervention groups.
The decision whether a fetal balloon dilatation shall be attempted is not part of the study protocol. The number of examinations of mother/fetus/infant in this study is not different from the number of examinations that will be recommended for someone choosing not to be part of this study. Participation in the study does not affect the care and treatment mothers and fetuses are receiving during pregnancy, nor how the infant is examined and treated after birth.
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.
Primary outcome measures
- Transplantation-free survival [Time frame: Follow-up from study inclusion during fetal life until 2 years postnatal age]
Secondary outcome measures (5)
- Intervention-related fetal death [Time frame: From the time of fetal intervention until 24 hours after the intervention]
- Fetal death not directly related to the intervention [Time frame: From 24 hours after fetal intervention until fetal death, up to 20 weeks after study inclusion.]
- Maternal complications to fetal intervention procedure [Time frame: From time of fetal intervention until 24 hours after the intervention]
- Preterm delivery [Time frame: From time of fetal intervention until 37 weeks gestational age, maximum 14 weeks]
- Fetal left heart growth [Time frame: 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]
Eligibility criteria
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):
- 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
Exclusion criteria
- Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Pediatric Cardiology - University Hospital Bonn — Bonn
- Department of Pediatric and Congenital Cardiology, University of Heidelberg — Heidelberg
- University hospital Technical university, mother- and-child center — Munich
Sweden · 3 centers
- Department of Pediatric Cardiology, Skane University Hospital — Lund
- Department of pediatric cardiology, Karolinska Institute — Stockholm
- Department of Pediatrics, Umeå University Hospital — Umeå
United States · 2 centers
- Fetal Cardiovascular Program, University of California San Francisco — San Francisco
- Congenital Heart Collaborative, Nationwide Children's Hospital — Columbus
Austria · 1 center
- Kinderherzzentrum Linz — Linz
Canada · 1 center
- The Hospital for Sick Children Toronto — Toronto
Finland · 1 center
- Department of Paediatric Cardiology, Helsinki University Children's Hospital — Helsinki
Poland · 1 center
- Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medica — Warsaw
Spain · 1 center
- Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre — Madrid
Identifiers
NCT: NCT05386173 · FASSprosp