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RECRUITINGOBSERVATIONAL

Effect of Fetal Aortic Valvuloplasty on Outcomes

Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (13)

Fetal Cardiovascular Program, University of California San Francisco
San Francisco, California, United States
Congenital Heart Collaborative, Nationwide Children's Hospital
Columbus, Ohio, United States
Kinderherzzentrum Linz
Linz, Austria
The Hospital for Sick Children Toronto
Toronto, Canada
Department of Paediatric Cardiology, Helsinki University Children's Hospital
Helsinki, Finland
Pediatric Cardiology - University Hospital Bonn
Bonn, Germany
Department of Pediatric and Congenital Cardiology, University of Heidelberg
Heidelberg, Germany
University hospital Technical university, mother- and-child center
Munich, Germany
Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education.
Warsaw, Poland
Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre
Madrid, Spain
Department of Pediatric Cardiology, Skane University Hospital
Lund, Sweden
Department of pediatric cardiology, Karolinska Institute
Stockholm, Sweden
Department of Pediatrics, Umeå University Hospital
Umeå, Sweden