Effect of Fetal Aortic Valvuloplasty on Outcomes

NCT05386173 · tracked via the Priya Life Science Germany tracker

Sponsor

Queen Silvia Children's Hospital, Gothenburg, Sweden

Phase

Observational

Started

2021-01-01

Last updated

2025-03-21

Condition(s) studied

Congenital Heart DiseaseAortic Valve StenosisFetal Cardiac DisorderHypoplastic Left Heart Syndrome

Investigational drug(s) / intervention(s)

Fetal aortic balloon dilatation

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.

Study 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.

Eligibility

Sex

ALL

Min age

23 Weeks

Max age

31 Weeks

Healthy volunteers

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.

Primary outcome measure(s)

Transplantation-free survival — Follow-up from study inclusion during fetal life until 2 years postnatal age
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.

Trial sites (13)

Facility	City	Region	Status
Fetal Cardiovascular Program, University of California San Francisco	San Francisco	California	Recruiting
Congenital Heart Collaborative, Nationwide Children's Hospital	Columbus	Ohio	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

Other trials for the same condition

accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis Active, not recruiting

Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis Recruiting

The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R) Recruiting

The Prospective Segeberg TAVI Registry Recruiting

Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05386173 on ClinicalTrials.gov ↗ ← All trials in Germany