Actively Recruiting
Effect of Fetal Aortic Valvuloplasty on Outcomes
Led by Queen Silvia Children's Hospital, Gothenburg, Sweden · Updated on 2025-03-21
200
Participants Needed
13
Research Sites
469 weeks
Total Duration
On this page
Sponsors
Q
Queen Silvia Children's Hospital, Gothenburg, Sweden
Lead Sponsor
S
Swedish Heart Lung Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of Fetal Aortic Valvuloplasty on Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aortic valve stenosis with forward blood flow through the valve between 23+0 and 31+6 weeks of gestation
- Predominantly left-to-right shunt at the atrial level during the same gestational period
- Predominantly backward blood flow in the aortic arch between the first two brachiocephalic vessels
- Reduced left ventricular function on echocardiogram
- Left ventricular end-diastolic diameter Z-score greater than \u00b10
- Left ventricular inlet length in diastole Z-score thresholds based on gestational age:
-
\u00b10 if gestational age 6 24+6 weeks
-
-0.75 if 25+0 to 27+6 weeks
-
-1.50 if 6 28+0 weeks
-
- Mitral valve diameter in diastole Z-score greater than -2.0
- Availability of postnatal treatments: surgical or catheter-based aortic valvotomy, Ross-Konno surgery, Norwood or hybrid stage-one surgery
You will not qualify if you...
- Any other heart defect except persistent left superior vena cava and coarctation of the aorta
- Significant extracardiac abnormalities or known chromosomal disorders that could affect outcomes
- If such abnormalities or chromosomal conditions are diagnosed only after birth, the case will be excluded retrospectively
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Fetal Cardiovascular Program, University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
2
Congenital Heart Collaborative, Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
3
Kinderherzzentrum Linz
Linz, Austria
Actively Recruiting
4
The Hospital for Sick Children Toronto
Toronto, Canada
Actively Recruiting
5
Department of Paediatric Cardiology, Helsinki University Children's Hospital
Helsinki, Finland
Actively Recruiting
6
Pediatric Cardiology - University Hospital Bonn
Bonn, Germany
Actively Recruiting
7
Department of Pediatric and Congenital Cardiology, University of Heidelberg
Heidelberg, Germany
Actively Recruiting
8
University hospital Technical university, mother- and-child center
Munich, Germany
Actively Recruiting
9
Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education.
Warsaw, Poland
Actively Recruiting
10
Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre
Madrid, Spain
Actively Recruiting
11
Department of Pediatric Cardiology, Skane University Hospital
Lund, Sweden
Actively Recruiting
12
Department of pediatric cardiology, Karolinska Institute
Stockholm, Sweden
Actively Recruiting
13
Department of Pediatrics, Umeå University Hospital
Umeå, Sweden
Actively Recruiting
Research Team
M
Mats Mellander, Dr, Prof
CONTACT
A
Annika Öhman, Dr, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here