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Effect of Fetal Aortic Valvuloplasty on Outcomes
NCT05386173 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- PROCEDURE Fetal aortic balloon dilatation
Study Locations (13)
Other
- Kinderherzzentrum Linz — Linz
- The Hospital for Sick Children Toronto — Toronto
- Department of Paediatric Cardiology, Helsinki University Children's Hospital — Helsinki
- 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
- Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education. — Warsaw
- Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre — Madrid
- Department of Pediatric Cardiology, Skane University Hospital — Lund
- Department of pediatric cardiology, Karolinska Institute — Stockholm
- Department of Pediatrics, Umeå University Hospital — Umeå
California
- Fetal Cardiovascular Program, University of California San Francisco — San Francisco
Ohio
- Congenital Heart Collaborative, Nationwide Children's Hospital — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2029-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05386173
The ClinicalTrials.gov registry entry for NCT05386173 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Queen Silvia Children's Hospital, Gothenburg, Sweden, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention — of which Fetal aortic balloon dilatation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05386173 reports 13 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05386173 about?
NCT05386173 is a clinical study titled "Effect of Fetal Aortic Valvuloplasty on Outcomes". 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 som...
What is the current status of trial NCT05386173?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2021-01-01. Estimated completion is 2029-12-31.
What conditions does trial NCT05386173 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Aortic Valve Stenosis, Hypoplastic Left Heart Syndrome, Fetal Cardiac Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05386173?
The interventions under investigation include: Fetal aortic balloon dilatation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05386173?
This trial is sponsored by Queen Silvia Children's Hospital, Gothenburg, Sweden, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05386173 being conducted?
This trial has 13 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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