Effect of Fetal Aortic Valvuloplasty on Outcomes (NCT05386173)
Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
🩺 Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: Fetal Cardiovascular Program, University of California San Francisco — San Francisco, California
Age range: 23 Weeks to 31 Weeks
🧪 Interventions in This Study
- Fetal aortic balloon dilatation (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Fetal Cardiovascular Program, University of California San Francisco — San Francisco, California
- Congenital Heart Collaborative, Nationwide Children's Hospital — Columbus, Ohio
- 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,
📞 Contact the Study Coordinator
Phone: 0046705530606
Email: mats.mellander@vgregion.se
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.