Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Hypoplastic Left Heart Syndrome Clinical Trial

Official title: Evaluation of Outcomes of Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Status Not yet recruiting

Clinical Trial Summary

The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).

Clinical Trial Description

The condition occurs when part of the heart doesn't develop properly so the heart is not able to pump blood around the body effectively. Babies born with this condition require surgery and are often left with a lifelong heart disability. A number of babies with this condition will die during pregnancy or within the first year of life (approximately 10-40%). We are investigating a treatment given during pregnancy in which a balloon is used to increase the size of the baby's aortic valve. The aortic valve function is to allow easy flow from the heart to the body and prevent blood from returning to the heart (regurgitation). This is called fetal aortic valvuloplasty. A number of studies have shown promising results, including a higher of the baby surviving with both sides of the heart functioning (as opposed to only the right side), this may also lead to longer survival with a better quality of life. However, we do not have enough information to say this is always the best way to manage the condition. Currently, parents of babies with this condition, who meet certain eligibility criteria, are offered fetal aortic valvuloplasty during pregnancy. The alternative option is not to intervene during pregnancy but instead monitor the baby with regular ultrasounds. We call this conservative management. ;

Related Conditions & MeSH terms

• Hypoplastic Left Heart Syndrome
• Syndrome

• NCT number: NCT06342999
• Study type: Interventional
• Source: Mayo Clinic
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Completion date: July 2035