NCT06342999

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mauro H. Schenone · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Hypoplastic Left Heart Syndrome

Interventions

Type	Name	Description
PROCEDURE	Fetal Aortic Valvuloplasty Procedure	Treatment given during pregnancy in which a balloon is used to increase the size of the baby's aortic valve in vitro.
DEVICE	Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter	Balloon Catheter
DEVICE	Trek RX and Mini Trek RX Coronary Dilatation Catheter	Coronary Dilation Catheter

Timeline

• Start date: 2026-01-01
• Primary completion: 2036-07-01
• Completion: 2036-07-01
• First posted: 2024-04-02
• Last updated: 2025-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study