Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Not Applicable

• Conditions: Hypoplastic Left Heart Syndrome

• Registration Number: NCT06342999
• Lead Sponsor: Mauro H. Schenone

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-02
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Study Start: 2026-01-01
• Primary Completion: 2036-07
• Study Completion: 2036-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of cases in which the procedure was successful	Baseline	Procedure success defined as the aortic valve was crossed and the balloon inflated with clear evidence of improvement of blood flow through the aortic valve and or new aortic valve regurgitation
Number cases with pulmonary hypertension	Baseline
Number of cases in which a biventricular repair was achieved	Baseline

Secondary Outcome Measures

Name	Time	Method
Number of cases with perinatal death	Baseline
Number of maternal complications	Baseline
Number of cases delivered prematurely	Baseline

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States