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ENROLLING BY INVITATION
NCT06342999
NA

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Sponsor: Mauro H. Schenone

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

FEMALE

Age Range

Any - 45 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-01-01

Completion Date

2036-07

Last Updated

2025-07-17

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States