RecruitingNCT06342999

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Mauro H. SchenoneOne US siteView on ClinicalTrials.gov

AI Description

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

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Who can join
female, child, adult
Participants
80
Expected completion
2036-07
Funded by
other

Conditions studied

Hypoplastic Left Heart Syndrome

What is being tested

  • DEVICE: Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter
  • DEVICE: Trek RX and Mini Trek RX Coronary Dilatation Catheter
  • PROCEDURE: Fetal Aortic Valvuloplasty Procedure

What it measures

  • Number cases with pulmonary hypertension, Baseline
  • Number of cases in which a biventricular repair was achieved, Baseline
  • Number of cases in which the procedure was successful, 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, Baseline

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2026-05-01

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