Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Enrolling by invitation · Not applicable

Conditions studied: Hypoplastic Left Heart Syndrome

In brief

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

Key facts

Study ID

NCT06342999

Run by

Mauro H. Schenone

People needed

80

Starts

2027-01-01

Expected to finish

2036-07-01

Last updated by the study team

2026-05-01

Who can join

Age: any, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women 18-45 years of age.
• Gestational age between 21 0/7 and 29 6/7 weeks of gestation
• The mother must be healthy enough to undergo surgery.
• The individual being enrolled must be able to provide informed consent.
• Dominant cardiac defect is valvar
• Evolving hypoplastic left heart syndrome defined as depressed left ventricle systolic and at least one of the following:
• Retrograde flow in the transverse aortic arch
• Two of the following: (1) left to right flow across the atrial septum (bulging of the septum left to right in cases of intact atrial septum); (2) monophasic mitral valve inflow; (3) bidirectional flow in the pulmonary veins.
• Potential for a technically successful and postnatal biventricular outcome defined as left ventricle long axis Z-score equal or greater than -2 PLUS at least 4 of the following 5 criteria:
• Left ventricle long axis Z-score more than zero
• Left ventricle short axis Z-score more than zero
• Aortic annulus Z-score more than -3.5
• Mitral valve annulus Z-score more than -2
• Left ventricle generating a maximal instantaneous gradient (MIG) equal or greater than 20 mmHg (or by mitral regurgitation jet greater than or equal to 20 mmHg).

You may not qualify if…

• Patient is less than 18 years of age or more than 45 years of age.
• Contraindication to anesthesia or surgery
• Preterm labor or cervical length <20 mm at enrollment or uterine anomaly strongly predisposing to preterm delivery.
• Other fetal anomalies that significantly impact fetal/neonatal survival (e.g., congenital diaphragmatic hernia, bilateral renal agenesis, etc.)
• Fetal aneuploidy and pathogenic findings on Karyotype or Microarray that impact significantly the fetal/neonatal survival.
• Cases with all the following criteria:
• Left ventricle pressure ≤ 47 mmHg
• MV dimension Z-score < 0.1
• MV inflow time Z-score < -2

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.