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NCT06342999

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Enrolling by Invitation
NAUp to 45InterventionalTreatment
Mauro H. Schenone
~80 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:Fetal Aortic Valvuloplasty ProcedureEmerge Monorail and Over-The-Wire PTCA Dilatation CatheterTrek RX and Mini Trek RX Coronary Dilatation Catheter

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of cases in which the procedure was successful
Measured over Baseline
+2 more outcomes measured

Conditions

Hypoplastic Left Heart Syndrome

Explore related trials

Hypoplastic Left Heart Syndrome

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Mauro Schenone, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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

What this trial measures

  • Number of cases in which the procedure was successfulBaseline

    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 of cases in which a biventricular repair was achievedBaseline
  • Number cases with pulmonary hypertensionBaseline