Fetal heart surgery could change life for babies with Half-Formed hearts
NCT ID NCT06342999
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at a procedure done before birth to help babies with a severe heart defect called hypoplastic left heart syndrome (HLHS). The goal is to improve blood flow through the heart so that the baby may have a better chance at a two-sided heart repair after birth. The study involves 80 pregnant women and their babies, and tracks success rates, complications, and long-term outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jul 2036
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * 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 Criteria * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could a gentler breathing machine protect young hearts and brains after surgery?
- Blood protein test could predict Post-Surgery risks in kids with heart defects
- New app aims to ease Parents' stress over Baby's heart surgery decision
- Moms' stress in pregnancy linked to baby brain outcomes in heart defect study
- Heart stem cells show promise in kids with half a heart
- Heart defect study tracks kids' outcomes 11 years after surgery