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Fetal heart surgery could change life for babies with Half-Formed hearts

NCT ID NCT06342999

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jul 2036

An estimate. End dates often move.

Lead sponsor

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

Up to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. 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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.