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New study aims to predict heart surgery needs before birth

NCT ID NCT07095829

Knowledge-focused Sponsor: Hospital Universitario 12 de Octubre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study follows 150 fetuses diagnosed with a rare heart condition called pulmonary atresia with intact ventricular septum. Researchers will track their health before and after birth to develop a model that predicts which babies will need simpler versus more complex surgeries. The goal is to help doctors and families plan better for the baby's care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors predict before birth which babies with this heart defect will need simpler surgery, improving planning and outcomes.
What could go wrong
This is an observational study, not a treatment trial. It only collects data and does not test any new therapy, so it cannot directly improve health.

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.

Participants

About 150 people

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

Started

Feb 2024

Expected to finish

Dec 2029

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.

Who is studied

Screening data: All pregnant women with a fetus with suspected PA-CS/IVS will be screened for eligibility. If they meet all the inclusion criteria and none of the exclusion ones, they will be offered to participate. A complete count of screened, eligible, and included participants will be detailed in the final report of the study. Eligibility: As described in the next section, cases must meet all the inclusion criteria, and none of the exclusion ones.

Ages

16 to 28 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Absence of flow at the pulmonary valve (PA) or presence of thickened and domed. pulmonary valve cusps with a pinhole jet of flow. * Doppler evidence of ductal-dependent pulmonary circulation. * Intact ventricular septum. Exclusion Criteria: * Poor imaging windows and incomplete/poor quality scan * Termination of pregnancy * Cases initially included that undergo prenatal pulmonary valvuloplasty later on in pregnancy. * Unconfirmed PA-CS/IVS at birth. * Functional PA-CS/IVS (Ebstein malformation, monochorionic twins) * Any associated cardiac defect except persistent left superior vena cava and aberrant right subclavian artery. * Any significant (i.e that might influence outcome) extracardiac anomaly and/or known genetic syndromes. Also, if such a condition is present at inclusion but diagnosed only after birth, the case will be retrospectively excluded.

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Conditions

The condition(s) this trial relates to.

congenital heart disease congenital pulmonary valve stenosis heart disorder pulmonary atresia-intact ventricular septum syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital heart disease Fetal cardiac disorder Pulmonary atresia with intact ventricular septum

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  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

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • University of Gothenburg

    ACTIVE_NOT_RECRUITING

    Gothenburg, Sweden

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