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Fontan surgery study: does lung blood flow type matter for kids with one heart chamber?

NCT ID NCT07535203

Knowledge-focused Sponsor: Sisca Natalia Siagian Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 52 children with cyanotic congenital heart disease and a single working heart chamber (univentricular heart) who undergo a series of surgeries ending with the Fontan procedure. Researchers will compare outcomes like survival, complications, and quality of life between two groups: those with too little blood flow to the lungs (pulmonary oligemia) and those with too much (pulmonary plethora). The goal is to understand how these differences affect recovery and long-term health after Fontan surgery.

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 study could help doctors better predict which children with univentricular heart will have better or worse outcomes after Fontan surgery, leading to more personalized care.
What could go wrong
This is an observational study, not a test of a new treatment. It only looks at existing differences in lung blood flow, so it cannot prove cause and effect. The small size (52 people) and single-center design may limit how widely the results apply.

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 52 people

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

Started

Jan 2025

Expected to finish

Jun 2027

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

This study will involve a cohort of clinically diagnosed patients with univentricular heart physiology who are undergoing the Fontan procedure as their final intervention.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Diagnosed cyanotic CHD * Univentricular heart physiology * Planned staged palliation including Fontan procedure * Informed consent obtained (patient or guardian) Exclusion Criteria: * Refusal to participate * Incomplete clinical data * Inability to complete follow-up

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Conditions

The condition(s) this trial relates to.

congenital heart disease Hypovolemia univentricular heart

As listed by the trial registrant

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

Congenital heart disease (CHD) Univentricular heart

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

  • National Cardiovascular Center Harapan Kita

    RECRUITING

    Jakarta, DKI Jakarta, 11420, Indonesia

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