Massive study tracks hidden dangers for kids with heart defects undergoing other surgeries
NCT ID NCT04604418
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 10,000 children with congenital heart disease who need surgery for non-heart issues. Researchers want to learn what complications occur and how hospitals use resources. The goal is to create better risk predictions and improve care for these patients.
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 better predict risks and plan care for children with heart disease having non-heart surgeries.
- What could go wrong
- This is an observational study, not a treatment trial. It will not test any new drug or therapy, so it cannot directly improve 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.
- Participants
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About 10,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Dec 2026
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.
Who is studied
Patients diagnosed with congenital heart disease and presenting to the participating institution for a noncardiac procedure are included in the study. All patients will be included.
- Ages
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Up to 21 years
- Sex
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Anyone
- Healthy volunteers
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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 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: 1. Males or females ages birth to 21 years. 2. Patients diagnosed with congenital heart disease 3. Patients undergoing a noncardiac procedure (surgical or nonsurgical) Exclusion Criteria: 1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers. 2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study
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Get notified about this study
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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
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Children's Healthcare of Atlanta - Egleston Hospita
ACTIVE_NOT_RECRUITINGAtlanta, Georgia, 30322, United States
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Children's Hospital of the King's Daughter
TERMINATEDNorfolk, Virginia, 23507, United States
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Children's National Medical Center
RECRUITINGWashington D.C., District of Columbia, 20310, United States
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Hospital for Sick Kids
RECRUITINGToronto, Ontario, M5G 1X8, Canada
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Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
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University of California, Los Angeles
ACTIVE_NOT_RECRUITINGLos Angeles, California, 90095, United States
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University of Minnesota Medical Center
ACTIVE_NOT_RECRUITINGMinneapolis, Minnesota, 55455, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can AI hear heart defects in children? a large trial puts it to the test
- Artificial intelligence may detect Children's heart disease from a routine ECG
- AI takes the wheel: could a computer outthink doctors on ventilator settings for kids?
- Oxygen test during pregnancy may predict brain development in Heart-Defect babies
- Digital coach helps kids heal after heart surgery
- Teens with heart disease try home video workouts to boost fitness