A crystal ball for heart defects: can a new model predict which children heal without surgery?
NCT ID NCT07741097
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This study looks at children diagnosed with a ventricular septal defect (a hole in the heart) to understand if and when the hole might close without treatment. Researchers will follow children from birth to age 14 and use echocardiography to track the defect. The goal is to build a model that helps predict spontaneous closure, which could guide decisions about whether surgery or other interventions are needed.
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 research could help doctors identify which children with a ventricular septal defect may not need surgery, allowing for a 'wait and see' approach and avoiding unnecessary procedures.
- What could go wrong
- This is an observational study, so it does not test a treatment. The prediction model may not be accurate for all children, and more research would be needed before it could be used in routine care.
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Study facts
What this study's own registry entry says, in plain language.
- Expected to start
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Oct 2020
An estimate. Start dates often move.
- Expected to finish
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Dec 2022
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
PMVSD children aged 0 to 14
- Ages
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Up to 14 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. The initial diagnosis age is from birth to 14 years old 2. Ultrasonography confirmed the presence of simple PMVSD or other simple congenital heart diseases without other complicated heart malformations (such as pulmonary venous drainage, conus trunk malformation, interruption of aortic arch, primary pulmonary hypertension, etc.) 3. No major disease at first diagnosis (life-threatening organic disease not caused by congenital heart disease) 4. The patient or guardian voluntarily signs the informed consent form Exclusion Criteria: 1. The initial diagnosis age\>14 years old. 2. With complicated congenital heart disease (such as pulmonary venous ectopic drainage, conus trunk malformation, interruption of aortic arch, primary pulmonary hypertension, etc.) 3. Serious diseases of other organs 4. Unable to cooperate with the doctor to complete regular outpatient follow-up or give up treatment
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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.
Contacts and locations
Locations
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.