Which heart repair lasts longer? a rare defect study seeks answers
NCT ID NCT05928234
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This observational study compares the long-term health of people born with a rare heart defect called pulmonary atresia with intact ventricular septum (PA-IVS). Researchers will look at two groups: those who had surgery to create a single pumping chamber (univentricular circulation) and those who have two pumping chambers (biventricular circulation). They will measure differences in survival, quality of life, other medical conditions, heart function, and exercise capacity. Participants will fill out a quality-of-life questionnaire, and some will undergo additional tests like an exercise stress test, echocardiogram, and heart MRI.
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 this study succeeds, it could help doctors understand which surgical approach for PA-IVS leads to better long-term health, guiding future treatment decisions.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. The results may not apply to all patients, and the two groups may differ in ways beyond their circulation type.
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 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of all individuals with PA-IVS who have been registered in Swedcon (a national register for patients with congenital heart defects) or in the National Patient Register and Cause of Death Register since 1980 and meet other inclusion criteria, including age.
- Ages
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15 years and older
- 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: * Individuals born with pulmonary atresia with intact ventricular septum (PA-IVS) who are 15 years or older at the start of the study. * Regarding the mortality variable, research subjects who have died after the age of 15 years old will be included. Exclusion Criteria: Individuals born with pulmonary atresia with intact ventricular septum who are younger than 15 years old at the start of the 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.
Contacts and locations
Locations
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Pediatric Heart Center, Queen Silvia's Children's hospital
Gothenburg, 416 85, Sweden
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Other studies related to the condition(s) this trial covers.