Plain-English translation of NCT05620030 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is not testing a new medication or procedure. Instead, it's documenting how doctors at Erlangen University Hospital use a structured protocol—a step-by-step plan—to monitor children born with univentricular hearts (hearts with only one working chamber instead of two). Children with this condition typically need three major surgeries within their first 3 to 4 years of life. The study will review the tests, imaging scans, and blood work doctors use before and after each surgery to track how well the heart is working and catch any problems early.
Children born with univentricular hearts face significant risk, especially between surgeries. Doctors at Erlangen have developed a careful monitoring plan that combines different types of scans, heart catheterization (a tube inserted to measure heart pressures), and blood tests. This study will examine whether this protocol—now used for years in their hospital—truly helps doctors make better decisions about surgery timing, personalize treatment for each child, and spot complications before they become dangerous.
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If your child is enrolled, you and your child will continue receiving standard care at Erlangen University Hospital following their established protocol. The study will collect information from the routine tests and imaging your child would already have—including heart catheterization, MRI scans, blood tests, and heart ultrasounds—before and after each surgery. The protocol ends six months after the final Fontan surgery. Researchers will review these records to understand how well the monitoring plan works and whether it helps improve outcomes for children like yours.
AI-generated summary from trial data · Aug 9, 2026 · Not medical advice
Germany