Evaluation of treatment for univentricular heart defects
Official title: Evaluation of the Standard Data Collected as Part of the Erlangen Protocol for the Treatment and Monitoring of Patients With Univentricular Heart Defects in Terms of the Fontan Procedure
Run by University of Erlangen-Nürnberg Medical School · NCT05620030 · Data updated 2026-11-12
This study is testing a new treatment approach for children with univentricular heart defects to see if it can improve their care and lower the risk of death.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 60 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen) |
| Status | Recruiting |
| Started | May 20, 2021 |
| Main results expected | May 20, 2031 |
| Study ends | May 20, 2041 |
| Registry record updated | November 17, 2022 |
| Trial ID | NCT05620030 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants and young children diagnosed with congenital univentricular heart defects requiring multi-stage treatment.
✕Probably not a fit
Patients with congenital heart defects that do not fall under the univentricular category may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on patients with univentricular heart defects, which are complex congenital malformations requiring multiple surgical interventions. The treatment typically involves three operations and various diagnostic procedures within the first few years of life to establish Fontan circulation. The study follows a clinical protocol developed in Erlangen that includes both invasive and non-invasive diagnostic examinations, such as cardiac catheterization and magnetic resonance imaging, to monitor patient outcomes. The aim is to improve the management and reduce mortality rates associated with these heart defects.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols and reduced mortality rates for patients with univentricular heart defects.
How similar studies have gone: Other studies have shown success in managing univentricular heart defects using standardized treatment protocols, indicating that this approach is both tested and promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * congenital heart defect of the univentricular type and the clinical necessity of a multi-stage treatment in terms of the Fontan procedure. Exclusion Criteria: * no exclusion criteria
Where it's running
-
Universitätsklinikum
Erlangen, Germany Recruiting
Study contacts
- Study coordinator: Sven Dittrich, Prof.
- Email: sven.dittrich@uk-erlangen.de
- Phone: 09131 85 33750
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Fontan outcomes with low versus high lung blood flow in single‑ventricle hearts
This project will test whether people with single‑ventricle congenital heart disease who have reduced versus increased pulmonary blood flow do better or worse after the Fontan operation.
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Cardiac imaging for patients with Fontan circulation
This study is testing if special heart scans can help find early heart problems in patients who have had Fontan surgery for univentricular heart conditions, so they can get treatment before things get worse.
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Using lab-grown heart cells to treat congenital heart disease
This study is testing if using heart cells made from patients' own skin can safely help people with congenital heart disease feel better.
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Long-term outcomes for patients with univentricular hearts after Fontan surgery
This study looks at how people with univentricular hearts do over the long term after Fontan surgery, focusing on their heart health, liver and kidney function, and overall well-being.
-
Registry to evaluate the safety of a new venous cannula for patients with heart failure
This study is testing the safety of a new venous cannula for patients with heart failure who are using a special heart pump to see how well it works and if it has any risks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.