Evaluation of treatment for univentricular heart defects
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
NA · University of Erlangen-Nürnberg Medical School · NCT05620030
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 60 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School (other) |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT05620030 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and young children diagnosed with congenital univentricular heart defects requiring multi-stage treatment.
Not a fit: Patients with congenital heart defects that do not fall under the univentricular category may not benefit from this study.
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 performed: Other studies have shown success in managing univentricular heart defects using standardized treatment protocols, indicating that this approach is both tested and promising.
Eligibility criteria
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 this trial is running
Erlangen
- Universitätsklinikum — Erlangen, Germany (RECRUITING)
Study contacts
- Study coordinator: Sven Dittrich, Prof.
- Email: sven.dittrich@uk-erlangen.de
- Phone: 09131 85 33750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Univentricular Heart