Condition: Univentricular Heart · Sponsor: University of Erlangen-Nürnberg Medical School
Univentricular heart defects are among the most complex congenital malformations. The treatment of these patients usually includes 3 operations and accompanying diagnostics, some of which are invasive, within the first 3 to 4 years of life until the "fontan circulation" is established. Unfortunately, the group of patients with a univentricular cardiac malformation is also the group with the highest mortality rate until the Fontan circulation is established. The expected mortality varies depending on the complexity of the underlying intracardiac and extracardiac malformations and possible concomitant morbidity; According to data from the National Quality Assurance in Germany, it is currently up to 30% in patients with hypoplastic left heart syndrome. However, the treatment methods are well standardized and there has been a clinical protocol in Erlangen since 2008 that includes diagnostic examinations using cardiac catheterization (HKU) and magnetic resonance imaging (MRT), as well as non-invasive, instrument-based diagnostics and targeted blood tests in a consistent sequence before and after the operations regulates. The Erlangen protocol ends with the cardiac MRT six months after the Fontan operation (syn: total cavopulmonary connection \[TCPC\]). If MRT imaging is not possible (e.g. if a cardiac pacemaker is present) or if there is a clinical indication (e.g. an obstruction noticeable on MRT or the presence of an "overflow with right-left shunt"), HKU is performed in the fir…
This description comes directly from the study's public registry record.
Sven Dittrich, Prof. · 09131 85 33750 · sven.dittrich@uk-erlangen.de
Isabelle Schöffl, PD · 09131 85 33750 · isabelle.schoeffl@uk-erlangen.de
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| Universitätsklinikum | Erlangen, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05620030