CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Data collection within medical filesother
Likely dose
Not stated in record
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Search/NCT03048071
NCT03048071N/ACompleted

Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position: a Comparative Study

Pierre Wauthy·observational·Posted Feb 9, 2017·Updated Nov 22, 2017

In Brief

An observational study evaluating Data collection within medical files for Congenital Heart Disease. Completed, enrolled 84 participants across 1 site.

Detailed Summary

Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used.Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP). The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. This conduit, however, is not perfect. Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartFeb 14, 2017
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.4 years ago

Interventions

Data collection within medical filesother

Data collection within medical files