Clinical trial NCT03348397: Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns
Official title: Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns : Fifteen Years' Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Defect
Right Ventricular Outflow Tract Reconstruction
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 53
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent a right ventricular outflow tract reconstruction between January 1992 and December 2014 at the Hôpital Universitaire des Enfants Reine Fabiola, Belgium

Brief summary: Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative, but conflicting evidence exists. This retrospective study compared the outcome of these two conduits in a newborn population.


Eligibility criteria: Inclusion Criteria:

neonatal patients who had a reconstruction of the right ventricular outflow tract with a pulmonary homograft or a Contegra between January 1992 and December 2014 at HUDERF

Exclusion Criteria:

NA

Primary outcomes:
measure: Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra
timeFrame: up to 195 months post right ventricular outflow tract recontruction
Secondary outcomes:
measure: Proportion of early conduit-related reintervention according to the Nakata index
timeFrame: up to 195 months post right ventricular outflow tract recontruction
measure: Proportion of early conduit-related reintervention according to the congenital heart defect diagnosis
timeFrame: up to 195 months post right ventricular outflow tract recontruction
measure: Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegra
timeFrame: up to 195 months post right ventricular outflow tract recontruction
measure: Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with pulmonary homograft
timeFrame: up to 195 months post right ventricular outflow tract recontruction
measure: Overal mortality in right ventricular outflow tract recontructed with contegra
timeFrame: up to 195 months post right ventricular outflow tract recontruction
measure: Overal mortality in right ventricular outflow tract recontructed with pulmonary homograft
timeFrame: up to 195 months post right ventricular outflow tract recontruction
measure: Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegra
timeFrame: up to 195 months post right ventricular outflow tract recontruction
measure: Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograft
timeFrame: up to 195 months post right ventricular outflow tract recontruction
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire Des Enfants Reine Fabiola
Study officials:
affiliation: Queen Fabiola Children's University Hospital
name: Pierre Wauthy, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falchetti A, Demanet H, Dessy H, Melot C, Pierrakos C, Wauthy P. Contegra versus pulmonary homograft for right ventricular outflow tract reconstruction in newborns. Cardiol Young. 2019 Apr;29(4):505-510. doi: 10.1017/S1047951119000143. Epub 2019 Apr 3.