Congenital Heart Defect Clinical Trial
Official title:
Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns : Fifteen Years' Experience
Verified date | November 2017 |
Source | Queen Fabiola Children's University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | October 30, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Days |
Eligibility |
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: |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Universitaire Des Enfants Reine Fabiola | Brussels |
Lead Sponsor | Collaborator |
---|---|
Queen Fabiola Children's University Hospital |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra | up to 195 months post right ventricular outflow tract recontruction | ||
Secondary | Proportion of early conduit-related reintervention according to the Nakata index | up to 195 months post right ventricular outflow tract recontruction | ||
Secondary | Proportion of early conduit-related reintervention according to the congenital heart defect diagnosis | up to 195 months post right ventricular outflow tract recontruction | ||
Secondary | Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegra | up to 195 months post right ventricular outflow tract recontruction | ||
Secondary | Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with pulmonary homograft | up to 195 months post right ventricular outflow tract recontruction | ||
Secondary | Overal mortality in right ventricular outflow tract recontructed with contegra | up to 195 months post right ventricular outflow tract recontruction | ||
Secondary | Overal mortality in right ventricular outflow tract recontructed with pulmonary homograft | up to 195 months post right ventricular outflow tract recontruction | ||
Secondary | Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegra | up to 195 months post right ventricular outflow tract recontruction | ||
Secondary | Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograft | up to 195 months post right ventricular outflow tract recontruction |
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