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Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns

Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns : Fifteen Years' Experience

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03348397
Enrollment
53
Registered
2017-11-20
Start date
2017-03-01
Completion date
2017-10-30
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Defect, Right Ventricular Outflow Tract Reconstruction

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.

Interventions

PROCEDUREright ventricular outflow tract reconstruction with contegra

Contegra pulmonary valved conduit is an animal jugular vein that contains a valve with three leaflets that are similar to a human heart valve.

PROCEDUREright ventricular outflow tract reconstruction with pulmonary homograft

cryopreserved pulmonary homografts

Sponsors

Queen Fabiola Children's University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegraup to 195 months post right ventricular outflow tract recontruction

Secondary

MeasureTime frame
Proportion of early conduit-related reintervention according to the congenital heart defect diagnosisup to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegraup to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with pulmonary homograftup to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention according to the Nakata indexup to 195 months post right ventricular outflow tract recontruction
Overal mortality in right ventricular outflow tract recontructed with pulmonary homograftup to 195 months post right ventricular outflow tract recontruction
Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegraup to 195 months post right ventricular outflow tract recontruction
Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograftup to 195 months post right ventricular outflow tract recontruction
Overal mortality in right ventricular outflow tract recontructed with contegraup to 195 months post right ventricular outflow tract recontruction

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026