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OpenTrials
Completed

NCT Number: NCT03348397

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

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.

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Key information

Conditions

Congenital Heart Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Right Ventricular Outflow Tract Reconstruction

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

right ventricular outflow tract reconstruction with contegra

Procedure

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

right ventricular outflow tract reconstruction with pulmonary homograft

Procedure

cryopreserved pulmonary homografts

Primary outcomes

  1. Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra

    Time frame: up to 195 months post right ventricular outflow tract recontruction

Secondary outcomes

  1. Proportion of early conduit-related reintervention according to the Nakata index

    Time frame: up to 195 months post right ventricular outflow tract recontruction

  2. Proportion of early conduit-related reintervention according to the congenital heart defect diagnosis

    Time frame: up to 195 months post right ventricular outflow tract recontruction

  3. Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegra

    Time frame: up to 195 months post right ventricular outflow tract recontruction

  4. Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with pulmonary homograft

    Time frame: up to 195 months post right ventricular outflow tract recontruction

  5. Overal mortality in right ventricular outflow tract recontructed with contegra

    Time frame: up to 195 months post right ventricular outflow tract recontruction

  6. Overal mortality in right ventricular outflow tract recontructed with pulmonary homograft

    Time frame: up to 195 months post right ventricular outflow tract recontruction

  7. Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegra

    Time frame: up to 195 months post right ventricular outflow tract recontruction

  8. Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograft

    Time frame: up to 195 months post right ventricular outflow tract recontruction

Sponsors and collaborators

Lead sponsor

Queen Fabiola Children's University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2017
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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