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

NCT03348397 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2017-11-20

No results posted yet for this study

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.

Conditions

  • Congenital Heart Defect
  • Right Ventricular Outflow Tract Reconstruction

Interventions

PROCEDURE

right 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.

PROCEDURE

right ventricular outflow tract reconstruction with pulmonary homograft

cryopreserved pulmonary homografts

Sponsors & Collaborators

  • Queen Fabiola Children's University Hospital

    lead OTHER

Principal Investigators

  • Pierre Wauthy, MDPhD · Queen Fabiola Children's University Hospital

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2017-06-01
Completion
2017-10-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348397 on ClinicalTrials.gov