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CompletedNCT03348397Updated Nov 20, 2017

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

An observational study in Congenital Heart Defect and Right Ventricular Outflow Tract Reconstruction, sponsored by Queen Fabiola Children's University Hospital. Completed at 1 site in Belgium. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by Queen Fabiola Children's University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
53
Ages
Up to 30 Days
Sex
All
01

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.

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Conditions studied

  • Congenital Heart Defect
  • Right Ventricular Outflow Tract Reconstruction
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Who can participate

Ages eligible
Up to 30 Days
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

NA

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
53 participants (actual)
Patient registry
No

Groups and cohorts

  • Contegra patients

    Procedure: right ventricular outflow tract reconstruction with contegra

  • Pulmonary homograft patients

    Procedure: right ventricular outflow tract reconstruction with pulmonary homograft

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

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What researchers measure

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

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Study locations

1 site
  • Hôpital Universitaire Des Enfants Reine Fabiola
    Brussels, 1020, Belgium
07

References and documents

Publications

  • 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. PubMed 30942148 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03348397
Lead sponsor
Queen Fabiola Children's University Hospital
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Mar 1, 2017
Primary completion
Jun 1, 2017
Completion
Oct 30, 2017
Last update
Nov 20, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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