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

Congenital Heart Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348397
• Other study ID #: P2016/Cardio/RVOTtherapy
• Status: Completed
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 16, 2017
• Start date: March 1, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: November 2017
• Source: Queen Fabiola Children's University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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:

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital
• Right Ventricular Outflow Tract Reconstruction

Intervention

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.
• right ventricular outflow tract reconstruction with pulmonary homograft
cryopreserved pulmonary homografts

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

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