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

Completed

• Conditions: Congenital Heart Defect; Right Ventricular Outflow Tract Reconstruction
• Interventions: Procedure: right ventricular outflow tract reconstruction with pulmonary homograft; Procedure: right ventricular outflow tract reconstruction with contegra

• Registration Number: NCT03348397
• Lead Sponsor: Queen Fabiola Children's University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-10-30
• Status Verified: 2017-11
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-16
• Last Update Submitted: 2017-11-16
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary homograft patients	right ventricular outflow tract reconstruction with pulmonary homograft	-
Contegra patients	right ventricular outflow tract reconstruction with contegra	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of early conduit-related reintervention according to the Nakata index	up to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegra	up to 195 months post right ventricular outflow tract recontruction
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
Overal mortality in right ventricular outflow tract recontructed with pulmonary homograft	up to 195 months post right ventricular outflow tract recontruction
Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegra	up to 195 months post right ventricular outflow tract recontruction
Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograft	up to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention according to the congenital heart defect diagnosis	up to 195 months post right ventricular outflow tract recontruction
Overal mortality in right ventricular outflow tract recontructed with contegra	up to 195 months post right ventricular outflow tract recontruction

Trial Locations

Locations (1)

Hôpital Universitaire Des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium