Long Term Results in Hypoplastic Aortic Arch Repair in Neonates Using a Glutaraldehyde Treated Autologous Pericardial Patch

• Conditions: Congenital Hypoplasia of Aortic Arch

• Registration Number: NCT03588312
• Lead Sponsor: Queen Fabiola Children's University Hospital

Brief Summary

Hypoplastic aortic arch is a congenital heart defect that is prejudicial for the growth of newborns. It is often associated to other heart defects. Different surgical techniques exist to address this defect, but the literature is very poor with regards to the use of an autologous pericardial patch. Most use extensive dissection techniques or synthetic patches. Here investigators report institution's original approach using the newborns own pericardium for what investigators believe to be an optimal correction of the hypoplasia., with preserved growth potential.

Detailed Description

Retrospective analysis of an already well codified surgical intervention carried out in HUDERF under extra-corporeal circulation

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-17
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Newborns with a hypoplastic aortic arch undergoing a first intervention

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	30 days post surgery

Secondary Outcome Measures

Name	Time	Method
Freedom from re-intervention	Up to 18 years post initial surgery

Trial Locations

Locations (1)

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