Long Term Results in Hypoplastic Aortic Arch Repair in Neonates Using a Glutaraldehyde Treated Autologous Pericardial Patch
- Conditions
- Congenital Hypoplasia of Aortic Arch
- Interventions
- Procedure: Aortoplasty using autologous pericardial patch
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Newborns with a hypoplastic aortic arch undergoing a first intervention
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description complex heart defects. Aortoplasty using autologous pericardial patch Newborns with hypoplastic aortic arch in complex congenital heart defects requiring aortoplasty simple heart defects Aortoplasty using autologous pericardial patch Newborns with hypoplastic aortic arch in simple congenital heart defects requiring aortoplasty
- 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