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

Congenital Hypoplasia of Aortic Arch Clinical Trial

— Aortoplasty  

Official title:

Retrospective Analysis of Results in Children Treated by an Autologous Pericardial Patch to Repair a Hypoplastic Aortic Arch Associated to Other Congenital Heart Defects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588312
• Other study ID #: P2017/Cardio/AorticPlasty
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: July 2018
• Source: Queen Fabiola Children's University Hospital
• Contact: Louis Chebli, MD
• Phone: 0032 475262210
• Email: louis.chebli[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• Newborns with a hypoplastic aortic arch undergoing a first intervention

Exclusion Criteria:

Related Conditions & MeSH terms

• Aortic Coarctation
• Congenital Hypoplasia of Aortic Arch
• Heart Defects, Congenital

Intervention

Procedure:
• Aortoplasty using autologous pericardial patch
hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.

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	Overall survival		30 days post surgery
Secondary	Freedom from re-intervention		Up to 18 years post initial surgery