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

July 19, 2018 updated by: Queen Fabiola Children's University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Recruiting
        • Hopital Universitaire des Enfants Reine Fabiola
        • Contact:
        • Principal Investigator:
          • Pierre Wauthy, MD PhD
        • Sub-Investigator:
          • Louis Chebli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All newborns treated in Hopital Universitaire Des Enfants - Reine Fabiola (Brussels, Belgium) for a hypoplastic aortic arch and other congenital heart defects.

Description

Inclusion Criteria:

  • Newborns with a hypoplastic aortic arch undergoing a first intervention

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
simple heart defects
Newborns with hypoplastic aortic arch in simple congenital heart defects requiring aortoplasty
Procedure: Aortoplasty using autologous pericardial patch
hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.
complex heart defects.
Newborns with hypoplastic aortic arch in complex congenital heart defects requiring aortoplasty
Procedure: Aortoplasty using autologous pericardial patch
hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 30 days post surgery
30 days post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from re-intervention
Time Frame: Up to 18 years post initial surgery
Up to 18 years post initial surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Fabiola Children's University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2017/Cardio/AorticPlasty

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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