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

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ClinicalTrials.gov Identifier: NCT03588312
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Congenital Hypoplasia of Aortic Arch Procedure: Aortoplasty using autologous pericardial patch

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

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 30 days post surgery ]

Secondary Outcome Measures :
  1. Freedom from re-intervention [ Time Frame: Up to 18 years post initial surgery ]


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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Newborns with a hypoplastic aortic arch undergoing a first intervention

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588312


Contacts
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Contact: Louis Chebli, MD 0032 475262210 louis.chebli@chu-brugmann.be
Contact: Pierre Wauthy, MD PhD 0032 2 4772111 pierre.wauthy@chu-brugmann.be

Locations
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Belgium
Hôpital Universitaire Des Enfants Reine Fabiola Recruiting
Brussels, Belgium, 1020
Contact: Pierre Wauthy, MD PhD    0032 2 4772111    pierre.wauthy@chu-brugmann.be   
Principal Investigator: Pierre Wauthy, MD PhD         
Sub-Investigator: Louis Chebli, MD         
Sponsors and Collaborators
Queen Fabiola Children's University Hospital

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Responsible Party: Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier: NCT03588312     History of Changes
Other Study ID Numbers: P2017/Cardio/AorticPlasty
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Queen Fabiola Children's University Hospital:
Aortic arch hypoplasia
Glutaraldehyde treated autologous pericardium
Single stage repair
Congenital heart defects
Newborns

Additional relevant MeSH terms:
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Heart Defects, Congenital
Aortic Coarctation
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Glutaral
Disinfectants
Anti-Infective Agents