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

NCT ID: NCT03588312

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-09-01

Brief Summary

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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

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

Conditions

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Congenital Hypoplasia of Aortic Arch

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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simple heart defects

Newborns with hypoplastic aortic arch in simple congenital heart defects requiring aortoplasty

Aortoplasty using autologous pericardial patch

Intervention Type PROCEDURE

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

Aortoplasty using autologous pericardial patch

Intervention Type PROCEDURE

hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.

Interventions

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Aortoplasty using autologous pericardial patch

hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Newborns with a hypoplastic aortic arch undergoing a first intervention

Exclusion Criteria

* none
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Fabiola Children's University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Louis Chebli, MD

Role: CONTACT

0032 475262210

Pierre Wauthy, MD PhD

Role: CONTACT

0032 2 4772111

Facility Contacts

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Pierre Wauthy, MD PhD

Role: primary

0032 2 4772111

Other Identifiers

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P2017/Cardio/AorticPlasty

Identifier Type: -

Identifier Source: org_study_id

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