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Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns

NCT ID: NCT03348397

Last Updated: 2017-11-20

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

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-10-30

Brief Summary

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Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative, but conflicting evidence exists. This retrospective study compared the outcome of these two conduits in a newborn population.

Detailed Description

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Conditions

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Congenital Heart Defect Right Ventricular Outflow Tract Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Contegra patients

right ventricular outflow tract reconstruction with contegra

Intervention Type PROCEDURE

Contegra pulmonary valved conduit is an animal jugular vein that contains a valve with three leaflets that are similar to a human heart valve.

Pulmonary homograft patients

right ventricular outflow tract reconstruction with pulmonary homograft

Intervention Type PROCEDURE

cryopreserved pulmonary homografts

Interventions

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right ventricular outflow tract reconstruction with contegra

Contegra pulmonary valved conduit is an animal jugular vein that contains a valve with three leaflets that are similar to a human heart valve.

Intervention Type PROCEDURE

right ventricular outflow tract reconstruction with pulmonary homograft

cryopreserved pulmonary homografts

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

neonatal patients who had a reconstruction of the right ventricular outflow tract with a pulmonary homograft or a Contegra between January 1992 and December 2014 at HUDERF

Exclusion Criteria

NA
Maximum Eligible Age

30 Days

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

Principal Investigators

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Pierre Wauthy, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Queen Fabiola Children's University Hospital

Locations

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Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Falchetti A, Demanet H, Dessy H, Melot C, Pierrakos C, Wauthy P. Contegra versus pulmonary homograft for right ventricular outflow tract reconstruction in newborns. Cardiol Young. 2019 Apr;29(4):505-510. doi: 10.1017/S1047951119000143. Epub 2019 Apr 3.

Reference Type DERIVED
PMID: 30942148 (View on PubMed)

Other Identifiers

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P2016/Cardio/RVOTtherapy

Identifier Type: -

Identifier Source: org_study_id