NCT00277940

Brief Summary

Abnormalities of the aorta have been identified in patients who have undergone repair of coarctation of the aorta by various surgical techniques. These abnormalities are thought to contribute to ventricular hypertrophy, hypertension and exercise intolerance. Aortic arch reconstruction is performed for a variety of lesions besides simple coarctation of the aorta; these include hypoplastic left heart syndrome and its variants. In the latter group of patients extensive reconstruction is performed usually with a pulmonary homograft. We have previously shown that the neo-aortic dimensions and geometry are abnormal. The elastic properties of the neo-aorta, however, have not previously been described.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
Last Updated

July 6, 2011

Status Verified

May 1, 2007

First QC Date

January 13, 2006

Last Update Submit

July 5, 2011

Conditions

Congenital Disorders

Keywords

PediatricCardiacNeoaortic Elastic PropertiesAortic Arch Reconstruction

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

retro chart review

You may qualify if:

  • Single ventricle congenital heart disease 1) palliated with bi-directional Glenn procedure after having the Norwood procedure (experimental group) or 2) palliated with the bi-directional Glenn without having the Norwood procedure as stage I palliation-i.e. Tricuspid Atresia, Pulmonary Atresia (control group)
  • Undergoing routine Fontan procedure

You may not qualify if:

  • Semi-lunar valve insufficiency \> trivial
  • Residual coarctation noted on routine pre-Fontan catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • William T Mahle, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 18, 2006

Last Updated

July 6, 2011

Record last verified: 2007-05

Locations

US(1)