Clinical Trials Directory

Trials / Completed

CompletedNCT00266968

Outcomes of Children With Congenital Single Ventricle Heart

Assessment of the Outcomes of Children With Congenital Single Ventricle Heart

Status
Completed
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
Children's Healthcare of Atlanta · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

Congenital heart disease affects 1 in 100 newborn babies each year and more than 2,000,000 Americans have a congenital heart defect. One common defect treated at Children's Healthcare of Atlanta at Egleston is single ventricle heart. Due to these overwhelming numbers, the use of diagnostic imaging technology to assess these defects and heart function is an important step in the evolving care of this patient group.

Detailed description

The definition of single ventricle can mean a ventricle that is hypoplastic, too small, or completely absent. Either the right or left ventricle may be affected. There may also be other cardiac anomalies present. Infants with a single ventricle develop distress after birth when the ductus arteriosus and foramen ovale close. This may happen within hours or days of delivery. The severity of symptoms is determined by the degree of defect. But, single ventricle patients will not survive without treatment. Patients with only one functioning ventricle can usually expect either a heart transplant or a series of palliative surgeries or sometimes both. Their care is very complex requiring a team of dedicated practitioners to manage drug therapy, medical support and surgery. At Children's Healthcare of Atlanta at Egleston, it is standard of care for a patient with a single ventricle heart to undergo many non-invasive imaging studies and sometimes invasive studies such as heart catheterization. Results of the studies provide valuable information used for treatment decisions and evaluation of heart function. We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.

Conditions

Timeline

Start date
2000-01-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2005-12-20
Last updated
2014-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00266968. Inclusion in this directory is not an endorsement.