Outcomes of Children With Congenital Single Ventricle Heart

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Healthcare of Atlanta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00266968
First received: December 19, 2005
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of the Outcomes of Children With Congenital Single Ventricle Heart

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 200
Study Start Date: January 2000
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

subjects seen at Children's Healthcare of Atlanta with single ventrical heart

Criteria

Inclusion Criteria:

  • Single Ventrical heart

Exclusion Criteria:

  • those patients who do not have single ventrical heart
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266968

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Angel Cuadrado, MD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Chairman, Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier: NCT00266968     History of Changes
Other Study ID Numbers: 03-005
Study First Received: December 19, 2005
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
pediatric
cardiac
single ventricle

ClinicalTrials.gov processed this record on April 17, 2014