Outcomes of Children With Congenital Single Ventricle Heart
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|ClinicalTrials.gov Identifier: NCT00266968|
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : December 2, 2014
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Assessment of the Outcomes of Children With Congenital Single Ventricle Heart|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
- We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies. [ Time Frame: 13 years ]We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266968
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Angel Cuadrado, MD||Children's Healthcare of Atlanta|