Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266968
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2005-12-19
Brief Title:
Outcomes of Children With Congenital Single Ventricle Heart
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Assessment of the Outcomes of Children With Congenital Single Ventricle Heart
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Congenital heart disease affects 1 in 100 newborn babies each year and more than 2000000 Americans have a congenital heart defect One common defect treated at Childrens 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 Childrens 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
At Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None