Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266916
Status:
TERMINATED
Last Update Posted:
2007-05-23
First Post:
2005-12-19
Brief Title:
Percutaneous Interventions in Adults With CHD
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Percutaneous Interventions in Adults With Complex Cyanotic Congenital Heart Disease
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
data collection sufficient
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine the clinical benefits of percutaneous intervention to improve pulmonary blood flow on oxygen saturations symptoms exercise tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are not candidates for surgical repair
Detailed Description:
This is a single center retrospective study of adult patients with a diagnosis of un-repaired complex cyanotic congenital heart disease including Eisenmengers Syndrome single ventricle pulmonary atresia with aorticopulmonary collaterals complete atrio-ventricular canal defects double inlet left ventricle heterotaxy syndromes and truncus arteriosus Patients with surgically placed systemic to pulmonary artery shunts will be included
Although generally incompatible with adult survival rare patients with un-operated or palliated complex cyanotic congenital heart defects CCHD survive well into adulthood Symptoms related to poor pulmonary blood flow and or increasing pulmonary vascular resistance progress with advancing age Percutaneous interventions to improve symptoms and relieve hypoxemia have not been previously reported in adult patients with complex cyanotic congenital heart disease Percutaneous interventions in patients with cyanotic congenital heart disease may be generally broken down into three types percutaneous occlusion of shunt lesions percutaneous balloon valvotomy or valvuloplasty and balloon angioplasty and stenting of vascular structures 1 Percutaneous interventions for occluded or stenotic systemic to pulmonary artery shunts in childhood have been described 23 However procedures to improve pulmonary blood flow in adults with CCHD have not previously been described
Although generally incompatible with adult survival rare patients with un-operated or palliated complex cyanotic congenital heart defects CCHD survive well into adulthood Symptoms related to poor pulmonary blood flow and or increasing pulmonary vascular resistance progress with advancing age Percutaneous interventions to improve symptoms and relieve hypoxemia have not been previously reported in adult patients with complex cyanotic congenital heart disease Percutaneous interventions in patients with cyanotic congenital heart disease may be generally broken down into three types percutaneous occlusion of shunt lesions percutaneous balloon valvotomy or valvuloplasty and balloon angioplasty and stenting of vascular structures 1 Percutaneous interventions for occluded or stenotic systemic to pulmonary artery shunts in childhood have been described 23 However procedures to improve pulmonary blood flow in adults with CCHD have not previously been described
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