Percutaneous Interventions in Adults With CHD
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ClinicalTrials.gov Identifier: NCT00266916 |
Recruitment Status
:
Terminated
(data collection sufficient)
First Posted
: December 20, 2005
Last Update Posted
: May 23, 2007
|
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Condition or disease |
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Congenital Disorders |
This is a single center, retrospective study of adult patients with a diagnosis of un-repaired complex cyanotic congenital heart disease including Eisenmenger’s 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 (2,3). However, procedures to improve pulmonary blood flow in adults with CCHD have not previously been described.
Study Type : | Observational |
Enrollment : | 9 participants |
Observational Model: | Defined Population |
Observational Model: | Natural History |
Time Perspective: | Longitudinal |
Time Perspective: | Retrospective |
Official Title: | Percutaneous Interventions in Adults With Complex Cyanotic Congenital Heart Disease |
Study Start Date : | January 1996 |
Study Completion Date : | August 2006 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- greater than 18 years of age
- complex cyanotic heart disease
- oxygen saturation prior to intervention < 90%
Exclusion Criteria:
- those who do not meet inclusion criteria

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): NCT00266916
United States, Georgia | |
Children's Healthcare of Atlanta | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Wendy M. Book, MD | Children's Healthcare of Atlanta |
ClinicalTrials.gov Identifier: | NCT00266916 History of Changes |
Other Study ID Numbers: |
05-138 |
First Posted: | December 20, 2005 Key Record Dates |
Last Update Posted: | May 23, 2007 |
Last Verified: | May 2007 |
Keywords provided by Children's Healthcare of Atlanta:
adult congenital heart disease percutaneous occlusion |
percutaneous balloon valvotomy balloon angioplasty complex cyanotic congenital heart defects (CCHD) |