Percutaneous Interventions in Adults With CHD

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Congenital Disorders

Detailed Description:

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:	Wendy M. Book, MD	Children's Healthcare of Atlanta

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00266916 History of Changes
Other Study ID Numbers:	05-138
First Posted:	December 20, 2005
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)