Percutaneous Interventions in Adults With CHD

This study has been terminated.
(data collection sufficient)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00266916
First received: December 19, 2005
Last updated: May 22, 2007
Last verified: May 2007
  Purpose

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
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Percutaneous Interventions in Adults With Complex Cyanotic Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 9
Study Start Date: January 1996
Estimated Study Completion Date: August 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266916

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

No publications provided

ClinicalTrials.gov Identifier: NCT00266916     History of Changes
Other Study ID Numbers: 05-138
Study First Received: December 19, 2005
Last Updated: May 22, 2007
Health Authority: United States: Institutional Review Board

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)

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014