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Percutaneous Interventions in Adults With CHD

Sponsor
Children's Healthcare of Atlanta (Other)
Overall Status
Terminated
CT.gov ID
NCT00266916
Collaborator
(none)
9
Enrollment
1
Location
127
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Retrospective
    Official Title:
    Percutaneous Interventions in Adults With Complex Cyanotic Congenital Heart Disease
    Study Start Date :
    Jan 1, 1996
    Study Completion Date :
    Aug 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00266916
      Other Study ID Numbers:
      • 05-138
      First Posted:
      Dec 20, 2005
      Last Update Posted:
      May 23, 2007
      Last Verified:
      May 1, 2007
      Keywords provided by , ,
      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

      Study Results

      No Results Posted as of May 23, 2007