NCT00266916

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 1996

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

May 23, 2007

Status Verified

May 1, 2007

First QC Date

December 19, 2005

Last Update Submit

May 22, 2007

Conditions

Congenital Disorders

Keywords

adultcongenital heart diseasepercutaneous occlusionpercutaneous balloon valvotomyballoon angioplastycomplex cyanotic congenital heart defects (CCHD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • greater than 18 years of age
  • complex cyanotic heart disease
  • oxygen saturation prior to intervention \< 90%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Study Officials

  • Wendy M. Book, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 20, 2005

Study Start

January 1, 1996

Study Completion

August 1, 2006

Last Updated

May 23, 2007

Record last verified: 2007-05

Locations

US(1)