NCT00308217

Brief Summary

The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

First QC Date

March 27, 2006

Last Update Submit

December 11, 2013

Conditions

Heart Disease, CongenitalSingle VentricleHypoplastic Left Heart Syndrome

Keywords

Heart Disease, CongenitalSingle VentricleHypoplastic Left Heart Syndrome

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with single ventricle physiology scheduled for ultimate Fontan surgical palliation at Children's Healthcare of Atlanta will be eligible.
  • All subjects must sign informed consent prior to enrollment in study.

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

Heart Defects, CongenitalUniventricular HeartHypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Robert M Campbell, MD

    Associate Professor, Emory University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 29, 2006

Study Start

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

US(1)