Outcomes of Children With Congenital Single Ventricle Heart

Assessment of the Outcomes of Children With Congenital Single Ventricle Heart

Congenital heart disease affects 1 in 100 newborn babies each year and more than 2,000,000 Americans have a congenital heart defect. One common defect treated at Children's Healthcare of Atlanta at Egleston is single ventricle heart. Due to these overwhelming numbers, the use of diagnostic imaging technology to assess these defects and heart function is an important step in the evolving care of this patient group.

Study Overview

• Status: Completed
• Conditions: Congenital Disorders

Detailed Description

The definition of single ventricle can mean a ventricle that is hypoplastic, too small, or completely absent. Either the right or left ventricle may be affected. There may also be other cardiac anomalies present. Infants with a single ventricle develop distress after birth when the ductus arteriosus and foramen ovale close. This may happen within hours or days of delivery. The severity of symptoms is determined by the degree of defect. But, single ventricle patients will not survive without treatment. Patients with only one functioning ventricle can usually expect either a heart transplant or a series of palliative surgeries or sometimes both. Their care is very complex requiring a team of dedicated practitioners to manage drug therapy, medical support and surgery.

At Children's Healthcare of Atlanta at Egleston, it is standard of care for a patient with a single ventricle heart to undergo many non-invasive imaging studies and sometimes invasive studies such as heart catheterization. Results of the studies provide valuable information used for treatment decisions and evaluation of heart function. We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects seen at Children's Healthcare of Atlanta with single ventrical heart

Description

Inclusion Criteria:

• Single Ventrical heart

Exclusion Criteria:

• those patients who do not have single ventrical heart

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.	We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.	13 years

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Angel Cuadrado, MD, Children's healthcare of Atlanta

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 19, 2005
• First Submitted That Met QC Criteria: December 19, 2005
• First Posted (Estimate): December 20, 2005

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: pediatric; cardiac; single ventricle
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Univentricular Heart
• Other Study ID Numbers: 03-005