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Intra-Atrial vs. Extra-Cardiac Technique During Fontan Operation

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ClinicalTrials.gov Identifier: NCT00266942
Recruitment Status : Terminated (data collection ended)
First Posted : December 20, 2005
Last Update Posted : May 23, 2007
Information provided by:
Children's Healthcare of Atlanta

Brief Summary:
Our aim is a retrospective chart review seeking to determine any differences in the main clinical and outcome variables as well as general outcome data such as functional recovery, readmission rates, somatic growth and mortality. An n size of 150 to 200 for each of the 2 groups will give us excellent power to detect potential differences.

Condition or disease
Congenital Disorders

Detailed Description:

The Fontan procedure is indicated as final-stage treatment for pediatric cardiac patients with single ventricle physiology. This procedure, whose aim is to provide for total cavopulmonary disconnect and perfusion of the pulmonary arteries via systemic veins, is performed via two differing techniques: intra-atrial, so-called lateral tunnel technique, employing PTFE graft material and internal atrial baffle, versus the extracardiac technique, using larger PTFE tubing and externally constructed baffle.

There is persistent debate regarding the optimal technique to use, centered around the following main issues: 1) need for use of cardiopulmonary bypass and attendant consequences, 2) rates of thrombosis and embolism, 3) incidence of postoperative protein-losing enteropathy (PLE), 4) incidence of arrhythmias, and 5) baffle patency rates. A handful of small- to medium-sized studies has addressed the above issues, but, importantly, has not used patient data from the same institution. Here at CHOA, there are an estimated 200+ lateral tunnel, and have been up to 125 to 150 extracardiac Fontan procedures, performed in the last 15 years (1.1.1980-3.31.2005). Data from these cases would be potentially very helpful in answering all of these questions.

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: The Determination of Differences Between Intr-Atrial vs. Extra-Cardiac Technique During the Fontan Operation: A Retrospective Review
Study Start Date : January 1990
Estimated Study Completion Date : January 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children's Healthcare of Atlanta patients
  • lateral tunnel procedure during 1.1.1990-3.31.2005
  • extracardiac Fontan procedures during 1.1.1990 - 3.31.2005

Exclusion Criteria:

  • those who do not meet inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266942

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Principal Investigator: Jason M. Budde, MD Children's Healthcare of Atlanta

ClinicalTrials.gov Identifier: NCT00266942     History of Changes
Other Study ID Numbers: 05-109
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: May 23, 2007
Last Verified: May 2007

Keywords provided by Children's Healthcare of Atlanta:
Fontan procedure
single ventricle physiology
extracardiac technique