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

Sponsor
Children's Healthcare of Atlanta (Other)
Overall Status
Terminated
CT.gov ID
NCT00266942
Collaborator
(none)
400
Enrollment
1
Location
204
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    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 :
    Jan 1, 1990
    Study Completion Date :
    Jan 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 18 Years
      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

      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: Jason M. Budde, MD, Children's Healthcare of Atlanta

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00266942
      Other Study ID Numbers:
      • 05-109
      First Posted:
      Dec 20, 2005
      Last Update Posted:
      May 23, 2007
      Last Verified:
      May 1, 2007
      Keywords provided by , ,
      Fontan procedure
      single ventricle physiology
      intra-atrial
      extracardiac technique

      Study Results

      No Results Posted as of May 23, 2007