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

NCT ID: NCT00266942

Last Updated: 2007-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

1990-01-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Congenital Disorders

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Healthcare of Atlanta

OTHER

Sponsor Role lead

Principal Investigators

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Jason M. Budde, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Healthcare of Atlanta

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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05-109

Identifier Type: -

Identifier Source: org_study_id