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

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Congenital Disorders

Clinical Trial Details

NCT number	NCT00266942
Study type	Observational
Source	Children's Healthcare of Atlanta
Contact
Status	Terminated
Phase	N/A
Start date	January 1990
Completion date	January 2007

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Not yet recruiting	`NCT03291678` - Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy	N/A
Completed	`NCT00489788` - Predictors for Pulmonary Valve Replacement - Anatomic and Hemodynamic Using MRI	N/A
Terminated	`NCT00268060` - Infant Medical Records: Case Report Proposal	N/A
Not yet recruiting	`NCT05955794` - Vocal Pattern Assessment as a New Key to Identifying Rare Syndromes	N/A
Completed	`NCT00257517` - Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle	N/A
Completed	`NCT00478296` - Pulmonary Hypertension in Trisomy 21 Patients	N/A
Completed	`NCT04556487` - Turkish Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)
Terminated	`NCT00261989` - Pulse Oximetry Readings and Hourly Variation in Oximetry Readings With CHD	N/A
Completed	`NCT00211081` - Spironolactone in Patients With Single Ventricle Heart	N/A
Terminated	`NCT00268099` - Optimal Timing for Repair of Right-to-Left Shunt Lesions	N/A
Active, not recruiting	`NCT05752019` - TAAI Erasmus Research Initiative to Fight CF: Monitoring Inflammation in CF Lung Disease Into a New Era
Completed	`NCT00490295` - Biomarkers for Detection of Brain Ischemia	N/A
Terminated	`NCT00327899` - Home Inotropic Therapy in Children	N/A
Terminated	`NCT00229905` - Child With Anomalous Drainage of IVC to Left Atrium	N/A
Completed	`NCT00277901` - MRI Assessment of RV Function: Patients With TOF or Aortic Coarctation	N/A
Terminated	`NCT00366314` - Frequency of Accessing Central Lines for Blood Samples	N/A
Terminated	`NCT00268034` - Left Ventricular Aneurysms in Children	N/A
Completed	`NCT00366847` - Computer Modeling of Congenital Heart Disease	N/A
Withdrawn	`NCT00460824` - A Retrospective Review - Anti-HLA Antibodies	N/A