Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266942
Status:
TERMINATED
Last Update Posted:
2007-05-23
First Post:
2005-12-19
Brief Title:
Intra-Atrial vs Extra-Cardiac Technique During Fontan Operation
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
The Determination of Differences Between Intr-Atrial vs Extra-Cardiac Technique During the Fontan Operation A Retrospective Review
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
data collection ended
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 111980-3312005 Data from these cases would be potentially very helpful in answering all of these questions
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 111980-3312005 Data from these cases would be potentially very helpful in answering all of these questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None