Viewing Study NCT00446160



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00446160
Status: COMPLETED
Last Update Posted: 2019-02-21
First Post: 2007-03-09

Brief Title: Adult Congenital Heart Disease Surgery
Sponsor: Emory University
Organization: Emory University

Study Overview

Official Title: Proposal for Retrospective Review of an Adult Congenital Heart Surgery Program
Status: COMPLETED
Status Verified Date: 2019-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: It is now estimated that the number of adults with congenital heart disease in the US is over 800000 Unfortunately these patients in some way have become a lost population They have congenital abnormalities familiar to a childrens hospital yet have surpassed the age cutoff for admission

Recently we have developed a specialized program to care for this unique patient population Dedicated programs such as ours hope to optimize patient care consolidate specialized resources provide sufficient patient numbers for training and maintain expertise and facilitate research in this unique population
Detailed Description: In the United States approximately 30000 children are born with congenital heart disease every year As technology operative technique and critical care medicine have improved significantly over the years more of these children are surviving into adulthood

Care of the congenital cardiac surgical patient requires a concerted effort on the part of the surgeons perfusionists anesthesiologists intensivists nurses respiratory therapists rehabilitation services and social workers It is hoped that the same excellent care received in a childrens congenital heart surgery program can be continued as these patients graduate into an adult program

This is a retrospective chart review examining patients over the age of 18 years who have undergone operations for congenital heart disease The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location personnel and case type All charts reviewed will be of patients who had their surgery at Childrens Healthcare of Atlanta or Emory University between January 1 2000 and December 31 2006 We will review approximately 225 charts for this study

The first aim of the study would be to examine the demographics of the adult congenital heart surgery program itself The following information will be collected

Location of the surgery - childrens hospital vs adult hospital
Surgeon - adult cardiac surgeon vs congenital cardiac surgeon

The second aim of the study would be to analyze the types of surgeries being performed The following information will be collected

Pathologic diagnosis
Number of re-operative sternotomies
Number of open-heart surgeries

The third aim of the study would be to analyze our outcomes The following information will be collected

- Number of surgical mortalities

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