Adult Congenital Heart Disease Surgery

Congenital Disorders Clinical Trial

Official title:

Proposal for Retrospective Review of an Adult Congenital Heart Surgery Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446160
• Other study ID #: IRB00002790
• Status: Completed
• Start date: January 2000
• Est. completion date: July 1, 2016

Study information

• Verified date: February 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is now estimated that the number of adults with congenital heart disease in the U.S is over 800,000. Unfortunately, these patients, in some way, have become a lost population. They have congenital abnormalities familiar to a children's 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.

Description:

In the United States, approximately 30,000 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 children's 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 Children's 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 - children's 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• surgery at Children's Healthcare of Atlanta or Emory University between 1.1.2000 and 12.31.2007

• surgery on patients after 18 years to approximately 65 years of age

Exclusion Criteria:

• Those who do not meet inclusion criteria

Related Conditions & MeSH terms

• Congenital Disorders
• Heart Diseases

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Retrospective chart review