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Critical Congenital Heart Defect (CHD) Outcomes in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00208689
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Martha L. Clabby, MD, Emory University

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 21, 2005
Last Update Posted Date February 13, 2014
Study Start Date January 2004
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Critical Congenital Heart Defect (CHD) Outcomes in Children
Official Title A Review of the Diagnosis, Treatment and Outcomes of Children With Critical Congenital Heart Defects
Brief Summary

Congenital heart disease in infants and children often challenges healthcare providers both in regards to diagnosis and in the management of these conditions. The field becomes more complicated as one examines the myriad of defects that present and the complex care that is required. Over the last 20-25 years, the remarkable advances in the medical and surgical management of the most complex lesions have decreased neonatal mortality, such that many more survive the neonatal period. Therefore, new challenges regarding the continued care of this patient cohort of high-risk infants and children exist. In order to continue the improvement of treatment(s) offered to these patients, continuous review and analysis of the current standard of care is needed.

In this study, the investigators will collect information related to the current surgical and medical therapies offered to patients enrolled in the High Risk Congenital Heart Program at Children's Healthcare of Atlanta. All of the procedure and visit information will be a part of the child's standard of care. This information will be placed in a database. The investigators hope to learn more about the short-term and long-term effects of current therapies and procedures.

Detailed Description

Patients, age newborn to 21 years, followed in the High Risk Congenital Heart Defect Clinic at Children's Healthcare of Atlanta at Egleston will be asked to participate in this trial. The term "high risk" is assigned to a patient with the following diagnoses or medical problems: critical aortic stenosis, truncus arteriosus (with or without interrupted aortic arch), patients with complex single ventricle physiology (such as hypoplastic left heart syndrome, unbalanced AV canal, tricuspid atresia, transposition of the great vessels with ventricular septal defect and pulmonary stenosis, mitral atresia, pulmonary atresia with intact ventricular septum), left ventricular outflow tract obstruction requiring Konno procedure, transposition of the great vessels (with or without ventricular septal defect), pulmonary atresia with ventricular septal defect, interrupted aortic arch (with or without ventricular septal defect), anatomy requiring "double switch" procedure, aortic arch abnormality requiring transverse arch graft, total anomalous pulmonary venous return, anatomy requiring any of the following procedures: Damas-Kaye-Stansel procedure, ventricular septal defect enlargement, or resection of subpulmonic stenosis during arterial switch procedure, atrial septectomy, neonatal repositioning of the tricuspid valve for Ebstein anomaly, Ross procedure in infancy; mitral stenosis with mitral valve replacement in infancy, and any other cardiac abnormality requiring surgical repair in infancy with residual hemodynamically significant lesions. In addition, patients with infantile Marfan syndrome, or kawasaki disease with coronary artery aneurysm will also be included.

Informed consent will be obtained from the parent or legally authorized representative for all study participants. An Assent, either verbal or written, will also be obtained if the child is over the age of six (6). A sequential and unique subject number (i.e. NES.001, NES.002) will be assigned by the investigator or designee to each qualified subject after informed consent has been obtained. Once a subject number is assigned, it will not be used again by the investigator. Subjects who are asked to participate but refuse participation in the study will not be assigned a study number.

Investigational Plan:

A single-center, retrospective registry design will be utilized. After consent, the following data will be collected from each study participant's chart each time he or she attends clinic:

  • Name
  • Contact information (or confirm contact information)
  • Names of other care providers
  • Primary Diagnosis
  • Secondary Diagnoses
  • Age at time of visit
  • Vital signs including blood pressure, heart rate, respirations, pulse oximetry
  • Weight at time of visit
  • If applicable, echocardiography data including m-mode, tissue doppler and color flow Doppler
  • History and Physical including surgical history
  • Medications
  • Nutritional Status
  • Growth Parameters
  • If applicable, most recent standard of care laboratories
  • If applicable, MRI results
  • EKG findings

All procedures are standard of care. The collection of data for this registry will not effect the care provided to each patient. The individual physician has the right to diagnose and treat each patient according to standard of care procedures and his/her own medical judgement.

Participation in this registry will last as long as the patient is being followed in the high risk clinic at Children's Healthcare of Atlanta.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Congenital Heart Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Enrollment
 (submitted: September¬†13,¬†2005)
150
Original Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Critical congenital heart disease
  • Signed informed consent

Exclusion Criteria:

  • Not diagnosed with critical congenital heart disease
  • No signed informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00208689
Other Study ID Numbers 1058-2003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Martha L. Clabby, MD, Emory University
Study Sponsor Emory University
Collaborators Not Provided
Investigators
Principal Investigator: Martha Clabby, MD Emory University and Children's Healthcare of Atlanta
PRS Account Emory University
Verification Date February 2014