Automated Cardioverter Defibrillator in Children

Tracking Information
First Submitted Date	December 20, 2005
First Posted Date	December 22, 2005
Last Update Posted Date	December 2, 2014
Study Start Date	January 1998
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00268021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Automated Cardioverter Defibrillator in Children
Official Title	The Use of Automated Cardioverter Defibrillator in Children (AICD)
Brief Summary	Automated implantable cardioverter defibrillators ,AICD, and Biventricular,BiV, Pacemakers have been shown in randomized trials to offer an advantage in adults with decreased ventricular ejection fraction, heart failure, spontaneous non-sustained ventricular tachycardia VT, inducible non-suppressible VT and the combination of low ejection fraction and prior myocardial infarction,14. Pediatric patients with a variety of different heart abnormalities are at high risk for life threatening arrhythmias and poor ventricular function or heart failure,16. Therefore, extrapolating this adult data, AICDs and BiV pacemakers have been used with increasing frequency in the pediatric and congenital heart disease population. Improvements in device size and lead design allows AICD and BiV implantation in the very young, in small size patients and in patients with complex cardiac anomalies,1. The use of BiV pacemakers and the patterns of AICD discharge are similar in young patients and in adults, suggesting that the risk of life threatening arrhythmia and heart failure are also similar,16. However, this patient population behaves differently from the adult population in the incidence of pacemaker complications, circadian arrhythmias,7, and more importantly, a relatively high incidence of complications related to AICD insertion, 8. There is a need for more studies to establish the risk-benefit ratio of these devices in the pediatric setting.
Detailed Description	This is a retrospective review of all the patients that had an AICD or BiV pacemakers inserted at Children's Healthcare of Atlanta at Egleston, Emory University, between January 1st, 1998 and July 30th, 2004. The goal of our study is to establish the prevalence of beneficial and adverse effects in the AICD and BiV patient population. Demographic, clinical and electrophysiologic characteristics during the hospitalization as well as at follow-up will be obtained from the medical records and are summarized in the following tables Note: We defined infection as elevated temperature above 38.1 C associated with elevated WBC and positive cultures. Appendix A We plan to collect the following demographic information. Age Weight Delivery method Gestational age Weight at birth Delivery complications Cardiac anomalies Other anomalies We plan to collect the following medical information/diagnoses. Indication Cardiac arrest Sustained ventricular tachycardia Inducible ventricular tachycardia Syncope Palpitations Severe hypertrophic cardiomyopathy Congenital heart disease Primary electrical disease Hypertrophic cardiomyopathy Idiopathic dilated cardiomyopathy We will collect the following AICD information. Lead Transvenous Subcutaneous array Epicardial patches Generator type We will collect the following outcomes information (AICD and BiV). Variable Appropriate discharge (AICD only) Inappropriate discharge (AICD only) Lead failure Overall survival Hospital Length of Stay Infection Blood transfusion/bleeding Hospital Re-admission Mortality/Morbidity information Cause of inappropriate AICD discharge/shock Long term complications
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Subjects with AICD or BiV insertions
Condition	Congenital Disorders
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	Completed
Actual Enrollment; (submitted: April 10, 2012)	34
Original Enrollment	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: patients with AICD inserted at Children's Healthcare of Atlanta; patients with BiV pacemaker inserted at Children's Healthcare of Atlanta; insertions between 1.1.1998 and 7.30.2004 Exclusion Criteria: those patients who do not meet inclusion criteria
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	NCT00268021
Other Study ID Numbers	04-082
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Children's Healthcare of Atlanta
Study Sponsor	Children's Healthcare of Atlanta
Collaborators	Not Provided
Investigators	Principal Investigator: Kirk R Kanter, MD Children's Healthcare of Atlanta
PRS Account	Children's Healthcare of Atlanta
Verification Date	November 2014