Automated Cardioverter Defibrillator 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. Identifier: NCT00268021
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Children's Healthcare of Atlanta

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.

Condition or disease
Congenital Disorders

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
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of Automated Cardioverter Defibrillator in Children (AICD)
Study Start Date : January 1998

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with AICD or BiV insertions

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268021

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Principal Investigator: Kirk R Kanter, MD Children's Healthcare of Atlanta

Responsible Party: Children's Healthcare of Atlanta Identifier: NCT00268021     History of Changes
Other Study ID Numbers: 04-082
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Children's Healthcare of Atlanta:
biventricular pacemaker
automated implantable cardioverter defibrillator