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Automated Cardioverter Defibrillator in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Children's Healthcare of Atlanta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00268021
First received: December 20, 2005
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of Automated Cardioverter Defibrillator in Children (AICD)

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 34
Study Start Date: January 1998
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

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with AICD or BiV insertions

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268021

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

No publications provided

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00268021     History of Changes
Other Study ID Numbers: 04-082
Study First Received: December 20, 2005
Last Updated: April 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014