Automated Cardioverter Defibrillator in Children
The Use of Automated Cardioverter Defibrillator in Children (AICD)
The Use of Automated Cardioverter Defibrillator in Children (AICD)
Sponsor study identifier
observational
34
1 country
1
Study Start
January 1998
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedAutomated 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1998
Date type not reportedThis date has not been verified as actual or estimated.
December 20, 2005
Actual (reported)December 22, 2005
Actual (reported)Subjects with AICD or BiV insertions
Contact the study team to confirm eligibility.
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Kirk R Kanter, MD
Children's Healthcare of Atlanta
34 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2005
First Posted
December 22, 2005
Study Start
January 1998
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
December 2, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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