Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268021
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2005-12-20
Brief Title:
Automated Cardioverter Defibrillator in Children
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
The Use of Automated Cardioverter Defibrillator in Children AICD
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Automated implantable cardioverter defibrillators AICD and BiventricularBiV 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 infarction14 Pediatric patients with a variety of different heart abnormalities are at high risk for life threatening arrhythmias and poor ventricular function or heart failure16 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 anomalies1 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 similar16 However this patient population behaves differently from the adult population in the incidence of pacemaker complications circadian arrhythmias7 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 Childrens 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 381 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 informationdiagnoses 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 transfusionbleeding Hospital Re-admission MortalityMorbidity information Cause of inappropriate AICD dischargeshock Long term complications
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 381 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 informationdiagnoses 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 transfusionbleeding Hospital Re-admission MortalityMorbidity information Cause of inappropriate AICD dischargeshock Long term complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None