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Automated Cardioverter Defibrillator in Children
| Tracking Information | ||||
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| First Received Date ICMJE | December 20, 2005 | |||
| Last Updated Date | November 26, 2014 | |||
| Start Date ICMJE | January 1998 | |||
| Primary Completion Date | Not Provided | |||
| Current Primary Outcome Measures ICMJE | Not Provided | |||
| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | Complete list of historical versions of study NCT00268021 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Automated Cardioverter Defibrillator in Children | |||
| Official Title ICMJE | 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 |
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| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Subjects with AICD or BiV insertions | |||
| Condition ICMJE | Congenital Disorders | |||
| Intervention ICMJE | Not Provided | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 34 | |||
| Completion Date | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 21 Years (Child, Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00268021 | |||
| Other Study ID Numbers ICMJE | 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 ICMJE | Children's Healthcare of Atlanta | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Children's Healthcare of Atlanta | |||
| Verification Date | November 2014 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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