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Automated Cardioverter Defibrillator in Children

NCT00268021 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2014-12-02

No results posted yet for this study

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.

Conditions

  • Congenital Disorders

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    lead OTHER

Principal Investigators

  • Kirk R Kanter, MD · Children's Healthcare of Atlanta

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00268021 on ClinicalTrials.gov