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NCT00268021 · ClinicalTrials.gov registry record
Automated Cardioverter Defibrillator in Children
A clinical trial of Congenital Disorders, sponsored by Children's Healthcare of Atlanta.
- Completed
- Registry status
- 34
- Enrollment target
- 1
- Study location
NCT00268021: Completed study of Congenital Disorders, sponsored by Children's Healthcare of Atlanta.
NCT00268021 is a study of Congenital Disorders that has completed, run by Children's Healthcare of Atlanta. The registered enrollment target is 34 participants, below the 526-participant average among 4 other Congenital Disorders trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00268021, a study of Congenital Disorders, has completed, sponsored by Children's Healthcare of Atlanta.
- COMPLETED
- Registry status
- 34 participants
- Enrollment target
- 1
- Study location
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 Studied
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 1998-01 |
What the finished NCT00268021 record still lists
NCT00268021 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 526-participant average among 4 other Congenital Disorders trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Congenital Disorders appearing as the primary indexed condition, and to 0 interventions.
NCT00268021 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT00268021 about?
NCT00268021 is a clinical study titled "Automated Cardioverter Defibrillator in Children". 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-suppressibl...
What is the current status of trial NCT00268021?
This trial is currently completed. The enrollment target is 34 participants. The study started on 1998-01.
What conditions does trial NCT00268021 study?
This clinical trial studies the following conditions: Congenital Disorders.
Who is sponsoring clinical trial NCT00268021?
This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00268021 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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