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Automated Cardioverter Defibrillator in Children
NCT00268021 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00268021
The ClinicalTrials.gov registry entry for NCT00268021 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Healthcare of Atlanta, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Congenital Disorders appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00268021 reports 1 study location spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00268021?
This trial is sponsored by Children's Healthcare of Atlanta, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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