A trial design for evaluation of empiric programming of implantable cardioverter defibrillators to improve patient management

A trial design for evaluation of empiric programming of implantable cardioverter defibrillators to improve patient management

The delivery of implantable cardioverter defibrillator (ICD) therapy is sophisticated and requires the programming of over 100 settings. Physicians tailor these settings with the intention of optimizing ICD therapeutic efficacy, but the usefulness of this approach has not been studied and is unknown...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine Vol. 5; no. 1; p. 12
Main Authors: Morgan, John M, Sterns, Laurence D, Hanson, Jodi L, Ousdigian, Kevin T, Otterness, Mary F, Wilkoff, Bruce L
Format: Journal Article
Language:English
Published: England BioMed Central 12-11-2004
BioMed Central Ltd
BMC
Subjects:
Cardiac arrhythmia
Clinical trials
Data collection
detection
empiric
Hypotheses
ICD
Implantable cardioverter defibrillator
Medical practices
Morbidity
Patients
Physicians
programming
Review
shocks
therapy
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Summary:The delivery of implantable cardioverter defibrillator (ICD) therapy is sophisticated and requires the programming of over 100 settings. Physicians tailor these settings with the intention of optimizing ICD therapeutic efficacy, but the usefulness of this approach has not been studied and is unknown. Empiric programming of settings such as anti-tachycardia pacing (ATP) has been demonstrated to be effective, but an empiric approach to programming all VT/VF detection and therapy settings has not been studied. A single standardized empiric programming regimen was developed based on key strategies with the intention of restricting shock delivery to circumstances when it is the only effective and appropriate therapy. The EMPIRIC trial is a worldwide, multi-center, prospective, one-to-one randomized comparison of empiric to physician tailored programming for VT/VF detection and therapy in a broad group of about 900 dual chamber ICD patients. The trial will provide a better understanding of how particular programming strategies impact the quantity of shocks delivered and facilitate optimization of complex ICD programming.
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ISSN:1468-6708
1468-6694
1745-6215
DOI:10.1186/1468-6708-5-12