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

• 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
• DOI: 10.1186/1468-6708-5-12
• EISSN: 1468-6694; 1745-6215
• ISSN: 1468-6708

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.