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Published in: Trials 1/2006

Open Access 01-12-2006 | Study protocol

I Design of the Primary Prevention Parameters Evaluation (PREPARE) trial of implantablecardioverter defibrillators to reduce patient morbidity [NCT00279279]

Authors: Bruce L Wilkoff, Richard Stern, Brian Williamson, Mark Wathen, Keith Holloman, Ann Fieberg, Mark Brown

Published in: Trials | Issue 1/2006

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Abstract

Background

Implantable Cardioverter Defibrillator (ICD) therapy has been proven to be beneficial and efficacious for the treatment of serious ventricular tachyarrhythmias in primary prevention patients. However, primary prevention patients appear to have a lower incidence of ventricular arrhythmias in comparison to secondary prevention patients and consequently likely experience a higher proportion of detections due to supraventricular arrhythmias. Recent trials have demonstrated that strategic and specific programming choices reduce the number of inappropriate shocks and that anti-tachycardia pacing (ATP) is an effective alternative to shock therapy for many sustained ventricular arrhythmias.

Methods

The P rimary Pre vention Par ameters E valuation (PREPARE) study is a multi-center cohort study, evaluating the efficacy of a pre-specified strategic profile of VT/VF detection and therapy settings in 700 primary prevention patients in an effort to safely reduce the number of shock therapies delivered. The patients, both with and without cardiac resynchronization therapy, are compared to a well-qualified set (n = 691) of historical controls derived from the MIRACLE ICD and EMPIRIC trials. This manuscript describes the design of the PREPARE study. The study results, to be presented separately, will characterize the efficacy of this programming set (PREPARE) compared with physician-tailored programming (MIRACLE ICD and EMPIRIC).
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Metadata
Title
I Design of the Primary Prevention Parameters Evaluation (PREPARE) trial of implantablecardioverter defibrillators to reduce patient morbidity [NCT00279279]
Authors
Bruce L Wilkoff
Richard Stern
Brian Williamson
Mark Wathen
Keith Holloman
Ann Fieberg
Mark Brown
Publication date
01-12-2006
Publisher
BioMed Central
Published in
Trials / Issue 1/2006
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-7-18

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