1Design of the Primary Prevention Parameters Evaluation (PREPARE) trial of implantablecardioverter defibrillators to reduce patient morbidity [NCT00279279]

Bruce L Wilkoff^*¹ , Richard Stern^*² , Brian Williamson^*³ , Mark Wathen^*⁴ , Keith Holloman^*⁵ , Ann Fieberg^*⁵ and Mark Brown^*⁵

¹The Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA

²Doctors Medical Center, San Pablo, CA, USA

³William Beaumont Hospital, Troy, MI, USA

⁴Vanderbilt University, Nashville, TN, USA

⁵Medtronic, Inc, Minneapolis, MN, USA

author email corresponding author email* Contributed equally

Trials 2006, 7:18doi:10.1186/1745-6215-7-18


Published:	25 May 2006

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 Primary Prevention Parameters Evaluation (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).