Study protocol

Design of the Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients

Jane Chen^{* 1} , Bruce L Wilkoff² , Wassim Choucair^{* 3} , Todd J Cohen^{* 4} , George H Crossley^{* 5} , W Ben Johnson^{* 6} , Luc R Mongeon^{* 7} , Gerald A Serwer^{* 8} and Lou Sherfesee^{* 7}

¹Department of Internal Medicine, Cardiovascular Division, Washington University School of Medicine, Saint Louis, Missouri, USA

²Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA

³Cardiology Associates of Corpus Christi, Corpus Christi, Texas, USA

⁴Department of Medicine, Winthrop University Hospital, Mineola, New York, USA

⁵Electrophysiology Department, St. Thomas Research Institute, Nashville, Tennessee, USA

⁶Iowa Heart Center, Des Moines, Iowa, USA

⁷Medtronic, Inc, Minneapolis, Minnesota, USA

⁸Department of Pediatrics, University of Michigan Congenital Heart Center, University of Michigan Health System, Ann Arbor, Michigan, USA

author email corresponding author email* Contributed equally

Trials 2008, 9:18doi:10.1186/1745-6215-9-18

Published:	3 April 2008

Abstract

Background

Although pacemakers are primarily used for the treatment of bradycardia, diagnostic data available in current pacemakers allow them to be also used as sophisticated, continuous monitoring devices. Easy access to these stored data may assist clinicians in making diagnostic and therapeutic decisions sooner, thus avoiding potential long-term sequelae due to untreated clinical disorders. Internet-based remote device interrogation systems provide clinicians with frequent and complete access to stored data in pacemakers. In addition to monitoring device function, remote monitors may be a helpful tool in assisting physicians in the management of common arrhythmia disorders.

Methods

The Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial is a prospective, randomized, parallel, unblinded, multicenter, open label clinical trial to determine the utility of remote pacemaker interrogation in the earlier diagnosis of clinically actionable events compared to the existing practice of transtelephonic monitoring. There have been 980 patients enrolled and randomized to receive pacemaker follow up with either remote interrogation using the Medtronic CareLink^® Network (CareLink) versus the conventional method of transtelephonic monitoring (TTM) in addition to periodic in-person interrogation and programming evaluations. The purpose of this manuscript is to describe the design of the PREFER trial. The results, to be presented separately, will characterize the number of clinically actionable events as a result of pacemaker follow-up using remote interrogation instead of TTM.

Trial registration

ClinicalTrials.gov: NCT00294645.