PACING
Managed ventricular pacing vs. conventional dual-chamber pacing for elective replacements: the PreFER MVP study: clinical background, rationale, and design
1 Department of Cardiology, Hospital General Universitario de Valencia, Avenida Tres Cruces s/n, Valencia 46014, Spain; 2 S. Anna Hospital, Como, Italy; 3 Klinikum der Justus-Liebig-Universitat Gießen, Gießen, Germany; 4 University Hospital Brno Bohunice, Czech Republic; 5 Landeskrankenhaus—Universitätsklinikum Graz, Graz, Austria; 6 Aarhus Universitetshospital, Skejby, Denmark; 7 Centre Cardiologique du Nord, Saint-Denis, France; 8 San Filippo Neri Hospital, Rome, Italy; 9 Johann-Gutenberg-Universität, Mainz, Germany; 10 Medtronic Bakken Research Center B.V., Maastricht, The Netherlands; 11 Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium
Aims: Several clinical studies have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can be detrimental. The managed ventricular pacing (MVP) algorithm is designed to give preference to spontaneous AV conduction, thus minimizing RV pacing. The clinical outcomes of MVP are being studied in several ongoing trials in patients undergoing a first device implantation, but it is unknown to what extent MVP is beneficial in patients with a history of ventricular pacing. The purpose of the Prefer for Elective Replacement MVP (PreFER MVP) study is to assess the superiority of the MVP algorithm to conventional pacemaker and implantable cardioverter-defibrillator programming in terms of freedom from hospitalization for cardiovascular causes in a population of patients exposed to long periods of ventricular pacing.
Methods and results: PreFER MVP is a prospective, 1:1 parallel, randomized (MVP ON/MVP OFF), single-blinded multi-centre trial. The study population consists of patients with more than 40% ventricular pacing documented with their previous device. Approximately, 600 patients will be randomized and followed for at least 24 months. The primary endpoint comprises cardiovascular hospitalization.
Conclusion: The PreFER MVP trial is the first large prospective randomized clinical trial evaluating the effect of MVP in patients with a history of RV pacing.
Key Words: Right ventricular, Managed ventricular pacing, Congestive heart failure, Atrial fibrillation
* Corresponding author: C/Gongora 1, 26, Valencia 46015, Spain. Tel: +34 961 972 155; fax: +34 961 972 161. E-mail address: quesada_aur{at}gva.es
ClinicalTrials.gov identifier NCT00293241
[ClinicalTrials.gov]
Manuscript submitted 11 November 2007. Accepted after revision 19 January 2008.