The MINERVA study design and rationale: A controlled randomized trial to assess the clinical benefit of minimizing ventricular pacing in pacemaker patients with atrial tachyarrhythmias

Reinhard C. Funck, Giuseppe Boriani, Antonis S. Manolis, Helmut Püererfellner, Luis Mont, Raymond Tukkie, André Pisapia, Carsten W. Israel, Nicoletta Grovale, Andrea Grammatico, Luigi Padeletti

Research output: Contribution to journalArticle

Abstract

Background: Dual-chamber (DDD) pacing has generally been regarded as "physiologic pacing" and therefore expected to be superior to ventricular pacing. Major randomized trials have so far failed to demonstrate significant reductions in the incidences of mortality, stroke, and heart failure. It has been shown that unnecessary ventricular pacing in patients with sinus node dysfunction or only intermittent atrioventricular block is associated with ventricular desynchronization and increased risk of atrial tachyarrhythmias (ATA). Methods: The MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure (MINERVA) study is a prospective, multi-center, randomized, international, single-blind, controlled trial designed to determine whether physiologic pacing through the managed ventricular pacing (MVP) algorithm combined with preventive atrial pacing (PAP) and atrial antitachycardia pacing (ATP) is superior to standard DDD pacing in terms of 2-year reduction in death, permanent ATA, and cardiovascular hospitalizations. Patients with standard class I or II indications for permanent DDD pacing and history of ATA will receive a Medtronic EnRhythm implantable pacemaker (Medtronic, Minneapolis, MN). After a 1-month run-in period, patients will be randomized in a 1:1:1 manner to the DDD (control group, all OFF), the DDDRP (MVP + PAP + ATP ON), and the MVP group (only MVP ON). Up to 1,300 patients will be included in approximately 70 centers in Europe, the Middle East, and Asia. Conclusions: The MINERVA study will make an important contribution to the management of patients with paroxysmal ATA and accepted indications for dual-chamber pacemaker implantation by determining whether physiologic pacing combined with PAP and ATP is superior to standard DDD pacing in terms of reduction of mortality, incidence of permanent ATA, and cardiovascular hospitalizations.

Original languageEnglish
Pages (from-to)445-451
Number of pages7
JournalAmerican Heart Journal
Volume156
Issue number3
DOIs
Publication statusPublished - Sep 2008

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Funck, R. C., Boriani, G., Manolis, A. S., Püererfellner, H., Mont, L., Tukkie, R., Pisapia, A., Israel, C. W., Grovale, N., Grammatico, A., & Padeletti, L. (2008). The MINERVA study design and rationale: A controlled randomized trial to assess the clinical benefit of minimizing ventricular pacing in pacemaker patients with atrial tachyarrhythmias. American Heart Journal, 156(3), 445-451. https://doi.org/10.1016/j.ahj.2008.05.004