Atrial Fibrillation Clinical Trial
Official title:
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular hospitalizations.
Kristensen et al. reported that AAIR pacing reduces atrial fibrillation (AF) development
compared to DDDR pacing in sinus node disfunction patients.
Several authors have shown that, in patients with intact AV conduction, unnecessary chronic
RV pacing can cause detrimental effects such as AF, left ventricular (LV) dysfunction and
congestive heart failure. These findings arose the hypothesis that the non-physiologic
nature of ventricular pacing may result in electrophysiological and LV remodeling changes
that have potentially deleterious long-term effects.
The MVP mode, present in the Medtronic pacemaker EnRhythm, provides atrial based pacing with
ventricular backup. It operates in true AAI(R) mode, it provides ventricular backup in case
of a single conduction loss and converts to DDD(R) mode in case of persistent loss of AV
conduction.
Aim of this study is to test the impact of the MVP pacing mode and atrial preventive and
antitachycardia pacing therapies on the reduction of a composite clinical outcome composed
by any death, permanent AF, cardiovascular hospitalizations.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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