Overview

This trial is active, not recruiting.

Condition pacemaker implantation for sinus node disease
Treatment pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
Sponsor Deutsches Herzzentrum Muenchen
Collaborator Klinikum Bamberg
Start date November 2007
End date December 2011
Trial size 70 participants
Trial identifier NCT01803217, GER-EP-010

Summary

Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators.

The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
(Active Comparator)
pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function

Primary Outcomes

Measure
Right ventricular pacing percentage
time frame: 3 months

Secondary Outcomes

Measure
BNP levels
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Indication for the implantation of a dual-chamber pacemaker Exclusion Criteria: Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator

Additional Information

Official title AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing
Description Comparison of the effect of an atrioventricular hysteresis function with a mode switch to atrial pacing on the right ventricular pacing percentage in a multi-centre, prospective, randomized, single blinded, cross-over study.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Deutsches Herzzentrum Muenchen.