The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients. The expected benefits will be a result of the reduction of the percentage of ventricular pacing. It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation. The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
650
AAISafeR/SafeR ON
DDD(R) (SafeR OFF)
736 Cambridge Street
Brighton, Massachusetts, United States
CHU - Hopital Sud
Amiens, France
Centre hospitalier de Béthune
Béthune, France
CHU - Hopital Michallon
Grenoble, France
CHP Beauregard
Marseille, France
CHU A de Villeneuve
The outcome measure is the % of ventricular pacing and hospitalizations for specified cardiac reasons (symptomatic AF, cardioversions for AF and heart failure)
Time frame: 3 years
Evolution of paroxysmal AV blocks
Time frame: 3 years
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Montpellier, France
Clinique Bizet
Paris, France
CHU Hopital C. Nicolle
Rouen, France
CCN
Saint-Denis, France
CHU - Hopital Nord
Saint-Etienne, France
...and 27 more locations