The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization \[VRS\]) will be assessed in a combined pathway, compared to a control group. The efficacy of the overall available therapies to prevent AF and its symptoms will then be assessed also.
Due to anti-arrhythmic pharmacological drugs failure to suppress atrial fibrillation (AF), interest towards preventive pacing treatments is increasing. The importance of this option in the panoply of the preventive tools is fully justified, only by considering the insufficiency, the complexity, or the poor reproducibility of the other non-pharmaceutical approaches. Preventive pacing therapies rely on their potential effect on different onset modalities emphasized by previous studies, and more generally by stabilizing atrial tissue when potential triggers are appearing. On top of that, cardiac stimulator can deliver these therapies when identifying these triggers but also can offer incomparable diagnostic tools, in terms of sensitivity, specificity and continuity in the monitoring. Four preventive pacing therapies have already been evaluated, the objective of this study is to show the clinical benefit brought by the new features of the Selection 9000 / Vitatron T70 DR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
360
Show clinical benefit of post-AF response and VRS algorithms, when combined versus compared with a control group: In a conventional dual chamber (DDD) configuration
In a configuration including all the preventive pacing therapies of the device
The primary endpoint is the atrial fibrillation burden.
Assess the effect of post-AF response and VRS, when combined versus compared with a control group, in a conventional DDD configuration and another configuration which includes all PPT, on: Number (Nb) of hospitalizations
Nb of cardioversions
Symptom score
Restarts
Daily incidence of AF
Mean sinus rhythm duration
Assess clinical benefit of the overall AF therapies, as compared with the first four algorithms of the previous device (one continuous overdrive +3 triggered overdrive), on the same outcomes as above and AF burden
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CHG
Abbeville, France
RECRUITINGHopital Privé
Antony, France
RECRUITINGCH
Auxerre, France
RECRUITINGCH
Avignon, France
RECRUITINGClinique de Bordeaux Cauderan
Bordeaux, France
RECRUITINGCHU
Caen, France
RECRUITINGCH
Castres, France
RECRUITINGHIA Percy
Clamart, France
RECRUITINGCH
Colmar, France
COMPLETEDCH René Pleven
Dinan, France
RECRUITING...and 27 more locations