Sinus Node Dysfunction Clinical Trial
Official title:
Spontaneous Atrio Ventricular Conduction Preservation
In case of sinus node dysfunction, it is often necessary to choose the safer option provided
by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.
In addition to saving energy, the latter mode allows spontaneous ventricular activation, the
haemodynamic consequences of which are, in most cases, better than those obtained with dual
chamber pacing.
Recent studies as the MOST study suggest also that ventricular desynchronization imposed by
right ventricular apical pacing even when AV synchrony is preserved increases the risk of
atrial fibrillation in patients with SND. Similar results were already given by anterior
studies (PIPAF) which, taking into account the percentage of ventricular pacing, suggested
that AF prevention algorithm in combination with a preserved native conduction are efficient
in reducing AF burden.
However, current practice is to implant a dual chamber pacemaker to prevent the risk of
atrioventricular block (AVB) even if DDDR pacing with a fixed long AV delay was found
inefficient in reducing ventricular pacing and was associated with a high risk of
arrhythmias.
The Symphony 2550 cardiac pacemaker offers pacing modes that automatically switch from
AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder,
irrespective of whether or not these are accompanied by an atrial arrhythmia, returning
spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. These 2
particular modes are called the AAI SafeR and DDD/AMC (R) mode.
The main differences between both modes are that (i) AAI SafeR does not trigger any AV Delay
after a sensed or paced atrial event which allows long PR intervals or even limited
ventricular pauses with no switch to DDD(R), while (ii) DDD/AMC (R) is able to optimize AV
Delay after switching to DDD(R) according to measured spontaneous conduction times and to
provide an acceleration in case of vaso-vagal syndrome. This pacing mode has previously been
assessed in clinical studies.
This study intends to demonstrate that the automatic modes switching significantly reduce
the percentage of ventricular pacing in patients implanted with a spontaneous AV conduction
and reduce the occurrence of atrial arrhythmias, on a mid-term follow-up period, in
comparison to standard DDD pacing with long AVDelay.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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