Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
AF Septal Pacing (Clinical Investigation Plan)
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum. The possibility to terminate atrial arrythmias will also be evaluated.
The evidence of treating AF by pacing is limited, although these algorithms are of interest,
since they appear to be safe and usually add little additional cost.
Using a computer model, a new dual-stage septal pacing has been developed.The proposed septal
pacing algorithm could suppress AF reentries in a more robust way than classical single site
rapid pacing. The feasibility of pacing both atria simultaneously from a single lead placed
in the interatrial septum has been previously demonstrated clinically. The septal pacing
concept has also been successfully tested in a computer model of AF and in a pig model .
Experimental studies are now needed to determine whether similar termination mechanisms and
efficacies can be observed in humans.
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to
evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on
the interatrial septum
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