Atrial Flutter Clinical Trial
Official title:
EP Dynamics (EPD) Research First In Man Clinical Study
Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time
in humans, in subjects undergoing ablation for the treatment of atrial flutter.
Prospective, single-center, non-randomized, open label, single arm study. Ten consented
subjects who are scheduled to undergo ablation due to atrial flutter. All subjects will
undergo baseline assessment; intervention (standard fluoroscopy guided RF ablation procedure)
and post procedure follow up. All subjects will have a follow up visit within 24 hours post
procedure.
All procedures will be performed under standard fluoroscopic guidance for the treatment of
atrial flutter ablation procedure, and the D700 system will be used additionally to
demonstrate system safety, feasibility and usability.
The entire procedure will be conducted as customary, using standard and approved off-
the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF
generator and recording system), in a completely clinically independent manner from the D700
system that will merely be a 'silent witness'. The operator will neither use nor rely on any
of the D700 system output for clinical decision making.
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