Atrial Fibrillation Clinical Trial
Official title:
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure. Furthermore, safety, usability and clinical applicability of the system for guided AF ablation will be confirmed.
Prospective, single-center, non-randomized, non-blinded, open label, and single arm study.
All procedures will be performed under CARTO-3 guidance for the treatment of atrial
fibrillation (AF). The EPD D700 system will be used in-tandem, to record pre-, during and
immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality
and permanency. Additionally, D700 system safety, feasibility, usability and clinical
applicability will be documented.
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 EPD D700 system. The physician will neither use nor rely on any of the D700 system
output for clinical decision making and will be blinded to the D700 lesion assessment
forecasts. After 30 days following the initial procedure, a repeated procedure will be
performed for gap detection and its results will be correlated with the D700 predictions.
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