Genesis Clinical Trial
The Genesis Feasibility Study is designed to collect clinical information on the use of the Over- The-Wire Mesh Ablation System (OTW MAS) to access and perform electrophysiological mapping, cardiac stimulation and radiofrequency ablation in the region of the pulmonary vein (PV) ostia for the treatment of patients with Paroxysmal Atrial Fibrillation. The OTW MAS is an electrophysiology catheter which has combined mapping and ablation capability.
The system is investigational and is not approved to be sold commercially in any geography.
Approximately 60 patients will participate in the study at a total of 6 locations in Canada (2) and Europe (UK 1/ Germany 3).
CAUTION: Investigational device. Limited by U.S. (Federal) law to investigational use.
