The device under evaluation is the 4mm Therapy™ Cool Flex Ablation Catheter. The Therapy™ Cool Flex catheter is a flexible tip, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes.

The following CE Mark devices will be used in conjunction with the Therapy™ Cool Flex Ablation Catheter

• IBI-1500T11 Cardiac Ablation Generator (RF ablation generator) with software version 3.0 or higher.
• Cool Point™ Irrigation Pump
• Cool Point™ Tubing set
• Data Logger

• Ablation parameters (such as average power delivered , average tip temperature , average impedance )
• Lesion locations (such as PVI, Septal line, Mitral isthmus, CTI or any other lesion location)
• Mapping techniques (Mapping system and catheter)
• RF application time ( Calculated from the total number of RF application and duration of each RF application)
• Ablation procedure time (Time from the first to the last RF application)
• Total irrigation fluid administered during ablation procedure
• Fluoroscopy time

• Recurrence of AF through six months post last RF ablation procedure using Cool Flex catheter. A 24 hour Holter will be provided to the patients for six month follow-up visit in order to monitor AF episodes. An AF episode will be considered a recurrence only if it lasts for 30 seconds or more.
• AF recurrences during the blanking period (defined below) will not be reported.

All serious adverse events through six month follow-up