Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation
The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).
Subjects who satisfy the inclusion and exclusion criteria will be treated with an RF ablation
catheter and Artisan guide catheters controlled by the Sensei X Robotic Catheter System.
Subject will be followed for a period of one year post ablation procedure.
Follow up visit time frames will be conducted at 7-day, 30-day, 90-day, 180-day and 365-day.
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