Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus

Dr. Gregory Feld, M.D. is conducting a research study to find out more about the effects of using the Amigo™ Robotic System for ablation of the cavo-tricuspid isthmus (flutter isthmus) on catheter stability (stabilization of the catheter during the procedure in order to prevent movement and dislodgement) using a combination of contact force (a measurement of the force applied by the catheter tip against the tissue during the ablation procedure), location, and duration measurements during ablation of the atrial flutter circuit. Published studies have indicated that robotic catheter manipulation is safe, may reduce patient and physician x-ray exposure, and ablation procedure time. Measuring contact force has also been shown to improve both short-term and long-term procedure success. However, research on ablation of the CTI specifically, is limited. This is a randomized study comparing robotic catheter manipulation using the Amigo Robotic System to manual catheter manipulation for ablation of the CTI on measures including catheter stability, contact force, procedure time, and fluoroscopy (X-ray) time.

The ablation procedure is standard of care, however, if patients chose to enroll in the study they will be randomized to one of two groups: either manual or robotic catheter manipulation. Throughout the procedure, research personnel will collect information from the procedure including measurements of contact force, catheter stability, procedure duration, and fluoroscopy (X-ray) time. If, in addition to ablation of the cavo-tricuspid isthmus for atrial flutter, a patient is scheduled to undergo ablation of the left atrium for atrial fibrillation or left atrial flutter, this will be performed subsequently in a standard manner, and will not be considered part of the research. Ablation of the CTI generally takes 45-60 minutes regardless of the technique used for manipulation of the catheters.

The patient's participation in the study will only last one day, the length of study procedure. There is no follow up associated with this study. All subjects will received standard of care treatment following their ablation.

Inclusion criteria

• Must be scheduled to undergo radiofrequency catheter ablation of the cavo-tricuspid isthmus for atrial fibrillation (AF) or atrial flutter (AFL) according to appropriate clinical indications.
• Must be able and willing to provide written informed consent
• Must be at least 18 years old.

Exclusion criteria

• Patient's refusal to participate in the study
• Lack of indication for CTI ablation (eg: prior CTI ablation with persistent bidirectional isthmus block)
• Pregnancy