Khan, Ejaz M.; Frumkin, William; Ng, G. Andre; Neelagaru, Suresh; Abi-Samra, Freddy M.; Lee, Jay; Giudici, Michael; Gohn, Douglas; Winkle, Roger A.; Sussman, Jonathan; Knight, Bradley P.; Berman, Adam; Calkins, Hugh
Abstract
Amigo (TM) (Catheter Robotics, Inc., Mount Olive, NJ) remote catheter system (RCS) was designed to provide a simple and relatively inexpensive system for remote catheter manipulation. The purpose of this study was to evaluate the performance and safety of Amigo in mapping the right side of the heart.; This non-randomized, prospective clinical trial was conducted at 13 sites (NCT: #01139814). Using the controller, a mapping catheter was moved to eight pre-specified locations in a specific sequence: right ventricular apex, mid-right ventricular septum, right ventricular outflow tract, His-bundle position, coronary sinus ostium, high right atrium, lateral tricuspid annulus, and low lateral right atrium. The pre-specified efficacy endpoint was to achieve 80 % successful navigation to all locations. Time to each location, location accuracy, and quality of contact were confirmed by imaging and specific criteria for electrograms and pacing thresholds. In 181 patients, a total of 1,396 of 1,448 (96 %) locations were successfully mapped with all protocol criteria met (one-sided p value < 0.0001). The median time to move the catheter to a new location was 24 s. The Amigo-related major complication rate was 0 % which was significantly less than the predefined endpoint of 4 % (one-sided p = 0.003).; We found the Amigo RCS to be safe and effective for positioning a mapping catheter at sites within the right atrium and ventricle.
