TY - JOUR
T1 - First experience with a novel robotic remote catheter system
T2 - Amigo™ mapping trial
AU - Khan, Ejaz M.
AU - Frumkin, William
AU - Ng, G. Andre
AU - Neelagaru, Suresh
AU - Abi-Samra, Freddy M.
AU - Lee, Jay
AU - Giudici, Michael
AU - Gohn, Douglas
AU - Winkle, Roger A.
AU - Sussman, Jonathan
AU - Knight, Bradley P.
AU - Berman, Adam
AU - Calkins, Hugh
PY - 2013/8
Y1 - 2013/8
N2 - Introduction: Amigo™ (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. Methods and results: 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). Conclusion: We found the Amigo RCS to be safe and effective for positioning a mapping catheter at sites within the right atrium and ventricle.
AB - Introduction: Amigo™ (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. Methods and results: 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). Conclusion: We found the Amigo RCS to be safe and effective for positioning a mapping catheter at sites within the right atrium and ventricle.
KW - Catheter
KW - Manipulation
KW - Mapping
KW - Navigation
KW - Radiation exposure
KW - Robotic
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U2 - 10.1007/s10840-013-9791-9
DO - 10.1007/s10840-013-9791-9
M3 - Article
C2 - 23636870
AN - SCOPUS:84879984434
SN - 1383-875X
VL - 37
SP - 121
EP - 129
JO - Journal of Interventional Cardiac Electrophysiology
JF - Journal of Interventional Cardiac Electrophysiology
IS - 2
ER -