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
Clinical Research Department, Winchester Medical Center, 1840 Amherst Street, Winchester, VA 22601, USA.
J Interv Card Electrophysiol. 2013 Aug;37(2):121-9. doi: 10.1007/s10840-013-9791-9. Epub 2013 May 1.
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.
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.
Amigo™（导管机器人公司，新泽西州橄榄山）远程导管系统（RCS）旨在提供一种简单且相对经济的远程导管操作系 统。本研究的目的是评估Amigo在心脏右侧标测中的性能和安全性。
本非随机、前瞻性临床试验在13个地点进行（NCT：#01139814）。使用控制器，将标测导管按特定顺序移动到八个预先指定的位置：右心室心尖、右心室间隔中部、右心室流出道、希氏束位置、冠状窦口、高位右心房、三尖瓣环外侧和低位右心房外侧。预先指定的疗效终点是成功导航至所有位置的成功率达到80%。通过成像以及心电图和起搏阈值的特定标准确定到达每个位置的时间、位置准确性和接触质量。在181例患者中，1448个位置中的1396个（96%）成功标测，所有方案标准均得到满足（单侧p值<0.0001）。将导管移动到新位置的中位时间为24秒。与Amigo相关的主要并发症发生率为0%，显著低于预先定义的4%的终点（单侧p = 0.003）。
我们发现Amigo RCS在将标测导管定位在右心房和心室内的部位时安全有效。
