The aim of this study is to evaluate the safety and feasibility of using the Amigo Remote Catheter System (RCS) in arrhythmia ablation procedures. Because Amigo allows the physician to operate all catheter function outside of the radiation field, operator exposure time was also evaluated. This is a nonrandomized, prospective clinical trial conducted at 1 site (identifier: NCT01834872). The study prospectively enrolled 50 consecutive patients (mean age 59 ± 15 years, 72% men) with any type of arrhythmia (23 atrial fibrillation ablation, 12 common atrial flutters, 10 patients with other supraventricular tachycardia, 4 ventricular tachycardia, and 1 patient with palpitations with no arrhythmia induced) referred for catheter ablation, in which we used RCS. Fifty matched ablation procedures (mean age 57 ± 14 years, 70% men) performed during the same time period, without RCS, were enrolled into the control group. Acute ablation success was 96% with RCS and 98% in the manual group. In only 2 cases, the physician switched to manual ablation (1 ventricular tachycardia and 1 accessory pathway) to complete the procedure. There were no complications related to the use of RCS. No differences were observed in total procedure time, total fluoroscopy time, or total radiofrequency delivery compared with the manual group. In procedures performed with RCS, the operator's fluoroscopy exposure time was reduced by 68 ± 16%. In conclusion, arrhythmia ablation with RCS is safe and feasible. Furthermore, it significantly reduces operator's exposure to radiation.
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Published online: December 13, 2013
Accepted: November 14, 2013
Received in revised form: November 14, 2013
Received: September 7, 2013
See page 831 for disclosure information.
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