Format

Send to:

Choose Destination
See comment in PubMed Commons below
J Interv Card Electrophysiol. 2013 Aug;37(2):121-9. doi: 10.1007/s10840-013-9791-9. Epub 2013 May 1.

First experience with a novel robotic remote catheter system: Amigo™ mapping trial.

Author information

  • 1Clinical Research Department, Winchester Medical Center, 1840 Amherst Street, Winchester, VA 22601, USA. ejazkhan@arrhythmiaspecialists.com

Abstract

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.

PMID:
23636870
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Springer
    Loading ...
    Write to the Help Desk