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

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

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.

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Author information

Authors and Affiliations

  1. Clinical Research Department, Winchester Medical Center, 1840 Amherst Street, Winchester, VA, 22601, USA

    Ejaz M. Khan

  2. Lenox Hill Hospital, New York, NY, USA

    William Frumkin

  3. Glenfield Hospital, Leicester, UK

    G. Andre Ng

  4. The Heart Hospital at Northwest Texas Hospital, Amarillo, TX, USA

    Suresh Neelagaru

  5. Ochsner Medical Center, New Orleans, LA, USA

    Freddy M. Abi-Samra

  6. Hoag Memorial Hospital Presbyterian, Orange, CA, USA

    Jay Lee

  7. Division of Cardiology, University of Iowa Hospitals, Iowa City, IA, USA

    Michael Giudici

  8. Lancaster General Hospital, Lancaster, PA, USA

    Douglas Gohn

  9. Sequoia Hospital, Redwood City, CA, USA

    Roger A. Winkle

  10. Gagnon Cardiovascular Institute, Morristown, NJ, USA

    Jonathan Sussman

  11. Northwestern University, Chicago, IL, USA

    Bradley P. Knight

  12. Medical College of Georgia, Augusta, GA, USA

    Adam Berman

  13. Johns Hopkins Hospital, Baltimore, MD, USA

    Hugh Calkins

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  1. Ejaz M. Khan
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  2. William Frumkin
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  3. G. Andre Ng
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  5. Freddy M. Abi-Samra
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  6. Jay Lee
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  7. Michael Giudici
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  8. Douglas Gohn
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  9. Roger A. Winkle
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  10. Jonathan Sussman
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  11. Bradley P. Knight
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  12. Adam Berman
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  13. Hugh Calkins
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Corresponding author

Correspondence to Ejaz M. Khan.

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Khan, E.M., Frumkin, W., Ng, G.A. et al. First experience with a novel robotic remote catheter system: Amigo™ mapping trial. J Interv Card Electrophysiol 37, 121–129 (2013). https://doi.org/10.1007/s10840-013-9791-9

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  • DOI: https://doi.org/10.1007/s10840-013-9791-9

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