title: First experience with a novel robotic remote catheter system: Amigo™ mapping trial.
abstract: BACKGROUND
  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.
  
  
  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).
  
  
  CONCLUSIONS
  We found the Amigo RCS to be safe and effective for positioning a mapping catheter at sites within the right atrium and ventricle.
authors: Clinical Research Department, Winchester Medical Center, 1840 Amherst Street, Winchester, VA 22601, USA. ejazkhan@arrhythmiaspecialists.com
authors: Ejaz M
authors: EM
authors: Khan
authors: William
authors: W
authors: Frumkin
authors: G Andre
authors: GA
authors: Ng
authors: Suresh
authors: S
authors: Neelagaru
authors: Freddy M
authors: FM
authors: Abi-Samra
authors: Jay
authors: J
authors: Lee
authors: Michael
authors: M
authors: Giudici
authors: Douglas
authors: D
authors: Gohn
authors: Roger A
authors: RA
authors: Winkle
authors: Jonathan
authors: J
authors: Sussman
authors: Bradley P
authors: BP
authors: Knight
authors: Adam
authors: A
authors: Berman
authors: Hugh
authors: H
authors: Calkins
mesh_terms: D001145:Arrhythmias, Cardiac / Q000175:diagnosis*; D018780:Body Surface Potential Mapping / Q000295:instrumentation*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D062906:Cardiac Catheters; D003936:Diagnosis, Computer-Assisted / Q000295:instrumentation*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D012371:Robotics / Q000295:instrumentation*; D012680:Sensitivity and Specificity; D017216:Telemedicine / Q000295:instrumentation*; D014584:User-Computer Interface
references: J Cardiovasc Electrophysiol. 2012 Aug;23(8):820-6
references: 22509886
references: J Interv Card Electrophysiol. 2008 Jan;21(1):19-26
references: 18202905
references: Health Phys. 2008 Mar;94(3):211-27
references: 18301095
references: EuroIntervention. 2012 May 15;8(1):169-70
references: 22580262
references: Europace. 2008 Nov;10 Suppl 3:iii57-61
references: 18955400
references: AJR Am J Roentgenol. 2001 Jul;177(1):3-11
references: 11418388
references: J Cardiovasc Electrophysiol. 2009 Nov;20(11):1193-6
references: 19572952
references: J Am Coll Cardiol. 2006 Apr 4;47(7):1390-400
references: 16580527
references: AORN J. 2011 Jun;93(6):767-74
references: 21624529
references: Circ Arrhythm Electrophysiol. 2009 Apr;2(2):120-8
references: 19808456
references: Anesth Analg. 2005 Dec;101(6):1725-1726
references: 16301249
references: Heart Rhythm. 2012 Aug;9(8):1280-5
references: 22516184
references: Circ Arrhythm Electrophysiol. 2009 Dec;2(6):611-9
references: 20009075
references: Europace. 2011 Jul;13(7):955-62
references: 21421574
references: Control Clin Trials. 1988 Sep;9(3):189-205
references: 3053041
references: J Am Coll Cardiol. 2003 Dec 3;42(11):1952-8
references: 14662258
references: J Vasc Interv Radiol. 2009 Feb;20(2):147-52; quiz 53
references: 19062308
references: Heart Rhythm. 2006 Jan;3(1):71-6
references: 16399057
references: Circulation. 2007 May 29;115(21):2705-14
references: 17502570
references: J Interv Card Electrophysiol. 2011 Apr;30(3):233-40
references: 21253840
references: Heart Rhythm. 2012 Nov;9(11):1789-95
references: 22820056