First experience with a novel robotic remote catheter system: Amigo™ mapping trial
| Autor: | Freddy M. Abi-Samra, Roger A. Winkle, Ejaz M. Khan, Jonathan Sussman, Michael C. Giudici, William I Frumkin, Jay Lee, Bradley P. Knight, G. André Ng, Hugh Calkins, Douglas C. Gohn, Adam E. Berman, Suresh Neelagaru |
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| Rok vydání: | 2012 |
| Předmět: |
Male
medicine.medical_specialty Cardiac Catheterization Sensitivity and Specificity Cardiac Catheters Catheter manipulation User-Computer Interface Physiology (medical) medicine Ventricular outflow tract Humans Major complication Diagnosis Computer-Assisted Atrium (heart) business.industry Body Surface Potential Mapping Reproducibility of Results Arrhythmias Cardiac Equipment Design Robotics Middle Aged Telemedicine Surgery Equipment Failure Analysis Catheter medicine.anatomical_structure Ventricle cardiovascular system Right atrium Female Radiology Cardiology and Cardiovascular Medicine business |
| Zdroj: | Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing. 37(2) |
| ISSN: | 1572-8595 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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