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

Area of Science:

• Cardiovascular Medicine
• Medical Device Technology
• Electrophysiology

Background:

• The Amigo™ remote catheter system (RCS) was developed for cost-effective, remote catheter manipulation.
• Existing systems for cardiac catheterization can be complex and expensive.

Purpose of the Study:

• To evaluate the performance and safety of the Amigo™ RCS for mapping the right side of the heart.
• Assess the system's efficacy in reaching specific anatomical locations within the right atrium and ventricle.

Main Methods:

• A non-randomized, prospective clinical trial involving 181 patients across 13 sites.
• A mapping catheter was navigated to eight pre-specified locations using the Amigo™ controller.
• Efficacy was determined by successful navigation, time to location, accuracy, and quality of electrograms/pacing thresholds.

Main Results:

• Successful mapping was achieved in 96% (1,396/1,448) of targeted locations, exceeding the 80% efficacy endpoint.
• The median time to navigate to a new location was 24 seconds.
• A 0% major complication rate was observed, significantly lower than the predefined 4% endpoint.

Conclusions:

• The Amigo™ RCS is a safe and effective tool for positioning mapping catheters in the right atrium and ventricle.
• The system's high success rate and safety profile support its use in cardiac electrophysiology procedures.