The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
181
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Sequoia Hospital
Redwood City, California, United States
Northwestern Medical Center
Chicago, Illinois, United States
Navigation Performance
Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.
Time frame: During Procedure
Evaluation of Major Complications
Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.
Time frame: Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Genesis Health,
Davenport, Iowa, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Gagnon Cardiovascular Institute/Morristown Memorial Hospital
Morristown, New Jersey, United States
Lenox Hill Hospital
New York, New York, United States
Lancaster Heart & Stroke Foundation
Lancaster, Pennsylvania, United States
Lone Star Heart Center
Amarillo, Texas, United States
...and 2 more locations