Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 181
- Locations
- 22
- Primary Endpoint
- Navigation Performance
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> 18years of age.
- •Indicated for a right-sided electrophysiology ablation study (e.g., atrial flutter, AVNRT, right-sided accessory pathway, or ventricular tachycardia).
- •Willingness, ability, and commitment to participate in the procedure visit and a follow-up evaluation including a clinic visit at 7 (-0, +7) days after the study procedure.
- •Completion of Informed Consent.
Exclusion Criteria
- •Any contraindication to cardiac catheterization, including pregnancy.
- •Enrollment in any other ongoing cardiac device trial.
- •Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle.
- •Corrected or uncorrected atrial septal defect (ASD).
- •Poor general health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.).
- •Medical condition that will require anticoagulation during study or ablation procedure.
- •Presence of atrial fibrillation or atrial flutter at time of study procedure.
- •Other condition observed prior to the procedure where, in the view of the physician, participation in the study could further present a risk to the subject.
Outcomes
Primary Outcomes
Navigation Performance
Time Frame: During Procedure
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.
Evaluation of Major Complications
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.
Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.
Secondary Outcomes
No secondary outcomes reported