N/A
N=181
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
Atrial Flutter · Ventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT01139814 ↗Enrolled (actual)
181
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Navigation Performance — 1396 Successful locations
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amigo catheter robot (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Catheter Robotics, Inc.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Navigation Performance |
1396 | — |
| PRIMARY Evaluation of Major Complications |
— | — |
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).
Eligibility Criteria
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.
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Data sourced from ClinicalTrials.gov (NCT01139814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.