N/A
Completed N=181
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
atrial flutter · Ventricular Tachycardia
Source: ClinicalTrials.gov NCT01139814 ↗
Enrolled (actual)
181
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Navigation Performance — 1396 Successful locations
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Navigation Performance |
1396 | — |
| PRIMARY Evaluation of Major Complications |
— | — |
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. Informational only — not medical advice.