Status:
COMPLETED
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
Lead Sponsor:
Catheter Robotics, Inc.
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Atrial Flutter
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- \> 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
- 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.
- \-
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT01139814
Start Date
June 1 2010
End Date
October 1 2011
Last Update
April 11 2013
Active Locations (12)
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1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
2
Sequoia Hospital
Redwood City, California, United States, 94062
3
Northwestern Medical Center
Chicago, Illinois, United States, 60611
4
Genesis Health,
Davenport, Iowa, United States, 52803