Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies

Completed · Not applicable

Conditions studied: Atrial Flutter, Ventricular Tachycardia

In brief

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).

Key facts

Study ID

NCT01139814

Run by

Catheter Robotics, Inc.

People needed

181

Starts

2010-06-01

Expected to finish

2011-10-01

Last updated by the study team

2013-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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.

You may not qualify if…

• 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.

Where it is running

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Sequoia Hospital — Redwood City, California, United States
• Northwestern Medical Center — Chicago, Illinois, United States
• 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
• Valley Health — Winchester, Virginia, United States
• Glenfield Hospital — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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