CompletedNot Applicable

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

United States181 participantsStarted 2010-06

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Navigation Performance

Timeframe: During Procedure

Evaluation of Major Complications

Timeframe: 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.

Trial details

NCT IDNCT01139814

SponsorCatheter Robotics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2013-03-01

View on ClinicalTrials.gov More Atrial Flutter trials