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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Atrial Flutter Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Catheter Robot

device

Group Type EXPERIMENTAL

Amigo catheter robot

Intervention Type DEVICE

The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.

Interventions

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Amigo catheter robot

The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. \> 18years of age.
2. Indicated for a right-sided electrophysiology ablation study (e.g., atrial flutter, AVNRT, right-sided accessory pathway, or ventricular tachycardia).
3. 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.
4. Completion of Informed Consent.

Exclusion Criteria

1. Any contraindication to cardiac catheterization, including pregnancy.
2. Enrollment in any other ongoing cardiac device trial.
3. Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle.
4. Corrected or uncorrected atrial septal defect (ASD).
5. 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.).
6. Medical condition that will require anticoagulation during study or ablation procedure.
7. Presence of atrial fibrillation or atrial flutter at time of study procedure.
8. 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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No