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

April 9, 2013 updated by: Catheter Robotics, Inc.

Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leicester, United Kingdom
        • Glenfield Hospital
  • United States
    • California
      • Newport Beach, California, United States, 92658
        • Hoag Memorial Hospital Presbyterian
      • Redwood City, California, United States, 94062
        • Sequoia Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Center
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Health,
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Gagnon Cardiovascular Institute/Morristown Memorial Hospital
    • New York
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster Heart & Stroke Foundation
    • Texas
      • Amarillo, Texas, United States, 79106
        • Lone Star Heart Center
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Valley Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Catheter Robot
device
Device: Amigo catheter robot
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Navigation Performance
Time Frame: During Procedure
Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.
During Procedure
Evaluation of Major Complications
Time Frame: 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.
Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catheter Robotics, Inc.

Collaborators

Medpace, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (ESTIMATE)

June 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-001-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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