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

This study has been completed.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Catheter Robotics, Inc.
ClinicalTrials.gov Identifier:
NCT01139814
First received: June 7, 2010
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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).


Condition Intervention
Atrial Flutter
Ventricular Tachycardia
Device: Amigo catheter robot

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies

Resource links provided by NLM:


Further study details as provided by Catheter Robotics, Inc.:

Primary Outcome Measures:
  • Navigation Performance [ Time Frame: During Procedure ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]
    Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.


Enrollment: 181
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Catheter Robot
device
Device: Amigo catheter robot
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139814

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

No publications provided

Responsible Party: Catheter Robotics, Inc.
ClinicalTrials.gov Identifier: NCT01139814     History of Changes
Other Study ID Numbers: 2008-001-01
Study First Received: June 7, 2010
Results First Received: March 1, 2013
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Catheter Robotics, Inc.:
atrial flutter
AVNRT
right sided accessory pathway
ventricular tachycardia
Patients who have one or more standard indications for a right-sided diagnostic electrophysiology procedure.

Additional relevant MeSH terms:
Atrial Flutter
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014