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

Primary Purpose

Atrial Flutter, Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Amigo catheter robot
Sponsored by
Catheter Robotics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Flutter focused on measuring atrial flutter, AVNRT, right sided accessory pathway, ventricular tachycardia, Patients who have one or more standard indications for a right-sided diagnostic electrophysiology procedure.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

    -

Sites / Locations

  • Hoag Memorial Hospital Presbyterian
  • Sequoia Hospital
  • Northwestern Medical Center
  • Genesis Health,
  • Ochsner Medical Center
  • Johns Hopkins University
  • Gagnon Cardiovascular Institute/Morristown Memorial Hospital
  • Lenox Hill Hospital
  • Lancaster Heart & Stroke Foundation
  • Lone Star Heart Center
  • Valley Health
  • Glenfield Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Catheter Robot

Arm Description

device

Outcomes

Primary Outcome Measures

Navigation Performance
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
Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2010
Last Updated
April 9, 2013
Sponsor
Catheter Robotics, Inc.
Collaborators
Medpace, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01139814
Brief Title
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catheter Robotics, Inc.
Collaborators
Medpace, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter, Ventricular Tachycardia
Keywords
atrial flutter, AVNRT, right sided accessory pathway, ventricular tachycardia, Patients who have one or more standard indications for a right-sided diagnostic electrophysiology procedure.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Catheter Robot
Arm Type
Experimental
Arm Description
device
Intervention Type
Device
Intervention Name(s)
Amigo catheter robot
Intervention Description
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.
Primary Outcome Measure Information:
Title
Navigation Performance
Description
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.
Time Frame
During Procedure
Title
Evaluation of Major Complications
Description
Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
Northwestern Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Genesis Health,
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Gagnon Cardiovascular Institute/Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Lancaster Heart & Stroke Foundation
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Lone Star Heart Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Valley Health
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Glenfield Hospital
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23636870
Citation
Khan EM, Frumkin W, Ng GA, Neelagaru S, Abi-Samra FM, Lee J, Giudici M, Gohn D, Winkle RA, Sussman J, Knight BP, Berman A, Calkins H. First experience with a novel robotic remote catheter system: Amigo mapping trial. J Interv Card Electrophysiol. 2013 Aug;37(2):121-9. doi: 10.1007/s10840-013-9791-9. Epub 2013 May 1.
Results Reference
derived

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

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