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

Ventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139814
• Other study ID #: 2008-001-01
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: April 9, 2013
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2013
• Source: Catheter Robotics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Flutter
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Amigo catheter robot
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.

Locations

Country	Name	City	State
United Kingdom	Glenfield Hospital	Leicester
United States	Lone Star Heart Center	Amarillo	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	Northwestern Medical Center	Chicago	Illinois
United States	Genesis Health,	Davenport	Iowa
United States	Lancaster Heart & Stroke Foundation	Lancaster	Pennsylvania
United States	Gagnon Cardiovascular Institute/Morristown Memorial Hospital	Morristown	New Jersey
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Lenox Hill Hospital	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Sequoia Hospital	Redwood City	California
United States	Valley Health	Winchester	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Catheter Robotics, Inc.	Medpace, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During Procedure	No
Primary	Evaluation of Major Complications	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.	Yes