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

Not Applicable

Completed

• Conditions: Atrial Flutter; Ventricular Tachycardia
• Interventions: Device: Amigo catheter robot

• Registration Number: NCT01139814
• Lead Sponsor: Catheter Robotics, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2013-03-01
• Results First Submitted QC: 2013-03-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-09
• Results First Posted: 2013-04-10
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Catheter Robot	Amigo catheter robot	device

Primary Outcome Measures

Name	Time	Method
Navigation Performance	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.
Evaluation of Major Complications	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.

Trial Locations

Locations (12)

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

Northwestern Medical Center; 🇺🇸 Chicago, Illinois, United States

Gagnon Cardiovascular Institute/Morristown Memorial Hospital; 🇺🇸 Morristown, New Jersey, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Lancaster Heart & Stroke Foundation; 🇺🇸 Lancaster, Pennsylvania, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Lone Star Heart Center; 🇺🇸 Amarillo, Texas, United States

Valley Health; 🇺🇸 Winchester, Virginia, United States

Glenfield Hospital; 🇬🇧 Leicester, United Kingdom

Sequoia Hospital; 🇺🇸 Redwood City, California, United States

Genesis Health,; 🇺🇸 Davenport, Iowa, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States