Clinical trial NCT01139814: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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.
Lead sponsor: Catheter Robotics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2010-06-09
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility 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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Primary outcomes:
measure: Navigation Performance
timeFrame: During Procedure
measure: Evaluation of Major Complications
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: Chicago
country: United States
facility: Northwestern Medical Center
state: Illinois
city: Davenport
country: United States
facility: Genesis Health,
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Morristown
country: United States
facility: Gagnon Cardiovascular Institute/Morristown Memorial Hospital
state: New Jersey
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Lancaster
country: United States
facility: Lancaster Heart & Stroke Foundation
state: Pennsylvania
city: Amarillo
country: United States
facility: Lone Star Heart Center
state: Texas
city: Winchester
country: United States
facility: Valley Health
state: Virginia
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
Study officials:
References:
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.