Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
This study has been completed.
Sponsor:
Catheter Robotics, Inc.
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
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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:
- > 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.
-
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 June 17, 2013