Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiolo… (NCT01139814) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
United States, United Kingdom181 participantsStarted 2010-06
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Navigation Performance
Timeframe: During Procedure
2
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.
. 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.