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Completed

NCT Number: NCT01139814

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glenfield Hospital, Leicester, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

Amigo catheter robot

Device

The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.

Primary outcomes

  1. Navigation Performance

    Time frame: 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.

  2. 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.

    Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.

Sponsors and collaborators

Lead sponsor

Catheter Robotics, Inc.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2010
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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