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

This study has been completed.
Sponsor:
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

June 7, 2010
April 9, 2013
June 2010
October 2011   (final data collection date for primary outcome measure)
  • 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.
  • 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 prespecified 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.
  • Mapping Performance [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    Mapping Performance -- At each location, the mapping results will be evaluated consistent with current clinical standards for imaging, recorded electrograms, pacing thresholds, and local activation times.
Complete list of historical versions of study NCT01139814 on ClinicalTrials.gov Archive Site
Not Provided
  • Responder Analysis [ Time Frame: During Procedure ] [ Designated as safety issue: No ]
    Responder Analysis to evaluate the per-subject performance of the Amigo controlled navigation and mapping.
  • Total fluoroscopy time with Amigo [ Time Frame: During Procedure ] [ Designated as safety issue: No ]
    Total fluoroscopy time with the Amigo during procedure
  • Total procedure time [ Time Frame: During Procedure ] [ Designated as safety issue: No ]
    Total procedure time with the Amigo
  • All AEs [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]
    All Adverse Events
Not Provided
Not Provided
 
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System 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).

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Atrial Flutter
  • Ventricular Tachycardia
Device: Amigo catheter robot
The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.
Experimental: Catheter Robot
device
Intervention: Device: Amigo catheter robot
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
October 2011
October 2011   (final data collection date for primary outcome measure)

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.

    -

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01139814
2008-001-01
No
Catheter Robotics, Inc.
Catheter Robotics, Inc.
Medpace, Inc.
Not Provided
Catheter Robotics, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP