ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01139814
Recruitment Status : Completed
First Posted : June 9, 2010
Results First Posted : April 10, 2013
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Catheter Robotics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Atrial Flutter
Ventricular Tachycardia
Intervention Device: Amigo catheter robot
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intent-to-Treat
Hide Arm/Group Description

Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.

Amigo RCS is an accessory for use in the cardiac EP setting to allow the operator to manipulate a steerable cardiac catheter and perform a conventional electrophysiology procedure. The intent of the device is to allow the operator to complete the procedure in a conventional x-ray guided EP lab. Catheter control can be performed while standing (or sitting) some distance from the subject to minimize absorbed radiology dose and minimize operator fatigue from standing for long periods of time with the standard lead aprons/personal protection devices.

Period Title: Overall Study
Started 181
Completed 181
Not Completed 0
Arm/Group Title Intent-to-Treat
Hide Arm/Group Description Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
Overall Number of Baseline Participants 181
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants
56.6  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants
Female
100
  55.2%
Male
81
  44.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 181 participants
United States 152
United Kingdom 29
1.Primary Outcome
Title Navigation Performance
Hide Description 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.
Time Frame During Procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intent-to-Treat
Hide Arm/Group Description:
A subject was considered Intent-to-treat once the subject was evaluated for the study criteria on the day of procedure, the Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
Overall Number of Participants Analyzed 181
Overall Number of Units Analyzed
Type of Units Analyzed: Locations
1448
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Successful locations
1396
(1370 to 1422)
2.Primary Outcome
Title Evaluation of Major Complications
Hide Description Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intent-to-Treat
Hide Arm/Group Description:
Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
Overall Number of Participants Analyzed 181
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Participants
0
(0 to 4)
Time Frame Evaluation of adverse events definitely or probably related to Amigo RCS controlled mapping through 7 day follow-up.
Adverse Event Reporting Description Only adverse events related to the device are posted
 
Arm/Group Title Intent-to-Treat
Hide Arm/Group Description Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
All-Cause Mortality
Intent-to-Treat
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intent-to-Treat
Affected / at Risk (%) # Events
Total   0/181 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.55%
Intent-to-Treat
Affected / at Risk (%) # Events
Total   1/181 (0.55%)    
Cardiac disorders   
Atrial Tachycardia  [1]  1/181 (0.55%)  1
Indicates events were collected by systematic assessment
[1]
Subject experienced SVT during mapping with Amigo. Attempts were made to terminate arrhythmia but a right bundle morphology was seen for the rest of the procedure. The CEC adjudicated the event as non serious, minor and probably related to device.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vice President, Clinical and Regulatory Affairs
Organization: Catheter Robotics, Inc.
Phone: 973-426-0300
Responsible Party: Catheter Robotics, Inc.
ClinicalTrials.gov Identifier: NCT01139814     History of Changes
Other Study ID Numbers: 2008-001-01
First Submitted: June 7, 2010
First Posted: June 9, 2010
Results First Submitted: March 1, 2013
Results First Posted: April 10, 2013
Last Update Posted: April 11, 2013