Trial Outcomes & Findings for Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies (NCT NCT01139814)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

181 participants

Primary outcome timeframe

During Procedure

Results posted on

2013-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Intent-to-Treat 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.
Overall Study STARTED	181
Overall Study COMPLETED	181
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intent-to-Treat n=181 Participants 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.
Age Continuous	56.6 years STANDARD_DEVIATION 16.4 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants
Region of Enrollment United States	152 participants n=5 Participants
Region of Enrollment United Kingdom	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intent-to-Treat n=1448 Locations 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.
Navigation Performance	1396 Successful locations Interval 1370.0 to 1422.0

PRIMARY outcome

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.

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

Outcome measures

Outcome measures
Measure	Intent-to-Treat n=181 Participants 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.
Evaluation of Major Complications	0 Participants Interval 0.0 to 4.0

Adverse Events

Intent-to-Treat

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intent-to-Treat n=181 participants at risk 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.
Cardiac disorders Atrial Tachycardia	0.55% 1/181 • Number of events 1 • Evaluation of adverse events definitely or probably related to Amigo RCS controlled mapping through 7 day follow-up. Only adverse events related to the device are posted

Additional Information

Vice President, Clinical and Regulatory Affairs

Catheter Robotics, Inc.

Phone: 973-426-0300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60