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

• Sponsor: Catheter Robotics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01139814
• Collaborator: Medpace, Inc. (Industry)
• Enrollment: 181
• Locations: 12
• Arm: 1
• Duration (Months): 16
• Patients Per Site: 15.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Flutter; Ventricular Tachycardia	Device: Amigo catheter robot	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 181 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Clinical Study to Evaluate the Effectiveness and Safety of the Catheter Robotics Amigo Remote Catheter System for Performing Right-Sided Electrophysiology Mapping Studies
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Catheter Robot device	Device: Amigo catheter robot; The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.

Outcome Measures

Primary Outcome Measures

1. Navigation Performance [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hoag Memorial Hospital Presbyterian	Newport Beach	California	United States	92658
2	Sequoia Hospital	Redwood City	California	United States	94062
3	Northwestern Medical Center	Chicago	Illinois	United States	60611
4	Genesis Health,	Davenport	Iowa	United States	52803
5	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
6	Johns Hopkins University	Baltimore	Maryland	United States	21287
7	Gagnon Cardiovascular Institute/Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
8	Lenox Hill Hospital	New York	New York	United States	10075
9	Lancaster Heart & Stroke Foundation	Lancaster	Pennsylvania	United States	17602
10	Lone Star Heart Center	Amarillo	Texas	United States	79106
11	Valley Health	Winchester	Virginia	United States	22601
12	Glenfield Hospital	Leicester		United Kingdom

Sponsors and Collaborators

• Catheter Robotics, Inc.
• Medpace, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Catheter Robotics, Inc.
• ClinicalTrials.gov Identifier: NCT01139814
• Other Study ID Numbers: 2008-001-01
• First Posted: Jun 9, 2010
• Last Update Posted: Apr 11, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Catheter Robotics, Inc.: atrial flutter; AVNRT; right sided accessory pathway; ventricular tachycardia; Patients who have one or more standard indications for a right-sided diagnostic electrophysiology procedure.
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Atrial Flutter

Study Results

Participant Flow

Arm/Group Title	Intent-to-Treat
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

Baseline Characteristics

Arm/Group Title	Intent-to-Treat
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 Participants	181
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.6 (16.4)
Sex: Female, Male (Count of Participants)
Female	100 55.2%
Male	81 44.8%
Region of Enrollment (participants) [Number]
United States	152 84%
United Kingdom	29 16%

Outcome Measures

1. Primary Outcome

Title	Navigation Performance
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intent-to-Treat
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.
Measure Participants	181
Measure Locations	1448
Number (95% Confidence Interval) [Successful locations]	1396

2. Primary Outcome

Title	Evaluation of Major Complications
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intent-to-Treat
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.
Measure Participants	181
Number (95% Confidence Interval) [Participants]	0 0%

Adverse Events

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
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Intent-to-Treat
	Affected / at Risk (%)	# Events
Total	0/181 (0%)
Other (Not Including Serious) Adverse Events
	Intent-to-Treat
	Affected / at Risk (%)	# Events
Total	1/181 (0.6%)
Cardiac disorders
Atrial Tachycardia	1/181 (0.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.