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

History of Changes

Results First Received: March 1, 2013

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Conditions:	Atrial Flutter Ventricular Tachycardia
Intervention:	Device: Amigo catheter robot

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Description

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.

Participant Flow: Overall Study

	Intent-to-Treat
STARTED	181
COMPLETED	181
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Intent-to-Treat
Number of Participants [units: participants]	181
Age [units: years] Mean ± Standard Deviation	56.6 ± 16.4
Gender [units: participants]
Female	100
Male	81
Region of Enrollment [units: participants]
United States	152
United Kingdom	29

Outcome Measures

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1. Primary:

Navigation Performance [ Time Frame: During Procedure ]

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2. Primary:

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. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Vice President, Clinical and Regulatory Affairs
Organization: Catheter Robotics, Inc.
phone: 973-426-0300
e-mail: research@catheterrobotics.com

No publications provided

Responsible Party:	Catheter Robotics, Inc.
ClinicalTrials.gov Identifier:	NCT01139814 History of Changes
Other Study ID Numbers:	2008-001-01
Study First Received:	June 7, 2010
Results First Received:	March 1, 2013
Last Updated:	April 9, 2013
Health Authority:	United States: Food and Drug Administration

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