Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus (Amigo-AFL)

June 7, 2019 updated by: Gregory Kent Feld, University of California, San Diego
The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of the CTI is standard treatment for patients with a history of atrial flutter, and those undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation are used in standard clinical practice at The University of California, San Diego (UCSD) for ablation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dr. Gregory Feld, M.D. is conducting a research study to find out more about the effects of using the Amigo™ Robotic System for ablation of the cavo-tricuspid isthmus (flutter isthmus) on catheter stability (stabilization of the catheter during the procedure in order to prevent movement and dislodgement) using a combination of contact force (a measurement of the force applied by the catheter tip against the tissue during the ablation procedure), location, and duration measurements during ablation of the atrial flutter circuit. Published studies have indicated that robotic catheter manipulation is safe, may reduce patient and physician x-ray exposure, and ablation procedure time. Measuring contact force has also been shown to improve both short-term and long-term procedure success. However, research on ablation of the CTI specifically, is limited. This is a randomized study comparing robotic catheter manipulation using the Amigo Robotic System to manual catheter manipulation for ablation of the CTI on measures including catheter stability, contact force, procedure time, and fluoroscopy (X-ray) time.

The ablation procedure is standard of care, however, if patients chose to enroll in the study they will be randomized to one of two groups: either manual or robotic catheter manipulation. Throughout the procedure, research personnel will collect information from the procedure including measurements of contact force, catheter stability, procedure duration, and fluoroscopy (X-ray) time. If, in addition to ablation of the cavo-tricuspid isthmus for atrial flutter, a patient is scheduled to undergo ablation of the left atrium for atrial fibrillation or left atrial flutter, this will be performed subsequently in a standard manner, and will not be considered part of the research. Ablation of the CTI generally takes 45-60 minutes regardless of the technique used for manipulation of the catheters.

The patient's participation in the study will only last one day, the length of study procedure. There is no follow up associated with this study. All subjects will received standard of care treatment following their ablation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Sulpizio Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be scheduled to undergo radiofrequency catheter ablation of the cavo-tricuspid isthmus for atrial fibrillation (AF) or atrial flutter (AFL) according to appropriate clinical indications.
  • Must be able and willing to provide written informed consent
  • Must be at least 18 years old.

Exclusion Criteria:

  • Patient's refusal to participate in the study
  • Lack of indication for CTI ablation (eg: prior CTI ablation with persistent bidirectional isthmus block)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Manual Catheter Manipulation
25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.
Device: Manual Catheter Manipulation

Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to manual catheter manipulation.

Other Names:
  • cavo-tricuspid isthmus ablation
  • atrial flutter ablation
  • arrhythmia
  • radiofrequency catheter ablation
Experimental: Amigo™ Robotic Catheter Manipulation
25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.
Device: Amigo™ Robotic Catheter Manipulation

Ablation is a standard procedure that patients may undergo for the atrial flutter.

In this study, this group will be assigned to robotic catheter manipulation.

Other Names:
  • cavo-tricuspid isthmus ablation
  • atrial flutter ablation
  • arrhythmia
  • radiofrequency catheter ablation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Contact Force Through Measurement of Force-time Integral (FTI)
Time Frame: At time of the ablation procedure, which typically lasts 30-60 minutes
Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System
At time of the ablation procedure, which typically lasts 30-60 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fluoroscopy Time Measurements
Time Frame: at time of ablation procedure
Determine fluoroscopy time to reach CTI block.
at time of ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Catheter Robotics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory Feld, MD, UC San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 150318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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