Comparison of Carto Versus Ensite 3D Electroanatomical Mapping Systems for Arrhythmias Ablations

April 12, 2017 updated by: Gregory Golovchiner, MD, Rabin Medical Center

Comparative Study of Two 3D Electroanatomical Mapping Systems for Ablations of Different Complex Arrhythmias

Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These two systems has been compared in only a few studies. Recent technical advances resulted in the development of new versions of both systems. To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems. The aim of the study to compare two systems for the use in the ablation of complex arrhythmias.

Study Overview

Status

Status

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Withdrawn

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

Background:

Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. It is nowadays an excepted method especially for complex arrhythmias such as atrial fibrillation and ventricular tachycardia.

The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These mapping systems have helped to decrease procedural complexity, procedure time, and improve safety. The EnSite NavX system uses impedance measurements between the individual catheter electrodes and the patches placed on the patient's chest and abdomen. The CARTO system utilizes magnetic location technology to provide accurate visualization of the magnet sensor-equipped catheter tip.

These two systems has been compared in only a few studies. Different results have been found in simple ablations versus more complex ablation of atrial fibrillation. Recent technical advances resulted in the development of new versions of both systems. Carto Express version allows quicker mapping and reconstruction of heart cavities and great vessels geometry as compared to previous versions of Carto XP. EnSite Velocity system incorporates more precise catheter visualization, and allows quicker mapping as compared to previous version of EnSite.

To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems.

Study design Prospective single-center non-randomized open label comparison study. Primary objective Comparison of Carto Express system vs. EnSite Velocity system for ablation of complex arrhythmias.

End points:

  1. Procedure duration.
  2. Fluoroscopy time
  3. Procedure success -will be measured in terms of the 1-year recurrent arrhythmia rate Study population Patients planned for ablation of complex arrhythmia.

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

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

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18- 80.
  2. Ability to sign informed consent.

  3. History of one of the following arrhythmias requiring the use of 3D electroanatomical mapping:

    • Symptomatic paroxysmal or persistent atrial fibrillation with failed treatment of at least two anti-arrhythmic drugs.
    • Ischemic ventricular tachycardia necessitating ablation as per decision of electrophysiologist.
    • Symptomatic atrial tachycardia after failed medical treatment.
    • Symptomatic idiopathic ventricular tachycardia.

Exclusion Criteria:

  1. Unstable patients not allowing performing procedure more than 2 hours
  2. Patients planned for one of the two systems compared for whatever reason Ex. procedure planned with NAVX system Array Balloon).

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: Carto
Patients in whom Carto system will be used
Device: Carto
Group of patients where Carto Express system will be used for electroanatomical mapping.
Active Comparator: Ensite
Patients in whom Ensite system will be used
Device: Ensite
Group of patients where Ensite Velocity system will be used for electroanatomical mapping.

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
Procedure duration
Time Frame: Procedure duration - average expected 2.5 hours
Average procedure duration (needle to catheters withdrawal)
Procedure duration - average expected 2.5 hours

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
Time Frame: Procedures will be evaluated for the fluoro time, expected average 30 min
Average fluro time in each of groups.
Procedures will be evaluated for the fluoro time, expected average 30 min
Procedure success
Time Frame: Patients will be followed for one year for recurrency of arrhythmia
Recurrency of the arrhythmia assessed by blinded electrophysiologist
Patients will be followed for one year for recurrency of arrhythmia

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.
Rabin Medical Center

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 Golovchiner, MD, Rabin Medical Center

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

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.
July 1, 2015

Primary Completion (Anticipated)

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.
July 1, 2016

Study Completion (Anticipated)

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.
October 1, 2016

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).
July 23, 2012

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.
July 26, 2012

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.
July 27, 2012

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.
April 13, 2017

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.
April 12, 2017

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.
April 1, 2017

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.
  • 0067-12-RMC

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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