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

Primary Purpose

Arrhythmias

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carto
Ensite
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmias focused on measuring Arrhythmia, Electroanatomical mapping

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Carto

    Ensite

    Arm Description

    Patients in whom Carto system will be used

    Patients in whom Ensite system will be used

    Outcomes

    Primary Outcome Measures

    Procedure duration
    Average procedure duration (needle to catheters withdrawal)

    Secondary Outcome Measures

    Fluoroscopy time
    Average fluro time in each of groups.
    Procedure success
    Recurrency of the arrhythmia assessed by blinded electrophysiologist

    Full Information

    First Posted
    July 23, 2012
    Last Updated
    April 12, 2017
    Sponsor
    Rabin Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01651702
    Brief Title
    Comparison of Carto Versus Ensite 3D Electroanatomical Mapping Systems for Arrhythmias Ablations
    Official Title
    Comparative Study of Two 3D Electroanatomical Mapping Systems for Ablations of Different Complex Arrhythmias
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Poor recruit rate
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arrhythmias
    Keywords
    Arrhythmia, Electroanatomical mapping

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Carto
    Arm Type
    Active Comparator
    Arm Description
    Patients in whom Carto system will be used
    Arm Title
    Ensite
    Arm Type
    Active Comparator
    Arm Description
    Patients in whom Ensite system will be used
    Intervention Type
    Device
    Intervention Name(s)
    Carto
    Intervention Description
    Group of patients where Carto Express system will be used for electroanatomical mapping.
    Intervention Type
    Device
    Intervention Name(s)
    Ensite
    Intervention Description
    Group of patients where Ensite Velocity system will be used for electroanatomical mapping.
    Primary Outcome Measure Information:
    Title
    Procedure duration
    Description
    Average procedure duration (needle to catheters withdrawal)
    Time Frame
    Procedure duration - average expected 2.5 hours
    Secondary Outcome Measure Information:
    Title
    Fluoroscopy time
    Description
    Average fluro time in each of groups.
    Time Frame
    Procedures will be evaluated for the fluoro time, expected average 30 min
    Title
    Procedure success
    Description
    Recurrency of the arrhythmia assessed by blinded electrophysiologist
    Time Frame
    Patients will be followed for one year for recurrency of arrhythmia

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18- 80. Ability to sign informed consent. 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: Unstable patients not allowing performing procedure more than 2 hours Patients planned for one of the two systems compared for whatever reason Ex. procedure planned with NAVX system Array Balloon).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory Golovchiner, MD
    Organizational Affiliation
    Rabin Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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