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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Gregory Golovchiner, MD, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01651702
First received: July 23, 2012
Last updated: July 26, 2012
Last verified: July 2012

July 23, 2012
July 26, 2012
July 2012
July 2014   (final data collection date for primary outcome measure)
Procedure duration [ Time Frame: Procedure duration - average expected 2.5 hours ] [ Designated as safety issue: No ]
Average procedure duration (needle to catheters withdrawal)
Same as current
Complete list of historical versions of study NCT01651702 on ClinicalTrials.gov Archive Site
  • Fluoroscopy time [ Time Frame: Procedures will be evaluated for the fluoro time, expected average 30 min ] [ Designated as safety issue: No ]
    Average fluro time in each of groups.
  • Procedure success [ Time Frame: Patients will be followed for one year for recurrency of arrhythmia ] [ Designated as safety issue: No ]
    Recurrency of the arrhythmia assessed by blinded electrophysiologist
Same as current
Not Provided
Not Provided
 
Comparison of Carto Versus Ensite 3D Electroanatomical Mapping Systems for Arrhythmias Ablations
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Arrhythmias
  • Device: Carto
    Group of patients where Carto Express system will be used for electroanatomical mapping.
  • Device: Ensite
    Group of patients where Ensite Velocity system will be used for electroanatomical mapping.
  • Active Comparator: Carto
    Patients in whom Carto system will be used
    Intervention: Device: Carto
  • Active Comparator: Ensite
    Patients in whom Ensite system will be used
    Intervention: Device: Ensite
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
October 2014
July 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact: Gregory Golovchine, Dr. 03-9377120 gregoryg@clalit.org.il
Not Provided
 
NCT01651702
0067-12-RMC
No
Gregory Golovchiner, MD, Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Gregory Golovchiner, MD Rabin Medical Center
Rabin Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP