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
  Purpose

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.


Condition Intervention
Arrhythmias
Device: Carto
Device: Ensite

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Two 3D Electroanatomical Mapping Systems for Ablations of Different Complex Arrhythmias

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Procedure duration [ Time Frame: Procedure duration - average expected 2.5 hours ] [ Designated as safety issue: No ]
    Average procedure duration (needle to catheters withdrawal)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651702

Contacts
Contact: Gregory Golovchine, Dr. 03-9377120 gregoryg@clalit.org.il

Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Gregory Golovchiner, MD Rabin Medical Center
  More Information

No publications provided

Responsible Party: Gregory Golovchiner, MD, Principle Invistigator, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01651702     History of Changes
Other Study ID Numbers: 0067-12-RMC
Study First Received: July 23, 2012
Last Updated: July 26, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Arrhythmia
Electroanatomical mapping

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014