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Withdrawn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
About this trial
This is an interventional treatment trial for Arrhythmias focused on measuring Arrhythmia, Electroanatomical mapping
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).
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
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Withdrawn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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