Comparison of Carto Versus Ensite 3D Electroanatomical Mapping Systems for Arrhythmias Ablations
|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|
- Procedure duration [ Time Frame: Procedure duration - average expected 2.5 hours ] [ Designated as safety issue: No ]Average procedure duration (needle to catheters withdrawal)
- 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
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Carto
Patients in whom Carto system will be used
Group of patients where Carto Express system will be used for electroanatomical mapping.
Active Comparator: Ensite
Patients in whom Ensite system will be used
Group of patients where Ensite Velocity system will be used for electroanatomical mapping.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651702
|Principal Investigator:||Gregory Golovchiner, MD||Rabin Medical Center|