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.

Study Overview

• Status: Withdrawn
• Conditions: Arrhythmias
• Intervention / Treatment: Device: Carto; Device: Ensite

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure duration	Average procedure duration (needle to catheters withdrawal)	Procedure duration - average expected 2.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluoroscopy time	Average fluro time in each of groups.	Procedures will be evaluated for the fluoro time, expected average 30 min
Procedure success	Recurrency of the arrhythmia assessed by blinded electrophysiologist	Patients will be followed for one year for recurrency of arrhythmia

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Gregory Golovchiner, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Arrhythmia; Electroanatomical mapping
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 0067-12-RMC