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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01651702
Enrollment
0
Registered
2012-07-27
Start date
2015-07-31
Completion date
2016-10-31
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias

Keywords

Arrhythmia, Electroanatomical mapping

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: 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.

Interventions

DEVICECarto

Group of patients where Carto Express system will be used for electroanatomical mapping.

DEVICEEnsite

Group of patients where Ensite Velocity system will be used for electroanatomical mapping.

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Procedure durationProcedure duration - average expected 2.5 hoursAverage procedure duration (needle to catheters withdrawal)

Secondary

MeasureTime frameDescription
Fluoroscopy timeProcedures will be evaluated for the fluoro time, expected average 30 minAverage fluro time in each of groups.
Procedure successPatients will be followed for one year for recurrency of arrhythmiaRecurrency of the arrhythmia assessed by blinded electrophysiologist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026