Comparison of Carto Versus Ensite 3D Electroanatomical Mapping Systems for Arrhythmias Ablations

NCT01651702 | Withdrawn

• 1 other identifier: 0067-12-RMC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arrhythmias

Keywords

Arrhythmia; Electroanatomical mapping

Outcome Measures

Primary Outcomes (1)

• Procedure duration

  Average procedure duration (needle to catheters withdrawal)

  Procedure duration - average expected 2.5 hours

Secondary Outcomes (2)

• Fluoroscopy time

  Procedures will be evaluated for the fluoro time, expected average 30 min

• Procedure success

  Patients will be followed for one year for recurrency of arrhythmia

Study Arms (2)

Carto

ACTIVE COMPARATOR

Patients in whom Carto system will be used

Device: Carto

Ensite

ACTIVE COMPARATOR

Patients in whom Ensite system will be used

Device: Ensite

Interventions

Carto DEVICE

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

Carto

Ensite DEVICE

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

Ensite

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Golovchiner, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Invistigator

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 27, 2012
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04