Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

NCT ID: NCT01432743

Last Updated: 2011-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-04-30

Brief Summary

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Comparison of Two Strategies for Catheter Ablation of Atrial Fibrillation - a comparison of ablation guided by Cartomerge and NavX Fusion. 3D mapping systems are widely used in catheter ablation of AF. Integration of a previously acquired image of the left atrium into the electroanatomical (EA) map offers several potential advantages, including visualisation of the complex anatomy of the left atrium, reduction of fluoroscopy time and improved results . The two most widely used systems are Cartomerge (Biosense Webster, etc) and NavX Fusion (SJM, etc). Although both systems have been independently validated, their clinical utility has not previously been directly compared in a randomised trial

Detailed Description

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Patients are randomised to either NavX Fusion or Cartomerge. They undergo a standard catheter ablation procedure and data is collected. Both systems are routinely used in our clinical practise. This is a comparison trial of 2 mapping technologies.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cartomerge

Use of Cartomerge to guide ablation

Group Type EXPERIMENTAL

Cartomerge

Intervention Type PROCEDURE

Guidance of catheter ablation using Cartomerge guidance

NavX Fusion

Use of NavX fusion to guide ablation

Group Type ACTIVE_COMPARATOR

NavX Fusion

Intervention Type PROCEDURE

Using NavX Fusion to guide catheter ablation

Interventions

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NavX Fusion

Using NavX Fusion to guide catheter ablation

Intervention Type PROCEDURE

Cartomerge

Guidance of catheter ablation using Cartomerge guidance

Intervention Type PROCEDURE

Other Intervention Names

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NavX Fusion (St Jude) - electroanatomic mapping Cartomerge (Biosense Webster) - electroanatomic mapping

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years of age
* Be undergoing their first planned procedure for electrophysiology mapping and ablation in the left atrium of AF
* Be willing and able to sign the study specific informed consent
* Have a negative pregnancy test for female subjects of child bearing potential

Exclusion Criteria

* Have a left ventricular ejection fraction (LVEF) of \<40% as evaluated by pre-procedure TTE
* Have any contraindication or allergy to routine procedural medications or catheter materials
* Have any condition for which the investigator feels it is unsafe for the subject to undergo an invasive electrophysiology procedure (EP) catheterisation
* Be currently participating in another clinical research study
* Have any condition for which the subject's life expectancy is less than twelve months
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr Richard Schilling

Professor of Cardiology and Cardiac Electrophysiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Schilling, FRCP

Role: PRINCIPAL_INVESTIGATOR

Barts and the London NHS Trust

Locations

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Barts and the London NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Finlay MC, Hunter RJ, Baker V, Richmond L, Goromonzi F, Thomas G, Rajappan K, Duncan E, Tayebjee M, Dhinoja M, Sporton S, Earley MJ, Schilling RJ. A randomised comparison of Cartomerge vs. NavX fusion in the catheter ablation of atrial fibrillation: the CAVERN Trial. J Interv Card Electrophysiol. 2012 Mar;33(2):161-9. doi: 10.1007/s10840-011-9632-7. Epub 2011 Nov 26.

Reference Type DERIVED
PMID: 22119854 (View on PubMed)

Other Identifiers

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005126

Identifier Type: -

Identifier Source: org_study_id

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