Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Cartomerge; Procedure: NavX Fusion

• Registration Number: NCT01432743
• Lead Sponsor: Barts & The London NHS Trust

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2011-02-21
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-12
• Last Update Submitted: 2011-09-12
• Study First Posted: 2011-09-13
• Last Update Posted: 2011-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cartomerge	Cartomerge	Use of Cartomerge to guide ablation
NavX Fusion	NavX Fusion	Use of NavX fusion to guide ablation

Primary Outcome Measures

Name	Time	Method
AF recurrence	6 months	Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up

Secondary Outcome Measures

Name	Time	Method
Lesion distance from CT shell	At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start)	Establish accuracy of lesion placement in relation to previously acquired CT shell to act as an indicator of guidance accuracy
Procedural time points	At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure)	Measurement of all procedural time points during procedure, along with x-ray dose and screening times.

Trial Locations

Locations (1)

Barts and the London NHS Trust; 🇬🇧 London, United Kingdom