Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

Study Overview
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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.

Official Title
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Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: NavX Fusion
* Procedure: Cartomerge


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cartomerge<br>Use of Cartomerge to guide ablation | Procedure: Cartomerge<br>* Guidance of catheter ablation using Cartomerge guidance<br>* Other names: Cartomerge (Biosense Webster) - electroanatomic mapping;|
| Active Comparator: NavX Fusion<br>Use of NavX fusion to guide ablation | Procedure: NavX Fusion<br>* Using NavX Fusion to guide catheter ablation<br>* Other names: NavX Fusion (St Jude) - electroanatomic mapping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF recurrence | Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D mapping, Image integration, Atrial fibrillation, Catheter Ablation