Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

Barts & The London NHS Trust101 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

AF recurrence

Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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.

Time frame: At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure)