Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation (CAVERN)

Barts & The London NHS Trust

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Procedure: Cartomerge; Procedure: NavX Fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01432743

005126

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Cartomerge

Experimental group

Description:

Use of Cartomerge to guide ablation

Treatment:

Procedure: Cartomerge

NavX Fusion

Active Comparator group

Description:

Use of NavX fusion to guide ablation

Treatment:

Procedure: NavX Fusion