Clinical trial NCT01432743: Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
Official title: Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: 3D mapping
Image integration
Atrial fibrillation
Catheter Ablation
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AF recurrence
timeFrame: 6 months
Secondary outcomes:
measure: Lesion distance from CT shell
timeFrame: At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start)
measure: Procedural time points
timeFrame: At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
Study officials:
affiliation: Barts and the London NHS Trust
name: Richard Schilling, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.