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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Richard Schilling, Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01432743
First received: February 21, 2011
Last updated: September 12, 2011
Last verified: September 2011

February 21, 2011
September 12, 2011
September 2007
March 2011   (final data collection date for primary outcome measure)
AF recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up
Same as current
Complete list of historical versions of study NCT01432743 on ClinicalTrials.gov Archive Site
  • Lesion distance from CT shell [ Time Frame: At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start) ] [ Designated as safety issue: No ]
    Establish accuracy of lesion placement in relation to previously acquired CT shell to act as an indicator of guidance accuracy
  • Procedural time points [ Time Frame: At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure) ] [ Designated as safety issue: No ]
    Measurement of all procedural time points during procedure, along with x-ray dose and screening times.
Same as current
Not Provided
Not Provided
 
Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • Procedure: NavX Fusion
    Using NavX Fusion to guide catheter ablation
    Other Name: NavX Fusion (St Jude) - electroanatomic mapping
  • Procedure: Cartomerge
    Guidance of catheter ablation using Cartomerge guidance
    Other Name: Cartomerge (Biosense Webster) - electroanatomic mapping
  • Experimental: Cartomerge
    Use of Cartomerge to guide ablation
    Intervention: Procedure: Cartomerge
  • Active Comparator: NavX Fusion
    Use of NavX fusion to guide ablation
    Intervention: Procedure: NavX Fusion
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. Epub 2011 Nov 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
April 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01432743
005126
No
Dr Richard Schilling, Barts & The London NHS Trust
Barts & The London NHS Trust
Not Provided
Principal Investigator: Richard Schilling, FRCP Barts and the London NHS Trust
Barts & The London NHS Trust
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP