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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01432743
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : September 13, 2011
Information provided by (Responsible Party):
Dr Richard Schilling, Barts & The London NHS Trust

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: NavX Fusion Procedure: Cartomerge Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
Study Start Date : September 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cartomerge
Use of Cartomerge to guide ablation
Procedure: Cartomerge
Guidance of catheter ablation using Cartomerge guidance
Other Name: Cartomerge (Biosense Webster) - electroanatomic mapping

Active Comparator: NavX Fusion
Use of NavX fusion to guide ablation
Procedure: NavX Fusion
Using NavX Fusion to guide catheter ablation
Other Name: NavX Fusion (St Jude) - electroanatomic mapping

Primary Outcome Measures :
  1. AF recurrence [ Time Frame: 6 months ]
    Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up

Secondary Outcome Measures :
  1. 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) ]
    Establish accuracy of lesion placement in relation to previously acquired CT shell to act as an indicator of guidance accuracy

  2. Procedural time points [ Time Frame: At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure) ]
    Measurement of all procedural time points during procedure, along with x-ray dose and screening times.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01432743

United Kingdom
Barts and the London NHS Trust
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Barts & The London NHS Trust
Principal Investigator: Richard Schilling, FRCP Barts and the London NHS Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Richard Schilling, Professor of Cardiology and Cardiac Electrophysiology, Barts & The London NHS Trust Identifier: NCT01432743     History of Changes
Other Study ID Numbers: 005126
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Dr Richard Schilling, Barts & The London NHS Trust:
3D mapping
Image integration
Atrial fibrillation
Catheter Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes