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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
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Procedure: NavX Fusion
Procedure: Cartomerge
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 101
Study Start Date: September 2007
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432743

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

No publications provided by Barts & The London NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Richard Schilling, Professor of Cardiology and Cardiac Electrophysiology, Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01432743     History of Changes
Other Study ID Numbers: 005126
Study First Received: February 21, 2011
Last Updated: September 12, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013