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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
NavX Fusion
Cartomerge
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring 3D mapping, Image integration, Atrial fibrillation, Catheter Ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Barts and the London NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cartomerge

NavX Fusion

Arm Description

Use of Cartomerge to guide ablation

Use of NavX fusion to guide ablation

Outcomes

Primary Outcome Measures

AF recurrence
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
Establish accuracy of lesion placement in relation to previously acquired CT shell to act as an indicator of guidance accuracy
Procedural time points
Measurement of all procedural time points during procedure, along with x-ray dose and screening times.

Full Information

First Posted
February 21, 2011
Last Updated
September 12, 2011
Sponsor
Barts & The London NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01432743
Brief Title
Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
Acronym
CAVERN
Official Title
Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barts & The London NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
3D mapping, Image integration, Atrial fibrillation, Catheter Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cartomerge
Arm Type
Experimental
Arm Description
Use of Cartomerge to guide ablation
Arm Title
NavX Fusion
Arm Type
Active Comparator
Arm Description
Use of NavX fusion to guide ablation
Intervention Type
Procedure
Intervention Name(s)
NavX Fusion
Other Intervention Name(s)
NavX Fusion (St Jude) - electroanatomic mapping
Intervention Description
Using NavX Fusion to guide catheter ablation
Intervention Type
Procedure
Intervention Name(s)
Cartomerge
Other Intervention Name(s)
Cartomerge (Biosense Webster) - electroanatomic mapping
Intervention Description
Guidance of catheter ablation using Cartomerge guidance
Primary Outcome Measure Information:
Title
AF recurrence
Description
Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lesion distance from CT shell
Description
Establish accuracy of lesion placement in relation to previously acquired CT shell to act as an indicator of guidance accuracy
Time Frame
At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start)
Title
Procedural time points
Description
Measurement of all procedural time points during procedure, along with x-ray dose and screening times.
Time Frame
At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Schilling, FRCP
Organizational Affiliation
Barts and the London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22119854
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.
Results Reference
derived

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Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

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