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

September 12, 2011 updated by: Dr Richard Schilling, Barts & The London NHS Trust
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Barts and the London NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cartomerge
Use of Cartomerge to guide ablation
Procedure: Cartomerge
Guidance of catheter ablation using Cartomerge guidance
Other Names:
  • 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 Names:
  • NavX Fusion (St Jude) - electroanatomic mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF recurrence
Time Frame: 6 months
Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start)
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.
At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Investigators

  • Principal Investigator: Richard Schilling, FRCP, Barts and the London NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (ESTIMATE)

September 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2011

Last Update Submitted That Met QC Criteria

September 12, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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