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Completed

NCT Number: NCT01432743

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NavX Fusion

Procedure

Using NavX Fusion to guide catheter ablation

Other names: NavX Fusion (St Jude) - electroanatomic mapping

Cartomerge

Procedure

Guidance of catheter ablation using Cartomerge guidance

Other names: Cartomerge (Biosense Webster) - electroanatomic mapping

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Acronym: CAVERN

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2011
Registry last updated
Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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