NCT01432743

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P25-P50 for phase_2 atrial-fibrillation

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

3.5 years

First QC Date

February 21, 2011

Last Update Submit

September 12, 2011

Conditions

Atrial Fibrillation

Keywords

3D mappingImage integrationAtrial fibrillationCatheter Ablation

Outcome Measures

Primary Outcomes (1)

  • AF recurrence

    Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up

    6 months

Secondary Outcomes (2)

  • Lesion distance from CT shell

    At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start)

  • Procedural time points

    At start, during and end of inpatient catheter ablation procedure. (between 0 & 6 hours after start of ablation procedure)

Study Arms (2)

Cartomerge

EXPERIMENTAL

Use of Cartomerge to guide ablation

Procedure: Cartomerge

NavX Fusion

ACTIVE COMPARATOR

Use of NavX fusion to guide ablation

Procedure: NavX Fusion

Interventions

NavX FusionPROCEDURE

Using NavX Fusion to guide catheter ablation

Also known as: NavX Fusion (St Jude) - electroanatomic mapping
NavX Fusion
CartomergePROCEDURE

Guidance of catheter ablation using Cartomerge guidance

Also known as: Cartomerge (Biosense Webster) - electroanatomic mapping
Cartomerge

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22119854DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Schilling, FRCP

    Barts and the London NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology and Cardiac Electrophysiology

Study Record Dates

First Submitted

February 21, 2011

First Posted

September 13, 2011

Study Start

September 1, 2007

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

GB(1)