Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— CAVERN  

Official title:

Cartomerge Versus NavX Fusion in Catheter Ablation of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432743
• Other study ID #: 005126
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2011
• Last updated: September 12, 2011
• Start date: September 2007
• Est. completion date: April 2011

Study information

• Verified date: September 2011
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• NavX Fusion
Using NavX Fusion to guide catheter ablation
• Cartomerge
Guidance of catheter ablation using Cartomerge guidance

Locations

Country	Name	City	State
United Kingdom	Barts and the London NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrence	Documentation of symptomatic arrhythmia or arrhythmia on a 7 day holter monitor at six-month follow-up	6 months	No
Secondary	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	At completion of catheter ablation procedure (distance at defined procedure endpoint) (between 0 - 6 hours after procedure start)	No
Secondary	Procedural time points	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)	No