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Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF) (CAFE AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
catheter ablation
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 AF, catheter ablation, fractionated electrogram, complex fractionated atrial electrogram (CFAE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with persistent AF listed for first time catheter ablation

Exclusion Criteria:

  • age < 18 years
  • pregnancy
  • contraindications to procedure
  • recent myocardial infarction, coronary intervention, or cardiac surgery

Sites / Locations

  • Barts and The London NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Targeting of most fractionated electrograms first

Targeting least fractionated electrograms first

Arm Description

During catheter ablation of AF patients will have fractionated electrograms targeted. In the experimental group the fractionated electrograms believed to be most critical will be targeted first.

During catheter ablation of AF fractionated electrograms are targeted. In this arm the least fractionated electrograms will be targeted first.

Outcomes

Primary Outcome Measures

change in AF cycle length when targeting fractionated electrograms of different morphology.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2009
Last Updated
August 1, 2011
Sponsor
Barts & The London NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00894400
Brief Title
Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF)
Acronym
CAFE AF
Official Title
Characterisation of Fractionated Electrograms Critical for Maintenance of AF
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Barts & The London NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to characterise which fractionated electrogram morphologies are important to target in the catheter ablation of atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
AF, catheter ablation, fractionated electrogram, complex fractionated atrial electrogram (CFAE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeting of most fractionated electrograms first
Arm Type
Experimental
Arm Description
During catheter ablation of AF patients will have fractionated electrograms targeted. In the experimental group the fractionated electrograms believed to be most critical will be targeted first.
Arm Title
Targeting least fractionated electrograms first
Arm Type
Active Comparator
Arm Description
During catheter ablation of AF fractionated electrograms are targeted. In this arm the least fractionated electrograms will be targeted first.
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
catheter ablation using radiofrequency energy
Primary Outcome Measure Information:
Title
change in AF cycle length when targeting fractionated electrograms of different morphology.
Time Frame
immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with persistent AF listed for first time catheter ablation Exclusion Criteria: age < 18 years pregnancy contraindications to procedure recent myocardial infarction, coronary intervention, or cardiac surgery
Facility Information:
Facility Name
Barts and The London NHS Trust
City
London
ZIP/Postal Code
EC1 A7BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21844156
Citation
Hunter RJ, Diab I, Tayebjee M, Richmond L, Sporton S, Earley MJ, Schilling RJ. Characterization of fractionated atrial electrograms critical for maintenance of atrial fibrillation: a randomized, controlled trial of ablation strategies (the CFAE AF trial). Circ Arrhythm Electrophysiol. 2011 Oct;4(5):622-9. doi: 10.1161/CIRCEP.111.962928. Epub 2011 Aug 15.
Results Reference
derived

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Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF)

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