Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF)
CAFE AF
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 2, 2011
August 1, 2011
2.1 years
May 6, 2009
August 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in AF cycle length when targeting fractionated electrograms of different morphology.
immediate
Study Arms (2)
Targeting of most fractionated electrograms first
EXPERIMENTALDuring 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.
Targeting least fractionated electrograms first
ACTIVE COMPARATORDuring catheter ablation of AF fractionated electrograms are targeted. In this arm the least fractionated electrograms will be targeted first.
Interventions
catheter ablation using radiofrequency energy
Eligibility Criteria
You may qualify if:
- patients with persistent AF listed for first time catheter ablation
You may not qualify if:
- age \< 18 years
- pregnancy
- contraindications to procedure
- recent myocardial infarction, coronary intervention, or cardiac surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barts and The London NHS Trust
London, EC1 A7BE, United Kingdom
Related Publications (1)
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.
PMID: 21844156DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 7, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
August 2, 2011
Record last verified: 2011-08