Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF) (CAFE AF)
August 1, 2011 updated by: Barts & The London NHS Trust
Characterisation of Fractionated Electrograms Critical for Maintenance of AF
The purpose of this study is to characterise which fractionated electrogram morphologies are important to target in the catheter ablation of atrial fibrillation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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London, United Kingdom, EC1 A7BE
- Barts and the London NHS Trust
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Targeting of most fractionated electrograms first
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.
|
catheter ablation using radiofrequency energy
|
|
Active Comparator: Targeting least fractionated electrograms first
During catheter ablation of AF fractionated electrograms are targeted.
In this arm the least fractionated electrograms will be targeted first.
|
catheter ablation using radiofrequency energy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
change in AF cycle length when targeting fractionated electrograms of different morphology.
Time Frame: immediate
|
immediate
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
May 6, 2009
First Submitted That Met QC Criteria
May 6, 2009
First Posted (Estimate)
May 7, 2009
Study Record Updates
Last Update Posted (Estimate)
August 2, 2011
Last Update Submitted That Met QC Criteria
August 1, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/H0703/6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.