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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00894400
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : August 2, 2011
Sponsor:
Information provided by:
Barts & The London NHS Trust

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: catheter ablation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Characterisation of Fractionated Electrograms Critical for Maintenance of AF
Study Start Date : April 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Procedure: catheter ablation
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.
Procedure: catheter ablation
catheter ablation using radiofrequency energy



Primary Outcome Measures :
  1. change in AF cycle length when targeting fractionated electrograms of different morphology. [ Time Frame: immediate ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894400


Locations
United Kingdom
Barts and The London NHS Trust
London, United Kingdom, EC1 A7BE
Sponsors and Collaborators
Barts & The London NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Richard Schilling, Barts and The London NHS Trust
ClinicalTrials.gov Identifier: NCT00894400     History of Changes
Other Study ID Numbers: 09/H0703/6
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: August 2011

Keywords provided by Barts & The London NHS Trust:
AF
catheter ablation
fractionated electrogram
complex fractionated atrial electrogram (CFAE)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes