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

This study has been completed.

Sponsor:

Information provided by:

Barts & The London NHS Trust

ClinicalTrials.gov Identifier:

NCT00894400

First received: May 6, 2009

Last updated: August 1, 2011

Last verified: August 2011

History of Changes

Purpose

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

Condition	Intervention
Atrial Fibrillation	Procedure: catheter ablation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Characterisation of Fractionated Electrograms Critical for Maintenance of AF

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:

change in AF cycle length when targeting fractionated electrograms of different morphology. [ Time Frame: immediate ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	April 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894400

Locations

United Kingdom
Barts and The London NHS Trust
London, United Kingdom, EC1 A7BE

Sponsors and Collaborators

Barts & The London NHS Trust

More Information

No publications provided by Barts & The London NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Aug 15.

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
Study First Received:	May 6, 2009
Last Updated:	August 1, 2011
Health Authority:	United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013

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