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
  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:


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):
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 April 16, 2014