NCT00894400

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 2, 2011

Status Verified

August 1, 2011

Enrollment Period

2.1 years

First QC Date

May 6, 2009

Last Update Submit

August 1, 2011

Conditions

Keywords

AFcatheter ablationfractionated electrogramcomplex fractionated atrial electrogram (CFAE)

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

EXPERIMENTAL

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

Targeting least fractionated electrograms first

ACTIVE COMPARATOR

During catheter ablation of AF fractionated electrograms are targeted. In this arm the least fractionated electrograms will be targeted first.

Procedure: catheter ablation

Interventions

catheter ablation using radiofrequency energy

Targeting least fractionated electrograms firstTargeting of most fractionated electrograms first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

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

Locations