Benefit of CFAE Ablation (BOCA)

October 11, 2017 updated by: Oxford University Hospitals NHS Trust

A Study to Investigate the Benefit Of Complex Fractionated Atrial Electrogram (CFAE) Ablation in Addition to Circumferential Pulmonary Vein and Linear Ablations in the Treatment of Persistent Atrial Fibrillation. (BOCA)

The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation in addition to pulmonary vein isolation and linear ablations improves single procedural success rate over a 12 month follow up period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • United Kingdom
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • persistent atrial fibrillation

Exclusion Criteria:

  • previous catheter or surgical ablation for atrial fibrillation
  • pregnancy

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
Active Comparator: PVI + Linear ablation
Arm A: patients have PVI and roof and mitral isthmus lines
Procedure: Radiofrequency catheter Ablation
In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines)
Active Comparator: PVI + linear ablation + CFAE
Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation
Procedure: Radiofrequency catheter ablation
In this arm, catheter ablation would be performed in the left atrium, including pulmonary vein isolation, linear ablations (roof and mitral isthmus lines) and Complex Fractionated Atrial Electrograms (CFAE) ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Single procedural success rate (free from AF off anti-arrhythmic drugs)
Time Frame: 12 MONTHS
12 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple procedure success rate
Time Frame: 12 months after last ablation
12 months after last ablation
Complication rate
Time Frame: 30 days of procedure
30 days of procedure
Percentage of AF termination
Time Frame: Time 0
This information will be recorded immediately after the procedure.
Time 0
recurrence of atrial fibrillation or organised atrial tachycardia
Time Frame: 12 months after the last procedure
12 months after the last procedure
Ablation time
Time Frame: Time 0
This information will be recorded immediately after the procedure.
Time 0
Procedure time
Time Frame: Time 0
This information will be recorded immediately after the procedure
Time 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Collaborators

Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

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.

General Publications

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

March 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/H0605/97

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.

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