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Benefit of CFAE Ablation (BOCA)

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Radiofrequency catheter Ablation
Radiofrequency catheter ablation
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring catheter ablation, atrial fibrillation, pulmonary vein isolation, linear ablation, CFAE ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • persistent atrial fibrillation

Exclusion Criteria:

  • previous catheter or surgical ablation for atrial fibrillation
  • pregnancy

Sites / Locations

  • Royal Bournemouth Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PVI + Linear ablation

PVI + linear ablation + CFAE

Arm Description

Arm A: patients have PVI and roof and mitral isthmus lines

Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation

Outcomes

Primary Outcome Measures

Single procedural success rate (free from AF off anti-arrhythmic drugs)

Secondary Outcome Measures

Multiple procedure success rate
Complication rate
Percentage of AF termination
This information will be recorded immediately after the procedure.
recurrence of atrial fibrillation or organised atrial tachycardia
Ablation time
This information will be recorded immediately after the procedure.
Procedure time
This information will be recorded immediately after the procedure

Full Information

First Posted
October 12, 2012
Last Updated
October 11, 2017
Sponsor
Oxford University Hospitals NHS Trust
Collaborators
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01711047
Brief Title
Benefit of CFAE Ablation
Acronym
BOCA
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford University Hospitals NHS Trust
Collaborators
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
catheter ablation, atrial fibrillation, pulmonary vein isolation, linear ablation, CFAE ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVI + Linear ablation
Arm Type
Active Comparator
Arm Description
Arm A: patients have PVI and roof and mitral isthmus lines
Arm Title
PVI + linear ablation + CFAE
Arm Type
Active Comparator
Arm Description
Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter Ablation
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Single procedural success rate (free from AF off anti-arrhythmic drugs)
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
Multiple procedure success rate
Time Frame
12 months after last ablation
Title
Complication rate
Time Frame
30 days of procedure
Title
Percentage of AF termination
Description
This information will be recorded immediately after the procedure.
Time Frame
Time 0
Title
recurrence of atrial fibrillation or organised atrial tachycardia
Time Frame
12 months after the last procedure
Title
Ablation time
Description
This information will be recorded immediately after the procedure.
Time Frame
Time 0
Title
Procedure time
Description
This information will be recorded immediately after the procedure
Time Frame
Time 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: persistent atrial fibrillation Exclusion Criteria: previous catheter or surgical ablation for atrial fibrillation pregnancy
Facility Information:
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26283145
Citation
Wong KC, Paisey JR, Sopher M, Balasubramaniam R, Jones M, Qureshi N, Hayes CR, Ginks MR, Rajappan K, Bashir Y, Betts TR. No Benefit of Complex Fractionated Atrial Electrogram Ablation in Addition to Circumferential Pulmonary Vein Ablation and Linear Ablation: Benefit of Complex Ablation Study. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1316-24. doi: 10.1161/CIRCEP.114.002504. Epub 2015 Aug 17.
Results Reference
derived

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Benefit of CFAE Ablation

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