Benefit of CFAE Ablation
BOCA
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)
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2010
Longer than P75 for not_applicable
2 active sites
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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2012
CompletedFirst Posted
Study publicly available on registry
October 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedOctober 12, 2017
October 1, 2017
3.4 years
October 12, 2012
October 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Single procedural success rate (free from AF off anti-arrhythmic drugs)
12 MONTHS
Secondary Outcomes (6)
Multiple procedure success rate
12 months after last ablation
Complication rate
30 days of procedure
Percentage of AF termination
Time 0
recurrence of atrial fibrillation or organised atrial tachycardia
12 months after the last procedure
Ablation time
Time 0
- +1 more secondary outcomes
Study Arms (2)
PVI + Linear ablation
ACTIVE COMPARATORArm A: patients have PVI and roof and mitral isthmus lines
PVI + linear ablation + CFAE
ACTIVE COMPARATORArm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation
Interventions
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)
Eligibility Criteria
You may qualify if:
- persistent atrial fibrillation
You may not qualify if:
- previous catheter or surgical ablation for atrial fibrillation
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Royal Bournemouth Hospital
Bournemouth, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Related Publications (1)
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.
PMID: 26283145DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2012
First Posted
October 22, 2012
Study Start
March 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
October 12, 2017
Record last verified: 2017-10