Benefit of CFAE Ablation

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01711047

Acronym

BOCA

Enrollment

120

Registered

2012-10-22

Start date

2010-03-31

Completion date

2013-08-31

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

Keywords

catheter ablation, atrial fibrillation, pulmonary vein isolation, linear ablation, CFAE ablation

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.

Interventions

PROCEDURERadiofrequency 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)

PROCEDURERadiofrequency 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* persistent atrial fibrillation

Exclusion criteria

* previous catheter or surgical ablation for atrial fibrillation * pregnancy

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026