Overview

This trial is active, not recruiting.

Condition persistent atrial fibrillation
Treatments radiofrequency catheter ablation
Sponsor Oxford University Hospitals NHS Trust
Collaborator Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Start date March 2010
End date August 2013
Trial size 120 participants
Trial identifier NCT01711047, 09/H0605/97

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Arm A: patients have PVI and roof and mitral isthmus lines
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)
Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation
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.

Primary Outcomes

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

Secondary Outcomes

Measure
Multiple procedure success rate
time frame: 12 months after last ablation
Complication rate
time frame: 30 days of procedure
Percentage of AF termination
time frame: Time 0
recurrence of atrial fibrillation or organised atrial tachycardia
time frame: 12 months after the last procedure
Ablation time
time frame: Time 0
Procedure time
time frame: Time 0

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - persistent atrial fibrillation Exclusion Criteria: - previous catheter or surgical ablation for atrial fibrillation - pregnancy

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Oxford University Hospitals NHS Trust.