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NCT01711047 Clinical Trial

Benefit of CFAE Ablation

Persistent Atrial Fibrillation Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01711047
Other study ID # 09/H0605/97
Secondary ID
Status Completed
Phase N/A
First received October 12, 2012
Last updated October 11, 2017
Start date March 2010
Est. completion date August 2013

Study information
Verified date October 2017
Source Oxford University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- persistent atrial fibrillation

Exclusion Criteria:

- previous catheter or surgical ablation for atrial fibrillation

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

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)
• 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.

Locations
Country Name City State
United Kingdom Royal Bournemouth Hospital Bournemouth
United Kingdom John Radcliffe Hospital Oxford

Sponsors (2)
Lead Sponsor Collaborator
Oxford University Hospitals NHS Trust Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Single procedural success rate (free from AF off anti-arrhythmic drugs) 12 MONTHS
Secondary Multiple procedure success rate 12 months after last ablation
Secondary Complication rate 30 days of procedure
Secondary Percentage of AF termination This information will be recorded immediately after the procedure. Time 0
Secondary recurrence of atrial fibrillation or organised atrial tachycardia 12 months after the last procedure
Secondary Ablation time This information will be recorded immediately after the procedure. Time 0
Secondary Procedure time This information will be recorded immediately after the procedure Time 0
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