Persistent Atrial FibrillationBOCANCT01711047
Benefit of CFAE Ablation
A study testing Radiofrequency catheter Ablation in people with Persistent Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Radiofrequency catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persistent atrial fibrillation
Who cannot join
- previous catheter or surgical ablation for atrial fibrillation
- pregnancy
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Bournemouth Hospital
Bournemouth
John Radcliffe Hospital
Oxford, OX3 9DU
About this study
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)
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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Radiofrequency catheter Ablation
- Keywords
- catheter ablation, atrial fibrillation, pulmonary vein isolation, linear ablation, CFAE ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency catheter AblationProcedure or surgery
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 ablationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| PVI + Linear ablation | Active comparator | Arm A: patients have PVI and roof and mitral isthmus lines Receives: Procedure: Radiofrequency catheter Ablation |
| PVI + linear ablation + CFAE | Active comparator | Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation Receives: Procedure: Radiofrequency catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single procedural success rate (free from AF off anti-arrhythmic drugs)
Measured: 12 MONTHS
Secondary outcomes (6)
Multiple procedure success rate
Measured: 12 months after last ablation
Complication rate
Measured: 30 days of procedure
Percentage of AF termination
This information will be recorded immediately after the procedure.
Measured: Time 0
recurrence of atrial fibrillation or organised atrial tachycardia
Measured: 12 months after the last procedure
Ablation time
This information will be recorded immediately after the procedure.
Measured: Time 0
Procedure time
This information will be recorded immediately after the procedure
Measured: Time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startMar 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711047
- Sponsor's protocol ID
- 09/H0605/97
- Acronym
- BOCA
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2012
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26283145
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01711047
- Acronym / sponsor ID
- BOCA / 09/H0605/97
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- catheter ablation, atrial fibrillation, pulmonary vein isolation, linear ablation, CFAE ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Study start
- Mar 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI + Linear ablation | Active comparator | Procedure: Radiofrequency catheter AblationArm A: patients have PVI and roof and mitral isthmus lines |
| PVI + linear ablation + CFAE | Active comparator | Procedure: Radiofrequency catheter ablationArm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persistent atrial fibrillation
Key exclusion criteria (2 listed)
- previous catheter or surgical ablation for atrial fibrillation
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency catheter AblationIn 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) | Procedure or surgery | PVI + Linear ablation |
| Radiofrequency catheter ablationIn 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. | Procedure or surgery | PVI + linear ablation + CFAE |
Primary outcome
Single procedural success rate (free from AF off anti-arrhythmic drugs)
Time frame: 12 MONTHS
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Derived from this study: PubMed 26283145Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency catheter Ablation in people with Persistent Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single procedural success rate (free from AF off anti-arrhythmic drugs) (time frame: 12 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01711047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.