Atrial FibrillationCAFE AFNCT00894400
Characterisation of Fractionated Electrograms Critical for Maintenance of Atrial Fibrillation (AF)
A study testing catheter ablation in people with Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to characterise which fractionated electrogram morphologies are important to target in the catheter ablation of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to May 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with persistent AF listed for first time catheter ablation
Who cannot join
- age < 18 years
- pregnancy
- contraindications to procedure
- recent myocardial infarction, coronary intervention, or cardiac surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation of Fractionated Electrograms Critical for Maintenance of AF
The purpose of this study is to characterise which fractionated electrogram morphologies are important to target in the catheter ablation of atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- catheter ablation
- Keywords
- AF, catheter ablation, fractionated electrogram, complex fractionated atrial electrogram (CFAE)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablationProcedure or surgery
catheter ablation using radiofrequency energy
| Study group | Role | What they receive |
|---|---|---|
| Targeting of most fractionated electrograms first | Experimental | During catheter ablation of AF patients will have fractionated electrograms targeted. In the experimental group the fractionated electrograms believed to be most critical will be targeted first. Receives: Procedure: catheter ablation |
| Targeting least fractionated electrograms first | Active comparator | During catheter ablation of AF fractionated electrograms are targeted. In this arm the least fractionated electrograms will be targeted first. Receives: Procedure: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in AF cycle length when targeting fractionated electrograms of different morphology.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2011
- Study completionMay 2011
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 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894400
- Sponsor's protocol ID
- 09/H0703/6
- Acronym
- CAFE AF
- Status last verified
- Aug 2011
- First submitted
- 6 May 2009
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hunter RJ, Diab I, Tayebjee M, Richmond L, Sporton S, Earley MJ, Schilling RJ. Characterization of fractionated atrial electrograms critical for maintenance of atrial fibrillation: a randomized, controlled trial of ablation strategies (the CFAE AF trial). Circ Arrhythm Electrophysiol. 2011 Oct;4(5):622-9. doi: 10.1161/CIRCEP.111.962928. Epub 2011 Aug 15.
PubMed 21844156
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Fractionated Electrograms Critical for Maintenance of AF
- ClinicalTrials.gov ID
- NCT00894400
- Acronym / sponsor ID
- CAFE AF / 09/H0703/6
- Conditions
- Atrial Fibrillation
- Keywords
- AF, catheter ablation, fractionated electrogram, complex fractionated atrial electrogram (CFAE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 May 2009 (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 purpose of this study is to characterise which fractionated electrogram morphologies are important to target in the catheter ablation of atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeting of most fractionated electrograms first | Experimental | Procedure: catheter ablationDuring catheter ablation of AF patients will have fractionated electrograms targeted. In the experimental group the fractionated electrograms believed to be most critical will be targeted first. |
| Targeting least fractionated electrograms first | Active comparator | Procedure: catheter ablationDuring catheter ablation of AF fractionated electrograms are targeted. In this arm the least fractionated electrograms will be targeted first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with persistent AF listed for first time catheter ablation
Key exclusion criteria (4 listed)
- age < 18 years
- pregnancy
- contraindications to procedure
- recent myocardial infarction, coronary intervention, or cardiac surgery
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 |
|---|---|---|
| catheter ablationcatheter ablation using radiofrequency energy | Procedure or surgery | Targeting least fractionated electrograms first, Targeting of most fractionated electrograms first |
Primary outcome
change in AF cycle length when targeting fractionated electrograms of different morphology.
Time frame: immediate
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 2 Aug 2011.
- Derived from this study: PubMed 21844156Hunter RJ, Diab I, Tayebjee M, Richmond L, Sporton S, Earley MJ, Schilling RJ. Characterization of fractionated atrial electrograms critical for maintenance of atrial fibrillation: a randomized, controlled trial of ablation strategies (the CFAE AF trial). Circ Arrhythm Electrophysiol. 2011 Oct;4(5):622-9. doi: 10.1161/CIRCEP.111.962928. Epub 2011 Aug 15.
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Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter ablation in people with Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site 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 4 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 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
change in AF cycle length when targeting fractionated electrograms of different morphology. (time frame: immediate). 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 NCT00894400, 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 2 Aug 2011.