Atrial FibrillationPhase 3NCT00873067
Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation
A Phase 3 study testing Additional Complex Fractionated Electrograms ablation and Standard atrial fibrillation ablation procedure in people with Atrial Fibrillation and Catheter Ablation, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation, Catheter Ablation
- What is being tested?
- Additional Complex Fractionated Electrograms ablation and Standard atrial fibrillation ablation procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Sep 2013
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with persistent (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
- Presence of atrial fibrillation at the beginning of the procedure
Who cannot join
- Hypo or hyperthyroidism
- Persistent long-lasting or non-defined duration atrial fibrillation
- Hypertrophic myocardiopathy
- Implantable defibrillation or pacemaker implanted
- Moderate or severe mitral valve disease or mitral prosthetic valve
- Ejection fraction less than 30%
Show all 19Show fewer
- Left atrial anteroposterior diameter more than 50 mm.
- Previous atrial fibrillation ablation
- Contraindication to anticoagulation
- Left atrium thrombus
- Current infective disease or sepsis
- Pregnant women
- Current unstable angor
- Acute myocardial infarction in last 3 months
- Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
- Reduced expectancy of life (less than 12 months)
- Patient participating in another clinical study that investigates a drug or device
- Psychologically unstable patient or denies to give informed consent
- Any cause that contraindicate ablation procedure or antiarrhythmic drug
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clinic Universitari de Barcelona
Barcelona, Barcelona, 08036
About this study
The aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Being tested
- Additional Complex Fractionated Electrograms ablation, Standard atrial fibrillation ablation procedure
- Keywords
- Atrial fibrillation, Complex fractionated electrograms, 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.
Additional Complex Fractionated Electrograms ablationProcedure or surgery
Also called Complex atrial fractionated electrograms ablation
Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.
Standard atrial fibrillation ablation procedureProcedure or surgery
Also called ACVP ablation, Roof line
Standard procedure for persistent atrial fibrillation including circumferential pulmonary vein ablation and roof line, both being tested. No other lines or lesions will be performed.
| Study group | Role | What they receive |
|---|---|---|
| ACVP plus roof line | Active comparator | Standard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested. Receives: Procedure: Standard atrial fibrillation ablation procedure |
| Additional CFAEs ablation | Active comparator | Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes. Receives: Procedure: Additional Complex Fractionated Electrograms ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial arrhythmias without antiarrhythmic drugs
Measured: 1-year follow-up
Secondary outcomes (4)
Freedom form atrial arrhythmias with or without antiarrhythmic drugs
Measured: 1-year follow-up
Presence of any complications in the acute phase or during follow-up
Measured: 1-year follow-up
Freedom from atypical atria flutter
Measured: 1-year follow-up
Increase in radioscopy time and radiofrequency application time
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio Clinic Barcelona
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
- Investigators
- Lluís Mont, MD, Study chair, Hospital Clinic Universitary de BarcelonaElena Arbelo, MD, PhD, Study director, Hospital Clínic Universitari de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873067
- Sponsor's protocol ID
- HCP/08/207-4495-CFAE
- Status last verified
- Sep 2011
- First submitted
- 31 Mar 2009
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT00873067
- Acronym / sponsor ID
- HCP/08/207-4495-CFAE
- Conditions
- Atrial Fibrillation, Catheter Ablation
- Keywords
- Atrial fibrillation, Complex fractionated electrograms, CFAE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Fundacio Clinic Barcelona
- Study start
- Jan 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Apr 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 aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACVP plus roof line | Active comparator | Procedure: Standard atrial fibrillation ablation procedureStandard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested. |
| Additional CFAEs ablation | Active comparator | Procedure: Additional Complex Fractionated Electrograms ablationAtrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with persistent (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
- Presence of atrial fibrillation at the beginning of the procedure
Key exclusion criteria (19 listed)
- Hypo or hyperthyroidism
- Persistent long-lasting or non-defined duration atrial fibrillation
- Hypertrophic myocardiopathy
- Implantable defibrillation or pacemaker implanted
- Moderate or severe mitral valve disease or mitral prosthetic valve
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 |
|---|---|---|
| Additional Complex Fractionated Electrograms ablationAlso: Complex atrial fractionated electrograms ablationAtrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes. | Procedure or surgery | Additional CFAEs ablation |
| Standard atrial fibrillation ablation procedureAlso: ACVP ablation, Roof lineStandard procedure for persistent atrial fibrillation including circumferential pulmonary vein ablation and roof line, both being tested. No other lines or lesions will be performed. | Procedure or surgery | ACVP plus roof line |
Primary outcome
Freedom from atrial arrhythmias without antiarrhythmic drugs
Time frame: 1-year follow-up
4 secondary outcomes
Freedom form atrial arrhythmias with or without antiarrhythmic drugs
Time frame: 1-year follow-up
Presence of any complications in the acute phase or during follow-up
Time frame: 1-year follow-up
Freedom from atypical atria flutter
Time frame: 1-year follow-up
Increase in radioscopy time and radiofrequency application time
Time frame: 1-year follow-up
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 27 Feb 2014.
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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.
Lluís Mont, MD study chair
Hospital Clinic Universitary de Barcelona
Elena Arbelo, MD, PhD study director
Hospital Clínic Universitari de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Additional Complex Fractionated Electrograms ablation and Standard atrial fibrillation ablation procedure in people with Atrial Fibrillation and Catheter Ablation, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 inclusion and 19 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 27 Feb 2014. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Freedom from atrial arrhythmias without antiarrhythmic drugs (time frame: 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2014.