Atrial FibrillationPhase 4SARANCT00863213
Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
A Phase 4 study testing Atrial fibrillation ablation and Antiarrhythmic drug in people with Atrial Fibrillation, run by Hospital Clinic of Barcelona at 8 sites in Spain.
Trial summary
The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial fibrillation ablation and Antiarrhythmic drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 8 sitesSpain
- Study dates
- Mar 2009to Dec 2012
- Phase
- Phase 4
- 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 atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
Who cannot join
- Hypo or hyperthyroidism
- Persistent atrial fibrillation lasting more than 1 year or non-defined duration
- 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
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital Clinic Universitari
Barcelona, Barcelona, 08036
Hospital de Sant Pau
Barcelona, Barcelona
Hospital de Cruces
Bilbao, Bizkaia
Clínica Puerta de Hierro
Madrid, Madrid
Hospital 12 de Octubre
Madrid, Madrid
Hospital Clínico San Carlos
Madrid, Madrid
Hospital Gregorio Marañon
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
About this study
The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial fibrillation ablation, Antiarrhythmic drug
- Keywords
- Catheter Ablation, Radiofrequency, Atrial fibrillation, Antiarrhythmic Drugs
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationProcedure or surgery
Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used.
It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested.
Antiarrhythmic drugDrug
Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation Ablation | Experimental | Not described Receives: Procedure: Atrial fibrillation ablation |
| Drug therapy | Active comparator | Not described Receives: Drug: Antiarrhythmic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
Measured: 1-year follow-up
Secondary outcomes (10)
Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.
Measured: 1-year follow-up
Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.
Measured: 1-year follow-up
Decrease in atrial fibrillation/atrial flutter related hospital admissions
Measured: 1-year follow-up
Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.
Measured: 1-year follow-up
Change in need of cardioversions
Measured: From 3rd to 12th months
Need of atrio-ventricular node ablation
Measured: 1-year follow-up
Need of crossover to the other arm of the study (only when primary end point has been reached)
Measured: 1-year follow-up
Need of a new intervention or ablation during blanking period
Measured: Until 3rd month
Detection of asymptomatic episodes by Reveal XT
Measured: 1-year follow-up
Presence of any complications in the acute phase or during follow-up
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 posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionDec 2012
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Fundacio Clinic Barcelona, Biosense Webster, Inc.
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
- Investigators
- Lluís Mont, MD, Study chair, Hospital Clinic of BarcelonaAngel Arenal, MD, Study director, Hospital Gregorio MarañonJulian Villacastin, MD, Study director, Hospital San Carlos, MadridJosep Brugada, prof Md. PHD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863213
- Sponsor's protocol ID
- SARA-08
- Other IDs
- EudraCT: 2008-006095-30
- Acronym
- SARA
- Status last verified
- Apr 2013
- First submitted
- 16 Mar 2009
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mont L, Bisbal F, Hernandez-Madrid A, Perez-Castellano N, Vinolas X, Arenal A, Arribas F, Fernandez-Lozano I, Bodegas A, Cobos A, Matia R, Perez-Villacastin J, Guerra JM, Avila P, Lopez-Gil M, Castro V, Arana JI, Brugada J; SARA investigators. Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J. 2014 Feb;35(8):501-7. doi: 10.1093/eurheartj/eht457. Epub 2013 Oct 17.
PubMed 24135832
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00863213
- Acronym / sponsor ID
- SARA / SARA-08
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter Ablation, Radiofrequency, Atrial fibrillation, Antiarrhythmic Drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Medtronic, Fundacio Clinic Barcelona, Biosense Webster, Inc.
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Mar 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 compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation Ablation | Experimental | Procedure: Atrial fibrillation ablation |
| Drug therapy | Active comparator | Drug: Antiarrhythmic drug |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
Key exclusion criteria (19 listed)
- Hypo or hyperthyroidism
- Persistent atrial fibrillation lasting more than 1 year or non-defined duration
- 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 |
|---|---|---|
| Atrial fibrillation ablationAtrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used. It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested. | Procedure or surgery | Atrial Fibrillation Ablation |
| Antiarrhythmic drugUsual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases. | Drug | Drug therapy |
Primary outcome
Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
Time frame: 1-year follow-up
10 secondary outcomes
Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.
Time frame: 1-year follow-up
Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.
Time frame: 1-year follow-up
Decrease in atrial fibrillation/atrial flutter related hospital admissions
Time frame: 1-year follow-up
Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.
Time frame: 1-year follow-up
Change in need of cardioversions
Time frame: From 3rd to 12th months
Need of atrio-ventricular node ablation
Time frame: 1-year follow-up
Need of crossover to the other arm of the study (only when primary end point has been reached)
Time frame: 1-year follow-up
Need of a new intervention or ablation during blanking period
Time frame: Until 3rd month
Detection of asymptomatic episodes by Reveal XT
Time frame: 1-year follow-up
Presence of any complications in the acute phase or during follow-up
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 26 Apr 2013.
- Derived from this study: PubMed 24135832Mont L, Bisbal F, Hernandez-Madrid A, Perez-Castellano N, Vinolas X, Arenal A, Arribas F, Fernandez-Lozano I, Bodegas A, Cobos A, Matia R, Perez-Villacastin J, Guerra JM, Avila P, Lopez-Gil M, Castro V, Arana JI, Brugada J; SARA investigators. Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J. 2014 Feb;35(8):501-7. doi: 10.1093/eurheartj/eht457. Epub 2013 Oct 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.
Lluís Mont, MD study chair
Hospital Clinic of Barcelona
Angel Arenal, MD study director
Hospital Gregorio Marañon
Julian Villacastin, MD study director
Hospital San Carlos, Madrid
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atrial fibrillation ablation and Antiarrhythmic drug in people with Atrial Fibrillation, run by Hospital Clinic of Barcelona at 8 sites 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 1 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 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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, lasting more than 24 hours or requiring cardioversion. (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?
On the ClinicalTrials.gov record for NCT00863213, 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 26 Apr 2013.