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Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation (SARA)

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ClinicalTrials.gov Identifier: NCT00863213
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : April 26, 2013
Sponsor:
Collaborators:
Medtronic
Fundacio Clinic Barcelona
Biosense Webster, Inc.
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Atrial fibrillation ablation Drug: Antiarrhythmic drug Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Study Start Date : March 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Atrial Fibrillation Ablation Procedure: Atrial fibrillation ablation

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.
Active Comparator: Drug therapy Drug: Antiarrhythmic drug
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.


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. [ Time Frame: 1-year follow-up ]

Secondary Outcome Measures :
  1. Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs. [ Time Frame: 1-year follow-up ]
  2. Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences. [ Time Frame: 1-year follow-up ]
  3. Decrease in atrial fibrillation/atrial flutter related hospital admissions [ Time Frame: 1-year follow-up ]
  4. Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL. [ Time Frame: 1-year follow-up ]
  5. Change in need of cardioversions [ Time Frame: From 3rd to 12th months ]
  6. Need of atrio-ventricular node ablation [ Time Frame: 1-year follow-up ]
  7. Need of crossover to the other arm of the study (only when primary end point has been reached) [ Time Frame: 1-year follow-up ]
  8. Need of a new intervention or ablation during blanking period [ Time Frame: Until 3rd month ]
  9. Detection of asymptomatic episodes by Reveal XT [ Time Frame: 1-year follow-up ]
  10. Presence of any complications in the acute phase or during follow-up [ Time Frame: 1-year follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)

Exclusion Criteria:

  • 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%
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863213


Locations
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Spain
Hospital de Cruces
Bilbao, Bizkaia, Spain
Hospital Clinic Universitari
Barcelona, Spain, 08036
Hospital de Sant Pau
Barcelona, Spain
Clínica Puerta de Hierro
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
Medtronic
Fundacio Clinic Barcelona
Biosense Webster, Inc.
Investigators
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Study Chair: Lluís Mont, MD Hospital Clinic of Barcelona
Study Director: Angel Arenal, MD Hospital Gregorio Marañon
Study Director: Julian Villacastin, MD Hospital San Carlos, Madrid
Study Director: Josep Brugada, prof Md. PHD Hospital Clinic of Barcelona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Josep Lluis Mont Girbau, MD Phd, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00863213    
Other Study ID Numbers: SARA-08
EudraCT: 2008-006095-30
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013
Keywords provided by Josep Lluis Mont Girbau, Hospital Clinic of Barcelona:
Catheter Ablation, Radiofrequency
Atrial fibrillation
Antiarrhythmic Drugs
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents