Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
SARA
2 other identifiers
interventional
152
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 atrial-fibrillation
Started Mar 2009
Typical duration for phase_4 atrial-fibrillation
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 26, 2013
April 1, 2013
2 years
March 16, 2009
April 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
1-year follow-up
Secondary Outcomes (10)
Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.
1-year follow-up
Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.
1-year follow-up
Decrease in atrial fibrillation/atrial flutter related hospital admissions
1-year follow-up
Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.
1-year follow-up
Change in need of cardioversions
From 3rd to 12th months
- +5 more secondary outcomes
Study Arms (2)
Atrial Fibrillation Ablation
EXPERIMENTALDrug therapy
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- Medtroniccollaborator
- Fundacio Clinic Barcelonacollaborator
- Biosense Webster, Inc.collaborator
Study Sites (8)
Hospital Clinic Universitari
Barcelona, Barcelona, 08036, Spain
Hospital de Sant Pau
Barcelona, Barcelona, Spain
Hospital de Cruces
Bilbao, Bizkaia, Spain
Clínica Puerta de Hierro
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Gregorio Marañon
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Related Publications (1)
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.
PMID: 24135832DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Phd
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 17, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2011
Study Completion
December 1, 2012
Last Updated
April 26, 2013
Record last verified: 2013-04