Clinical trial NCT00863213: Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Official title: Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Catheter Ablation, Radiofrequency
Atrial fibrillation
Antiarrhythmic Drugs
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Fundacio Clinic Barcelona
name: Biosense Webster, Inc.
First posted: 2009-03-17
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
timeFrame: 1-year follow-up
Secondary outcomes:
measure: Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.
timeFrame: 1-year follow-up
measure: Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.
timeFrame: 1-year follow-up
measure: Decrease in atrial fibrillation/atrial flutter related hospital admissions
timeFrame: 1-year follow-up
measure: Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.
timeFrame: 1-year follow-up
measure: Change in need of cardioversions
timeFrame: From 3rd to 12th months
measure: Need of atrio-ventricular node ablation
timeFrame: 1-year follow-up
measure: Need of crossover to the other arm of the study (only when primary end point has been reached)
timeFrame: 1-year follow-up
measure: Need of a new intervention or ablation during blanking period
timeFrame: Until 3rd month
measure: Detection of asymptomatic episodes by Reveal XT
timeFrame: 1-year follow-up
measure: Presence of any complications in the acute phase or during follow-up
timeFrame: 1-year follow-up
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital de Cruces
state: Bizkaia
city: Barcelona
country: Spain
facility: Hospital Clinic Universitari
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Madrid
country: Spain
facility: Clínica Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Lluís Mont, MD
role: STUDY_CHAIR
affiliation: Hospital Gregorio Marañon
name: Angel Arenal, MD
role: STUDY_DIRECTOR
affiliation: Hospital San Carlos, Madrid
name: Julian Villacastin, MD
role: STUDY_DIRECTOR
affiliation: Hospital Clinic of Barcelona
name: Josep Brugada, prof Md. PHD
role: STUDY_DIRECTOR
References:
citation: 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.