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

Hospital Clinic of Barcelona

Status and phase

Completed

Phase 4

Conditions

Atrial Fibrillation

Treatments

Drug: Antiarrhythmic drug

Procedure: Atrial fibrillation ablation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00863213

SARA-08

EudraCT: 2008-006095-30

Details and patient eligibility

About

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.

Enrollment

152 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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