Status:
COMPLETED
Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Medtronic
Fundacio Clinic Barcelona
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 fibrilla...
Eligibility Criteria
Inclusion
- Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00863213
Start Date
March 1 2009
End Date
December 1 2012
Last Update
April 26 2013
Active Locations (8)
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1
Hospital Clinic Universitari
Barcelona, Barcelona, Spain, 08036
2
Hospital de Sant Pau
Barcelona, Barcelona, Spain
3
Hospital de Cruces
Bilbao, Bizkaia, Spain
4
Clínica Puerta de Hierro
Madrid, Madrid, Spain