Overview

Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborators:
Biosense Webster, Inc.
Fundacio Clinic
Fundacio Clinic Barcelona
Medtronic
Treatments:
Anti-Arrhythmia Agents
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