Gap-AF

Study design

Randomized trial to investigate the significance of complete versus incomplete electrical isolation of pulmonary veins by radiofrequency-induced linear lesions in patients with paroxysmal atrial fibrillation

Inclusion Criteria

Idiopathic paroxysmal symptomatic atrial fibrillation refractory to antiarrhythmic therapy

Age 50 – 85 years

Patient willing to participate in randomized trial and an invasive follow-up at month 3 (-6)

Structural normal heart

Patient willing and able to participate in 12 months follow-up period

ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) for at least one AF event in the prior year (related to symptomatic or asymptomatic episodes) with an average number of one episode per month

Written informed consent of the patient

Exclusion Criteria

Patients who have had previous pulmonary vein ablation procedures Patients with atrial fibrillation secondary to a reversible cause

Known presence of intracardiac or other thrombi

Evidence of obstructive lung disease requiring bronchodilator therapy

Pregnant females or those of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment.

Other medical illness (i.e. cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)

History of bleeding diathesis or suspected pro-coagulant state contraindication to anticoagulation therapy