Atrial fibrillation Circulatory System Atrial fibrillation
Conditions
Interventions
Participants are randomly allocated into two treatment groups:
Group 1: Participants in the first group are given antiaarhythmic drugs + catheter ablation (pulmonary vein ablation, right isthmus abla
Sponsors
Casa di Cura San Michele
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 80 years 2. History of paroxysmal (1 or more episodes of AF a month in the last 12 months, each lasting more than 60 min but less than 7 days, with all episodes terminating spontaneously) or persistent (2 or more episodes of AF in the last 12 months , each lasting more than 7 days before being terminated medically) atrial fibrillation first diagnosed at least 6 months before enrollment 3. Intolerant of antiarrhythmic drugs or in whom 2 or more antiarrhythmic drug regimens had failed
Exclusion criteria
Exclusion criteria: 1. Permanent atrial fibrillation (atrial fibrillation was the sole rhythm for the last 12 months) 2. Atrial fibrillation secondary to a transient or correctable abnormality, including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy 3. Persistence of atrial fibrillation episodes triggered by another uniform arrhythmia (i.e. atrial flutter or atrial tachycardia) despite previous supraventricular tachycardia ablation 4. Intra-atrial thrombus, tumour, or other abnormality precluding catheter insertion 5. Wolff–Parkinson–White syndrome 6. Heart failure with NYHA class III or IV or left ventricular ejection fraction 60 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of sinus rhythm at follow-up, measured with transtelephonic ECG for the first 3 months, with 24 hour Holter monitoring for the first 12 months, and with 12-lead ECG for 144 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative survival, measured as whether a patient is alive at 144 months follow-up (+/- 3 months). | — |
Countries
Italy
Outcome results
None listed