Catheter ablation for the cure of atrial fibrillation study
- Conditions
- Atrial fibrillationCirculatory System
- Registration Number
- ISRCTN46898887
- Lead Sponsor
- Casa di Cura San Michele
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 137
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
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 <35%
7. Unstable angina or acute myocardial infarction within 3 months
8. Cardiac revascularization or other cardiac surgery within 6 months or with prior atrial surgery
9. Renal failure requiring dialysis, or hepatic failure
10. An implanted device (pacemaker or cardioverter-defibrillator)
11. Left atrial diameter >60 mm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cumulative survival, measured as whether a patient is alive at 144 months follow-up (+/- 3 months).