DSMB recommendation; enrollment too slow

The purpose of the study is to demonstrate that in patients of 70 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to prevent recurrence of AF.

Atrial fibrillation (AF) is the most common arrhythmia. The prevalence of AF is highly age dependent as 70% of AF patients is between 65 and 85 years old. With increasing life expectancy, AF prevalence will increase 2,5 times during the next 50 years and constitute an even more important health concern. In younger patients Pulmonary vein ablation is an accepted procedure with superior efficacy compared to medical treatment. In this study the safety and efficacy of PVI in patients over 70 years old will be evaluated.

Inclusion Criteria:

• Age ≥ 65 years at moment of screening, able to sign informed consent.
• Documented paroxysmal AF in association with complaints in the last year, with at least 2 episodes of complaints attributed to AF in the previous 2 months.
• Paroxysmal AF documented with at least one ECG with sinus rhythm not after cardioversion in the last year.
• No prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total.

Exclusion Criteria:

• EF < 35 % or description of "poor left ventricular function" on echocardiogram. Measurement should not be older than 6 months at moment of screening.
• Aortic, mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade >3)
• Acute illness: unstable angina, infectious disease.
• Primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome, long QT syndrome.
• Reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia).
• Previous ablation.
• Contraindications for amiodarone; liver dysfunction (serum alanine aminotransferase >2.5 times upper limit); thyroid dysfunction; chronic lung disease; baseline QTc >460 ms. sinus node dysfunction (pause more than 3 seconds in sinus rhythm); second or third degree AV-block.
• Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamin K antagonists.
• Any myocardial infarction or PCI in previous 6 months.
• CABG in previous 6 months.
• Renal dysfunction: creatinine clearance <45 ml/min
• Severe co-morbidity. Life expectancy less than 1 year.
• Thrombus in left atrium
• Untreatable allergy to contrast media