Pulmonary Vein Isolation vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With AF

Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. It was shown, that catheter ablation failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up. It was also shown, that these episodes will become more asymptomatic. This raises concerns that the symptomatic improvement might be the result of a placebo effect, which will be elucidated with this study.

Inclusion Criteria: 1. Patients with symptomatic atrial fibrillation scheduled for pulmonary vein isolation 2. Class I or class IIa indication for pulmonary vein isolation by current guidelines 3. Age ≥ 18 years 4. Written informed consent Exclusion Criteria: 1. History of previous pulmonary vein isolation or surgical treatment of atrial fibrillation 2. Reversible causes of atrial fibrillation (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection) 3. Moderate or severe valvular heart disease 4. CHA2DS2-VASc-Score =0 (males) or 1 (females) or contraindication to oral anticoagulation 5. Acute coronary syndrome, percutaneous coronary intervention, valve surgery or percutaneous intervention or cardiac bypass surgery and stroke within the last 3 months 6. Reduced left ventricular ejection fraction \< 35% 7. Hypertrophic obstructive cardiomyopathy 8. Medical conditions limiting the expected survival to \< 1 year 9. Participation in any other randomized controlled trial 10. Women of childbearing potential without appropriate contraceptive measures (oral contraceptives, vaginal ring, intrauterine devices, implanon, injections, partner with vasectomy) pregnant woman or woman with desire for children 11. Any condition that - in the opinion of the investigator - may prevent the subject from adhering to the study protocol (e.g. history of non-compliance, drug addiction) 12. Subjects under legal supervision or guardianship 13. Unable to give informed consent