Landiolol for Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Inclusion Criteria:

1. Male or female patients ≥ 18 years old
2. Written informed consent from patient
3. Patients are in sinus rhythm
4. Oral Betablocker in the patients long-term medication
5. One of the following cardiac surgical procedures which is planned on cardiopulmonarybypass (CPB):
6. Single valve surgery
7. Single or multiple CABG procedures
8. Single valve surgery in combination with one or multiple coronary artery bypassgrafts (CABGs)
9. Multiple valve surgery in combination with or without CABG
10. Single or multiple valve surgery in combination with ascending aorta procedurewith or without additional CABG
11. Re-surgery of aortic valve, mitral valve, aortic arch or ascending aorta with orwithout CABG
12. Cardiac surgery is performed electively

Exclusion Criteria:

1. Bodyweight > 101kg and/or BMI ≥ 40
2. Cardiac surgery is planned as minimally invasive procedure (e.g., without thoracotomyor with lateral incision, minimal thoracotomy) or planned as off-pump surgery
3. Planned maze procedure, radiofrequency ablation, pulmonary vein ablation, resection ofthe atrial appendix or atrial resections during the surgery
4. Sinus bradycardia (resting heart rate < 50/min) at screening and before start of IMPtreatment
5. Second- or third-degree atrioventricular block at screening and before start of IMPtreatment
6. Clinical hypothyroidism or hyperthyroidism at screening
7. History of ventricular arrhythmia
8. Permanent atrial fibrillation or atrial fibrillation at time of screening and IMPadministration
9. Emergency cardiac surgery
10. Requiring inotropic, vasopressor or requiring ventilatory support at time of screening
11. Circulatory shock requiring mechanical circulatory support before initiation of studymedication
12. Distributive shock (cardiac index>2.2 L/min with norepinephrine dose > 0.3 µg/kg/minto reach mean arterial pressure > 65mmHg) before initiation of study medication
13. More than 5 units of RBC necessary to maintain a haemoglobin level >8mg/dl at the endof surgery
14. Prior cardiac surgery within the past 6 months
15. History of heart transplantation or planned heart transplantation
16. Any other disease or condition that is likely to interfere with the evaluation of thestudy drug, outcome assessment or satisfactory conduct of the study:
17. Active infective endocarditis
18. Stroke or transient ischemic attack (TIA) within the last 6 months
19. Concomitant disease with a life expectancy of less than 6 months
20. Cardiopulmonary resuscitation within the last 4 weeks
21. Patients requiring renal replacement therapy
22. Active infection on current systemic antibiotics and/ or temperature greater than 38°Cat time of screening and before start of surgery
23. Haemoglobin < 5 mmol/l (< 8.06 g/dl)
24. Any systemic anti-cancer therapy within past 3 months
25. Patients with known hypersensitivity to any constituent of the IMP
26. General exclusion criteria:
27. Pregnant (in women of childbearing potential a urine or blood pregnancy test hasto be performed) or breast-feeding women. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practiceappropriate contraceptive measures (e.g., implanon, injections, oralcontraceptives, intrauterine devices, partner with vasectomy, abstinence) whileparticipating in the trial
28. Participation in any interventional clinical trial within the last one-monthprior randomization in this clinicaltrial (screening failures can be rescreened,if appropriate)
29. Alcohol, drug, or medication abuse
30. Employee at the study site, spouse/partner or relative of any study staff (e.g.,investigator, subinvestigators, or study nurse) or relationship to the sponsor