Impact of Beta Blockers on TAVI (BETA-TAVI)

This is a prospective, multicentre, investigator-initiated, randomized clinical trial clinical trial investigating the impact of beta-blockers administration among patients undergoing TAVI for severe aortic valve stenosis. Adults already receiving beta-blockers be assigned randomly in 1:1 ratio to either continue or withdraw the beta-blockers medication at least 72 hours before and at least 7 days after TAVI. The primary endpoint is permanent pacemaker implantation rates in 7 days after the procedure. Secondary endpoints include death, cardiogenic shock and arrhythmias/conduction abmormalities with time frame 12 months.

Inclusion Criteria:Adults ≥18 years old.Patient with severe symptomatic aortic stenosis defined by mean aortic gradient > 40 mmHg or/and peak jet velocity > 4.0 m/s or/and aortic valve area (AVA) < 1cm2 or/and AVA indexed to body surface area (BSA) of <0.6 cm2/m2Patient is symptomatic (heart failure with New York Heart Association (NYHA) Functional Class ≥II.Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of at least a cardiologist and surgeon.Patients with anatomic characteristics suitable for TAVI.Patients receiving beta-blockers as a part of the indicated treatment plan for the valvulopathy itself or co-morbidities.Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.Patient has given written consent to participate in the trial.Exclusion Criteria:A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, bivalirudin, clopidogrel, titanium, nickel, cobaltium, chromium, contrast media.Patients with permanent pacemaker or defibrillator.Ongoing infection, including active endocarditis.Patients with prosthetic aortic valve.Echocardiographic evidence of LV or LA thrombus.The patient that has any contraindication for antithrombotic treatment.Patient that denies blood transfusion.Estimated life expectancy of less than 12 months.Pregnancy.2nd and 3rd degree atrioventricular (AV) block.Bradycardia (<55 beats per minute).Any other condition witch, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he/she is enrolled in the study.Co-morbidity that excludes follow-up.Enrolment in another study that competes or interferes with this study.