Impact of Beta-blockers Among Patients Undergoing TAVI: a Randomized Multicenter Trial

BETA-TAVI Trial

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.

2024-03-01

2025-01-30

2025-01-31

Not yet recruiting

Early phase I

347

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/m2 * Patient 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible patients will be assigned randomly in 1:1 ratio to either continue or withdraw the already receiving beta-blockers medication', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 347, 'type': 'ESTIMATED'}}

2023-12-27