💬In plain words
What the trial is, and whether it could suit you
The BETA-TAVI trial is a prospective, investigator-initiated, multicenter, randomized, open-label, non-inferiority trial designed to evaluate the safety of continuing versus temporarily interrupting chronic beta-blocker therapy in patients undergoing transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis.
A total of 348 patients receiving chronic oral beta-blocker therapy will be randomized in a 1:1 ratio to either continuation of their prescribed beta-blocker from at least 72 hours before TAVI through 7 days after the procedure or temporary interruption of beta-blocker therapy during the same period. Treatment modifications will be permitted when clinically indicated.
The primary objective is to determine whether beta-blocker continuation is non-inferior to interruption regarding the incidence of new permanent pacemaker implantation within 7 days after T
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📋 Eligibility rules (as published)
Study population
Eligibility Adults scheduled to undergo TAVI for severe symptomatic aortic stenosis are eligible when they are receiving chronic oral beta-blocker therapy and satisfy all inclusion criteria without meeting any exclusion criterion.
Inclusion criteria Age 18 years or older. Severe symptomatic aortic stenosis, defined by one or more of the following: mean transvalvular gradient \>=40 mmHg, peak aortic-jet velocity \>=4.0 m/s, aortic-valve area \<=1.0 cm2, or indexed aorticvalve area \<=0.6 cm2/m2. Clinical and anatomical suitability for TAVI confirmed by the local multidisciplinary Heart Team.
Current oral beta-blocker treatment for a recognized clinical indication. Ability and willingness to comply with the assigned treatment strategy and follow-up schedule.
Written informed consent before any trial-specific procedure.
Exclusion criteria Existing permanent pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization device. Second-degree Mobitz II, advanced second-degree or third-degree atrioventricular block at screening, unless a permanent device is already clinically indicated independently of the trial.
Resting heart rate below 50 beats/min at the screening or baseline electrocardiogram.
A clinical condition requiring mandatory beta-blocker continuation or mandatory withdrawal such that randomization would be unsafe or inappropriate. Active infection, including active infective endocarditis. Left-atrial or left-ventricular thrombus on imaging. Contraindication to the antithrombotic regimen required for TAVI. Known hypersensitivity to required procedural drugs, contrast media or device components that cannot be adequately managed. Estimated life expectancy below 12 months because of non-cardiac disease. Pregnancy or potential for pregnancy without reliable contraception. Comorbidity or social circumstance expected to prevent reliable assessment of the 7-day primary endpoint or scheduled follow-up. Participation in another interventional study that is considered likely to interfere with the assigned treatment or endpoint assessment.
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