Impact of Beta Blockers on TAVI (BETA-TAVI)
Key facts
- Where
- Athens, GreeceSee the site
- Phase
- Phase 4
Where in Greece
- First Department of Cardiology, National and Kapodistrian University of AthensAthens, GreeceContact: Konstantinos Toutouzas, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- National and Kapodistrian University of Athens
- Trial code
- NCT05721170
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
Impact of Beta-blocker Continuation Versus Interruption in Patients Undergoing Transcatheter Aortic Valve Implantation
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 TAVI, using an absolute non-inferiority margin of 6.5 percentage points.
Secondary outcomes include atrioventricular conduction disturbances, atrial and ventricular arrhythmias, hemodynamic deterioration, subsequent permanent pacemaker implantation, and all-cause and cardiovascular mortality. Clinical follow-up will be performed at discharge, 7 days, 30 days, and 12 months after TAVI.
Inclusion: Age ≥18 years; Severe symptomatic aortic stenosis (mean gradient ≥40 mmHg, peak velocity ≥4.0 m/s, aortic valve area ≤1.0 cm², or indexed valve area ≤0.6 cm²/m²); Clinical and anatomical suitability for TAVI confirmed by the Heart Team; Current oral beta-blocker therapy for an established clinical indication; Ability and willingness to comply with the assigned treatment strategy and follow-up; Written informed consent.
Exclusion: Contraindication to antithrombotic therapy required for TAVI; Pre-existing permanent pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization device; Resting heart rate <50 beats/min; Clinical condition requiring mandatory continuation or discontinuation of beta-blocker therapy; Active infection, including infective endocarditis; Unmanageable hypersensitivity to procedural medications, contrast media, or device components; Life expectancy <12 months due to non-cardiac disease; Second-degree Mobitz II, advanced second-degree, or third-degree atrioventricular block at screening; Left atrial or ventricular thrombus; Pregnancy or potential for pregnancy without reliable contraception; Comorbidity or social circumstances preventing reliable endpoint assessment or follow-up; Participation in another interventional trial that could interfere with study treatment or outcomes.