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NCT05721170
Impact of Beta Blockers on TAVI (BETA-TAVI)
Conditions: Aortic Valve Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 348
Sponsor: National and Kapodistrian University of Athens
Location: Nicosia General Hospital Nicosia
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* Pre-existing permanent pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization device
* Second-degree Mobitz II, advanced second-degree, or third-degree atrioventricular block at screening
* Resting heart rate \
Source: ClinicalTrials.gov (NCT05721170). StuddyBuddy aggregates publicly available trial information.