Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting 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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05721170). StuddyBuddy aggregates publicly available trial information.