RecruitingPhase 4NCT05721170

Impact of Beta Blockers on TAVI (BETA-TAVI)

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

Sponsor

National and Kapodistrian University of Athens

Enrollment

347 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Stenosis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Study population
Eligible patients are adults that whom TAVI is indicated as therapy for severe aortic valve stenosis and will be assigned randomly in a 1:1 ratio to either continue or withdraw the beta-blockers medication. Furthermore, they should satisfy all eligibility criteria (inclusion and exclusion).
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.
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 based on the local Heart Team decision.
Patients receiving beta-blockers as a part of their indicated treatment plan.
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 Criteria11

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.
Echocardiographic evidence of LV or LA thrombus.
The patient that has any contraindication for antithrombotic treatment.
Estimated life expectancy of less than 12 months.
Pregnancy and pre-perimenopause.
nd and 3rd degree atrioventricular (AV) block.
Bradycardia (<50 beats per minute) at the electrocardiogram (ECG) on the screening/baseline visit.
Co-morbidity that excludes or significantly interferes with the follow-up visits.
Enrolment in another study that competes or interferes with this study.