Impact of Beta Blockers on TAVI (BETA-TAVI)

Recruiting now · Phase 4

Conditions studied: Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT05721170

Run by

National and Kapodistrian University of Athens

People needed

347

Starts

2024-06-01

Expected to finish

2028-01-31

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 2nd 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.

Where it is running

• Nicosia General Hospital — Nicosia, Cyprus (enrolling)
• First Department of Cardiology, National and Kapodistrian University of Athens — Athens, Attica, Greece (enrolling)

Full record on ClinicalTrials.gov

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