Impact of Beta Blockers on TAVI (BETA-TAVI)

• Status: Not yet recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National and Kapodistrian University of Athens
• Treatments: Adrenergic beta-Antagonists

Criteria

Inclusion Criteria:

• 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

• Patient is symptomatic (heart failure with New York Heart Association (NYHA) Functional Class ≥II.

• 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.

• Patients receiving beta-blockers as a part of the indicated treatment plan for the valvulopathy itself or co-morbidities.

• 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 Criteria:

• 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.

• Patients with prosthetic aortic valve.

• Echocardiographic evidence of LV or LA thrombus.

• The patient that has any contraindication for antithrombotic treatment.

• Patient that denies blood transfusion.

• Estimated life expectancy of less than 12 months.

• Pregnancy.

• 2nd and 3rd degree atrioventricular (AV) block.

• Bradycardia (<55 beats per minute).

• Any other condition witch, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he/she is enrolled in the study.

• Co-morbidity that excludes follow-up.

• Enrolment in another study that competes or interferes with this study.