Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter aortic valve replacement in the absence of B-blocker treatment: Transcatheter aortic valve replacement (TAVR) is performed in patients that temporarily pause B-blocker treatment.

Transcatheter aortic valve replacement: Transcatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment.

Study summary

This is a multi-centric, open-label, randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement.

Eligibility

Primary outcome measure(s)

• All-cause mortality — At 30 days
  To analyse the safety of B-blocker discontinuation, the all-cause mortality, as part of a composite endpoint, is assessed within 30 days after transcatheter aortic valve replacement (TAVR).
• Re-hospitalization due to heart failure — At 30 days
  To analyse the safety of B-blocker discontinuation, the incidence of re-hospitalization due to heart failure, as part of a composite endpoint, is assessed within 30 days after TAVR. Re-hospitalization due to heart failure is defined as an admission occurring after the index hospitalization or study enrollment, where new or worsening heart failure is the primary reason for a hospital stay exceeding 24 hours. This determination is based on symptoms and signs of heart failure, confirmed by diagnostic tests, and requires treatment with intravenous or mechanical heart failure therapies. This includes both primary (cardiac-related) and secondary (non-cardiac-related) causes.
• Stroke Rate — At 30 days
  To analyse the safety of B-blocker discontinuation, the incidence of stroke, as part of a composite endpoint, is assessed within 30 days after TAVR.
• Severe arrhythmia requiring treatment — At 30 days
  To analyse the safety of B-blocker discontinuation, the incidence of severe arrhythmia that requires treatment, as part of a composite endpoint, is assessed within 30 days after TAVR. Severe arrhythmia requiring treatment are e.g. new onset atrial fibrillation/flutter, ventricular tachycardia/ventricular fibrillation, new atrioventricular block (AB, first-, second- or third-degree), new left bundle branch block, new right bundle branch block, new severe bradycardia or tachycardia (\<40bpm or \>120bpm).

Trial sites (11)

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