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

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT06472934

Run by

University Hospital, Basel, Switzerland

People needed

498

Starts

2024-07-04

Expected to finish

2028-05-01

Last updated by the study team

2025-11-28

Who can join

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

You may qualify if…

• Informed Consent must be signed by the subject prior to any study intervention.
• Adult patients (> 18 years) with severe symptomatic aortic stenosis eligible and scheduled for elective TAVR and are able to give consentand are able to give consent
• Indication for B-blocker therapy with a prior treatment duration of at least 1 month before inclusion.

You may not qualify if…

• Emergency or urgent indication for TAVR.
• Hemodynamically unstable patients receiving inotropic medication.
• Prior permanent pacemaker implantation.
• Existing indication for pacemaker implantation.
• Hemodynamic relevant left ventricular outflow tract obstruction.
• Prior intolerance of B-blocker medication.
• Life expectancy < 1 year.
• Known or suspected non-compliance, drug, or alcohol abuse.
• Inability to give consent, or follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Being in a dependent relationship with the trial site
• Participation in another study with investigational drug within the 30 days preceding and during the present study.
• Previous enrolment into the current study.
• Pregnancy or breast feeding women

Where it is running

• Medical University of Graz — Graz, Austria (enrolling)
• University Hospital Salzburg — Salzburg, Austria (enrolling)
• University Medical Center Freiburg — Bad Krozingen, Germany (enrolling)
• Kerckhoff-Klinik GmbH — Bad Nauheim, Germany (enrolling)
• Herz- und Diabeteszentrum NRW Universitätsklinik — Bad Oeynhausen, Germany (enrolling)
• Universitätsklinikum Giessen und Marburg GmbH — Giessen, Germany (enrolling)
• Universitätsklinikum Schleswig-Holstein AöR — Kiel, Germany (enrolling)
• University Hospital Basel — Basel, Switzerland (enrolling)
• Inselspital, Bern University Hospital — Bern, Switzerland (enrolling)
• Geneva University Hospitals — Geneva, Switzerland (enrolling)
• University Hospital of Zürich — Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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