Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
Impact of Beta-blocker Administration on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR
University Hospital, Basel, Switzerland
498 participants
Jul 4, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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.
Exclusion Criteria13
- 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
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Interventions
Transcatheter aortic valve replacement (TAVR) is performed in patients that temporarily pause B-blocker treatment.
Transcatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment.
Locations(11)
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NCT06472934