RecruitingNot ApplicableNCT06472934

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

498 participants

Start Date

Jul 4, 2024

Study Type

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

Min Age: 18 Years

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

OTHERTranscatheter 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.

OTHERTranscatheter aortic valve replacement

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


Locations(11)

Medical University of Graz

Graz, Austria

University Hospital Salzburg

Salzburg, Austria

University Medical Center Freiburg

Bad Krozingen, Germany

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Herz- und Diabeteszentrum NRW Universitätsklinik

Bad Oeynhausen, Germany

Universitätsklinikum Giessen und Marburg GmbH

Giessen, Germany

Universitätsklinikum Schleswig-Holstein AöR

Kiel, Germany

University Hospital Basel

Basel, Switzerland

Inselspital, Bern University Hospital

Bern, Switzerland

Geneva University Hospitals

Geneva, Switzerland

University Hospital of Zürich

Zurich, Switzerland

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NCT06472934


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