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

Last updated: November 21, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Heart Defect

Treatment

Transcatheter aortic valve replacement

Transcatheter aortic valve replacement in the absence of B-blocker treatment

Clinical Study ID

NCT06472934
2024-00728; kt23Nestelberger2
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Informed Consent must be signed by the subject prior to any study intervention.

  • Adult patients (> 18 years) with severe symptomatic aortic stenosis eligible andscheduled 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 monthbefore inclusion.

Exclusion

Exclusion Criteria:

  • 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 tolanguage 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 dayspreceding and during the present study.

  • Previous enrolment into the current study.

  • Pregnancy or breast feeding women

Study Design

Total Participants: 498
Treatment Group(s): 2
Primary Treatment: Transcatheter aortic valve replacement
Phase:
Study Start date:
July 04, 2024
Estimated Completion Date:
May 31, 2028

Study Description

Aortic stenosis (AS) is a common heart valve problem in older adults, affecting about 5% of people over 65. It leads to symptoms like fainting, chest pain, difficulty breathing, and heart failure, which can increase the risk of serious health issues and death.

Transcatheter Aortic Valve Replacement (TAVR) is a well-established treatment for severe AS, especially for patients who are at high risk for traditional open-heart surgery. TAVR is becoming more common and is now being used in younger and lower-risk patients due to its favorable outcomes.

Many people with severe AS also have other heart conditions, and beta-blockers (B-blockers) are commonly used to manage these issues. B-blockers help treat heart failure, irregular heartbeats, high blood pressure, and coronary artery disease. About 34% to 51% of AS patients use B-blockers, but these medications can also cause side effects like slow heart rate and low blood pressure.

The need for a permanent pacemaker is the most common complication after TAVR, occuring in 9% to 26% of patients. This is because TAVR can affect the heart's electrical system. B-blockers might increase the risk of needing a pacemaker because they can further slow down the heart's electrical signals.

To reduce this risk, doctors sometimes stop B-blockers around the time of TAVR. However, this practice lacks support from clinical trials or guidelines, and stopping B-blockers can increase the risk of fast heartbeats and chest pain.

This aim of the clinical trial is to study the impact of B-blocker administration among patients undergoing TAVR. The trial will assess the safety of B-blocker discontinuation (primary endpoint) and by determining the incidence of permanent pacemaker implantation after TAVR (secondary endpoint).

The results of the trial will provide important insights into the optimal management of B-blockers in patients undergoing TAVR, potentially improving patient outcomes and guiding clinical practice.

Connect with a study center

  • Medical University of Graz

    Graz 2778067, 8036
    Austria

    Active - Recruiting

  • University Hospital Salzburg

    Salzburg 2766824, 5020
    Austria

    Active - Recruiting

  • University Medical Center Freiburg

    Bad Krozingen 2953414, 79189
    Germany

    Active - Recruiting

  • Kerckhoff-Klinik GmbH

    Bad Nauheim 2953395, 61231
    Germany

    Active - Recruiting

  • Herz- und Diabeteszentrum NRW Universitätsklinik

    Bad Oeynhausen 2953386, 32545
    Germany

    Active - Recruiting

  • Universitätsklinikum Giessen und Marburg GmbH

    Giessen 2920512, 35392
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein AöR

    Kiel 2891122, 24105
    Germany

    Active - Recruiting

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • University Hospital Basel

    Basel 2661604, 4031
    Switzerland

    Active - Recruiting

  • Inselspital, Bern University Hospital

    Bern, 3010
    Switzerland

    Site Not Available

  • Inselspital, Bern University Hospital

    Bern 2661552, 3010
    Switzerland

    Active - Recruiting

  • Geneva University Hospitals

    Geneva, 1205
    Switzerland

    Site Not Available

  • Geneva University Hospitals

    Geneva 2660646, 1205
    Switzerland

    Active - Recruiting

  • University Hospital of Zürich

    Zurich 2657896, 8091
    Switzerland

    Active - Recruiting

  • University Hospital of Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

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