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NCT Number: NCT06472934

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

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 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 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

Treatment and study plan

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

Other

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

Transcatheter aortic valve replacement

Other

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

Primary outcomes

  1. All-cause mortality

    Time frame: 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).

  2. Re-hospitalization due to heart failure

    Time frame: 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.

  3. Stroke Rate

    Time frame: 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.

  4. Severe arrhythmia requiring treatment

    Time frame: 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).

Secondary outcomes

  1. Permanent pacemaker implantation Rate

    Time frame: At 30 days and 1 year

    To analyse the efficacy of B-blocker discontinuation, the incidence of permanent pacemaker implantation is assessed within 30 days and 1 year after TAVR.

  2. Stroke Rate

    Time frame: At 30 days and 1 year

    The incidence of stroke is assessed within 30 days and 1 year after TAVR.

  3. All-cause mortality

    Time frame: At 30 days and 1 year

    The all-cause mortality is assessed within 30 days and 1 year after TAVR.

  4. Cardiovascular mortality

    Time frame: At 30 days and 1 year

    The cardiovascular mortality is assessed within 30 days and 1 year after TAVR. It is defined as either:

    • Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis),or other clear cardiovascular cause
    • Intraprocedural death
    • Sudden death
    • Death of unknown cause

  5. Re-hospitalization due to heart failure

    Time frame: At 30 days and 1 year

    The incidence of re-hospitalization due to heart failure, as part of a composite endpoint, is assessed within 30 days and 1 year 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.

  6. Severe arrhythmia requiring treatment

    Time frame: At 30 days and 1 year

    The incidence of severe arrhythmia that requires treatment, as part of a composite endpoint, is assessed within 30 days and 1 year 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).

Other outcomes

  1. Health economic assessment

    Time frame: At 30 days and 1 year

    An assessment of the impact on health economic is performed, which includes information regarding the length of intensive care unit stay, length of hospital stay, rate of pacemaker implantation, and results of the Kansas City Cardiomyopathy quality of life Questionnaire (KCCQ-12) which ranges from 0 to 100 with higher scores indicating better health status and quality of life, while lower scores suggest more severe symptoms and poorer quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Gilgen, Dr. med.

CONTACT

[email protected]

+41 61 328 74 23

Thomas Nestelberger, PD Dr.

CONTACT

[email protected]

+41 61 328 74 74

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2024
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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