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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Other: Transcatheter aortic valve replacement in the absence of B-blocker treatment; Other: Transcatheter aortic valve replacement

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 498
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Gilgen, Dr. med.; Phone Number: +41 61 328 74 23; Email: Nicole.Gilgen@usb.ch
• Study Contact Backup: Name: Thomas Nestelberger, PD Dr.; Phone Number: +41 61 328 74 74; Email: thomas.nestelberger@usb.ch

Study Locations

• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Medical University of Graz
    • Contact: Gabor G Toth, Prof.; Phone Number: + 43 316 385 81705; Email: gabor.g.toth@medunigraz.at
    • Principal Investigator: Gabor G Toth, Prof.
  • Salzburg, Austria, 5020
    • Recruiting
    • University Hospital Salzburg
    • Contact: Matthias Hammerer, Dr. med.; Phone Number: +43 57255 25700; Email: M.Hammerer@salk.at
    • Principal Investigator: Matthias Hammerer, Dr. med.
• Germany
  • Bad Krozingen, Germany, 79189
    • Recruiting
    • University Medical Center Freiburg
    • Contact: Mirjam Wild, Dr. med.; Phone Number: +49 7633 402 4282; Email: mirjam.wild@uniklinik-freiburg.de
    • Principal Investigator: Mirjam Wild, Dr. med.
  • Bad Nauheim, Germany, 61231
    • Recruiting
    • Kerckhoff-Klinik GmbH
    • Contact: Samuel T Sossalla, Prof. Dr.; Phone Number: +49 6032 996-20 00; Email: kardiologie@kerckhoff-klinik.de
    • Principal Investigator: Samuel T Sossalla, Prof. Dr.
  • Bad Oeynhausen, Germany, 32545
    • Recruiting
    • Herz- und Diabeteszentrum NRW Universitätsklinik
    • Principal Investigator: Tanja Rudolph, Prof. Dr.
    • Contact: Tanja Rudolph, Prof. Dr.; Phone Number: +49 5731 97-1276; Email: trudolph@hdz-nrw.de
  • Giessen, Germany, 35392
    • Recruiting
    • Universitätsklinikum Gießen und Marburg GmbH
    • Principal Investigator: Samuel T Sossalla, Prof. Dr.
    • Contact: Samuel T Sossalla, Prof. Dr.; Phone Number: +49 641- 985 42101; Email: DirektionMed1@uniklinikum-giessen.de
  • Kiel, Germany, 24105
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein AöR
    • Contact: Derk Frank, Prof.; Phone Number: +49 431 500-22801; Email: Derk.Frank@uksh.de
    • Principal Investigator: Derk Frank, Prof.
• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Nicole Gilgen, Dr. med.; Phone Number: +41 61 328 74 23; Email: Nicole.Gilgen@usb.ch
    • Contact: Thomas Nestelberger, PD Dr.; Phone Number: +41 61 328 74 74; Email: thomas.nestelberger@usb.ch
    • Principal Investigator: Thomas Nestelberger, PD Dr.
    • Sub-Investigator: Patrick Badertscher, Pd Dr.
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Bern University Hospital
    • Contact: Thomas Pilgrim, Prof. Dr.
    • Principal Investigator: Thomas Pilgrim, Prof. Dr.
  • Geneva, Switzerland, 1205
    • Recruiting
    • Geneva University Hospitals
    • Contact: Stéphane Noble, Prof. Dr.
    • Principal Investigator: Stéphane Noble, Prof. Dr.
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital of Zürich
    • Contact: Albert Markus Kasel, Prof. Dr.
    • Principal Investigator: Albert Markus Kasel, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pausing group; Subjects in the pausing group will stop their B-blocker medication 72h before the scheduled transcatheter aortic valve replacement (TAVR) procedure. Post-procedural B-blocker therapy will be resumed 72h after the procedure using the same type and dosage as prescribed before.	Other: Transcatheter 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.
Other: Control group; Subjects in the control group will keep their B-blocker medication in their prescribed dose during the scheduled TAVR procedure.	Other: Transcatheter aortic valve replacement; Transcatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	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).	At 30 days
Re-hospitalization due to heart failure	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.	At 30 days
Stroke Rate	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.	At 30 days
Severe arrhythmia requiring treatment	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).	At 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Permanent pacemaker implantation Rate	To analyse the efficacy of B-blocker discontinuation, the incidence of permanent pacemaker implantation is assessed within 30 days and 1 year after TAVR.	At 30 days and 1 year
Stroke Rate	The incidence of stroke is assessed within 30 days and 1 year after TAVR.	At 30 days and 1 year
All-cause mortality	The all-cause mortality is assessed within 30 days and 1 year after TAVR.	At 30 days and 1 year
Cardiovascular mortality	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	At 30 days and 1 year
Re-hospitalization due to heart failure	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.	At 30 days and 1 year
Severe arrhythmia requiring treatment	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).	At 30 days and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health economic assessment	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.	At 30 days and 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Thomas Nestelberger, PD Dr., University Hospital Basel, Department of Cardiology & Cardiovascular Research Institute Basel (CRIB)

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Beta-blockers; Transcatheter Aortic Valve Replacement
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: 2024-00728; kt23Nestelberger2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No