Aortic StenosisNCT06472934
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
A study testing Transcatheter aortic valve replacement in the absence of B-blocker treatment and Transcatheter aortic valve replacement in people with Aortic Stenosis, run by University Hospital, Basel, Switzerland at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter aortic valve replacement in the absence of B-blocker treatment and Transcatheter aortic valve replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 4 Jul 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
Germany5 sites, 5 recruiting
- Recruiting
University Medical Center Freiburg
Bad Krozingen, 79189
Mirjam Wild, Dr. med., +49 7633 402 4282, mirjam.wild@uniklinik-freiburg.de
Mirjam Wild, Dr. med.
- Recruiting
Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Samuel T Sossalla, Prof. Dr., +49 6032 996-20 00, kardiologie@kerckhoff-klinik.de
Samuel T Sossalla, Prof. Dr.
- Recruiting
Herz- und Diabeteszentrum NRW Universitätsklinik
Bad Oeynhausen, 32545
Tanja Rudolph, Prof. Dr., +49 5731 97-1276, trudolph@hdz-nrw.de
Tanja Rudolph, Prof. Dr.
- Recruiting
Universitätsklinikum Giessen und Marburg GmbH
Giessen, 35392
Samuel T Sossalla, Prof. Dr., +49 641- 985 42101, DirektionMed1@uniklinikum-giessen.de
Samuel T Sossalla, Prof. Dr.
- Recruiting
Universitätsklinikum Schleswig-Holstein AöR
Kiel, 24105
Derk Frank, Prof., +49 431 500-22801, Derk.Frank@uksh.de
Derk Frank, Prof.
Switzerland4 sites, 4 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Nicole Gilgen, Dr. med., +41 61 328 74 23, Nicole.Gilgen@usb.ch
Thomas Nestelberger, PD Dr., +41 61 328 74 74, thomas.nestelberger@usb.ch
- Recruiting
Inselspital, Bern University Hospital
Bern, 3010
Thomas Pilgrim, Prof. Dr.
Thomas Pilgrim, Prof. Dr.
- Recruiting
Geneva University Hospitals
Geneva, 1205
Stéphane Noble, Prof. Dr.
Stéphane Noble, Prof. Dr.
- Recruiting
University Hospital of Zürich
Zurich, 8091
Albert Markus Kasel, Prof. Dr.
Albert Markus Kasel, Prof. Dr.
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Graz
Graz, 8036
Gabor G Toth, Prof., + 43 316 385 81705, gabor.g.toth@medunigraz.at
Gabor G Toth, Prof.
- Recruiting
University Hospital Salzburg
Salzburg, 5020
Matthias Hammerer, Dr. med., +43 57255 25700, M.Hammerer@salk.at
Matthias Hammerer, Dr. med.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter aortic valve replacement in the absence of B-blocker treatment, Transcatheter aortic valve replacement
- Keywords
- Transcatheter Aortic Valve Replacement, Beta-blockers
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacement in the absence of B-blocker treatmentOther
Transcatheter aortic valve replacement (TAVR) is performed in patients that temporarily pause B-blocker treatment.
Transcatheter aortic valve replacementOther
Transcatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pausing group | Experimental | 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. Receives: Other: Transcatheter aortic valve replacement in the absence of B-blocker treatment |
| Control group | Other | Subjects in the control group will keep their B-blocker medication in their prescribed dose during the scheduled TAVR procedure. Receives: Other: Transcatheter aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At 30 days
Secondary outcomes (6)
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.
Measured: At 30 days and 1 year
Stroke Rate
The incidence of stroke is assessed within 30 days and 1 year after TAVR.
Measured: At 30 days and 1 year
All-cause mortality
The all-cause mortality is assessed within 30 days and 1 year after TAVR.
Measured: 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
Measured: 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.
Measured: 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).
Measured: At 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start4 Jul 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Nestelberger, PD Dr., Principal investigator, University Hospital Basel, Department of Cardiology & Cardiovascular Research Institute Basel (CRIB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472934
- Sponsor's protocol ID
- 2024-00728; kt23Nestelberger2
- Status last verified
- Nov 2025
- First submitted
- 13 Jun 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Beta-blocker Administration on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR
- ClinicalTrials.gov ID
- NCT06472934
- Acronym / sponsor ID
- 2024-00728; kt23Nestelberger2
- Conditions
- Aortic Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement, Beta-blockers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pausing group | Experimental | Other: Transcatheter aortic valve replacement in the absence of B-blocker treatmentSubjects 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. |
| Control group | Other | Other: Transcatheter aortic valve replacementSubjects in the control group will keep their B-blocker medication in their prescribed dose during the scheduled TAVR procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve replacement in the absence of B-blocker treatmentTranscatheter aortic valve replacement (TAVR) is performed in patients that temporarily pause B-blocker treatment. | Other | Pausing group |
| Transcatheter aortic valve replacementTranscatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment. | Other | Control group |
Primary outcome
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).
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.
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.
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).
6 secondary outcomes
Permanent pacemaker implantation Rate
Time frame: At 30 days and 1 year
Stroke Rate
Time frame: At 30 days and 1 year
All-cause mortality
Time frame: At 30 days and 1 year
Cardiovascular mortality
Time frame: At 30 days and 1 year
Re-hospitalization due to heart failure
Time frame: At 30 days and 1 year
Severe arrhythmia requiring treatment
Time frame: At 30 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Nestelberger, PD Dr. principal investigator
University Hospital Basel, Department of Cardiology & Cardiovascular Research Institute Basel (CRIB)
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter aortic valve replacement in the absence of B-blocker treatment and Transcatheter aortic valve replacement in people with Aortic Stenosis, run by University Hospital, Basel, Switzerland at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Gilgen, Dr. med. (+41 61 328 74 23, Nicole.Gilgen@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: At 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.