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

NCT06472934 | Recruiting DMC

• 1 other identifier: 2024-00728; kt23Nestelberger2
• Study Type: interventional
• Target: 498
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Aortic Stenosis

Keywords

Transcatheter Aortic Valve Replacement; Beta-blockers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Permanent pacemaker implantation Rate

  At 30 days and 1 year

• Stroke Rate

  At 30 days and 1 year

• All-cause mortality

  At 30 days and 1 year

• Cardiovascular mortality

  At 30 days and 1 year

• Re-hospitalization due to heart failure

  At 30 days and 1 year

Other Outcomes (1)

• Health economic assessment

  At 30 days and 1 year

Study Arms (2)

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.

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.

Other: Transcatheter aortic valve replacement

Interventions

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.

Pausing group

Transcatheter aortic valve replacement OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (11)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

University Hospital Salzburg

Salzburg, 5020, Austria

RECRUITING

University Medical Center Freiburg

Bad Krozingen, 79189, Germany

RECRUITING

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

RECRUITING

Herz- und Diabeteszentrum NRW Universitätsklinik

Bad Oeynhausen, 32545, Germany

RECRUITING

Universitätsklinikum Giessen und Marburg GmbH

Giessen, 35392, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein AöR

Kiel, 24105, Germany

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

University Hospital of Zürich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Thomas Nestelberger, PD Dr.

  University Hospital Basel, Department of Cardiology & Cardiovascular Research Institute Basel (CRIB)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Gilgen, Dr. med.

CONTACT

+41 61 328 74 23; Nicole.Gilgen@usb.ch

Thomas Nestelberger, PD Dr.

CONTACT

+41 61 328 74 74; thomas.nestelberger@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 25, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

DE (5); AU (2); CH (4)