Impact of Beta-blocker Administration on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
University Hospital Salzburg
RECRUITING
Salzburg
Germany
University Medical Center Freiburg
RECRUITING
Bad Krozingen
Kerckhoff-Klinik GmbH
RECRUITING
Bad Nauheim
Herz- und Diabeteszentrum NRW Universitätsklinik
RECRUITING
Bad Oeynhausen
Universitätsklinikum Giessen und Marburg GmbH
RECRUITING
Giessen
Universitätsklinikum Schleswig-Holstein AöR
RECRUITING
Kiel
Switzerland
University Hospital Basel
RECRUITING
Basel
Inselspital, Bern University Hospital
RECRUITING
Bern
Geneva University Hospitals
RECRUITING
Geneva
University Hospital of Zürich
RECRUITING
Zurich
Contact Information
Primary
Nicole Gilgen, Dr. med.
Nicole.Gilgen@usb.ch
+41 61 328 74 23
Backup
Thomas Nestelberger, PD Dr.
thomas.nestelberger@usb.ch
+41 61 328 74 74
Time Frame
Start Date: 2024-07-04
Estimated Completion Date: 2028-05
Participants
Target number of participants: 498
Treatments
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: Control group
Subjects in the control group will keep their B-blocker medication in their prescribed dose during the scheduled TAVR procedure.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland