Evaluating the effects of stopping beta-blockers during heart valve replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-centric, open-label, randomized trial investigates the safety and efficacy of temporarily discontinuing beta-blocker treatment in patients undergoing transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis. The study aims to determine whether stopping beta-blockers can reduce the risk of complications, such as the need for a permanent pacemaker, which can arise from the interaction between TAVR and the heart's electrical system. Eligible participants are adults over 18 years old who have been on beta-blocker therapy for at least one month prior to the study. The trial will compare outcomes between patients who continue beta-blocker treatment and those who do not during the TAVR procedure.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of Graz
  Graz, Austria Recruiting
• University Hospital Salzburg
  Salzburg, Austria Recruiting
• University Medical Center Freiburg
  Bad Krozingen, Germany Recruiting
• Kerckhoff-Klinik GmbH
  Bad Nauheim, Germany Recruiting
• Herz- und Diabeteszentrum NRW Universitätsklinik
  Bad Oeynhausen, Germany Recruiting
• Universitätsklinikum Giessen und Marburg GmbH
  Giessen, Germany Recruiting

Study contacts

• Principal investigator: Thomas Nestelberger, PD Dr. — University Hospital Basel, Department of Cardiology & Cardiovascular Research Institute Basel (CRIB)
• Study coordinator: Nicole Gilgen, Dr. med.
• Email: Nicole.Gilgen@usb.ch
• Phone: +41 61 328 74 23

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Exercise and nutrition support before and after TAVI for older adults with aortic stenosis

  This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.

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• Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI

  This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Istanbul · NCT07794436

• Systematic 14-day ambulatory heart monitoring after TAVI

  After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.

  Recruiting Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec · NCT07739316

• Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis

  This study tests an AI-based echocardiography score to help confirm severe aortic stenosis in adults who are also getting CT calcium scoring.

  Recruiting at 4 sites Azienda Ospedaliera "Sant'Andrea" · Bologna and 4 other locations · NCT07620925

• TAVI without on-site heart surgery: can selected centers do it safely?

  This trial tests whether transcatheter aortic valve implantation can be done safely in certain hospitals that don’t have on-site cardiac surgery, for patients with severe aortic stenosis who are appropriately selected.

  Recruiting at 10 sites University Hospital of Ferrara · Andria and 10 other locations · NCT07604402

• Willem AI for early detection of aortic stenosis from a 12‑lead ECG

  This project will test whether the Willem AI can detect aortic stenosis from routine 12‑lead ECGs in adults.

  Recruiting at 2 sites Idoven 1903 S.L. · Bonn and 1 other locations · NCT07479992

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.