Effects of beta blockers on patients undergoing TAVI for aortic valve stenosis

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 clinical trial investigates the impact of continuing or withdrawing beta-blocker medication in adults undergoing transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis. Participants will be randomly assigned to either continue or stop their beta-blocker treatment at least 72 hours before and 7 days after the procedure. The primary focus is on the rates of permanent pacemaker implantation within 7 days post-TAVI, while secondary outcomes include mortality, cardiogenic shock, and arrhythmias over a 12-month period. The study aims to clarify the role of beta-blockers in patients with severe valvulopathy undergoing TAVI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Severe symptomatic aortic stenosis (mean gradient ≥40 mmHg, peak velocity ≥4.0 m/s, aortic valve area ≤1.0 cm², or indexed valve area ≤0.6 cm²/m²)
* Clinical and anatomical suitability for TAVI confirmed by the Heart Team
* Current oral beta-blocker therapy for an established clinical indication
* Ability and willingness to comply with the assigned treatment strategy and follow-up
* Written informed consent

Exclusion Criteria:

* Pre-existing permanent pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization device
* Second-degree Mobitz II, advanced second-degree, or third-degree atrioventricular block at screening
* Resting heart rate \<50 beats/min
* Clinical condition requiring mandatory continuation or discontinuation of beta-blocker therapy
* Active infection, including infective endocarditis
* Left atrial or ventricular thrombus
* Contraindication to antithrombotic therapy required for TAVI
* Unmanageable hypersensitivity to procedural medications, contrast media, or device components
* Life expectancy \<12 months due to non-cardiac disease
* Pregnancy or potential for pregnancy without reliable contraception
* Comorbidity or social circumstances preventing reliable endpoint assessment or follow-up
* Participation in another interventional trial that could interfere with study treatment or outcomes

Where it's running

• Nicosia General Hospital
  Nicosia, Cyprus Recruiting
• First Department of Cardiology, National and Kapodistrian University of Athens
  Athens, Attica, Greece Recruiting

Study contacts

• Principal investigator: Leonidas Koliastasis, MD, MSc — National and Kapodistrian University of Athens
• Study coordinator: Leonidas Koliastasis, MD, MSc, PhD
• Email: lkoliastasis@gmail.com
• Phone: 6974270752

Similar studies

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

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

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.