Improving decision-making for patients with 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 effectiveness of a structured shared decision-making approach for patients with symptomatic severe aortic stenosis who are considering either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The trial aims to enhance patient-centered outcomes by integrating patient values and preferences into the treatment decision process. It is a randomized, open-label, single-center trial involving 140 patients referred for treatment. The study compares the structured decision-making approach against usual care to determine its impact on patient satisfaction and treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 70 years
2. Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area \<0.6cm2/m2
3. Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision

Exclusion Criteria:

1. Life expectancy \<1 year irrespective of valvular heart disease
2. Inability to provide informed consent
3. Participation in another clinical trial with an active intervention

Where it's running

• Bern University Hospital, Dep. of Cardiology
  Bern, Switzerland Recruiting
• Spitalzentrum Biel
  Biel, Switzerland Recruiting

Study contacts

• Principal investigator: Thomas Pilgrim, Prof. — Department of Cardiology, University Hospital Bern, Inselspital, Bern
• Study coordinator: Thomas Pilgrim, Prof.
• Email: thomas.pilgrim@insel.ch
• Phone: +41 31 632 50 00

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.