Actively Recruiting
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-08
140
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality. The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR. TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.
CONDITIONS
Official Title
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older
- Symptomatic severe aortic stenosis with an aortic valve area of 1.0 cm2 or less, or an aortic valve area indexed to body surface area less than 0.6 cm2/m2
- Both surgical and transfemoral transcatheter aortic valve replacement considered reasonable treatment options by heart team
You will not qualify if you...
- Life expectancy less than 1 year regardless of valvular heart disease
- Unable to provide informed consent
- Currently participating in another clinical trial with an active intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bern University Hospital, Dep. of Cardiology
Bern, Switzerland, 3010
Actively Recruiting
Research Team
T
Thomas Pilgrim, Prof.
CONTACT
C
Christoph Ryffel, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here