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Structured shared decision making for people choosing between two aortic valve replacement types

Tests a structured decision approach in people with severe aortic stenosis choosing valve replacement.

Key facts

Who runs it
Insel Gruppe AG, University Hospital Bern
Where
Bern and Biel, SwitzerlandSee the 2 sites
Trial code
Registry title
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Status
Recruiting
People taking part
140 people, planned
Started
17 Apr 2023
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Structured SDM
  • Usual Care
Record updated
16 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 70 or older with severe aortic stenosis that causes symptoms. Their heart team must judge both open-heart valve surgery (SAVR) and valve replacement through a leg artery (TAVR) as reasonable options. The trial compares a structured shared decision process with usual care.

Age
70 years or older
Sex
All sexes
Disease stage
Symptomatic severe aortic stenosis: aortic valve area ≤1.0 cm2, or valve area indexed to body surface area <0.6cm2/m2.

Main reasons for not taking part

  • Expected to live less than 1 year, from any cause
  • Unable to give informed consent
  • Taking part in another clinical trial with an active intervention

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Age ≥ 70 years
  • 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
  • Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision

Who cannot take part

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

Where in Switzerland

  • Bern University Hospital, Dep. of CardiologyBern, SwitzerlandContact: Thomas Pilgrim, Prof.Taking people
  • Spitalzentrum BielBiel, SwitzerlandContact: Rainer Zbinden, ProfTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Structured SDMOther group

    Structured shared decision making for the choice between SAVR and TAVR

  • Usual CareOther group

    Usual care for the choice between SAVR and TAVR

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial
Plain-language title
Structured shared decision making for people choosing between two aortic valve replacement typesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
16 September 2026