Aortic Valve StenosisTOGETHERNCT05711186
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
A study testing Structured SDM in people with Aortic Valve Stenosis and Symptomatic Aortic Stenosis, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Symptomatic Aortic Stenosis
- What is being tested?
- Structured SDM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 17 Apr 2023to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 join
- Life expectancy <1 year irrespective of valvular heart disease
- Inability to provide informed consent
- Participation in another clinical trial with an active intervention
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Bern University Hospital, Dep. of Cardiology
Bern, 3010
Thomas Pilgrim, Prof., +41 31 632 50 00, thomas.pilgrim@insel.ch
Thomas Pilgrim, Prof.
- Recruiting
Spitalzentrum Biel
Biel, 2501
Rainer Zbinden, Prof, +41 32 324 48 77, rainer.zbinden@szb-chb.ch
About this study
Official title: Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial
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
- Aortic Valve Stenosis, Symptomatic Aortic Stenosis
- Being tested
- Structured SDM, Usual Care
- Keywords
- Symptomatic Aortic Stenosis, Aortic Valve Stenosis, SAVR (Surgical Aortic Valve Replacement), Shared Decision-Making, TAVR (Transcatheter Aortic Valve Replacement), TAVI (Transcatheter Aortic Valve Implantation), Decision Support Techniques
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured SDMOther
The conversation between the heart team member and the patient will be structured according the adapted three-talk model for patients with symptomatic aortic stenosis and using the American College of Cardiology's decision aid for patients deciding between TAVR and SAVR
Usual CareOther
Usual care will include baseline visits without a structured SDM approach. Usual care includes at least one decision making talk with a heart team member discussing information about the disease, treatment options as well as benefits and risks of each procedure.
| Study group | Role | What they receive |
|---|---|---|
| Structured SDM | Other | Structured shared decision making for the choice between SAVR and TAVR Receives: Other: Structured SDM |
| Usual Care | Other | Usual care for the choice between SAVR and TAVR Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient decisional conflict
Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Measured: 3 days post baseline visit
Patient decisional regret
Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Measured: 30 days post TAVR/SAVR
Secondary outcomes (11)
Patient-centered communication
Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome)
Measured: 3 days post baseline visit
Patient knowledge about the treatment options and outcomes
Assessed by 6 multiple-choice items (ranges from 0 to 6, with higher scores indicating a better outcome)
Measured: 3 days post baseline visit
Patient procedural satisfaction
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Measured: 3 days post baseline visit
Patient decisional satisfaction
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Measured: 3 days post baseline visit; 30 days and 1 year post TAVR/SAVR
Incorporation of patient values
Assessed by values clarity subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Measured: 3 days post baseline visit
Patient feeling of not being informed
Assessed by informed subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Measured: 3 days post baseline visit
Quality of choice
Assessed by effective decision subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Measured: 3 days post baseline visit
Patient decisional regret
Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Measured: 1 year post TAVR/SAVR
Patient health-related quality of life
Assessed by KCCQ 12 (Kansas City Cardiomyopathy Questionnaire) (ranges from 0 to 100, with higher scores indicating a better outcome)
Measured: 30 days post TAVR/SAVR
The proportion of patients choosing TAVR/SAVR
Number of participants choosing valve replacement by TAVR or SAVR
Measured: Baseline
The incidences of major clinical adverse events
All-cause mortality, stroke, transient ischemic attack, bleeding event, kidney injury, systemic embolism, myocardial infarction, new onset atrial fibrillation, permanent pacemaker implantation and intervention related to the device
Measured: 30 days and 1 year post TAVR/SAVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start17 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Pilgrim, Prof., Principal investigator, Department of Cardiology, University Hospital Bern, Inselspital, BernChristoph Ryffel, Dr. med., Principal investigator, Department of Cardiology, University Hospital Bern, Inselspital, Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711186
- Sponsor's protocol ID
- TOGETHER (2022-01691)
- Acronym
- TOGETHER
- Status last verified
- May 2026
- First submitted
- 24 Jan 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No