An interventional study of Structured SDM and Usual Care in Aortic Valve Stenosis and Symptomatic Aortic Stenosis, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 2 sites in Switzerland. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Supportive care
Among 12 studies in Aortic Valve Stenosis by Insel Gruppe AG, University Hospital Bern — 3 open to participants now, 3 under way, none of them phase 3. Aortic Valve Stenosis · Insel Gruppe AG, University Hospital Bern.
Among the 12 studies in Aortic Valve Stenosis by Insel Gruppe AG, University Hospital Bern, this one is the only one that started in 2023, is one of 7 with no phase, and was the 10th registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 140 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →3 of the 12 studies in Aortic Valve Stenosis by Insel Gruppe AG, University Hospital Bern are open now, in 1 country. Each count lists the studies.
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 70 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2023.
Median enrollment 65 across the 8 interventional studies, 100 across the 4 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
1 of the studies in Aortic Valve Stenosis by Insel Gruppe AG, University Hospital Bern that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05711186Insel Gruppe AG, University Hospital BernStructured Shared Decision Making for Patients Undergoing SAVR or TAVR | 2026-12-31 |
Among the 12 studies in Aortic Valve Stenosis by Insel Gruppe AG, University Hospital Bern, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Structured shared decision making for the choice between SAVR and TAVR
Other: Structured SDM
Usual care for the choice between SAVR and TAVR
Other: Usual Care
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 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.
Patient decisional conflict
Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 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)
Time frame: 30 days post TAVR/SAVR
Patient-centered communication
Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome)
Time frame: 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)
Time frame: 3 days post baseline visit
Patient procedural satisfaction
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Time frame: 3 days post baseline visit
Patient decisional satisfaction
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 30 days post TAVR/SAVR
The proportion of patients choosing TAVR/SAVR
Number of participants choosing valve replacement by TAVR or SAVR
Time frame: 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
Time frame: 30 days and 1 year post TAVR/SAVR
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Dec 2026, 44 months after the start.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 44 months is close to that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
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Insel Gruppe AG, University Hospital Bern →