NCT05711186 Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
| NCT ID | NCT05711186 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-04-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2023-04-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Contact & Investigator
Thomas Pilgrim, Prof.
PRINCIPAL INVESTIGATOR
Department of Cardiology, University Hospital Bern, Inselspital, Bern
Frequently Asked Questions
Who can join the NCT05711186 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05711186 currently recruiting?
Yes, NCT05711186 is actively recruiting participants. Contact the research team at thomas.pilgrim@insel.ch for enrollment information.
Where is the NCT05711186 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT05711186 clinical trial?
NCT05711186 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Thomas Pilgrim, Prof. at Department of Cardiology, University Hospital Bern, Inselspital, Bern. The trial plans to enroll 140 participants.