Insel Group AG, University Hospital Bern
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.
Aortic Valve Stenosis
Symptomatic Aortic Stenosis
Structured SDM
Usual Care
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 140 participants |
Masking : | Single |
Primary Purpose : | Supportive Care |
Official Title : | Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial |
Actual Study Start Date : | April 17, 2023 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | May 30, 2026 |
Arm | Intervention/treatment |
---|---|
Other: Structured SDM Structured shared decision making for the choice between SAVR and TAVR |
Other: Structured SDM |
Other: Usual Care Usual care for the choice between SAVR and TAVR |
Other: Usual Care |
Ages Eligible for Study: | 70 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Bern University Hospital, Dep. of Cardiology
Bern, Switzerland, 3010