Condition: Aortic Valve Stenosis · Symptomatic Aortic Stenosis · Sponsor: Insel Gruppe 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.
This description comes directly from the study's public registry record.
Thomas Pilgrim, Prof. · +41 31 632 50 00 · thomas.pilgrim@insel.ch
Christoph Ryffel, Dr. med. · +41 31 632 50 00 · christoph.ryffel@insel.ch
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| Bern University Hospital, Dep. of Cardiology | Bern, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05711186