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Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

RecruitingNAAges 70 Years - anyAllInsel Gruppe AG, University Hospital Bern
NCT05711186 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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
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What it tests

  • Structured SDM
  • Usual Care
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Where

2 sites
Bern University Hospital, Dep. of Cardiology
Bern, Switzerland
Spitalzentrum Biel
Biel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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