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RECRUITINGINTERVENTIONAL

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 1. Life expectancy \<1 year irrespective of valvular heart disease 2. Inability to provide willing to sign a consent form 3. Participation in another clinical trial with an active intervention Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Structured SDM

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

OTHER

Usual Care

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.

Locations (1)

Bern University Hospital, Dep. of Cardiology
Bern, Switzerland