RecruitingNot ApplicableNCT05711186

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


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

140 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 70 Years

Inclusion Criteria3

  • Age ≥ 70 years
  • 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
  • Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision

Exclusion Criteria3

  • Life expectancy <1 year irrespective of valvular heart disease
  • Inability to provide informed consent
  • Participation in another clinical trial with an active intervention

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Interventions

OTHERStructured 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

OTHERUsual 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

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NCT05711186


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