Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorInsel Gruppe AG, University Hospital Bern

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Life expectancy <1 year irrespective of valvular heart disease

Inability to provide informed consent

Participation in another clinical trial with an active intervention

Trial design

Treatments tested in this trial

  • Structured SDM
  • Usual Care

Treatment groups

140 Participants
are divided into 2 treatment groups

Locations

1
Bern University Hospital, Dep. of Cardiology3010, Bern Switzerland

Sponsors and collaborators

Insel Gruppe AG, University Hospital Bern

Lead sponsor