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Recruiting NCT05711186

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

No phase Interventional Aortic Valve Stenosis Symptomatic Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Structured SDM, Usual Care.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis, Symptomatic Aortic Stenosis. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Patient decisional conflict [Time frame: 3 days post baseline visit]
  • Patient decisional regret [Time frame: 30 days post TAVR/SAVR]
Secondary outcome measures (11)
  • Patient-centered communication [Time frame: 3 days post baseline visit]
  • Patient knowledge about the treatment options and outcomes [Time frame: 3 days post baseline visit]
  • Patient procedural satisfaction [Time frame: 3 days post baseline visit]
  • Patient decisional satisfaction [Time frame: 3 days post baseline visit; 30 days and 1 year post TAVR/SAVR]
  • Incorporation of patient values [Time frame: 3 days post baseline visit]
  • Patient feeling of not being informed [Time frame: 3 days post baseline visit]
  • Quality of choice [Time frame: 3 days post baseline visit]
  • Patient decisional regret [Time frame: 1 year post TAVR/SAVR]
  • Patient health-related quality of life [Time frame: 30 days post TAVR/SAVR]
  • The proportion of patients choosing TAVR/SAVR [Time frame: Baseline]
  • The incidences of major clinical adverse events [Time frame: 30 days and 1 year post TAVR/SAVR]

Eligibility criteria

Inclusion criteria

  • 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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Switzerland · 1 center
  • Bern University Hospital, Dep. of Cardiology — Bern

Identifiers

NCT: NCT05711186 · TOGETHER (2022-01691)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗