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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
140
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
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.
Bern University Hospital, Dep. of Cardiology
Bern, Switzerland
RECRUITINGPatient decisional conflict
Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 3 days post baseline visit
Patient decisional regret
Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 30 days post TAVR/SAVR
Patient-centered communication
Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome)
Time frame: 3 days post baseline visit
Patient knowledge about the treatment options and outcomes
Assessed by 6 multiple-choice items (ranges from 0 to 6, with higher scores indicating a better outcome)
Time frame: 3 days post baseline visit
Patient procedural satisfaction
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Time frame: 3 days post baseline visit
Patient decisional satisfaction
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Time frame: 3 days post baseline visit; 30 days and 1 year post TAVR/SAVR
Incorporation of patient values
Assessed by values clarity subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 3 days post baseline visit
Patient feeling of not being informed
Assessed by informed subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 3 days post baseline visit
Quality of choice
Assessed by effective decision subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 3 days post baseline visit
Patient decisional regret
Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 1 year post TAVR/SAVR
Patient health-related quality of life
Assessed by KCCQ 12 (Kansas City Cardiomyopathy Questionnaire) (ranges from 0 to 100, with higher scores indicating a better outcome)
Time frame: 30 days post TAVR/SAVR
The proportion of patients choosing TAVR/SAVR
Number of participants choosing valve replacement by TAVR or SAVR
Time frame: Baseline
The incidences of major clinical adverse events
All-cause mortality, stroke, transient ischemic attack, bleeding event, kidney injury, systemic embolism, myocardial infarction, new onset atrial fibrillation, permanent pacemaker implantation and intervention related to the device
Time frame: 30 days and 1 year post TAVR/SAVR
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