Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Conditions
Keywords
Symptomatic Aortic Stenosis, Aortic Valve Stenosis, SAVR (Surgical Aortic Valve Replacement), Shared Decision-Making, TAVR (Transcatheter Aortic Valve Replacement), TAVI (Transcatheter Aortic Valve Implantation), Decision Support Techniques
Brief 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.
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.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient decisional conflict | 3 days post baseline visit | Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome) |
| Patient decisional regret | 30 days post TAVR/SAVR | Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-centered communication | 3 days post baseline visit | Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome) |
| Patient knowledge about the treatment options and outcomes | 3 days post baseline visit | Assessed by 6 multiple-choice items (ranges from 0 to 6, with higher scores indicating a better outcome) |
| Patient procedural satisfaction | 3 days post baseline visit | Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome) |
| Patient decisional satisfaction | 3 days post baseline visit; 30 days and 1 year post TAVR/SAVR | Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome) |
| Incorporation of patient values | 3 days post baseline visit | Assessed by values clarity subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome) |
| Patient feeling of not being informed | 3 days post baseline visit | Assessed by informed subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome) |
| Quality of choice | 3 days post baseline visit | Assessed by effective decision subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome) |
| Patient decisional regret | 1 year post TAVR/SAVR | Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome) |
| Patient health-related quality of life | 30 days post TAVR/SAVR | Assessed by KCCQ 12 (Kansas City Cardiomyopathy Questionnaire) (ranges from 0 to 100, with higher scores indicating a better outcome) |
| The proportion of patients choosing TAVR/SAVR | Baseline | Number of participants choosing valve replacement by TAVR or SAVR |
| The incidences of major clinical adverse events | 30 days and 1 year post TAVR/SAVR | 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 |
Countries
Switzerland
Contacts
CONTACTThomas Pilgrim, Prof.
CONTACTChristoph Ryffel, Dr. med.
PRINCIPAL_INVESTIGATORThomas Pilgrim, Prof.
Department of Cardiology, University Hospital Bern, Inselspital, Bern
PRINCIPAL_INVESTIGATORChristoph Ryffel, Dr. med.
Department of Cardiology, University Hospital Bern, Inselspital, Bern
Outcome results
None listed