Clinical trial NCT05711186: Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Official title: Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Symptomatic Aortic Stenosis
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
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 140
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient decisional conflict
timeFrame: 3 days post baseline visit
measure: Patient decisional regret
timeFrame: 30 days post TAVR/SAVR
Secondary outcomes:
measure: Patient-centered communication
timeFrame: 3 days post baseline visit
measure: Patient knowledge about the treatment options and outcomes
timeFrame: 3 days post baseline visit
measure: Patient procedural satisfaction
timeFrame: 3 days post baseline visit
measure: Patient decisional satisfaction
timeFrame: 3 days post baseline visit; 30 days and 1 year post TAVR/SAVR
measure: Incorporation of patient values
timeFrame: 3 days post baseline visit
measure: Patient feeling of not being informed
timeFrame: 3 days post baseline visit
measure: Quality of choice
timeFrame: 3 days post baseline visit
measure: Patient decisional regret
timeFrame: 1 year post TAVR/SAVR
measure: Patient health-related quality of life
timeFrame: 30 days post TAVR/SAVR
measure: The proportion of patients choosing TAVR/SAVR
timeFrame: Baseline
measure: The incidences of major clinical adverse events
timeFrame: 30 days and 1 year post TAVR/SAVR
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital, Dep. of Cardiology
Study officials:
affiliation: Department of Cardiology, University Hospital Bern, Inselspital, Bern
name: Thomas Pilgrim, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, University Hospital Bern, Inselspital, Bern
name: Christoph Ryffel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: