NCT Number: NCT05711186
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.
Interested in participating?
Request Info70 year and older
All sexes
Interventional
Not applicable
Bern, 3010, Switzerland
Location status: Recruiting
Christoph Ryffel, Dr. med.
PRINCIPAL_INVESTIGATOR
Jonas Lanz, PD
SUB_INVESTIGATOR
Thomas Pilgrim, Prof.
CONTACT
Thomas Pilgrim, Prof.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 days post baseline visit
Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 30 days post TAVR/SAVR
Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Time frame: 3 days post baseline visit
Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome)
Time frame: 3 days post baseline visit
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
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
Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 year post TAVR/SAVR
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
Assessed by KCCQ 12 (Kansas City Cardiomyopathy Questionnaire) (ranges from 0 to 100, with higher scores indicating a better outcome)
Time frame: Baseline
Number of participants choosing valve replacement by TAVR or SAVR
Time frame: 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
Contact information is provided by the study sponsor or research team.
Christoph Ryffel, Dr. med.
CONTACT
Thomas Pilgrim, Prof.
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial
Acronym: TOGETHER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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