Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Aortic Valve Stenosis Clinical Trial

— TOGETHER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711186
• Other study ID #: TOGETHER (2022-01691)
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Thomas Pilgrim, Prof.
• Phone: +41 31 632 50 00
• Email: thomas.pilgrim[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 30, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Symptomatic Aortic Stenosis

Intervention

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
• 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.

Locations

Country	Name	City	State
Switzerland	Bern University Hospital, Dep. of Cardiology	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient decisional conflict	Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)	3 days post baseline visit
Primary	Patient decisional regret	Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)	30 days post TAVR/SAVR
Secondary	Patient-centered communication	Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome)	3 days post baseline visit
Secondary	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)	3 days post baseline visit
Secondary	Patient procedural satisfaction	Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)	3 days post baseline visit
Secondary	Patient decisional satisfaction	Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)	3 days post baseline visit; 30 days and 1 year post TAVR/SAVR
Secondary	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)	3 days post baseline visit
Secondary	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)	3 days post baseline visit
Secondary	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)	3 days post baseline visit
Secondary	Patient decisional regret	Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)	1 year post TAVR/SAVR
Secondary	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)	30 days post TAVR/SAVR
Secondary	The proportion of patients choosing TAVR/SAVR	Number of participants choosing valve replacement by TAVR or SAVR	Baseline
Secondary	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	30 days and 1 year post TAVR/SAVR