Structured Shared Decision Making for Patients Undergoing SAVR or TAVR (TOGETHER)

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

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 Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Symptomatic Aortic Stenosis
• Intervention / Treatment: Other: Structured SDM; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Pilgrim, Prof.; Phone Number: +41 31 632 50 00; Email: thomas.pilgrim@insel.ch
• Study Contact Backup: Name: Christoph Ryffel, Dr. med.; Phone Number: +41 31 632 50 00; Email: christoph.ryffel@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Bern University Hospital, Dep. of Cardiology
    • Sub-Investigator: Jonas Lanz, PD
    • Principal Investigator: Thomas Pilgrim, Prof.
    • Contact: Thomas Pilgrim, Prof.; Phone Number: +41 31 632 50 00; Email: thomas.pilgrim@insel.ch
    • Principal Investigator: Christoph Ryffel, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Structured SDM; Structured shared decision making for the choice between SAVR and TAVR	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
Other: Usual Care; Usual care for the choice between SAVR and TAVR	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients choosing TAVR/SAVR	Number of participants choosing valve replacement by TAVR or SAVR	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	30 days and 1 year post TAVR/SAVR
Patient-centered communication	Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome)	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)	3 days post baseline visit
Patient procedural satisfaction	Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)	3 days post baseline visit
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Thomas Pilgrim, Prof., Department of Cardiology, University Hospital Bern, Inselspital, Bern; Principal Investigator: Christoph Ryffel, Dr. med., Department of Cardiology, University Hospital Bern, Inselspital, Bern

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; Shared Decision-Making; Decision Support Techniques; TAVI (Transcatheter Aortic Valve Implantation); Symptomatic Aortic Stenosis; SAVR (Surgical Aortic Valve Replacement); TAVR (Transcatheter Aortic Valve Replacement)
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: TOGETHER (2022-01691)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No