Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

NCT05711186 | Recruiting DMC

• 1 other identifier: TOGETHER (2022-01691)
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Patient-centered communication

  3 days post baseline visit

• Patient knowledge about the treatment options and outcomes

  3 days post baseline visit

• Patient procedural satisfaction

  3 days post baseline visit

• Patient decisional satisfaction

  3 days post baseline visit; 30 days and 1 year post TAVR/SAVR

• Incorporation of patient values

  3 days post baseline visit

Study Arms (2)

Structured SDM

OTHER

Structured shared decision making for the choice between SAVR and TAVR

Other: Structured SDM

Usual Care

OTHER

Usual care for the choice between SAVR and TAVR

Other: Usual Care

Interventions

Structured SDM OTHER

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

Structured SDM

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years
• 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
• Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision

You may not qualify if:

• Life expectancy \<1 year irrespective of valvular heart disease
• Inability to provide informed consent
• Participation in another clinical trial with an active intervention

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital, Dep. of Cardiology

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Pilgrim, Prof.

CONTACT

+41 31 632 50 00; thomas.pilgrim@insel.ch

Christoph Ryffel, Dr. med.

CONTACT

+41 31 632 50 00; christoph.ryffel@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: April 17, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): May 30, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)