NCT05711186

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2023-04-17
• Primary completion: 2024-12-31
• Completion: 2026-05-30
• First posted: 2023-02-02
• Last updated: 2024-10-30

Locations

1 site across 1 country: Switzerland