Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 24, 2023

Keywords

ClinConnect Summary

The TOGETHER trial is designed to help patients with severe aortic stenosis, a condition where the heart's aortic valve narrows, decide between two treatment options: surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). Both treatments are effective, but they have different advantages and recovery times. This study will explore whether a structured approach to shared decision-making, which means helping patients understand their choices and preferences, can lead to better outcomes for those making this decision.

To participate in this trial, you need to be at least 70 years old and have been diagnosed with symptomatic severe aortic stenosis, which means you have noticeable symptoms and your heart valve is significantly narrowed. You'll also need to be considered for both SAVR and TAVR based on your heart team's recommendation. If you join the trial, you will be randomly assigned to either receive the structured decision-making support or the usual care that patients typically get. This study is currently recruiting participants, and your involvement could help improve how patients make important treatment decisions in the future.

Gender

ALL

Eligibility criteria

• 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