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

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Aortic Valve Stenosis; Symptomatic Aortic Stenosis

Treatments: Other: Structured SDM; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05711186

TOGETHER (2022-01691)

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups

Structured SDM

Other group

Description:

Structured shared decision making for the choice between SAVR and TAVR

Treatment:

Other: Structured SDM

Usual Care

Other group

Description:

Usual care for the choice between SAVR and TAVR

Treatment:

Other: Usual Care