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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Bern University Hospital, Dep. of Cardiology
RECRUITING
Bern
Contact Information
Primary
Thomas Pilgrim, Prof.
thomas.pilgrim@insel.ch
+41 31 632 50 00
Backup
Christoph Ryffel, Dr. med.
christoph.ryffel@insel.ch
+41 31 632 50 00
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 140
Treatments
Other: Structured SDM
Structured shared decision making for the choice between SAVR and TAVR
Other: Usual Care
Usual care for the choice between SAVR and TAVR
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov