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NCT05711186 | Recruiting | Aortic Valve Stenosis


Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Sponsor:

Insel Group AG, University Hospital Bern

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.

Condition or disease

Aortic Valve Stenosis

Symptomatic Aortic Stenosis

Intervention/treatment

Structured SDM

Usual Care

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 140 participants
Masking : Single
Primary Purpose : Supportive Care
Official Title : Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial
Actual Study Start Date : April 17, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : May 30, 2026
Arm Intervention/treatment

Other: Structured SDM

Structured shared decision making for the choice between SAVR and TAVR

Other: Structured SDM

Other: Usual Care

Usual care for the choice between SAVR and TAVR

Other: Usual Care

Ages Eligible for Study: 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • Life expectancy <1 year irrespective of valvular heart disease
  • Inability to provide informed consent
  • Participation in another clinical trial with an active intervention

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Location Details


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Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Switzerland,

Bern University Hospital, Dep. of Cardiology

Bern, Switzerland, 3010

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