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Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Study acronym: TOGETHER
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 1 to 2
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 5 of 11 entries
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study completion date: May 30, 2026 to Dec 31, 2027
    v6
  3. 2 versions Re-verified since May 22, 2024, no change to tracked fieldsv4-v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2023 to Apr 17, 2023
    • Site details revised
    v3
  5. Secondary endpoints: details revised at 9 of 11 entries
    • Site contact updated
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05711186
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Conditions
(from sponsor)		 Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Related terms Aortic Valve Stenosis
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov